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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of PF-04965842 Monotherapy in Subjects Aged 12 Years and Older, With Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    2018-001136-21
    Trial protocol
    BG   HU   CZ   GB   DE   PL   LV  
    Global end of trial date
    13 Aug 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Feb 2020
    First version publication date
    07 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B7451013
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03575871
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of PF-04965842 compared with placebo in subjects aged 12 years and older with moderate to severe AD
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 32
    Country: Number of subjects enrolled
    Bulgaria: 22
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    China: 24
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    Germany: 39
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    Japan: 44
    Country: Number of subjects enrolled
    Korea, Republic of: 35
    Country: Number of subjects enrolled
    Latvia: 12
    Country: Number of subjects enrolled
    Poland: 52
    Country: Number of subjects enrolled
    United Kingdom: 23
    Country: Number of subjects enrolled
    United States: 58
    Worldwide total number of subjects
    391
    EEA total number of subjects
    175
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    40
    Adults (18-64 years)
    332
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects with age greater than or equal to (>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of >=40 kilograms were enrolled in the study. Eligible subjects had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.

    Pre-assignment
    Screening details
    This study was conducted from 29-June-2018 to 13-Aug-2019 at 106 sites in 13 countries.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    PF-04965842 100 mg
    Arm description
    Subjects were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Abrocitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 100 milligram (mg) tablet orally once daily for 12 weeks

    Arm title
    PF-04965842 200 mg
    Arm description
    Subjects were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Abrocitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks.

    Arm title
    Placebo
    Arm description
    Subjects were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks.

    Number of subjects in period 1
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Started
    158
    155
    78
    Completed
    137
    141
    52
    Not completed
    21
    14
    26
         Protocol Deviation
    1
    1
    1
         Other than specified
    2
    2
    -
         Lack of efficacy
    5
    4
    7
         Adverse event, serious fatal
    1
    -
    -
         Adverse event, non-fatal
    5
    5
    8
         Consent withdrawn by subject
    6
    1
    9
         Lost to follow-up
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-04965842 100 mg
    Reporting group description
    Subjects were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Reporting group title
    PF-04965842 200 mg
    Reporting group description
    Subjects were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Reporting group title
    Placebo
    Reporting group description
    Subjects were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Reporting group values
    PF-04965842 100 mg PF-04965842 200 mg Placebo Total
    Number of subjects
    158 155 78 391
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    17 15 8 40
        Adults (18-64 years)
    130 133 69 332
        From 65-84 years
    11 7 1 19
        85 years and over
    0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    37.4 ± 15.8 33.5 ± 14.7 33.4 ± 13.8 -
    Sex: Female, Male
    Units: Subjects
        Female
    64 67 31 162
        Male
    94 88 47 229
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    3 4 2 9
        Not Hispanic or Latino
    154 150 73 377
        Unknown or Not Reported
    1 1 3 5
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    46 54 29 129
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    9 6 6 21
        White
    101 91 40 232
        More than one race
    1 2 1 4
        Unknown or Not Reported
    1 2 2 5

    End points

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    End points reporting groups
    Reporting group title
    PF-04965842 100 mg
    Reporting group description
    Subjects were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Reporting group title
    PF-04965842 200 mg
    Reporting group description
    Subjects were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Reporting group title
    Placebo
    Reporting group description
    Subjects were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Primary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12

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    End point title
    Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12
    End point description
    IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0=clear, no inflammatory signs of AD; 1=almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2=mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3=moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4=severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study drug. Number of Subjects Analysed signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    155
    155
    77
    Units: percentage of subjects
        number (confidence interval 95%)
    28.4 (21.3 to 35.5)
    38.1 (30.4 to 45.7)
    9.1 (2.7 to 15.5)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0008 [1]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    19.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.6
         upper limit
    29
    Notes
    [1] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    28.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.6
         upper limit
    38.8
    Notes
    [2] - P-value was adjusted by randomization strata (baseline disease severity and age category).

