Fig. 1: Duration of treatment, cumulative duration of RBC-TI ≥8 weeks response, and rates of achievement of RBC-TI ≥8 weeks and ≥16 weeks, and mean Hb increase ≥1.5 g/dl.
A Duration of treatment during the entire treatment period. B Rate of achievement of RBC-TI ≥8 weeks and ≥16 weeks, and mean Hb increase ≥1.5 g/dl during the entire treatment period. C Cumulative duration of all periods of RBC-TI response ≥8 weeks at any time during the study. aTreatment end date is defined as the last dose date +20 days, study discontinuation date, cutoff date or death date, whichever is earlier. bResponse is defined as the absence of any RBC transfusion during any consecutive 56-day period during the entire treatment period. cResponse rate (%) was calculated using the number of responders divided by the number of patients multiplied by 100. dCochran-Mantel-Haenszel test stratified for average baseline RBC transfusion requirement (≥6 units vs. <6 units of RBC per 8 weeks) and baseline IPSS-R score (Very low or Low vs. Intermediate). eResponse is defined as the absence of any RBC transfusion during any consecutive 112-day period during the entire treatment period. fDefined as the proportion of patients with a Hb increase ≥1.5 g/dl compared with baseline that was sustained over any consecutive 56-day period in the absence of RBC transfusions. gFisher exact test comparing the luspatercept arm with the placebo arm. hThe cumulative duration of all periods of RBC-TI ≥8 weeks is defined as the sum of all durations of non-consecutive periods of RBC-TI response ≥8 weeks for patients during the entire treatment phase. iMedian is from the Kaplan–Meier method. CI confidence interval, Hb hemoglobin, HR hazard ratio, IPSS-R Revised International Prognostic Scoring System, NE not estimable, RBC red blood cell, RBC-TI RBC transfusion independence.
