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    Clinical Trial Results:
    A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination with Topical Corticosteroids in Adult Patients with Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

    Summary
    EudraCT number
    2017-004574-34
    Trial protocol
    GB   NL   FR   AT   BE   PL   FI   ES   IT  
    Global end of trial date

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Dec 2020
    First version publication date
    13 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I4V-MC-JAIN
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01624259
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Number: 16841
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    19 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2019
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 May 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
    Austria: 10
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    Belgium: 26
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    Poland: 41
    Country: Number of subjects enrolled
    Brazil: 48
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    France: 39
    Country: Number of subjects enrolled
    Germany: 88
    Country: Number of subjects enrolled
    Japan: 79
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Spain: 35
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    Switzerland: 4
    Worldwide total number of subjects
    463
    EEA total number of subjects
    318
    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)
    0
    Adults (18-64 years)
    448
    From 65 to 84 years
    14
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    No Text Available

    Pre-assignment
    Screening details
    Results reported are for primary outcome up to Week 16, and additional efficacy and safety at Week 24 per protocol. Data beyond Week 24 will be reported after final analysis.

    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
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo administered orally once daily in combination with topical corticosteroids.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered orally once daily.

    Arm title
    1 mg Baricitinib
    Arm description
    1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg Baricitinib administered orally once daily.

    Arm title
    2 mg Baricitinib
    Arm description
    2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2 mg Baricitinib administered orally once daily.

    Arm title
    4 mg Baricitinib
    Arm description
    4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
    Arm type
    Placebo

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg Baricitinib administered orally once daily.

    Number of subjects in period 1
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Started
    93
    93
    185
    92
    Received at Least One Dose of Study Drug
    93
    93
    184
    92
    Completed
    72
    80
    173
    85
    Not completed
    21
    13
    12
    7
         Consent withdrawn by subject
    4
    -
    -
    -
         Physician decision
    -
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    3
    1
         Lack of efficacy
    16
    10
    7
    6
         Protocol deviation
    -
    2
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo administered orally once daily in combination with topical corticosteroids.

    Reporting group title
    1 mg Baricitinib
    Reporting group description
    1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

    Reporting group title
    2 mg Baricitinib
    Reporting group description
    2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

    Reporting group values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib Total
    Number of subjects
    93 93 185 92 463
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.7 ( 13.6 ) 38.9 ( 14.0 ) 37.3 ( 13.6 ) 38.7 ( 13.3 ) -
    Gender categorical
    Units: Subjects
        Female
    44 35 52 35 166
        Male
    49 58 133 57 297
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    11 13 26 14 64
        Not Hispanic or Latino
    54 62 101 55 272
        Unknown or Not Reported
    28 18 58 23 127
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0
        Asian
    16 19 36 18 89
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0
        Black or African American
    3 3 2 3 11
        White
    74 70 145 71 360
        More than one race
    0 1 2 0 3
        Unknown or Not Reported
    0 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Austria
    1 3 2 4 10
        Netherlands
    3 0 9 4 16
        Belgium
    3 5 12 6 26
        Finland
    2 2 2 1 7
        Poland
    10 9 15 7 41
        Brazil
    8 10 20 10 48
        Italy
    11 9 13 4 37
        France
    9 6 16 8 39
        Germany
    15 18 37 18 88
        Japan
    15 16 32 16 79
        Russia
    5 2 5 2 14
        Spain
    7 7 15 6 35
        United Kingdom
    4 5 6 4 19
        Switzerland
    0 1 1 2 4

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo administered orally once daily in combination with topical corticosteroids.

    Reporting group title
    1 mg Baricitinib
    Reporting group description
    1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

    Reporting group title
    2 mg Baricitinib
    Reporting group description
    2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.

    Primary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib)

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    End point title
    Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib) [1]
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Analysis Population Description (APD): All participants randomized to placebo, 2 mg or 4 mg of study drug.
    End point type
    Primary
    End point timeframe
    Week 16
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, outcome measure assessed participants in 2 mg and 4 mg Baricitinib treatment arms.
    End point values
    Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    17.2 (10.9 to 26.1)
    27.6 (21.6 to 34.4)
    31.5 (22.9 to 41.6)
    Statistical analysis title
    EASI75 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.071
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.95
         upper limit
    3.32
    Statistical analysis title
    EASI75 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.031
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.07
         upper limit
    4.3

    Secondary: Percentage of Participants Achieving EASI75 (Placebo, 1 mg Baricitinib)

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    End point title
    Percentage of Participants Achieving EASI75 (Placebo, 1 mg Baricitinib) [2]
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who permanently discontinue, are rescued, or are without at least 1 post-baseline observation. APD: All participants randomized to placebo or 1 mg of study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, outcome measure assessed participants in the placebo and 1 mg Baricitinib treatment arms.
    End point values
    Placebo 1 mg Baricitinib
    Number of subjects analysed
    93
    93
    Units: percentage of participants
        number (confidence interval 95%)
    17.2 (10.9 to 26.1)
    22.6 (15.3 to 32.1)
    Statistical analysis title
    EASI75 - 1 mg
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.427
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.65
         upper limit
    2.77

    Secondary: Percentage of Participants Achieving IGA of 0 or 1 with a ≥ 2 Point Improvement

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    End point title
    Percentage of Participants Achieving IGA of 0 or 1 with a ≥ 2 Point Improvement
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    9.7 (5.2 to 17.4)
    12.9 (7.5 to 21.2)
    15.1 (10.7 to 21.0)
    21.7 (14.5 to 31.2)
    Statistical analysis title
    IGA of 0 or 1 - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.513
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.55
         upper limit
    3.35
    Statistical analysis title
    IGA of 0 or 1 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.242
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    3.53
    Statistical analysis title
    IGA of 0 or 1 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.03
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.09
         upper limit
    5.9

    Secondary: Percentage of Participants Achieving EASI90

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    End point title
    Percentage of Participants Achieving EASI90
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    6.5 (3.0 to 13.4)
    8.6 (4.4 to 16.1)
    10.3 (6.7 to 15.5)
    14.1 (8.4 to 22.7)
    Statistical analysis title
    EASI90 - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.611
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.45
         upper limit
    3.83
    Statistical analysis title
    EASI90 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.325
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.63
         upper limit
    3.99
    Statistical analysis title
    EASI90 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.85
         upper limit
    6.14

    Secondary: Percent Change from Baseline in EASI Score

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    End point title
    Percent Change from Baseline in EASI Score
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). Least Squares Mean (LSM) were calculated using mixed model repeated measures (MMRM) model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline score and baseline score-by-visit-interaction as fixed continuous effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 APD: All randomized participants with Week 16 EASI data.
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    54
    61
    144
    65
    Units: percent change
        least squares mean (standard error)
    -42.69 ( 4.135 )
    -60.34 ( 4.018 )
    -56.05 ( 2.755 )
    -63.31 ( 3.922 )
    Statistical analysis title
    PCFB EASI - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -17.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.71
         upper limit
    -6.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.627
    Statistical analysis title
    PCFB EASI - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -13.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -22.83
         upper limit
    -3.87
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.82
    Statistical analysis title
    PCFB EASI - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0002
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -20.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -31.54
         upper limit
    -9.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.554

    Secondary: Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)

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    End point title
    Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
    End point description
    The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    1.1 (0.2 to 5.8)
    6.5 (3.0 to 13.4)
    8.1 (5.0 to 12.9)
    6.5 (3.0 to 13.5)
    Statistical analysis title
    SCORAD75 - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.115
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    24.29
    Statistical analysis title
    SCORAD75 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.037
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.11
         upper limit
    30.88
    Statistical analysis title
    SCORAD75 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.083
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    28.08

    Secondary: Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)

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    End point title
    Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. All randomized participants with a baseline Itch NRS score >=4.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    85
    78
    166
    76
    Units: percentage of participants
        number (confidence interval 95%)
    8.2 (4.0 to 16.0)
    23.1 (15.1 to 33.6)
    22.9 (17.2 to 29.9)
    38.2 (28.1 to 49.4)
    Statistical analysis title
    NRS - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.012
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.29
         upper limit
    8.32
    Statistical analysis title
    NRS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.59
         upper limit
    8.66
    Statistical analysis title
    NRS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.00002
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    6.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.79
         upper limit
    16.82

    Secondary: Change from Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)

