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NCT01721057 · OUTCOME

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

A Study in Moderate to Severe Rheumatoid Arthritis Participants · 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; Baseline, Week 24

What was measured

The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) 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. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.

Analysis population: mITT population: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.

Groups in this outcome

Placebo

Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg

Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg

Baricitinib 4 mg administered orally once daily 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
Placebo228
Baricitinib 2 mg229
Baricitinib 4 mg227

Reported measurements

Absenteeism Week 12

Analysis denominator · Participants

GroupSource count
Placebo73
Baricitinib 2 mg72
Baricitinib 4 mg69
Values in percentage of impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo2.623.5Not reportedNot reportedNot reported
Baricitinib 2 mg-6.326.5Not reportedNot reportedNot reported
Baricitinib 4 mg2.524.7Not reportedNot reportedNot reported
Absenteeism Week 24

Analysis denominator · Participants

GroupSource count
Placebo44
Baricitinib 2 mg62
Baricitinib 4 mg56
Values in percentage of impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-2.113.9Not reportedNot reportedNot reported
Baricitinib 2 mg-3.828.2Not reportedNot reportedNot reported
Baricitinib 4 mg4.027.2Not reportedNot reportedNot reported
Presenteeism Week 12

Analysis denominator · Participants

GroupSource count
Placebo71
Baricitinib 2 mg69
Baricitinib 4 mg66
Values in percentage of impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-826Not reportedNot reportedNot reported
Baricitinib 2 mg-1725Not reportedNot reportedNot reported
Baricitinib 4 mg-1527Not reportedNot reportedNot reported
Presenteeism Week 24

Analysis denominator · Participants

GroupSource count
Placebo44
Baricitinib 2 mg61
Baricitinib 4 mg53
Values in percentage of impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-1726Not reportedNot reportedNot reported
Baricitinib 2 mg-2023Not reportedNot reportedNot reported
Baricitinib 4 mg-1721Not reportedNot reportedNot reported
Work Productivity Loss Week 12

Analysis denominator · Participants

GroupSource count
Placebo71
Baricitinib 2 mg69
Baricitinib 4 mg66
Values in percentage of impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-4.227.7Not reportedNot reportedNot reported
Baricitinib 2 mg-17.630.4Not reportedNot reportedNot reported
Baricitinib 4 mg-9.923.7Not reportedNot reportedNot reported
Work Producivity Loss Week 24

Analysis denominator · Participants

GroupSource count
Placebo44
Baricitinib 2 mg61
Baricitinib 4 mg53
Values in percentage of impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-15.926.1Not reportedNot reportedNot reported
Baricitinib 2 mg-19.625.0Not reportedNot reportedNot reported
Baricitinib 4 mg-14.323.0Not reportedNot reportedNot reported
Activity Impairment Week 12

Analysis denominator · Participants

GroupSource count
Placebo206
Baricitinib 2 mg222
Baricitinib 4 mg213
Values in percentage of impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-1325Not reportedNot reportedNot reported
Baricitinib 2 mg-1927Not reportedNot reportedNot reported
Baricitinib 4 mg-1925Not reportedNot reportedNot reported
Activity Impairment Week 24

Analysis denominator · Participants

GroupSource count
Placebo141
Baricitinib 2 mg187
Baricitinib 4 mg187
Values in percentage of impairment · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-1827Not reportedNot reportedNot reported
Baricitinib 2 mg-2328Not reportedNot reportedNot reported
Baricitinib 4 mg-2127Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.5
        value
        2.6
      2. group Id
        OG001
        spread
        26.5
        value
        -6.3
      3. group Id
        OG002
        spread
        24.7
        value
        2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        72
      3. group Id
        OG002
        value
        69
      units
      Participants
    title
    Absenteeism Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.9
        value
        -2.1
      2. group Id
        OG001
        spread
        28.2
        value
        -3.8
      3. group Id
        OG002
        spread
        27.2
        value
        4.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        62
      3. group Id
        OG002
        value
        56
      units
      Participants
    title
    Absenteeism Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        26
        value
        -8
      2. group Id
        OG001
        spread
        25
        value
        -17
      3. group Id
        OG002
        spread
        27
        value
        -15
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        69
      3. group Id
        OG002
        value
        66
      units
      Participants
    title
    Presenteeism Week 12
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        26
        value
        -17
      2. group Id
        OG001
        spread
        23
        value
        -20
      3. group Id
        OG002
        spread
        21
        value
        -17
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        61
      3. group Id
        OG002
        value
        53
      units
      Participants
    title
    Presenteeism Week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.7
        value
        -4.2
      2. group Id
        OG001
        spread
        30.4
        value
        -17.6
      3. group Id
        OG002
        spread
        23.7
        value
        -9.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        69
      3. group Id
        OG002
        value
        66
      units
      Participants
    title
    Work Productivity Loss Week 12
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.1
        value
        -15.9
      2. group Id
        OG001
        spread
        25.0
        value
        -19.6
      3. group Id
        OG002
        spread
        23.0
        value
        -14.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        61
      3. group Id
        OG002
        value
        53
      units
      Participants
    title
    Work Producivity Loss Week 24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        25
        value
        -13
      2. group Id
        OG001
        spread
        27
        value
        -19
      3. group Id
        OG002
        spread
        25
        value
        -19
    denoms
    1. counts
      1. group Id
        OG000
        value
        206
      2. group Id
        OG001
        value
        222
      3. group Id
        OG002
        value
        213
      units
      Participants
    title
    Activity Impairment Week 12
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        27
        value
        -18
      2. group Id
        OG001
        spread
        28
        value
        -23
      3. group Id
        OG002
        spread
        27
        value
        -21
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      2. group Id
        OG001
        value
        187
      3. group Id
        OG002
        value
        187
      units
      Participants
    title
    Activity Impairment Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      228
    2. group Id
      OG001
      value
      229
    3. group Id
      OG002
      value
      227
    units
    Participants
description
The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) 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. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.
dispersion Type
Standard Deviation
groups
  1. description
    Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
    id
    OG000
    title
    Placebo
  2. description
    Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
    id
    OG001
    title
    Baricitinib 2 mg
  3. description
    Baricitinib 4 mg administered orally once daily 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: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.
reporting Status
POSTED
time Frame
Baseline, Week 12; Baseline, Week 24
title
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