Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial.

作者：M. D. della Porta, G. Garcia-Manero, V. Santini, A. Zeidan, R. Komrokji, J. Shortt, D. Valcárcel, A. Jonášová, S. Dimicoli-Salazar, I. Tiong, Chien-Chin Lin, Jiahui Li, Jen-Nie Zhang, Richard Pilot, S. Kreitz, V. Pozharskaya, K. Keeperman, Shelonitda S. Rose, T. Prebet, Yin-Zhi Lai, A. Degulys, S. Paolini, T. Cluzeau, P. Fenaux, U. Platzbecker · 发表于：The Lancet Haematology · 年份：2024 · DOI：10.1016/s2352-3026(24)00203-5 · 被引用次数：40 · 研究领域：Medicine

BACKGROUND The preplanned interim analysis of the COMMANDS trial showed greater efficacy of luspatercept than epoetin alfa for treating anaemia in erythropoiesis-stimulating agent (ESA)-naive patients with transfusion-dependent, lower-risk myelodysplastic syndromes. In this Article, we report the results of the primary analysis of the trial. METHODS COMMANDS is a phase 3, open-label, randomised, controlled trial conducted at 142 sites in 26 countries. Eligible patients were those aged 18 years or older, with myelodysplastic syndromes of very low risk, low risk, or intermediate risk (as defined by the Revised International Prognostic Scoring System), who were ESA-naive and transfusion dependent, and had a serum erythropoietin concentration of less than 500 U/L. Patients were stratified by baseline red blood cell transfusion burden, serum erythropoietin concentration, and ring sideroblast status, and randomly allocated (1:1) to receive luspatercept (1·0-1·75 mg/kg body weight, subcutaneously, once every 3 weeks) or epoetin alfa (450-1050 IU/kg body weight, subcutaneously, once a week; maximum total dose 80 000 IU) for at least 24 weeks. The primary endpoint was red blood cell transfusion independence lasting at least 12 weeks with a concurrent mean haemoglobin increase of at least 1·5 g/dL (weeks 1-24), evaluated in the intention-to-treat population. The safety population included all patients who received at least one dose of treatment. This trial is registered with Clinical...