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    End point title
    Change from Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
    End point description
    The ADSS is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep due to itch, frequency of waking due to itch, and difficulty getting back to sleep last night due to itch. Item 2 frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Mean were calculated using an MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical and baseline and baseline-by-visit-interaction as fixed continuous effects. All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    53
    62
    135
    66
    Units: units on a scale
        least squares mean (standard error)
    -0.63 ( 0.149 )
    -1.05 ( 0.142 )
    -0.85 ( 0.099 )
    -1.42 ( 0.140 )
    Statistical analysis title
    Change from Baseline (CFB) ADSS - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.039
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.82
         upper limit
    -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.203
    Statistical analysis title
    CFB ADSS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.23
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.56
         upper limit
    0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.175
    Statistical analysis title
    CFB ADSS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.18
         upper limit
    -0.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.201

    Secondary: Change from Baseline in Skin Pain NRS

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    End point title
    Change from Baseline in Skin Pain NRS
    End point description
    Skin Pain NRS is a participant-administered,11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Mean were calculated using MMRM model includes treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. APD: All randomized participants with Week 16 Skin Pain NRS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    53
    62
    135
    66
    Units: units on a scale
        least squares mean (standard error)
    -1.56 ( 0.284 )
    -2.27 ( 0.274 )
    -2.40 ( 0.193 )
    -3.02 ( 0.271 )
    Statistical analysis title
    CFB Skin Pain NRS - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0714
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.47
         upper limit
    0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.388
    Statistical analysis title
    CFB Skin Pain NRS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0134
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    -0.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.337
    Statistical analysis title
    CFB Skin Pain NRS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0002
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.21
         upper limit
    -0.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.386

    Secondary: Percentage of Participants Achieving IGA of 0 or 1 with a >=2-point improvement

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    End point title
    Percentage of Participants Achieving IGA of 0 or 1 with a >=2-point improvement
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    24 Weeks
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    12.9 (7.5 to 21.2)
    20.4 (13.5 to 29.7)
    18.9 (13.9 to 25.2)
    13.0 (7.6 to 21.4)
    Statistical analysis title
    IGA of 0 or 1 - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.183
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.78
         upper limit
    3.75
    Statistical analysis title
    IGA of 0 or 1 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.235
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    3.11
    Statistical analysis title
    IGA of 0 or 1 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.991
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.43
         upper limit
    2.36

    Secondary: Percentage of Participants Achieving EASI50

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    End point title
    Percentage of Participants Achieving EASI50
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI50 is defined as a ≥ 50% improvement from baseline in the EASI score. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    35.5 (26.5 to 45.6)
    45.2 (35.4 to 55.3)
    51.4 (44.2 to 58.5)
    52.2 (42.1 to 62.1)
    Statistical analysis title
    EASI50 - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.263
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    2.57
    Statistical analysis title
    EASI50 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.016
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.13
         upper limit
    3.19
    Statistical analysis title
    EASI50 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.031
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.06
         upper limit
    3.52

    Secondary: Percentage of Participants Achieving EASI75

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    End point title
    Percentage of Participants Achieving EASI75
    End point description
    The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    17.2 (10.9 to 26.1)
    30.1 (21.7 to 40.1)
    27.6 (21.6 to 34.4)
    25.0 (17.3 to 34.7)
    Statistical analysis title
    EASI75 - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.058
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.98
         upper limit
    3.96
    Statistical analysis title
    EASI75 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.072
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.95
         upper limit
    3.32
    Statistical analysis title
    EASI75 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.224
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    3.18

    Secondary: Percentage of Participants Achieving IGA of 0

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    End point title
    Percentage of Participants Achieving IGA of 0
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 4.0)
    2.2 (0.6 to 7.5)
    1.1 (0.3 to 3.9)
    3.3 (1.1 to 9.2)
    Statistical analysis title
    IGA of 0 - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.265
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.29
         upper limit
    86.08
    Statistical analysis title
    IGA of 0 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.52
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.15
         upper limit
    43.09
    Statistical analysis title
    IGA of 0 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.164
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    7.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.45
         upper limit
    99.99

    Secondary: Change from Baseline in SCORAD

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    End point title
    Change from Baseline in SCORAD
    End point description
    The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 APD: All randomized participants with Week 16 SCORAD data.
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    54
    60
    142
    64
    Units: units on a scale
        least squares mean (standard error)
    -21.98 ( 2.171 )
    -28.06 ( 2.097 )
    -28.54 ( 1.438 )
    -31.74 ( 2.052 )
    Statistical analysis title
    CFB SCORAD - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.04
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -6.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.88
         upper limit
    -0.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.948
    Statistical analysis title
    CFB SCORAD - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.01
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -6.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.54
         upper limit
    -1.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.533
    Statistical analysis title
    CFB SCORAD - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -9.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.51
         upper limit
    -4.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.919

    Secondary: Percentage of Participants Achieving SCORAD90

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    End point title
    Percentage of Participants Achieving SCORAD90
    End point description
    The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the SCORAD score. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16 APD: All randomized participants.
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 4.0)
    2.2 (0.6 to 7.5)
    1.1 (0.3 to 3.9)
    2.2 (0.6 to 7.6)
    Statistical analysis title
    SCORAD90 - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.265
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.31
         upper limit
    73.93
    Statistical analysis title
    SCORAD90 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.511
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.16
         upper limit
    38.4
    Statistical analysis title
    SCORAD90 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.253
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.32
         upper limit
    77.11

    Secondary: Change from Baseline in Body Surface Area (BSA) Affected

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    End point title
    Change from Baseline in Body Surface Area (BSA) Affected
    End point description
    The BSA affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs. LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 APD: All randomized participants with Week 16 BSA data.
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    54
    61
    144
    65
    Units: units on a scale
        least squares mean (standard error)
    -19.76 ( 2.257 )
    -25.98 ( 2.178 )
    -25.26 ( 1.488 )
    -28.17 ( 2.125 )
    Statistical analysis title
    CFB BSA - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.044
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -6.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.26
         upper limit
    -0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.078
    Statistical analysis title
    CFB BSA - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.037
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.67
         upper limit
    -0.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.632
    Statistical analysis title
    CFB BSA - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -8.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.37
         upper limit
    -2.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.03

    Secondary: Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment

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    End point title
    Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
    End point description
    Percentage of participants developing skin infections requiring antibiotic treatment. APD: All randomized participants who received at least one dose of study drug and who did not discontinue from the study for the reason of "Lost to Follow-up" at the first post-baseline visit.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    184
    92
    Units: percentage of participants
        number (not applicable)
    5.4
    6.5
    6.5
    5.4
    Statistical analysis title
    Skin Infections - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Skin Infections - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.797
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Skin Infections - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval

    Secondary: Mean Number of Days without Topical Corticosteroids (TCS) Use

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    End point title
    Mean Number of Days without Topical Corticosteroids (TCS) Use
    End point description
    The ANCOVA model includes treatment, region, and baseline disease severity (IGA) as factors. APD: All randomized participants without use of TCS.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    89
    92
    178
    89
    Units: days
        least squares mean (standard error)
    12.18 ( 3.39 )
    20.80 ( 3.37 )
    17.65 ( 2.53 )
    19.43 ( 3.41 )
    Statistical analysis title
    TCS - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.056
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    8.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.22
         upper limit
    17.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.49
    Statistical analysis title
    TCS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.164
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    5.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.24
         upper limit
    13.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.92
    Statistical analysis title
    TCS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.11
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    7.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.66
         upper limit
    16.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.53

    Secondary: Mean Gram Quantity of Low and Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights)

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    End point title
    Mean Gram Quantity of Low and Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights)
    End point description
    Average weights of full tubes were used to determine the dispensed weights for each region. Returned tubes were weighed with cap without carton to determine the amount of TCS in grams (g) used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    93
    93
    185
    92
    Units: grams
        least squares mean (standard error)
    242.59 ( 27.60 )
    194.53 ( 27.42 )
    185.70 ( 20.67 )
    171.17 ( 27.16 )
    Statistical analysis title
    Low and Moderate Potency TCS - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.178
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -48.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -118
         upper limit
    21.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    35.63
    Statistical analysis title
    Low and Moderate Potency TCS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.066
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -56.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -117.56
         upper limit
    3.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    30.9
    Statistical analysis title
    Low and Moderate Potency TCS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.045
    Method
    ANOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -71.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -141.24
         upper limit
    -1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    35.57

    Secondary: Percent Change from Baseline in Itch NRS

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    End point title
    Percent Change from Baseline in Itch NRS
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects. APD: All randomized participants with Week 16 Itch NRS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    53
    62
    135
    66
    Units: percent change
        least squares mean (standard error)
    -17.48 ( 4.835 )
    -28.80 ( 4.663 )
    -32.89 ( 3.258 )
    -37.24 ( 4.609 )
    Statistical analysis title
    PCFB Itch NRS - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.088
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -11.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -24.33
         upper limit
    1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.62
    Statistical analysis title
    PCFB Itch NRS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.007
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -15.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -26.67
         upper limit
    -4.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.725
    Statistical analysis title
    PCFB Itch NRS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -19.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -32.71
         upper limit
    -6.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.583

    Secondary: Percent Change From Baseline in Itch NRS at Week 24

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    End point title
    Percent Change From Baseline in Itch NRS at Week 24
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects. APD: All randomized participants with Week 24 Itch NRS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    35
    50
    108
    54
    Units: units on a scale
        least squares mean (standard error)
    -15.35 ( 5.349 )
    -29.35 ( 5.039 )
    -30.11 ( 3.495 )
    -33.16 ( 4.972 )
    Statistical analysis title
    PCFB Itch NRS - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.055
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.28
         upper limit
    0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.263
    Statistical analysis title
    PCFB Itch NRS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.02
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -14.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -27.15
         upper limit
    -2.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.297
    Statistical analysis title
    PCFB Itch NRS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.014
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -17.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -32.01
         upper limit
    -3.62
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.216

    Secondary: Change from Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)

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    End point title
    Change from Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
    End point description
    The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by visit-interactions as fixed continuous effects. APD: All randomized participants with Week 16 POEM data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    55
    62
    145
    67
    Units: units on a scale
        least squares mean (standard error)
    -4.18 ( 0.907 )
    -6.24 ( 0.872 )
    -7.27 ( 0.602 )
    -9.27 ( 0.855 )
    Statistical analysis title
    CFB POEM - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.095
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.47
         upper limit
    -0.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.229
    Statistical analysis title
    CFB POEM - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.16
         upper limit
    -1.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.057
    Statistical analysis title
    CFB POEM - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.48
         upper limit
    -2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.216

    Secondary: Change from Baseline in the Patient Global Impression of Severity -Atopic Dermatitis (PGI-S-AD) Score

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    End point title
    Change from Baseline in the Patient Global Impression of Severity -Atopic Dermatitis (PGI-S-AD) Score
    End point description
    The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. APD: All randomized participants with Week 16 PGI-S-AD data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    53
    62
    135
    66
    Units: units on a scale
        least squares mean (standard error)
    -0.49 ( 0.107 )
    -0.74 ( 0.103 )
    -0.77 ( 0.072 )
    -1.07 ( 0.101 )
    Statistical analysis title
    CFB PGI-S-AD - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.097
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.53
         upper limit
    0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.146
    Statistical analysis title
    CFB PGI-S-AD - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.033
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.52
         upper limit
    -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.126
    Statistical analysis title
    CFB PGI-S-AD - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.86
         upper limit
    -0.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.145

    Secondary: Change from Baseline on the Hospital Anxiety Depression Scale (HADS)

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    End point title
    Change from Baseline on the Hospital Anxiety Depression Scale (HADS)
    End point description
    The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. APD: All randomized participants with Week 16 HADS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    55
    62
    145
    67
    Units: units on a scale
    least squares mean (standard error)
        Anxiety
    -0.48 ( 0.382 )
    -1.04 ( 0.366 )
    -1.59 ( 0.256 )
    -1.32 ( 0.362 )
        Depression
    -0.40 ( 0.383 )
    -0.69 ( 0.367 )
    -1.03 ( 0.256 )
    -1.57 ( 0.362 )
    Statistical analysis title
    CFB HADS - 1 mg Baricitinib
    Statistical analysis description
    HADS Anxiety
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.272
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.58
         upper limit
    0.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.516
    Notes
    [3] - Anxiety
    Statistical analysis title
    CFB HADS - 2 mg Baricitinib
    Statistical analysis description
    HADS Anxiety
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    = 0.013
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.99
         upper limit
    -0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.446
    Notes
    [4] - Anxiety
    Statistical analysis title
    CFB HADS - 4 mg Baricitinib
    Statistical analysis description
    HADS Anxiety
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    P-value
    = 0.099
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.85
         upper limit
    0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.511
    Notes
    [5] - Anxiety
    Statistical analysis title
    CFB HADS - 1 mg Baricitinib
    Statistical analysis description
    HADS Depression
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    P-value
    = 0.584
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    0.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.519
    Notes
    [6] - Depression
    Statistical analysis title
    CFB HADS - 2 mg Baricitinib
    Statistical analysis description
    HADS Depression
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    P-value
    = 0.162
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.51
         upper limit
    0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.448
    Notes
    [7] - Depression
    Statistical analysis title
    CFB HADS - 4 mg Baricitinib
    Statistical analysis description
    HADS Depression
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority [8]
    P-value
    = 0.024
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.18
         upper limit
    -0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.515
    Notes
    [8] - Depression

