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NCT03899259 · OUTCOME

Percent Change From Baseline in SALT Score at Week 36

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
LEAST_SQUARES_MEAN
Unit
percentage of change
Interval / dispersion
Standard Error
Time frame
Baseline, Week 36

What was measured

SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\< 4 years versus ≥4 years), treatment group, and baseline value in the model.

Analysis population: All randomized participants with nonmissing baseline and at least one postbaseline measure who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.

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
Placebo153
2 mg Baricitinib151
4 mg Baricitinib230

Reported measurements

Source class 1
Values in percentage of change · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-2.962.723Not reportedNot reportedNot reported
2 mg Baricitinib-28.212.770Not reportedNot reportedNot reported
4 mg Baricitinib-47.452.229Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -32.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -17.72
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.834
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Mean Difference (Final Values)
    param Value
    -25.25
    statistical Method
    ANCOVA
  2. ci Lower Limit
    -51.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -37.65
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.482
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Mean Difference (Final Values)
    param Value
    -44.49
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Lower Limit
    -32.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -17.72
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.834
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Mean Difference (Final Values)
    param Value
    -25.25
    statistical Method
    ANCOVA
  2. ci Lower Limit
    -51.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -37.65
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.482
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Mean Difference (Final Values)
    param Value
    -44.49
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.723
        value
        -2.96
      2. group Id
        OG001
        spread
        2.770
        value
        -28.21
      3. group Id
        OG002
        spread
        2.229
        value
        -47.45
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      151
    3. group Id
      OG002
      value
      230
    units
    Participants
description
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\< 4 years versus ≥4 years), treatment group, and baseline value in the model.
dispersion Type
Standard Error
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
LEAST_SQUARES_MEAN
population Description
All randomized participants with nonmissing baseline and at least one postbaseline measure who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.
reporting Status
POSTED
time Frame
Baseline, Week 36
title
Percent Change From Baseline in SALT Score at Week 36
type
SECONDARY
unit Of Measure
percentage of change

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Preserved source evidence · Not medical advice