Safety, Tolerability, and Immunogenicity of Prescribed Usage of Darbepoetin-Alfa (Hetero Biopharma) in Patients of Chronic Kidney Disease With Renal Anemia: A Post-Marketing Surveillance Study

Background This post-marketing surveillance (PMS), observational, prospective, safety study evaluated the safety, tolerability, and long-term immunogenicity of prescribed usage of Darbepoetin alfa (DA-alpha, manufactured by Hetero Biopharma, Hyderabad, India) in Indian patients having chronic kidney disease (CKD) with anemia. Methods All patients having chronic kidney disease with anemia and prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, adverse events details (AE term, start date, stop date, severity, action taken, outcome, and causality), periodic hemoglobin (Hb) levels, and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data were collected in 121 patients at the end of treatment and after one year. Results Eighty-seven 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 the treatment phase and after 12 months long-term follow-up period. The baseline mean hemoglobin value was 8.34 (SD 1.24) g/dL and the last visit mean hemoglobin value was 10.42 +/- 1.24 (mean +/- SD) g/dL. The mean difference between baseline and last visit in hemoglobin value was 2.10 [2.00, 2.20], statistically significant (p-value <0.0001). Conclusions The safety and tolerability of the usage of DA-alpha are similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.