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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Combination with Topical Corticosteroids in Adult Patients with Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2018-001726-26
    Trial protocol
    		 DE   AT   ES   PL   IT  
    Global end of trial date
    22 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2020
    First version publication date
    09 Aug 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I4V-MC-JAIY
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03733301
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17100
    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
    Final
    Date of interim/final analysis
    22 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of baricitinib in combination with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis.
    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
    		 Participants were allowed to use approved low to moderate potency topical corticosteroids (TCS) as background therapy. Triamcinolone 0.1% cream and /or hydrocortisone 2.5% ointment were provided by the sponsor for use as background therapy. In the event of these specific TCS being unavailable, and alternate equivalent-potency TCS may be provided.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 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
    Argentina: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 63
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Japan: 63
    Country: Number of subjects enrolled
    Taiwan: 36
    Country: Number of subjects enrolled
    Poland: 26
    Country: Number of subjects enrolled
    Italy: 19
    Country: Number of subjects enrolled
    Australia: 27
    Country: Number of subjects enrolled
    Germany: 47
    Country: Number of subjects enrolled
    Spain: 15
    Worldwide total number of subjects
    329
    EEA total number of subjects
    115
    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)
    322
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants who completed the 16-week treatment period had an option to enter extension study JAHN (NCT03334435).

    Pre-assignment
    Screening details
    		 No Text Available

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo administered orally once daily in combination with topical corticosteroids (TCS).
    Arm type
    		 Placebo

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

    Arm title
    		 2 mg Baricitinib
    Arm description
    		 2 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 4 mg Baricitinib.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    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 TCS. Placebo administered orally once daily to match 2 mg Baricitinib.
    Arm type
    		 Experimental

    Investigational medicinal product name
    4 mg Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    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 2 mg Baricitinib 4 mg Baricitinib
    Started
    109
    109
    111
    Received at Least One Dose of Study Drug
    108
    109
    111
    Completed
    102
    100
    107
    Not completed
    7
    9
    4
         Screen Fail
    1
    -
    -
         Consent withdrawn by subject
    3
    5
    1
         Adverse event, non-fatal
    -
    1
    3
         Non-compliance
    1
    -
    -
         Lack of efficacy
    2
    3
    -

    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 (TCS).

    Reporting group title
    2 mg Baricitinib
    Reporting group description
    		 2 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 4 mg Baricitinib.

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 2 mg Baricitinib.

    Reporting group values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib Total
    Number of subjects
    		 109 109 111 329
    Age categorical
    Units: Subjects
        <=18 years
    		 0 0 0 0
        Between 18 and 65 years
    		 106 105 111 322
        >=65 years
    		 3 4 0 7
    Gender categorical
    Units: Subjects
        Female
    		 38 39 36 113
        Male
    		 71 70 75 216
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 57 57 54 168
        Multiple
    		 6 2 3 11
        White
    		 46 50 54 150
    Region of Enrollment
    Units: Subjects
        Argentina
    		 8 6 11 25
        South Korea
    		 29 19 15 63
        Austria
    		 2 1 5 8
        Japan
    		 21 20 22 63
        Taiwan
    		 9 12 15 36
        Poland
    		 11 9 6 26
        Italy
    		 7 6 6 19
        Australia
    		 4 14 9 27
        Germany
    		 12 18 17 47
        Spain
    		 6 4 5 15

    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 (TCS).

    Reporting group title
    2 mg Baricitinib
    Reporting group description
    		 2 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 4 mg Baricitinib.

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily in combination with TCS. Placebo administered orally once daily to match 2 mg Baricitinib.

    Primary: Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥ 2 Point Improvement

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    End point title
    		 Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥ 2 Point Improvement
    End point description
    The IGA measures investigators global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Analysis Population Description (APD): All randomized participants.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: percentage of participants
        number (not applicable)
    14.7
    23.9
    30.6
    Statistical analysis title
    		 IGA of 0 or 1 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.082
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 3.85
    Statistical analysis title
    		 IGA of 0 or 1 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.38
         upper limit
    		 5.56

    Secondary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)

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    End point title
    		 Percentage of Participants Achieving Eczema Area and Severity Index 75 (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 to 72 (severe). 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 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: percentage of participants
        number (not applicable)
    22.9
    43.1
    47.7
    Statistical analysis title
    		 EASI75 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.44
         upper limit
    		 4.76
    Statistical analysis title
    		 EASI75 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 5.97

    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 to 72 (severe). 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 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: percentage of participants
        number (not applicable)
    13.8
    16.5
    24.3
    Statistical analysis title
    		 EASI90 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.574
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 2.62
    Statistical analysis title
    		 EASI90 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.045
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 4.02