    Secondary: Change from Baseline in the Dermatology Life Quality Index (DLQI)

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    End point title
    Change from Baseline in the Dermatology Life Quality Index (DLQI)
    End point description
    The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 (“no impact on participant's life” to “extremely large effect on participant's life”), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 APD: All randomized participants with Week 16 DLQI data.
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    55
    62
    145
    67
    Units: units on a scale
        least squares mean (standard error)
    -4.95 ( 0.752 )
    -6.18 ( 0.719 )
    -6.57 ( 0.494 )
    -7.95 ( 0.705 )
    Statistical analysis title
    CFB DLQI - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.228
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.23
         upper limit
    0.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.018
    Statistical analysis title
    CFB DLQI - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.065
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.35
         upper limit
    0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.876
    Statistical analysis title
    CFB DLQI - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.99
         upper limit
    -1.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.007

    Secondary: Change from Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire

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    End point title
    Change from Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
    End point description
    The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. APD: All randomized participants with Week 16 WPAI-AD data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    55
    62
    145
    67
    Units: units on a scale
    least squares mean (standard error)
        Absenteeism (37, 36, 85, 42)
    -4.77 ( 2.365 )
    -5.69 ( 2.433 )
    -2.98 ( 1.639 )
    -4.56 ( 2.258 )
        Presenteeism (34, 35, 83, 39)
    -14.86 ( 3.182 )
    -11.80 ( 3.161 )
    -14.56 ( 2.133 )
    -14.81 ( 3.000 )
        Work Productivity Loss (34, 35, 83, 39)
    -13.22 ( 3.560 )
    -12.07 ( 3.565 )
    -13.07 ( 2.440 )
    -14.12 ( 3.396 )
        Activity Impairment (55, 62, 145, 67)
    -16.46 ( 2.853 )
    -18.46 ( 2.729 )
    -20.86 ( 1.847 )
    -23.92 ( 2.660 )
    Statistical analysis title
    CFB Absenteeism - 1 mg Baricitinib
    Statistical analysis description
    Change from Baseline (CFB) Absenteeism
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.784
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.5
         upper limit
    5.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.339
    Notes
    [9] - Change from Baseline (CFB) Absenteeism
    Statistical analysis title
    CFB Absenteeism - 2 mg Baricitinib
    Statistical analysis description
    CFB Absenteeism
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.525
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    1.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.75
         upper limit
    7.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.813
    Notes
    [10] - CFB Absenteeism
    Statistical analysis title
    CFB Absenteeism - 4 mg Baricitinib
    Statistical analysis description
    CFB Absenteeism
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    P-value
    = 0.947
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.11
         upper limit
    6.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.204
    Notes
    [11] - CFB Absenteeism
    Statistical analysis title
    CFB Presenteeism - 1 mg Baricitinib
    Statistical analysis description
    CFB Presenteeism
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    P-value
    = 0.488
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    3.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.62
         upper limit
    11.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.409
    Notes
    [12] - CFB Presenteeism
    Statistical analysis title
    CFB Presenteeism - 2 mg Baricitinib
    Statistical analysis description
    CFB Presenteeism
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority [13]
    P-value
    = 0.936
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.02
         upper limit
    7.62
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.72
    Notes
    [13] - CFB Presenteeism
    Statistical analysis title
    CFB Presenteeism - 4 mg Baricitinib
    Statistical analysis description
    CFB Presenteeism
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority [14]
    P-value
    = 0.991
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.35
         upper limit
    8.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.267
    Notes
    [14] - CFB Presenteeism
    Statistical analysis title
    CFB Work Productivity Loss - 1 mg Baricitinib
    Statistical analysis description
    CFB Work Productivity Loss
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [15]
    P-value
    = 0.816
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    1.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.57
         upper limit
    10.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.938
    Notes
    [15] - CFB Work Productivity Loss
    Statistical analysis title
    CFB Work Productivity Loss - 2 mg Baricitinib
    Statistical analysis description
    CFB Work Productivity Loss
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority [16]
    P-value
    = 0.971
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.08
         upper limit
    8.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.178
    Notes
    [16] - CFB Work Productivity Loss
    Statistical analysis title
    CFB Work Productivity Loss - 4 mg Baricitinib
    Statistical analysis description
    CFB Work Productivity Loss
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority [17]
    P-value
    = 0.852
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.36
         upper limit
    8.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.804
    Notes
    [17] - CFB Work Productivity Loss
    Statistical analysis title
    CFB Activity Impairment - 1 mg Baricitinib
    Statistical analysis description
    CFB Activity Impairment
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [18]
    P-value
    = 0.607
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.61
         upper limit
    5.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.877
    Notes
    [18] - CFB Activity Impairment
    Statistical analysis title
    CFB Activity Impairment - 2 mg Baricitinib
    Statistical analysis description
    CFB Activity Impairment
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority [19]
    P-value
    = 0.186
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -4.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.92
         upper limit
    2.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.319
    Notes
    [19] - CFB Activity Impairment
    Statistical analysis title
    CFB Activity Impairment - 4 mg Baricitinib
    Statistical analysis description
    CFB Activity Impairment
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority [20]
    P-value
    = 0.052
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -7.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.96
         upper limit
    0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.82
    Notes
    [20] - CFB Activity Impairment

