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NCT03682536 · OUTCOME

Duration of Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days)

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20

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

Measure
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)

What was measured

Maximum duration of RBC transfusion independence for participants who achieve RBC-TI ≥ 84 days.

Analysis population: ITT Population (all randomized participants regardless of whether or not the participant received treatment) who were RBC-TI \>= 12 Weeks (Week 1-24) responders

Groups in this outcome

Luspatercept

Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.

Epoetin Alfa

Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).

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

Analysis denominator · Participants

GroupSource count
Luspatercept124
Epoetin Alfa88

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Luspatercept128.1Not reported108.3NAInsufficient number of participants with events
Epoetin Alfa89.7Not reported55.9157.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.330
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.864
    estimate Comment
    Calculated by Cox proportional hazard model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0096
    param Type
    Hazard Ratio (HR)
    param Value
    0.534
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.330
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.864
    estimate Comment
    Calculated by Cox proportional hazard model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0096
    param Type
    Hazard Ratio (HR)
    param Value
    0.534
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events
        group Id
        OG000
        lower Limit
        108.3
        upper Limit
        NA
        value
        128.1
      2. group Id
        OG001
        lower Limit
        55.9
        upper Limit
        157.3
        value
        89.7
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    2. group Id
      OG001
      value
      88
    units
    Participants
description
Maximum duration of RBC transfusion independence for participants who achieve RBC-TI ≥ 84 days.
dispersion Type
95% Confidence Interval
groups
  1. description
    Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
    id
    OG000
    title
    Luspatercept
  2. description
    Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
    id
    OG001
    title
    Epoetin Alfa
param Type
MEDIAN
population Description
ITT Population (all randomized participants regardless of whether or not the participant received treatment) who were RBC-TI \>= 12 Weeks (Week 1-24) responders
reporting Status
POSTED
time Frame
Week 1 through End of Treatment (Up to approximately an average of 66 weeks and a maximum of 202 weeks)
title
Duration of Red Blood Cell Transfusion Independence (RBC-TI) ≥ 12 Weeks (84 Days)
type
SECONDARY
unit Of Measure
Weeks

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice