OncohematologyOncohematologyОнкогематология1818-83462413-4023Publishing House ABV Press112210.17650/1818-8346-2026-21-3-49-57HEMATOLOGIC MALIGNANCIES: TREATMENTЛЕЧЕНИЕ ГЕМОБЛАСТОЗОВResearch ArticleLuspatercept in the treatment of patients with lower-risk myelodysplastic neoplasmsЛуспатерцепт в терапии пациентов с миелодиспластическими новообразованиями низкого рискаhttps://orcid.org/0000-0002-9032-6885TsvirkoK. S.ЦвиркоК. С.
Russian Federation
Ksenia_Kud_@mail.ruhttps://orcid.org/0000-0002-8401-0817TsvetkovN. Y.ЦветковН. Ю.
Russian Federation
Ksenia_Kud_@mail.ruhttps://orcid.org/0000-0003-0752-0757MorozovaE. V.МорозоваЕ. В.
Russian Federation
Ksenia_Kud_@mail.ruRaisa Gorbacheva Memorial Research Institute for Pediatric Oncology, Hematology and Transplantation, I. P. Pavlov First Saint Petersburg State Medical University, Ministry of Health of RussiaНИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова» Минздрава России3009202621349572509202625092026Copyright ©; 2026, ABV-pressCopyright ©; 2026, АБВ-­пресс2026ABV-pressАБВ-­прессhttps://oncohematology.abvpress.ru/ongm/about/editorialPolicieshttps://oncohematology.abvpress.ru/ongm/article/view/1122

Background. Anemia and transfusion dependence (TD) impair quality of life and survival in patients with lower-risk myelodysplastic neoplasms (MDS). Luspatercept, an activin receptor ligand inhibitor, represents a new class of drugs for correcting anemia in MDS.

Aim. To evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and TD based on clinical trial data and real-world clinical practice.

Materials and methods. A search from 2011 to 2025 for the key clinical trials (MEDALIST, COMMANDS) and recent publications was performed, and experience with luspatercept in clinical practice is presented.

Results. In the MEDALIST trial, among patients with ring sideroblasts refractory to erythropoiesis-stimulating agents, luspatercept provided transfusion independence ≥ 8 weeks in 38 % of patients (vs. 13 % in the placebo group). In the COMMANDS trial luspatercept was superior to epoetin α in achieving transfusion independence ≥ 12 weeks (59 % vs. 31 %). The highest efficacy was observed in patients with the SF3B1 mutation, low transfusion burden (< 4 RBC units / 8 weeks), and an endogenous erythropoietin level > 80 IU / L. Real-world data confirm these results.

Conclusion. Luspatercept has become the new standard of care for anemia in transfusion-dependent patients with lower-risk MDS, demonstrating high efficacy both after erythropoiesis-stimulating agent failure and as first-line therapy, especially in the subgroup with ring sideroblasts and the SF3B1 mutation.

Введение. Анемия и трансфузионная зависимость (ТЗ) ухудшают качество жизни и показатели выживаемости пациентов с миелодиспластическими новообразованиями (МДС) низкого риска. Луспатерцепт, блокатор лигандов рецептора активина, представляет собой новый класс препаратов для коррекции анемии при МДС.

Цель исследования – проанализировать и обобщить современные данные клинических исследований и реальной клинической практики об эффективности и безопасности луспатерцепта у пациентов с МДС низкого риска и ТЗ.

Материалы и методы. Проведен поиск данных с 2011 по 2025 г. по ключевым клиническим исследованиям (MEDALIST, COMMANDS) и современным публикациям, представлен опыт применения луспатерцепта в клинической практике.

Результаты. В исследовании MEDALIST у пациентов с МДС с кольцевыми сидеробластами, рефрактерных к эритропоэзстимулирующим препаратам, луспатерцепт обеспечивал трансфузионную независимость ≥ 8 нед в 38 % случаев (против 13 % в группе плацебо). В исследовании COMMANDS луспатерцепт превзошел эпоэтин α по достижению трансфузионной независимости ≥ 12 нед (59 % против 31 %). Наибольшая эффективность наблюдалась у пациентов с мутацией SF3B1, низкой ТЗ (< 4 ед / 8 нед) и уровнем эндогенного эритропоэтина > 80 МЕ / л. Данные реальной практики подтверждают эти результаты.

Заключение. Луспатерцепт стал новым стандартом терапии анемии у пациентов с МДС низкого риска и ТЗ, демонстрируя высокую эффективность как после неудачи эритропоэзстимулирующих препаратов, так и в 1-й линии лечения, особенно в подгруппе с кольцевыми сидеробластами и мутацией SF3B1.

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