    Secondary: Change from Baseline in the European Quality of Life–5 Dimensions–5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm

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    End point title
    Change from Baseline in the European Quality of Life–5 Dimensions–5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
    End point description
    The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. APD: All randomized participants with EQ-5D-5L US and UK Health scores.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    55
    62
    145
    67
    Units: units on a scale
    least squares mean (standard error)
        US Health State Index
    0.04 ( 0.016 )
    0.08 ( 0.016 )
    0.09 ( 0.011 )
    0.11 ( 0.015 )
        UK Health State Index
    0.06 ( 0.023 )
    0.11 ( 0.022 )
    0.13 ( 0.016 )
    0.15 ( 0.022 )
    Statistical analysis title
    Health State Index US - 1 mg Baricitinib
    Statistical analysis description
    CFB US Health State Index
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [21]
    P-value
    = 0.131
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.022
    Notes
    [21] - CFB US Health State Index
    Statistical analysis title
    Health State Index US - 2 mg Baricitinib
    Statistical analysis description
    CFB US Health State Index
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority [22]
    P-value
    = 0.017
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.01
         upper limit
    0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.019
    Notes
    [22] - CFB US Health State Index
    Statistical analysis title
    Health State Index US - 4 mg Baricitinib
    Statistical analysis description
    CFB US Health State Index
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority [23]
    P-value
    = 0.003
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.02
         upper limit
    0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.022
    Notes
    [23] - CFB US Health State Index
    Statistical analysis title
    Health State Index UK - 1 mg Baricitinib
    Statistical analysis description
    CFB UK Health State Index
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority [24]
    P-value
    = 0.102
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.031
    Notes
    [24] - CFB UK Health State Index
    Statistical analysis title
    Health State Index UK - 2 mg Baricitinib
    Statistical analysis description
    CFB UK Health State Index
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority [25]
    P-value
    = 0.014
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.01
         upper limit
    0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.027
    Notes
    [25] - CFB UK Health State Index
    Statistical analysis title
    Health State Index UK - 4 mg Baricitinib
    Statistical analysis description
    CFB UK Health State Index
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority [26]
    P-value
    = 0.003
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.03
         upper limit
    0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.031
    Notes
    [26] - CFB UK Health State Index

    Secondary: Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)

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    End point title
    Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
    End point description
    EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. APD: All randomized participants with Week 16 EQ-5D-5L VAS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    55
    62
    145
    67
    Units: units on a scale
        least squares mean (standard error)
    7.64 ( 2.407 )
    11.63 ( 2.306 )
    8.76 ( 1.588 )
    11.03 ( 2.260 )
    Statistical analysis title
    CFB EQ-5D-5L VAS - 1 mg Baricitinib
    Comparison groups
    Placebo v 1 mg Baricitinib
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.221
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    3.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.41
         upper limit
    10.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.256
    Statistical analysis title
    CFB EQ-5D-5L VAS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.689
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    1.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.4
         upper limit
    6.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.807
    Statistical analysis title
    CFB EQ-5D-5L VAS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.294
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    3.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.95
         upper limit
    9.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.226

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 24
    Adverse event reporting additional description
    Safety data includes data up to Week 24 data lock.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    1 mg Baricitinib
    Reporting group description
    -

    Reporting group title
    2 mg Baricitinib
    Reporting group description
    -

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    -

    Serious adverse events
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 93 (2.15%)
    5 / 93 (5.38%)
    4 / 184 (2.17%)
    6 / 92 (6.52%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    bowen's disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 93 (0.00%)
    0 / 184 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ligament rupture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    0 / 184 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    1 / 184 (0.54%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    1 / 184 (0.54%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    soft tissue inflammation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    0 / 184 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    conjunctivitis allergic
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    0 / 184 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 93 (1.08%)
    0 / 184 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    dermatitis atopic
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 93 (1.08%)
    1 / 184 (0.54%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dyshidrotic eczema
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    1 / 184 (0.54%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    bursitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    2 / 93 (2.15%)
    0 / 184 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 93 (1.08%)
    0 / 184 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    erysipelas
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 93 (0.00%)
    0 / 184 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    furuncle
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    1 / 184 (0.54%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative wound infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 93 (1.08%)
    0 / 184 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    0 / 184 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    staphylococcal infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 93 (0.00%)
    0 / 184 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo 1 mg Baricitinib 2 mg Baricitinib 4 mg Baricitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 93 (31.18%)
    32 / 93 (34.41%)
    69 / 184 (37.50%)
    50 / 92 (54.35%)
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 93 (6.45%)
    8 / 93 (8.60%)
    11 / 184 (5.98%)
    9 / 92 (9.78%)
         occurrences all number
    8
    14
    14
    11
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 93 (2.15%)
    2 / 93 (2.15%)
    5 / 184 (2.72%)
    5 / 92 (5.43%)
         occurrences all number
    2
    2
    5
    6
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 93 (3.23%)
    2 / 93 (2.15%)
    6 / 184 (3.26%)
    5 / 92 (5.43%)
         occurrences all number
    3
    2
    6
    5
    Respiratory, thoracic and mediastinal disorders
    oropharyngeal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 93 (1.08%)
    7 / 93 (7.53%)
    6 / 184 (3.26%)
    2 / 92 (2.17%)
         occurrences all number
    1
    8
    6
    2
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 93 (5.38%)
    2 / 93 (2.15%)
    4 / 184 (2.17%)
    5 / 92 (5.43%)
         occurrences all number
    6
    3
    4
    6
    Infections and infestations
    folliculitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 93 (2.15%)
    8 / 93 (8.60%)
    7 / 184 (3.80%)
    0 / 92 (0.00%)
         occurrences all number
    2
    9
    7
    0
    influenza
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 93 (2.15%)
    3 / 93 (3.23%)
    10 / 184 (5.43%)
    10 / 92 (10.87%)
         occurrences all number
    2
    4
    10
    10
    nasopharyngitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    13 / 93 (13.98%)
    15 / 93 (16.13%)
    34 / 184 (18.48%)
    27 / 92 (29.35%)
         occurrences all number
    18
    20
    43
    30
    oral herpes
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 93 (4.30%)
    4 / 93 (4.30%)
    5 / 184 (2.72%)
    5 / 92 (5.43%)
         occurrences all number
    4
    6
    8
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2019
    Amendment (c ): Key secondary endpoints were changed.
    19 Sep 2019
    Amendment (d): Update the Primary Endpoint from IGA 0,1 to EASI 75.
    06 Dec 2019
    Amendment (e): Updated risk information as well as the addition of a new bridging extension post week 104 (V22) of up to 96 additional weeks (for a total of 200 weeks).

    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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