Study of Biosimilar Erythropoietin Alfa Treatment in Adults with Anemia and Myelodysplastic Syndrome

What this Trial Is About

Researchers are studying the response to treatment with biosimilar erythropoietin alfa EPO alpha in patients with Myelodysplastic Syndrome MDS who have anemia. The study focuses on patients who either previously responded to original EPO alpha treatment or who are starting biosimilar EPO alpha for the first time. This research aims to understand the effectiveness and safety of biosimilar EPO alpha in MDS patients, as current data are limited and mainly extrapolated from other conditions with anemia. Participants are included if they have symptomatic anemia with hemoglobin below 10 gdL, are classified within very low, low, or intermediate risk groups according to the IPSS-R, and have a serum EPO level under 500 UL before treatment. The study observes patients who started biosimilar EPO alpha treatment between June 2018 and December 2021. This is an observational study, so it follows patients without assigning specific treatments but collects data on their response and clinical outcomes over time. During the study period, researchers will monitor the response to biosimilar EPO alpha treatment and maintain observation for six months from study start. They will assess the overall response rate and track major clinical outcomes related to treatment administration. Participants will have their health and treatment progress evaluated through data collection, including blood tests and clinical assessments, to measure safety and effectiveness in a real-life setting.

Evaluation of Response to Biosimilar Erythropoietin Alfa Therapy in Anemic Patients With Myelodysplastic Syndrome