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NCT01721044 · OUTCOME

Change From Baseline in European Quality of Life-5 Dimensions-5 Level 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
Units on a Scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 12, Week 24

What was measured

European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.

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. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.

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
Placebo168
Baricitinib 2 mg168
Baricitinib 4 mg173

Reported measurements

Index Score (US Algorithm) Wk 12 (N=168,168,173)
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.0350.167Not reportedNot reportedNot reported
Baricitinib 2 mg0.0800.152Not reportedNot reportedNot reported
Baricitinib 4 mg0.1280.148Not reportedNot reportedNot reported
Index Score (US Algorithm) Wk 24 (N=167,168,173)
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.0420.166Not reportedNot reportedNot reported
Baricitinib 2 mg0.0820.170Not reportedNot reportedNot reported
Baricitinib 4 mg0.1280.157Not reportedNot reportedNot reported
Index Score (UK Algorithm) Wk 12 (N=168,168,173)
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.0520.250Not reportedNot reportedNot reported
Baricitinib 2 mg0.1160.224Not reportedNot reportedNot reported
Baricitinib 4 mg0.1910.224Not reportedNot reportedNot reported
Index Score (UK Algorithm) Wk 24 (N=167,168,173)
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.0640.245Not reportedNot reportedNot reported
Baricitinib 2 mg0.1220.250Not reportedNot reportedNot reported
Baricitinib 4 mg0.1920.237Not reportedNot reportedNot reported
Self-Perceived Health Wk 12 (N=168,168,173)
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo4.129.0Not reportedNot reportedNot reported
Baricitinib 2 mg14.124.2Not reportedNot reportedNot reported
Baricitinib 4 mg10.327.3Not reportedNot reportedNot reported
Self-Perceived Health Wk 24 (N=167,168,173)
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo3.827.8Not reportedNot reportedNot reported
Baricitinib 2 mg11.426.5Not reportedNot reportedNot reported
Baricitinib 4 mg13.329.0Not 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
    Week 12, US Algorithm
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Description
    Week 12, US Algorithm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  3. ci Num Sides
    TWO_SIDED
    group Description
    Week 24, US Algorithm
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  4. ci Num Sides
    TWO_SIDED
    group Description
    Week 24, US Algorithm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.003
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  5. ci Num Sides
    TWO_SIDED
    group Description
    Week 12, UK Algorithm
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  6. ci Num Sides
    TWO_SIDED
    group Description
    Week 12, UK Algorithm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  7. ci Num Sides
    TWO_SIDED
    group Description
    Week 24, UK Algorithm
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  8. ci Num Sides
    TWO_SIDED
    group Description
    Week 24, UK Algorithm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.002
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    Week 12, US Algorithm
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  2. ci Num Sides
    TWO_SIDED
    group Description
    Week 12, US Algorithm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  3. ci Num Sides
    TWO_SIDED
    group Description
    Week 24, US Algorithm
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  4. ci Num Sides
    TWO_SIDED
    group Description
    Week 24, US Algorithm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.003
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  5. ci Num Sides
    TWO_SIDED
    group Description
    Week 12, UK Algorithm
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  6. ci Num Sides
    TWO_SIDED
    group Description
    Week 12, UK Algorithm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  7. ci Num Sides
    TWO_SIDED
    group Description
    Week 24, UK Algorithm
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
  8. ci Num Sides
    TWO_SIDED
    group Description
    Week 24, UK Algorithm
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.002
    p Value Comment
    a priori p-value significance threshold: 2-sided ≤0.05
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.167
        value
        0.035
      2. group Id
        OG001
        spread
        0.152
        value
        0.080
      3. group Id
        OG002
        spread
        0.148
        value
        0.128
    title
    Index Score (US Algorithm) Wk 12 (N=168,168,173)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.166
        value
        0.042
      2. group Id
        OG001
        spread
        0.170
        value
        0.082
      3. group Id
        OG002
        spread
        0.157
        value
        0.128
    title
    Index Score (US Algorithm) Wk 24 (N=167,168,173)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.250
        value
        0.052
      2. group Id
        OG001
        spread
        0.224
        value
        0.116
      3. group Id
        OG002
        spread
        0.224
        value
        0.191
    title
    Index Score (UK Algorithm) Wk 12 (N=168,168,173)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.245
        value
        0.064
      2. group Id
        OG001
        spread
        0.250
        value
        0.122
      3. group Id
        OG002
        spread
        0.237
        value
        0.192
    title
    Index Score (UK Algorithm) Wk 24 (N=167,168,173)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.0
        value
        4.1
      2. group Id
        OG001
        spread
        24.2
        value
        14.1
      3. group Id
        OG002
        spread
        27.3
        value
        10.3
    title
    Self-Perceived Health Wk 12 (N=168,168,173)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.8
        value
        3.8
      2. group Id
        OG001
        spread
        26.5
        value
        11.4
      3. group Id
        OG002
        spread
        29.0
        value
        13.3
    title
    Self-Perceived Health Wk 24 (N=167,168,173)
denoms
  1. counts
    1. group Id
      OG000
      value
      168
    2. group Id
      OG001
      value
      168
    3. group Id
      OG002
      value
      173
    units
    Participants
description
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
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. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
reporting Status
POSTED
time Frame
Baseline, Week 12, Week 24
title
Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores
type
SECONDARY
unit Of Measure
Units on a Scale

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Preserved source evidence · Not medical advice