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NCT02383589 · OUTCOME

Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score

A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) · Source last updated 2020-11-10

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

Measure
MEAN
Unit
Scores on a Scale
Interval / dispersion
Standard Error
Time frame
From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)

What was measured

Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.

Analysis population: The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes. Only participants for whom data were collected are included in the analysis.

Groups in this outcome

Rituximab (RTX)

Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.

Mycophenolate Mofetil (MMF)

Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.

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

Analysis denominator · Participants

GroupSource count
Rituximab (RTX)62
Mycophenolate Mofetil (MMF)63

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Rituximab (RTX)57
Mycophenolate Mofetil (MMF)58
Values in Scores on a Scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Rituximab (RTX)10.147.89Not reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)11.098.52Not reportedNot reportedNot reported
Week 52

Analysis denominator · Participants

GroupSource count
Rituximab (RTX)45
Mycophenolate Mofetil (MMF)27
Values in Scores on a Scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Rituximab (RTX)-8.8740.532Not reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)-6.0020.662Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -4.577
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.167
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0012
    p Value Comment
    P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment
    param Type
    Difference in Estimated Means
    param Value
    -2.872
    statistical Method
    Mixed Model Repeated Measures
Complete source fields
analyses
  1. ci Lower Limit
    -4.577
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.167
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0012
    p Value Comment
    P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment
    param Type
    Difference in Estimated Means
    param Value
    -2.872
    statistical Method
    Mixed Model Repeated Measures
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.89
        value
        10.14
      2. group Id
        OG001
        spread
        8.52
        value
        11.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        58
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.532
        value
        -8.874
      2. group Id
        OG001
        spread
        0.662
        value
        -6.002
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    Week 52
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      63
    units
    Participants
description
Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.
dispersion Type
Standard Error
groups
  1. description
    Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52.
    id
    OG000
    title
    Rituximab (RTX)
  2. description
    Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met.
    id
    OG001
    title
    Mycophenolate Mofetil (MMF)
param Type
MEAN
population Description
The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes. Only participants for whom data were collected are included in the analysis.
reporting Status
POSTED
time Frame
From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
title
Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score
type
SECONDARY
unit Of Measure
Scores on a Scale

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Preserved source evidence · Not medical advice