Biosimilar erythropoiesis-stimulating agents are an effective and safe option for the management of myelofibrosis-related anemia

Abstract

Objectives: Erythropoiesis-stimulating agents (ESA) have an established role in treating anemia in hematological malignancies. However, their role, particularly biosimilar ESA (B-ESA), in myelofibrosis (MF) is not well established. Methods: This study retrospectively collected data on 96 MF patients treated with B-ESA (alpha/zeta) for the management of anemia to assess safety, efficacy (anemia response [AR]), and survival. Results: Seventy-seven patients (80%) obtained AR. The median time to AR was 2.5 months. In multivariate analysis, significant predictive factors of AR were transfusion independency (p =.006) and ferritin levels <200 ng/ml (p =.009) at baseline. After a median follow-up of 43.8 months from diagnosis, 38 patients (39%) died, 11 (28.9%) from leukemic evolution. Only two patients (2.5%) stopped B-ESA for toxicity. The 24-month survival was significantly affected by response to B-ESA (70.8% in AR vs. 55.3% in non-responder patients, p =.016). In multivariate analysis, age ≤ 70 years (p =.029) and Hb > 8.5 g/dl (p =.047) at baseline were significantly associated with improved survival, with a trend for longer survival in AR patients (p =.06). Conclusions: B-ESA seems to be an effective and well-tolerated option for anemia treatment in the MF setting. This strategy deserves further clinical investigation.