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IWG 2006 criteria for HI-E: Hgb increase by 1.5 g/dL for at least 8 weeks or reduction of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks.7
Fenaux Study Design: A phase 3, double-blind, placebo-controlled study to assess the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk patients with MDS (N=130) with Hgb ≤10 g/dL, with no or moderate RBC-TI (≤4 RBC units/8 weeks). Patients were randomized 2:1 to receive epoetin-α 450 IU/kg/week or placebo for 24 weeks, followed by treatment extension in responders. The primary endpoint was erythroid response by IWG 2006 criteria through Week 24.2
Park Study Design: A multinational, retrospective, cohort study of patients (N=1698) with non-del(5q) lower-risk MDS treated with ESAs. Primary ESA failure was defined as the absence of erythroid response according to IWG 2006 criteria after 8 weeks of ESA treatment. Secondary failures of ESA treatment were defined as relapse after an initial HI-E. The potential effects of primary and secondary failure on subsequent outcomes were evaluated.3
Platzbecker Study Design: A phase 3, randomized, double-blind, placebo-controlled study of darbepoetin alfa in ESA-naive patients (N=147) with low- or intermediate-1 risk MDS and anemia. Patients were randomized 2:1 to receive darbepoetin alfa or placebo for 24 weeks followed by 48 weeks of open-label darbepoetin alfa for all patients and ongoing long-term follow-up. Endpoints included RBCT incidence and HI-E by IWG 2006 criteria.4
ESA=erythropoiesis-stimulating agent; HI-E=hematologic improvement-erythroid; Hgb=hemoglobin; IPSS=International Prognostic Scoring System; IWG=International Working Group; MDS=myelodysplastic syndromes; OS=overall survival; RBC=red blood cell; RBCT=red blood cell transfusion; RBC-TI=red blood cell transfusion independence; TB=transfusion burden.
Increasing Hgb and achieving RBC-TI remain critical needs
for patients with MDS-associated anemia1,6