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NCT03899259 · OUTCOME

Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline)

A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata · Source last updated 2026-04-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Week 36

What was measured

PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.

Analysis population: All randomized participants with baseline PRO measures for EB hair loss ≥2 and who had evaluable data for this outcome measure.

Groups in this outcome

Placebo

Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.

2 mg Baricitinib

Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.

4 mg Baricitinib

Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo107
2 mg Baricitinib108
4 mg Baricitinib165

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo4.7Not reported2.010.5Not reported
2 mg Baricitinib14.8Not reported9.322.7Not reported
4 mg Baricitinib35.8Not reported28.843.3Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    9.40
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.017
    param Type
    Odds Ratio (OR)
    param Value
    3.43
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    4.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    27.25
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    10.85
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    1.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    9.40
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.017
    param Type
    Odds Ratio (OR)
    param Value
    3.43
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    4.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    27.25
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    10.85
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        10.5
        value
        4.7
      2. group Id
        OG001
        lower Limit
        9.3
        upper Limit
        22.7
        value
        14.8
      3. group Id
        OG002
        lower Limit
        28.8
        upper Limit
        43.3
        value
        35.8
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    2. group Id
      OG001
      value
      108
    3. group Id
      OG002
      value
      165
    units
    Participants
description
PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.
    id
    OG000
    title
    Placebo
  2. description
    Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.
    id
    OG001
    title
    2 mg Baricitinib
  3. description
    Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
    id
    OG002
    title
    4 mg Baricitinib
param Type
NUMBER
population Description
All randomized participants with baseline PRO measures for EB hair loss ≥2 and who had evaluable data for this outcome measure.
reporting Status
POSTED
time Frame
Week 36
title
Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice