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NCT03899259 · OUTCOME

Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥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
95% Confidence Interval
Time frame
Week 36

What was measured

PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.

Analysis population: All randomized participants with baseline PRO Measure EL 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
Placebo89
2 mg Baricitinib90
4 mg Baricitinib133

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo1.1Not reported0.26.1Not reported
2 mg Baricitinib18.9Not reported12.128.2Not reported
4 mg Baricitinib34.6Not reported27.043.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    78.42
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.002
    param Type
    Odds Ratio (OR)
    param Value
    14.63
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    5.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    99.99
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    30.37
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    2.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    78.42
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.002
    param Type
    Odds Ratio (OR)
    param Value
    14.63
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    5.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    99.99
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    30.37
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        6.1
        value
        1.1
      2. group Id
        OG001
        lower Limit
        12.1
        upper Limit
        28.2
        value
        18.9
      3. group Id
        OG002
        lower Limit
        27.0
        upper Limit
        43.0
        value
        34.6
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    2. group Id
      OG001
      value
      90
    3. group Id
      OG002
      value
      133
    units
    Participants
description
PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.
dispersion Type
95% 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 Measure EL hair loss ≥2 and who had evaluable data for this outcome measure.
reporting Status
POSTED
time Frame
Week 36
title
Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice