Response Assessment to Erythropoietin-Zeta (Epo-Alpha Biosimilar) Therapy in Low-Risk Myelodysplastic Syndromes

Abstract

Background. This prospective observational study aimed to verify the efficacy of erythropoietin zeta in the treatment of patients with low-risk myelodysplastic syndrome. Methods. Patients with low/int-1 IPSS risk and serum erythropoietin level below 500 U/L were enrolled. Treatment consisted of erythropoietin zeta 40,000 U subcutaneously once a week. The primary endpoint was the erythroid response. According to Simon’s two-stage statistical design, 36 patients were recruited. The median age was 75 years (range 56–83 years), male/female ratio was 1.1/1, median baseline serum erythropoietin was 57.9 U/L (range 9.4–475 U/L). 53% of patients had low-risk disease, while the remaining had Int-1 risk. Results. After 8 weeks, a significant response (rise in Hb levels of at least 1.5 g/dL) was achieved in 18 patients (50%) out of 36. However, 17 patients did not improve; 8/17 patients pursued the 40,000 U weekly schedule of erythropoietin zeta, and 4/8 (50%) of them reached the erythroid response after 16 weeks. Nine patients underwent dosage doubling (40,000 U twice per week), and 5/9 (55%) of them achieved the erythroid response. Conclusion. Compared with data from the literature, this prospective study revealed that EPO-zeta is a safe and effective therapeutic option in low-risk MDS patients.

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

“…In particular, evidence from studies in MDS showed that B‐ESA were similar in terms of efficacy and safety to originator epoetin agents, as reported by a recent study in elderly MDS patients treated with B‐ESA alpha 23 and a larger meta‐analysis 24 . Recently, Vetro et al reported the efficacy and safety data in the management of anemia within a prospective study of 36 patients with low‐risk MDS who received B‐ESA zeta at a dose of 40 000 U/week administered subcutaneously 25 . An erythroid response was achieved in 50% and 75% of patients, respectively, after 8 and 16 weeks of treatment, with five patients requiring a doubling of the weekly B‐ESA dose to achieve AR.…”

“…1,7 B-ESA represent a low-cost alternative to originator erythropoietic agents in the treatment of chemotherapy-induced anemia in different oncology/hematology patients, 22 for example, in the setting of lymphoproliferative diseases and myelodysplastic syndromes (MDS). [23][24][25] In particular, evidence from studies in MDS showed that B-ESA were similar in terms of efficacy and safety to originator epoetin agents, as reported by a recent study in elderly MDS patients treated with B-ESA alpha 23 and a larger meta-analysis. 24 Recently, Vetro et al reported the efficacy and safety data in the management of anemia within a prospective study of 36 patients with low-risk MDS who received B-ESA zeta at a dose of 40 000 U/week administered subcutaneously.…”

“…B‐ESA represent a low‐cost alternative to originator erythropoietic agents in the treatment of chemotherapy‐induced anemia in different oncology/hematology patients, 22 for example, in the setting of lymphoproliferative diseases and myelodysplastic syndromes (MDS) 23–25 . In particular, evidence from studies in MDS showed that B‐ESA were similar in terms of efficacy and safety to originator epoetin agents, as reported by a recent study in elderly MDS patients treated with B‐ESA alpha 23 and a larger meta‐analysis 24 .…”

“…24 Recently, Vetro et al reported the efficacy and safety data in the management of anemia within a prospective study of 36 patients with low-risk MDS who received B-ESA zeta at a dose of 40 000 U/week administered subcutaneously. 25 An erythroid response was achieved in 50% and 75% of patients, respectively, after 8 and 16 weeks of treatment, with five patients requiring a doubling of the weekly B-ESA dose to achieve AR. Nine AEs were reported, which in five patients (i.e., 14% of the study population) were grade 3-4, mainly represented by infections and worsening of existing hypertension.…”