    Secondary: Percent Change from Baseline (PCFB) on EASI Score

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    End point title
    		 Percent Change from Baseline (PCFB) on 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 to 72 (severe). Least Squares Mean (LSM) were calculated using mixed model repeated measures (MMRM) 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
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    90
    100
    100
    Units: percent change
        least squares mean (standard error)
    -45.08 ( 3.828 )
    -58.16 ( 3.689 )
    -67.21 ( 3.679 )
    Statistical analysis title
    		 PCFB EASI - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.42
         upper limit
    		 -2.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.256
    Statistical analysis title
    		 PCFB EASI - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -22.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.48
         upper limit
    		 -11.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.259

    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), and subjective symptoms (C: 0-20) combine A/5+7^B/2+C to give a maximum possible score of 103, where 0 = no disease & 103 = severe disease. The SCORAD 75 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 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: percentage of participants
        number (not applicable)
    7.3
    11.0
    18.0
    Statistical analysis title
    		 SCORAD75 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.364
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 3.81
    Statistical analysis title
    		 SCORAD 75 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 6.34

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

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    End point title
    		 Percentage of Participants Achieving a 4-Point Improvement on the Itch Numeric Rating Scale (NRS)
    End point description
    The Itch NRS is a patient-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 patient’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. APD: All randomized participants with Baseline Itch Score >= 4.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    104
    97
    100
    Units: percentage of participants
        number (not applicable)
    20.2
    38.1
    44.0
    Statistical analysis title
    		 NRS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.48
         upper limit
    		 5.61
    Statistical analysis title
    		 NRS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.98
         upper limit
    		 7.46

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

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    End point title
    		 Change from Baseline (CFB) in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
    End point description
    The ADSS is a 3-item, patient-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Patients report their frequency of waking last night, item 2, 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 each day, using a daily diary, with respondents thinking about sleep “last night.” Each item is scored individually. LS Mean were calculated using MMRM 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. APD: 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 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    89
    98
    94
    Units: units on a scale
        least squares mean (standard error)
    -0.51 ( 0.151 )
    -1.33 ( 0.147 )
    -1.42 ( 0.147 )
    Statistical analysis title
    		 CFB ADSS - 2 mg
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.23
         upper limit
    		 -0.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.209
    Statistical analysis title
    		 CFB ADSS - 4 mg
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.33
         upper limit
    		 -0.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.209

    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
    The Skin Pain NRS is a patient-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 patient’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 Means were calculated using a 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 Skin Pain NRS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    89
    98
    94
    Units: units on a scale
        least squares mean (standard error)
    -2.06 ( 0.231 )
    -3.22 ( 0.224 )
    -3.73 ( 0.226 )
    Statistical analysis title
    		 CFB NRS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    -1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.78
         upper limit
    		 -0.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.319
    Statistical analysis title
    		 CFB NRS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 -1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.322

    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 to 72 (severe). 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 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: percentage of participants
        number (not applicable)
    41.3
    64.2
    70.3
    Statistical analysis title
    		 EASI50 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.57
    Confidence interval
         level
    		 96%
         sides
    2-sided
         lower limit
    		 1.47
         upper limit
    		 4.49
    Statistical analysis title
    		 EASI50 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 6.32

    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 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: percentage of participants
        number (not applicable)
    2.8
    3.7
    8.1
    Statistical analysis title
    		 IGA of 0 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.715
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 5.31
    Statistical analysis title
    		 IGA of 0 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.083
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 10.56

    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, & (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 Means were calculated using a 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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    90 [1]
    100 [2]
    99 [3]
    Units: units on a scale
        least squares mean (standard error)
    -21.40 ( 1.941 )
    -29.88 ( 1.867 )
    -35.78 ( 1.862 )
    Notes
    [1] - APD: All randomized participants with Week 16 SCORAD data.
    [2] - APD: All randomized participants with Week 16 SCORAD data.
    [3] - APD: All randomized participants with Week 16 SCORAD data.
    Statistical analysis title
    		 CFB SCORAD - 2 mg Baricitinib
    Comparison groups
    2 mg Baricitinib v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.72
         upper limit
    		 -3.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.663
    Statistical analysis title
    		 CFB SCORAD - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    189
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.62
         upper limit
    		 -9.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.662

    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 in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: (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 is defined as a ≥ 90% improvement from baseline in the SCORAD score. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: percentage of participants
        number (not applicable)
    0.9
    3.7
    7.2
    Statistical analysis title
    		 SCORAD90 - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.204
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 19.37
    Statistical analysis title
    		 SCORAD90 - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 38.53