    Primary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12

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    End point title
    Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12
    End point description
    EASI evaluates severity of subject's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au (Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al (El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    155
    154
    77
    Units: percentage of subjects
        number (confidence interval 95%)
    44.5 (36.7 to 52.3)
    61.0 (53.3 to 68.7)
    10.4 (3.6 to 17.2)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    33.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.3
         upper limit
    44.4
    Notes
    [3] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    50.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40
         upper limit
    60.9
    Notes
    [4] - P-value was adjusted by randomization strata (baseline disease severity and age category)

    Secondary: Percentage of Subjects who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12

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    End point title
    Percentage of Subjects who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12
    End point description
    Subjects were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analyzed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    156
    153
    76
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2
    23.1 (16.5 to 29.7)
    35.3 (27.7 to 42.9)
    3.9 (0.0 to 8.3)
        Week 4
    31.4 (24.1 to 38.7)
    50.3 (42.4 to 58.2)
    3.9 (0.0 to 8.3)
        Week 8
    39.1 (31.4 to 46.8)
    51.6 (43.7 to 59.6)
    11.8 (4.6 to 19.1)
        Week 12
    39.7 (32.1 to 47.4)
    49.0 (41.1 to 56.9)
    10.5 (3.6 to 17.4)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0002 [5]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    19.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11
         upper limit
    27.4
    Notes
    [5] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    31.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.3
         upper limit
    40.2
    Notes
    [6] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [7]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    27.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.9
         upper limit
    36.2
    Notes
    [7] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    46.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.2
         upper limit
    55.7
    Notes
    [8] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [9]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    27.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.8
         upper limit
    38
    Notes
    [9] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [10]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    39.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.9
         upper limit
    50.6
    Notes
    [10] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [11]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    29.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.9
         upper limit
    39.6
    Notes
    [11] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [12]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    38.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.1
         upper limit
    49.1
    Notes
    [12] - P-value was adjusted by randomization strata (baseline disease severity and age category).

    Secondary: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12

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    End point title
    Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12
    End point description
    PSAAD is a daily subject reported symptom electronic diary. Subjects rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Subject had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    156
    155
    77
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -2.4 (-2.8 to -2.1)
    -3.0 (-3.3 to -2.7)
    -0.8 (-1.3 to -0.3)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    -1.1
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -2.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.8
         upper limit
    -1.6

    Secondary: Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus

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    End point title
    Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus
    End point description
    Subjects were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to Day 15
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    90 [13]
    110 [14]
    20 [15]
    Units: days
        median (inter-quartile range (Q1-Q3))
    58.0 (11.0 to 99999)
    29.0 (8.0 to 87.0)
    112.0 (58.0 to 99999)
    Notes
    [13] - Here, '99999' indicate that upper limit was not evaluable as too few events were observed.
    [14] - Here, '99999' indicate that upper limit was not evaluable as too few events were observed.
    [15] - Here, '99999' indicate that upper limit was not evaluable as too few events were observed.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8

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    End point title
    Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8
    End point description
    EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, "n" signifies subjects evaluable for this endpoint at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4 and 8
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n=157, 152, 76)
    10.2 (5.5 to 14.9)
    24.3 (17.5 to 31.2)
    1.3 (0.0 to 3.9)
        Week 4 (n=155, 153, 77)
    26.5 (19.5 to 33.4)
    51.0 (43.1 to 58.9)
    6.5 (1.0 to 12.0)
        Week 8 (n=157, 154, 78)
    43.3 (35.6 to 51.1)
    60.4 (52.7 to 68.1)
    12.8 (5.4 to 20.2)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.015 [16]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    8.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.8
         upper limit
    14.9
    Notes
    [16] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [17]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    22.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15
         upper limit
    30.3
    Notes
    [17] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0004 [18]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    20
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.9
         upper limit
    29
    Notes
    [18] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [19]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    44.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    34.8
         upper limit
    53.8
    Notes
    [19] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [20]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    30.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    19.7
         upper limit
    41.2
    Notes
    [20] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [21]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    47.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    36.8
         upper limit
    58
    Notes
    [21] - P-value was adjusted by randomization strata (baseline disease severity and age category).

