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NCT01721044 · OUTCOME

Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores

A Moderate to Severe Rheumatoid Arthritis Study · Source last updated 2019-09-18

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

Measure
MEAN
Unit
Percentage of Impairment
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 12, Week 24

What was measured

The WPAI-RA 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. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)\*100, Percentage impairment while working presenteeism: Q5/10\*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))x(Q5/10)\]\*100; Percentage activity impairment activity impairment: Q6/10\*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.

Analysis population: mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized.

Groups in this outcome

Placebo

Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 2 mg

Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

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

Analysis denominator · Participants

GroupSource count
Placebo176
Baricitinib 2 mg174
Baricitinib 4 mg177

Reported measurements

Absenteeism Week 12
Values in Percentage of Impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo3.223.8Not reportedNot reportedNot reported
Baricitinib 2 mg-6.726.6Not reportedNot reportedNot reported
Baricitinib 4 mg-6.522.1Not reportedNot reportedNot reported
Absenteeism Week 24
Values in Percentage of Impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.912.4Not reportedNot reportedNot reported
Baricitinib 2 mg-1.931.4Not reportedNot reportedNot reported
Baricitinib 4 mg-2.329.5Not reportedNot reportedNot reported
Presenteeism Week 12
Values in Percentage of Impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-4.126.4Not reportedNot reportedNot reported
Baricitinib 2 mg-12.024.0Not reportedNot reportedNot reported
Baricitinib 4 mg-10.524.0Not reportedNot reportedNot reported
Presenteeism Week 24
Values in Percentage of Impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-7.130.5Not reportedNot reportedNot reported
Baricitinib 2 mg-11.424.9Not reportedNot reportedNot reported
Baricitinib 4 mg-15.625.4Not reportedNot reportedNot reported
Work Productivity Loss Week 12
Values in Percentage of Impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-4.227.8Not reportedNot reportedNot reported
Baricitinib 2 mg-13.726.7Not reportedNot reportedNot reported
Baricitinib 4 mg-12.324.8Not reportedNot reportedNot reported
Work Productivity Loss Week 24
Values in Percentage of Impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-6.033.4Not reportedNot reportedNot reported
Baricitinib 2 mg-13.227.6Not reportedNot reportedNot reported
Baricitinib 4 mg-14.832.4Not reportedNot reportedNot reported
Activity Impairment Week 12
Values in Percentage of Impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-10.422.8Not reportedNot reportedNot reported
Baricitinib 2 mg-16.025.5Not reportedNot reportedNot reported
Baricitinib 4 mg-18.124.8Not reportedNot reportedNot reported
Activity Impairment Week 24
Values in Percentage of Impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-15.725.5Not reportedNot reportedNot reported
Baricitinib 2 mg-20.823.7Not reportedNot reportedNot reported
Baricitinib 4 mg-25.825.2Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Description
    Absenteeism Week 12
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.362
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Description
    Absenteeism Week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.170
    statistical Method
    ANCOVA
  3. ci Num Sides
    TWO_SIDED
    group Description
    Absenteeism Week 24
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.753
    statistical Method
    ANCOVA
  4. ci Num Sides
    TWO_SIDED
    group Description
    Absenteeism Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.715
    statistical Method
    ANCOVA
  5. ci Num Sides
    TWO_SIDED
    group Description
    Presenteeism Week 12
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.077
    statistical Method
    ANCOVA
  6. ci Num Sides
    TWO_SIDED
    group Description
    Presenteeism Week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.058
    statistical Method
    ANCOVA
  7. ci Num Sides
    TWO_SIDED
    group Description
    Presenteeism Week 24
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.232
    statistical Method
    ANCOVA
  8. ci Num Sides
    TWO_SIDED
    group Description
    Presenteeism Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.534
    statistical Method
    ANCOVA
  9. ci Num Sides
    TWO_SIDED
    group Description
    Work Productivity Loss Week 12
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.079
    statistical Method
    ANCOVA
  10. ci Num Sides
    TWO_SIDED
    group Description
    Work Productivity Loss Week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.070
    statistical Method
    ANCOVA
  11. ci Num Sides
    TWO_SIDED
    group Description
    Work Productivity Loss Week 24
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.327
    statistical Method
    ANCOVA
  12. ci Num Sides
    TWO_SIDED
    group Description
    Work Productivity Loss Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.479
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    Absenteeism Week 12
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.362
