Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Phase IV Post-Authorization Study

Abstract

Background This phase IV, post–authorisation safety & efficacy study evaluated the safety, immunogenicity and tolerability of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) for the treatment of symptomatic anemia in Indian patients with chronic renal failure.Methods Adults patients of either gender suffering from anemia associated with chronic renal failure patients were prescribed and treated with DA-α and followed up for 1 year. 503 patients were enrolled into the study, of which 121 patients were evaluated for immunogenicity at the end of treatment phase (up to 24 weeks) and after 1-year (52 weeks after start of treatment) follow up. Safety end points were the incidence of treatment emergent adverse events (TEAEs) and immunogenicity as assessed by anti-drug antibody titers using validated enzyme linked immunosorbent assay (ELISA) methods. Efficacy end point included improvement in the hemoglobin, mean change in Hemoglobin (Hb) levels from baseline to end of treatment (up to 24 weeks). Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively