A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-12

AUTHORS

Pierre Fenaux, Valeria Santini, Maria Antonietta Aloe Spiriti, Aristoteles Giagounidis, Rudolf Schlag, Atanas Radinoff, Liana Gercheva-Kyuchukova, Achilles Anagnostopoulos, Esther Natalie Oliva, Argiris Symeonidis, Mathilde Hunault Berger, Katharina S. Götze, Anna Potamianou, Hari Haralampiev, Robert Wapenaar, Iordanis Milionis, Uwe Platzbecker

ABSTRACT

Erythropoiesis-stimulating agents are first choice for treating anemia in low-risk MDS. This double-blind, placebo-controlled study assessed the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (i.e., low-risk) MDS patients with Hb ≤ 10.0 g/dL, with no or moderate RBC transfusion dependence (≤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 (ER) through Week 24. Dose adjustments were driven by weekly Hb-levels and included increases, and dose reductions/discontinuation if Hb > 12 g/dL. An independent Response Review Committee (RRC) blindly reviewed all responses, applying IWG-2006 criteria but also considering dose adjustments, drug interruptions and longer periods of observation.A total of 130 patients were randomized (85 to epoetin-α and 45 to placebo). The ER by IWG-2006 criteria was 31.8% for epoetin-α vs 4.4% for placebo (p < 0.001); after RRC review, the ER was 45.9 vs 4.4% (p < 0.001), respectively. Epoetin-α reduced RBC transfusions and increased the time-to-first-transfusion compared with placebo.Thus, epoetin-α significantly improved anemia outcomes in low-risk MDS. IWG-2006 criteria for ER may require amendments to better apply to clinical studies. More... »

PAGES

2648-2658

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/s41375-018-0118-9

DOI

http://dx.doi.org/10.1038/s41375-018-0118-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1101834022

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29895954


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