    Secondary: Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 points Improvement From Baseline at Weeks 2, 4 and 8

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    End point title
    Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 points Improvement From Baseline at Weeks 2, 4 and 8
    End point description
    IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and 8
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n=157, 152, 76)
    5.1 (1.7 to 8.5)
    14.5 (8.9 to 20.1)
    0 (0.0 to 4.7)
        Week 4 (n=155, 153, 77)
    14.2 (8.7 to 19.7)
    33.3 (25.9 to 40.8)
    1.3 (0.0 to 3.8)
        Week 8 (n=157, 154, 78)
    22.3 (15.8 to 28.8)
    37.7 (30.0 to 45.3)
    10.3 (3.5 to 17.0)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0459 [22]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    5.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    10
    Notes
    [22] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0005 [23]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    14.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.8
         upper limit
    20.5
    Notes
    [23] - P-value was adjusted by randomization strata (baseline disease severity and age category)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0019 [24]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    12.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.3
         upper limit
    19.4
    Notes
    [24] - P-value was adjusted by randomization strata (baseline disease severity and age category)
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [25]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    31.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.6
         upper limit
    39.9
    Notes
    [25] - P-value was adjusted by randomization strata (baseline disease severity and age category)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0246 [26]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    11.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.4
         upper limit
    21.4
    Notes
    [26] - P-value was adjusted by randomization strata (baseline disease severity and age category)
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [27]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    26.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17
         upper limit
    36.9
    Notes
    [27] - P-value was adjusted by randomization strata (baseline disease severity and age category)

    Secondary: Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12
    End point description
    IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, induration lichenification, excoriation, and no oozing; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n=157, 152, 76)
    0 (0.0 to 2.3)
    2.0 (0.0 to 4.2)
    0 (0.0 to 4.7)
        Week 4 (n=155, 153, 77)
    1.9 (0.0 to 4.1)
    4.6 (1.3 to 7.9)
    0 (0.0 to 4.7)
        Week 8 (n=157, 154, 78)
    1.3 (0.0 to 3.0)
    4.5 (1.3 to 7.8)
    0 (0.0 to 4.6)
        Week 12 (n=155, 155, 77)
    5.2 (1.7 to 8.6)
    6.5 (2.6 to 10.3)
    0 (0.0 to 4.7)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.7
         upper limit
    3.7
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2262 [28]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    6.1
    Notes
    [28] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2223 [29]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    6.1
    Notes
    [29] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0597 [30]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    4.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    9.2
    Notes
    [30] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3207 [31]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    5.2
    Notes
    [31] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0586 [32]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    4.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    9.2
    Notes
    [32] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0419 [33]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    5.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.3
         upper limit
    10.1
    Notes
    [33] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0244 [34]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    6.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.2
         upper limit
    11.4
    Notes
    [34] - P-value was adjusted by randomization strata (baseline disease severity and age category).

    Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12
    End point description
    EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n=157, 152, 76)
    35.7 (28.2 to 43.2)
    55.3 (47.4 to 63.2)
    10.5 (3.6 to 17.4)
        Week 4 (n=155, 153, 77)
    58.7 (51.0 to 66.5)
    78.4 (71.9 to 84.9)
    28.6 (18.5 to 38.7)
        Week 8 (n=157, 154, 78)
    66.2 (58.8 to 73.6)
    82.5 (76.5 to 88.5)
    34.6 (24.1 to 45.2)
        Week 12 (n=155, 154, 77)
    68.4 (61.1 to 75.7)
    79.9 (73.5 to 86.2)
    19.5 (10.6 to 28.3)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [35]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.8
         upper limit
    35.2
    Notes
    [35] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [36]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    44.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    33.9
         upper limit
    54.6
    Notes
    [36] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [37]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    30.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17.5
         upper limit
    42.8
    Notes
    [37] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [38]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    49.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.8
         upper limit
    61.7
    Notes
    [38] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [39]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    31.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.8
         upper limit
    44.3
    Notes
    [39] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [40]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    47.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35.7
         upper limit
    59.6
    Notes
    [40] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [41]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    48.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.2
         upper limit
    60.1
    Notes
    [41] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [42]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    60.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.1
         upper limit
    71
    Notes
    [42] - P-value was adjusted by randomization strata (baseline disease severity and age category).

    Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12
    End point description
    EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n= 157, 152, 76)
    2.5 (0.1 to 5.0)
    9.2 (4.6 to 13.8)
    0 (0.0 to 4.7)
        Week 4 (n= 155, 153, 77)
    9.7 (5.0 to 14.3)
    22.9 (16.2 to 29.5)
    0 (0.0 to 4.7)
        Week 8 (n= 157, 154, 78)
    17.2 (11.3 to 23.1)
    34.4 (26.9 to 41.9)
    2.6 (0.0 to 6.1)
        Week 12 (n= 155, 154, 77)
    23.9 (17.2 to 30.6)
    37.7 (30.0 to 45.3)
    3.9 (0.0 to 8.2)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1623 [43]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    2.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    6.8
    Notes
    [43] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.007 [44]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    9.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.4
         upper limit
    14.7
    Notes
    [44] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0049 [45]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    9.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4
         upper limit
    15.4
    Notes
    [45] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [46]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    22.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    15.5
         upper limit
    30.2
    Notes
    [46] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0013 [47]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    14.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.2
         upper limit
    22
    Notes
    [47] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [48]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    31.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.1
         upper limit
    40.1
    Notes
    [48] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001 [49]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    20.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.9
         upper limit
    28.3
    Notes
    [49] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    33.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.6
         upper limit
    42.5

    Secondary: Percentage of Subjects Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12
    End point description
    EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n= 157, 152, 76)
    0 (0.0 to 2.3)
    1.3 (0.0 to 3.1)
    0 (0.0 to 4.7)
        Week 4 (n= 155, 153, 77)
    1.3 (0.0 to 3.1)
    3.9 (0.8 to 7.0)
    0 (0.0 to 4.7)
        Week 8 (n= 157, 154, 78)
    1.3 (0.0 to 3.0)
    3.9 (0.8 to 7.0)
    0 (0.0 to 4.6)
        Week 12 (n= 155, 154, 77)
    5.2 (1.7 to 8.6)
    7.1 (3.1 to 11.2)
    0 (0.0 to 4.7)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0 [50]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.7
         upper limit
    3.7
    Notes
    [50] - P-value could not be calculated since percentage of subjects with events was 0.
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3261 [51]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.8
         upper limit
    5.3
    Notes
    [51] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3207 [52]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    5.3
    Notes
    [52] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.081 [53]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    3.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    8.5
    Notes
    [53] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3207 [54]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    5.2
    Notes
    [54] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.081 [55]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    3.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    8.4
    Notes
    [55] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0419 [56]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    5.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.3
         upper limit
    10.1
    Notes
    [56] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.018 [57]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.8
         upper limit
    12.2
    Notes
    [57] - P-value was adjusted by randomization strata (baseline disease severity and age category).

    Secondary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12

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    End point title
    Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12
    End point description
    EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percent change
    least squares mean (confidence interval 95%)
        Change at Week 2
    -39.2 (-43.8 to -34.7)
    -51.3 (-55.9 to -46.7)
    -9.0 (-15.4 to -2.5)
        Change at Week 4
    -54.3 (-59.1 to -49.5)
    -69.0 (-73.7 to -64.2)
    -24.4 (-31.1 to -17.7)
        Change at Week 8
    -59.5 (-65.0 to -54.0)
    -73.2 (-78.7 to -67.7)
    -33.0 (-41.1 to -25.0)
        Change at Week 12
    -60.0 (-66.5 to -53.6)
    -73.3 (-79.7 to -66.9)
    -28.6 (-38.4 to -18.8)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -30.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -38.1
         upper limit
    -22.3
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -42.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -50.3
         upper limit
    -34.4
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -29.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -38.1
         upper limit
    -21.7
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -44.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -52.8
         upper limit
    -36.3
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -26.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -36.2
         upper limit
    -16.7
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -40.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -50
         upper limit
    -30.4
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -31.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -43.1
         upper limit
    -19.7
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -44.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -56.4
         upper limit
    -33