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Description
    Absenteeism Week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.170
    statistical Method
    ANCOVA
  3. ci Num Sides
    TWO_SIDED
    group Description
    Absenteeism Week 24
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.753
    statistical Method
    ANCOVA
  4. ci Num Sides
    TWO_SIDED
    group Description
    Absenteeism Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.715
    statistical Method
    ANCOVA
  5. ci Num Sides
    TWO_SIDED
    group Description
    Presenteeism Week 12
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.077
    statistical Method
    ANCOVA
  6. ci Num Sides
    TWO_SIDED
    group Description
    Presenteeism Week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.058
    statistical Method
    ANCOVA
  7. ci Num Sides
    TWO_SIDED
    group Description
    Presenteeism Week 24
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.232
    statistical Method
    ANCOVA
  8. ci Num Sides
    TWO_SIDED
    group Description
    Presenteeism Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.534
    statistical Method
    ANCOVA
  9. ci Num Sides
    TWO_SIDED
    group Description
    Work Productivity Loss Week 12
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.079
    statistical Method
    ANCOVA
  10. ci Num Sides
    TWO_SIDED
    group Description
    Work Productivity Loss Week 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.070
    statistical Method
    ANCOVA
  11. ci Num Sides
    TWO_SIDED
    group Description
    Work Productivity Loss Week 24
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.327
    statistical Method
    ANCOVA
  12. ci Num Sides
    TWO_SIDED
    group Description
    Work Productivity Loss Week 24
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.479
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.8
        value
        3.2
      2. group Id
        OG001
        spread
        26.6
        value
        -6.7
      3. group Id
        OG002
        spread
        22.1
        value
        -6.5
    title
    Absenteeism Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.4
        value
        0.9
      2. group Id
        OG001
        spread
        31.4
        value
        -1.9
      3. group Id
        OG002
        spread
        29.5
        value
        -2.3
    title
    Absenteeism Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.4
        value
        -4.1
      2. group Id
        OG001
        spread
        24.0
        value
        -12.0
      3. group Id
        OG002
        spread
        24.0
        value
        -10.5
    title
    Presenteeism Week 12
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.5
        value
        -7.1
      2. group Id
        OG001
        spread
        24.9
        value
        -11.4
      3. group Id
        OG002
        spread
        25.4
        value
        -15.6
    title
    Presenteeism Week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.8
        value
        -4.2
      2. group Id
        OG001
        spread
        26.7
        value
        -13.7
      3. group Id
        OG002
        spread
        24.8
        value
        -12.3
    title
    Work Productivity Loss Week 12
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.4
        value
        -6.0
      2. group Id
        OG001
        spread
        27.6
        value
        -13.2
      3. group Id
        OG002
        spread
        32.4
        value
        -14.8
    title
    Work Productivity Loss Week 24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.8
        value
        -10.4
      2. group Id
        OG001
        spread
        25.5
        value
        -16.0
      3. group Id
        OG002
        spread
        24.8
        value
        -18.1
    title
    Activity Impairment Week 12
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.5
        value
        -15.7
      2. group Id
        OG001
        spread
        23.7
        value
        -20.8
      3. group Id
        OG002
        spread
        25.2
        value
        -25.8
    title
    Activity Impairment Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      176
    2. group Id
      OG001
      value
      174
    3. group Id
      OG002
      value
      177
    units
    Participants
description
The WPAI-RA 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. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)\*100, Percentage impairment while working presenteeism: Q5/10\*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))x(Q5/10)\]\*100; Percentage activity impairment activity impairment: Q6/10\*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.
dispersion Type
Standard Deviation
groups
  1. description
    Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    OG000
    title
    Placebo
  2. description
    Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    OG001
    title
    Baricitinib 2 mg
  3. description
    Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    OG002
    title
    Baricitinib 4 mg
param Type
MEAN
population Description
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized.
reporting Status
POSTED
time Frame
Baseline, Week 12, Week 24
title
Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
type
SECONDARY
unit Of Measure
Percentage of Impairment

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Preserved source evidence · Not medical advice