    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 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
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    90 [4]
    100 [5]
    100 [6]
    Units: units on a scale
        least squares mean (standard error)
    -18.03 ( 1.888 )
    -27.00 ( 1.825 )
    -29.73 ( 1.814 )
    Notes
    [4] - APD: All randomized participants with Week 16 BSA data.
    [5] - APD: All randomized participants with Week 16 BSA data.
    [6] - APD: All randomized participants with Week 16 BSA data.
    Statistical analysis title
    		 CFB BSA - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.07
         upper limit
    		 -3.87
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.591
    Statistical analysis title
    		 CFB BSA - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -11.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.78
         upper limit
    		 -6.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.584

    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 receive at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    108
    109
    111
    Units: percentage of participants
        number (not applicable)
    2.8
    4.6
    2.7
    Statistical analysis title
    		 Skin Infections - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.721
    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
    219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.999
    Method
    		 Fisher exact
    Confidence interval

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

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    End point title
    		 Mean Gram Quantity of Moderate Potency Background Topical Corticosteroids (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 (IGA) and treatment as factors in the model. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 0 through Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: gram
        least squares mean (standard error)
    252.75 ( 17.536 )
    187.59 ( 17.508 )
    161.61 ( 17.280 )
    Statistical analysis title
    		 Moderate Potency Background TCS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.0073
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -65.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -112.87
         upper limit
    		 -17.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    24.149
    Statistical analysis title
    		 Moderate Potency Background TCS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -91.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -138.43
         upper limit
    		 -43.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    24.038

    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 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    89
    98
    94
    Units: percent change
        least squares mean (standard error)
    -27.00 ( 3.370 )
    -43.44 ( 3.263 )
    -51.22 ( 3.280 )
    Statistical analysis title
    		 PCFB Itch NRS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.6
         upper limit
    		 -7.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.658
    Statistical analysis title
    		 PCFB Itch NRS - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -24.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.42
         upper limit
    		 -15.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.672

    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 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 POEM data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    89
    99
    99
    Units: units on a scale
        least squares mean (standard error)
    -5.60 ( 0.764 )
    -8.50 ( 0.736 )
    -10.83 ( 0.730 )
    Statistical analysis title
    		 CFB POEM - 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
    		 = 0.006
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.96
         upper limit
    		 -0.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.046
    Statistical analysis title
    		 CFB POEM - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.28
         upper limit
    		 -3.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.043

    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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    89
    98
    94
    Units: units on a scale
        least squares mean (standard error)
    -0.69 ( 0.094 )
    -1.06 ( 0.091 )
    -1.18 ( 0.091 )
    Statistical analysis title
    		 CFB PGI-S-AD - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 -0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Statistical analysis title
    		 CFB PGI-S-AD - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 -0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13

    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 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 Week 16 HADS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    88
    99
    99
    Units: units on a scale
    least squares mean (standard error)
        Depression
    -1.31 ( 0.311 )
    -2.05 ( 0.298 )
    -2.33 ( 0.296 )
        Anxiety
    -1.89 ( 0.304 )
    -2.70 ( 0.292 )
    -2.80 ( 0.289 )
    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
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.083
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.57
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.425
    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
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 -0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.423
    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
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.051
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.63
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.415
    Notes
    [7] - HADS 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
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.028
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.72
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.413
    Notes
    [8] - HADS Anxiety

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

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    End point title
    		 Change from Baseline on 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 lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), 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. APD: All randomized participants with Week 16 DLQI data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    89
    99
    99
    Units: units on a scale
        least squares mean (standard error)
    -5.58 ( 0.608 )
    -7.50 ( 0.584 )
    -8.89 ( 0.851 )
    Statistical analysis title
    		 DLQI - 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
    		 = 0.022
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.56
         upper limit
    		 -0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.832
    Statistical analysis title
    		 DLQI - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.94
         upper limit
    		 -1.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.829

    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 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    87
    99
    111
    Units: units on a scale
    least squares mean (standard error)
        Absenteeism (n=47, 57, 57)
    -6.27 ( 1.897 )
    -4.25 ( 1.741 )
    -5.29 ( 1.737 )
        Presenteeism (n=46, 54, 54)
    -13.15 ( 3.203 )
    -21.28 ( 2.978 )
    -23.89 ( 2.955 )
        Work Productivity Loss (n=46, 54, 54)
    -14.25 ( 3.300 )
    -22.17 ( 3.070 )
    -24.96 ( 3.051 )
        Activity Impairment (n=87, 99, 98)
    -16.75 ( 2.570 )
    -26.55 ( 2.458 )
    -27.25 ( 2.447 )
    Statistical analysis title
    		 WPAI-AD Absenteeism - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.435
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.06
         upper limit
    		 7.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.569
    Statistical analysis title
    		 WPAI-AD Absenteeism - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.706
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 6.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.569
    Statistical analysis title
    		 WPAI-AD Presenteeism - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.066
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.78
         upper limit
    		 0.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.384
    Statistical analysis title
    		 WPAI-AD Presenteeism - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.3
         upper limit
    		 -2.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.336
    Statistical analysis title
    		 WPAI-AD Work Productivity Loss - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.081
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.84
         upper limit
    		 0.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.511
    Statistical analysis title
    		 WPAI-AD Work Productivity Loss - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.018
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.55
         upper limit
    		 1.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.473
    Statistical analysis title
    		 WPAI-AD Activity Impairment - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.71
         upper limit
    		 -2.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.511
    Statistical analysis title
    		 WPAI-AD Activity Impairment - 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.39
         upper limit
    		 -3.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5

    Secondary: Change From Baseline on 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 on the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
    End point description
    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 Week 16 EQ-5D-5L Health State Index US and UK data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    87
    99
    98
    Units: units on a scale
    least squares mean (standard error)
        Health State Index Score (US Algorithm)
    0.09 ( 0.013 )
    0.12 ( 0.012 )
    0.14 ( 0.012 )
        Health State Index Score (UK Algorithm)
    0.13 ( 0.018 )
    0.17 ( 0.017 )
    0.21 ( 0.017 )
    Statistical analysis title
    		 Health State Index US - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.176
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Statistical analysis title
    		 Health State Index US - 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
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Statistical analysis title
    		 Health State Index UK - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.176
    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
    0.024
    Statistical analysis title
    		 Health State Index UK - 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
    		 = 0.003
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.024

    Secondary: Change from Baseline on the EQ-5D-5L Visual Analog Scale (VAS)

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    End point title
    		 Change from Baseline on the EQ-5D-5L Visual Analog Scale (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-interaction 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 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    87
    99
    98
    Units: milliliters
        least squares mean (standard error)
    11.00 ( 1.903 )
    15.12 ( 1.806 )
    17.06 ( 1.805 )
    Statistical analysis title
    		 CFB EQ-5D-5L VAS - 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.113
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 9.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.593
    Statistical analysis title
    		 CFB EQ-5D-5L VAS - 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
    		 = 0.02
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 11.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.592

    Secondary: Mean Number of Days Without Use of Background TCS

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    End point title
    		 Mean Number of Days Without Use of Background TCS
    End point description
    The ANCOVA model includes treatment, region, and baseline disease severity (IGA) as factors. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 0 through Week 16
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: Days
        least squares mean (standard error)
    12.45 ( 3.17 )
    22.49 ( 3.16 )
    29.78 ( 3.12 )
    Statistical analysis title
    		 Background TCS 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 18.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.36
    Statistical analysis title
    		 Background TCS 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    17.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.79
         upper limit
    		 25.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.34

    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) 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 4
    End point values
    		 Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    109
    109
    111
    Units: Participants
        number (not applicable)
    5.5
    17.4
    19.8
    Statistical analysis title
    		 IGA of 0 or 1: 2 mg Baricitinib
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 10.03
    Statistical analysis title
    		 IGA of 0 or 1: 4 mg Baricitinib
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.77
         upper limit
    		 11.87

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 20 weeks
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo administered orally once daily.

    Reporting group title
    4mg Baricitinib
    Reporting group description
    		 4 mg Baricitinib administered orally once daily.

    Reporting group title
    2mg Baricitinib
    Reporting group description
    		 2 mg Baricitinib administered orally once daily.

    Serious adverse events
    		 Placebo 4mg Baricitinib 2mg Baricitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 108 (3.70%)
    4 / 111 (3.60%)
    2 / 109 (1.83%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    skin laceration
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 111 (0.90%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 111 (0.90%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 111 (0.90%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    dermatitis atopic
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 108 (0.00%)
    0 / 111 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 108 (0.00%)
    1 / 111 (0.90%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    eye infection toxoplasmal
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    postoperative abscess
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 111 (0.00%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 4mg Baricitinib 2mg Baricitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 108 (13.89%)
    26 / 111 (23.42%)
    24 / 109 (22.02%)
    Infections and infestations
    folliculitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    0 / 108 (0.00%)
    6 / 111 (5.41%)
    4 / 109 (3.67%)
         occurrences all number
    0
    6
    4
    nasopharyngitis
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    13 / 108 (12.04%)
    17 / 111 (15.32%)
    12 / 109 (11.01%)
         occurrences all number
    14
    18
    16
    upper respiratory tract infection
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    2 / 108 (1.85%)
    3 / 111 (2.70%)
    8 / 109 (7.34%)
         occurrences all number
    2
    4
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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