    Secondary: Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12

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    End point title
    Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12
    End point description
    4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated by handprint method. Number of handprints fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA calculated: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, higher values = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: Percentage of BSA
    least squares mean (confidence interval 95%)
        Week 2
    -27.8 (-33.0 to -22.6)
    -35.4 (-40.6 to -30.2)
    -1.3 (-8.7 to 6.0)
        Week 4
    -45.0 (-50.4 to -39.6)
    -55.7 (-61.1 to -50.3)
    -15.3 (-22.9 to -7.7)
        Week 8
    -53.4 (-60.0 to -46.8)
    -61.1 (-67.7 to -54.5)
    -20.5 (-30.1 to -10.9)
        Week 12
    -56.4 (-63.1 to -49.6)
    -65.0 (-71.7 to -58.3)
    -16.8 (-26.9 to -6.6)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -26.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -35.5
         upper limit
    -17.5
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -34.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -43.1
         upper limit
    -25.1
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -29.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -39
         upper limit
    -20.4
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -40.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -49.8
         upper limit
    -31.1
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -32.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -44.6
         upper limit
    -21.2
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -40.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -52.2
         upper limit
    -28.9
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -39.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -51.8
         upper limit
    -27.4
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -48.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -60.4
         upper limit
    -36

    Secondary: Percentage of Subjects With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12

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    End point title
    Percentage of Subjects With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12
    End point description
    4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. SA of body region: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. “n” = the number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n=157, 152, 76)
    1.9 (0.0 to 4.1)
    5.9 (2.2 to 9.7)
    0 (0.0 to 4.7)
        Week 4 (n=155, 153, 77)
    6.5 (2.6 to 10.3)
    17.0 (11.0 to 22.9)
    0 (0.0 to 4.7)
        Week 8 (n=157, 154, 78)
    15.9 (10.2 to 21.6)
    27.3 (20.2 to 34.3)
    1.3 (0.0 to 3.8)
        Week 12 (n=155, 154, 77)
    22.6 (16.0 to 29.2)
    34.4 (26.9 to 41.9)
    3.9 (0.0 to 8.2)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2353 [58]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    6
    Notes
    [58] - P-value was adjusted by randomization strata (baseline disease severity and age category)
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0332 [59]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    5.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    10.8
    Notes
    [59] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0227 [60]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    6.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.4
         upper limit
    11.6
    Notes
    [60] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001 [61]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    16.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.1
         upper limit
    23.5
    Notes
    [61] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0008 [62]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    14.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.7
         upper limit
    21.3
    Notes
    [62] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [63]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    25.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.1
         upper limit
    33.4
    Notes
    [63] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0003 [64]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    18.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.5
         upper limit
    26.5
    Notes
    [64] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    30.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    21.4
         upper limit
    39

    Secondary: Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12
    End point description
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA - head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis set population included. Number Analyzed = number of subjects evaluable at the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n= 157, 152, 76)
    12.7 (7.5 to 18.0)
    32.9 (25.4 to 40.4)
    0 (0.0 to 4.7)
        Week 4 (n= 155, 153, 77)
    36.1 (28.6 to 43.7)
    60.8 (53.0 to 68.5)
    7.8 (1.8 to 13.8)
        Week 8 (n= 157, 154, 78)
    43.3 (35.6 to 51.1)
    61.7 (54.0 to 69.4)
    15.4 (7.4 to 23.4)
        Week 12 (n= 155, 155, 76)
    49.0 (41.2 to 56.9)
    62.6 (55.0 to 70.2)
    12.8 (5.4 to 20.2)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0011 [65]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    12.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.5
         upper limit
    18.9
    Notes
    [65] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [66]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    32.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.6
         upper limit
    40.6
    Notes
    [66] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [67]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    28.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.5
         upper limit
    38.2
    Notes
    [67] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [68]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    52.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.2
         upper limit
    62.5
    Notes
    [68] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [69]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17
         upper limit
    39
    Notes
    [69] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [70]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    46.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    35.2
         upper limit
    57.1
    Notes
    [70] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [71]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    36.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    25.4
         upper limit
    47.1
    Notes
    [71] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [72]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    49.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    38.9
         upper limit
    60.3
    Notes
    [72] - P-value was adjusted by randomization strata (baseline disease severity and age category).

    Secondary: Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12
    End point description
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA - head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis set population included. Number Analyzed = number of subjects evaluable at the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 2 (n= 157, 152, 76)
    1.9 (0.0 to 4.1)
    5.3 (1.7 to 8.8)
    0 (0.0 to 4.7)
        Week 4 (n= 155, 153, 77)
    7.1 (3.1 to 11.1)
    17.6 (11.6 to 23.7)
    0 (0.0 to 4.7)
        Week 8 (n= 157, 154, 78)
    11.5 (6.5 to 16.4)
    26.0 (19.0 to 32.9)
    0 (0.0 to 4.6)
        Week 12 (n= 155, 155, 78)
    18.7 (12.6 to 24.8)
    30.3 (23.1 to 37.6)
    2.6 (0.0 to 6.1)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2261 [73]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    6
    Notes
    [73] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0451 [74]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    5.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.3
         upper limit
    10
    Notes
    [74] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0171 [75]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.8
         upper limit
    12.3
    Notes
    [75] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [76]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    17.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.9
         upper limit
    24.5
    Notes
    [76] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0018 [77]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    11.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.5
         upper limit
    17.5
    Notes
    [77] - P-value was adjusted by randomization strata (baseline disease severity and age category)
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [78]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    25.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.3
         upper limit
    33.1
    Notes
    [78] - P-value was adjusted by randomization strata (baseline disease severity and age category)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0005 [79]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    16.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.8
         upper limit
    23.6
    Notes
    [79] - P-value was adjusted by randomization strata (baseline disease severity and age category).
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [80]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in Percentage
    Point estimate
    27.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    19.3
         upper limit
    35.8
    Notes
    [80] - P-value was adjusted by randomization strata (baseline disease severity and age category).

    Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12

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    End point title
    Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12
    End point description
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA - head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0-100). Severity (B): severity sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2, severe=3. The severity scores summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, these 2 were scored by subject using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness summed to give 'C' (0-20). The SCORAD was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. This endpoint was not analyzed as planned because the severity assessment of itch was measured more effectively in other endpoints, such as the numerical rating scale.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    0 [81]
    0 [82]
    0 [83]
    Units: units on a scale
    Notes
    [81] - Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS.
    [82] - Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS.
    [83] - Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12

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    End point title
    Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12
    End point description
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA - head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis population set included. Number Analyzed = number of subjects evaluable at the specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Change at Week 2 (n= 155, 151, 76)
    -1.9 (-2.2 to -1.5)
    -2.9 (-3.3 to -2.5)
    -0.5 (-1.0 to 0.0)
        Change at Week 4 (n= 149, 151, 76)
    -2.8 (-3.1 to -2.4)
    -3.9 (-4.3 to -3.6)
    -1.0 (-1.5 to -0.5)
        Change at Week 8 (n= 148, 149, 66)
    -3.1 (-3.5 to -2.7)
    -3.9 (-4.3 to -3.5)
    -1.5 (-2.1 to -0.9)
        Change at Week 12 (n= 140, 146, 56)
    -3.0 (-3.4 to -2.6)
    -3.8 (-4.2 to -3.4)
    -2.1 (-2.7 to -1.5)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    -0.8
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -2.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    -1.8
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.4
         upper limit
    -1.2
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    -2.3
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    -0.9
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -2.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.1
         upper limit
    -1.7
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0164
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    -0.2
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    -1

    Secondary: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12

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    End point title
    Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12
    End point description
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA - head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis population set included.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, and 12
    End point values
    PF-04965842 100 mg PF-04965842 200 mg Placebo
    Number of subjects analysed
    158
    155
    78
    Units: percent change
    least squares mean (confidence interval 95%)
        Change at Week 2
    -27.2 (-30.5 to -23.9)
    -38.5 (-41.8 to -35.1)
    -6.3 (-11.0 to -1.6)
        Change at Week 4
    -38.9 (-42.6 to -35.1)
    -53.1 (-56.9 to -49.4)
    -17.2 (-22.5 to -12.0)
        Change at Week 8
    -42.6 (-46.7 to -38.4)
    -56.7 (-60.9 to -52.6)
    -23.1 (-29.2 to -17.1)
        Change at Week 12
    -45.8 (-50.9 to -40.7)
    -56.2 (-61.2 to -51.1)
    -22.7 (-30.4 to -15.1)
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -20.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -26.6
         upper limit
    -15.1
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -32.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -37.9
         upper limit
    -26.4
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -21.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.1
         upper limit
    -15.2
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -35.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -42.3
         upper limit
    -29.4
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -19.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -26.8
         upper limit
    -12.1
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -33.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -41
         upper limit
    -26.3
    Statistical analysis title
    PF-04965842 100 mg Versus Placebo
    Statistical analysis description
    Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 100 mg v Placebo
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -23.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -32.3
         upper limit
    -13.9
    Statistical analysis title
    PF-04965842 200 mg Versus Placebo
    Statistical analysis description
    Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
    Comparison groups
    PF-04965842 200 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    Difference in LS mean
    Point estimate
    -33.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -42.6
         upper limit
    -24.3

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 16
    Adverse event reporting additional description
    Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as nonserious in another subject or 1 subject may have experienced both serious and nonserious event during study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    PF-04965842 100 mg
    Reporting group description
    Subjects were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Reporting group title
    Placebo
    Reporting group description
    Subjects were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Reporting group title
    PF-04965842 200 mg
    Reporting group description
    Subjects were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.

    Serious adverse events
    PF-04965842 100 mg Placebo PF-04965842 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 158 (3.16%)
    1 / 78 (1.28%)
    2 / 155 (1.29%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 158 (0.00%)
    0 / 78 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 158 (0.00%)
    0 / 78 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 78 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 78 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Eczema herpeticum
         subjects affected / exposed
    0 / 158 (0.00%)
    1 / 78 (1.28%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 78 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis bacterial
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 78 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 78 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 78 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 158 (0.00%)
    1 / 78 (1.28%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PF-04965842 100 mg Placebo PF-04965842 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 158 (35.44%)
    22 / 78 (28.21%)
    52 / 155 (33.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 158 (5.70%)
    2 / 78 (2.56%)
    12 / 155 (7.74%)
         occurrences all number
    10
    4
    16
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    12 / 158 (7.59%)
    2 / 78 (2.56%)
    22 / 155 (14.19%)
         occurrences all number
    13
    2
    28
    Vomiting
         subjects affected / exposed
    2 / 158 (1.27%)
    1 / 78 (1.28%)
    8 / 155 (5.16%)
         occurrences all number
    2
    1
    9
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 158 (1.27%)
    0 / 78 (0.00%)
    9 / 155 (5.81%)
         occurrences all number
    2
    0
    9
    Dermatitis atopic
         subjects affected / exposed
    9 / 158 (5.70%)
    12 / 78 (15.38%)
    6 / 155 (3.87%)
         occurrences all number
    9
    13
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    20 / 158 (12.66%)
    5 / 78 (6.41%)
    12 / 155 (7.74%)
         occurrences all number
    20
    5
    12
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 158 (8.86%)
    3 / 78 (3.85%)
    5 / 155 (3.23%)
         occurrences all number
    16
    4
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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