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NCT03570749 · 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) - Phase 3

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata · Source last updated 2026-04-16

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 phase 3 participants with baseline with baseline PRO measure for EL ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.

Groups in this outcome

Placebo Phase 3

Participants received two placebo tablets administered orally QD.

2 mg Baricitinib Phase 3

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

4 mg Baricitinib Phase 3

Participants received one 4 mg Baricitinib tablet administered orally QD, 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
Placebo Phase 3100
2 mg Baricitinib Phase 3112
4 mg Baricitinib Phase 3161

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo Phase 32.0Not reported0.67.0Not reported
2 mg Baricitinib Phase 319.6Not reported13.328.0Not reported
4 mg Baricitinib Phase 329.8Not reported23.337.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    39.30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    10.34
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    5.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    67.68
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    18.47
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    2.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    39.30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    10.34
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    5.04
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    67.68
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    18.47
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        7.0
        value
        2.0
      2. group Id
        OG001
        lower Limit
        13.3
        upper Limit
        28.0
        value
        19.6
      3. group Id
        OG002
        lower Limit
        23.3
        upper Limit
        37.3
        value
        29.8
denoms
  1. counts
    1. group Id
      OG000
      value
      100
    2. group Id
      OG001
      value
      112
    3. group Id
      OG002
      value
      161
    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 administered orally QD.
    id
    OG000
    title
    Placebo Phase 3
  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 Phase 3
  3. description
    Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
    id
    OG002
    title
    4 mg Baricitinib Phase 3
param Type
NUMBER
population Description
All randomized phase 3 participants with baseline with baseline PRO measure for EL ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
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) - Phase 3
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice