Darbepoetin and Biosimilars for the Anaemia of Chronic Kidney Disease

Summary

A Cochrane review [Abstract] 1 included 21 studies invovling a total of 8 328 participants. In a single large study, darbepoetin alfa reduced the need for blood transfusion (RR 0.60, 95% CI 0.53 to 0.69; n=4038) and iron therapy compared with placebo in adults with CKD stage 3 to 5, but had little or no effect on survival (RR 1.05, 95% CI 0.93 to 1.19; n=4038), increased risks of hypertension, and had uncertain effects on quality of life. Data comparing darbepoetin alfa with epoetin alfa or beta or methoxy polyethylene glycol-epoetin beta were sparse and inconclusive. Comparisons of differing dosing schedules and routes of administration were compared in small numbers of participants and studies. Evidence for treatment effects of darbepoetin alfa were particularly limited for children with CKD, adults with CKD stage 5D, and recipients of a kidney transplant.

A meta-analysis 2 assessing different erythropoiesis-stimulating agents (ESA) and biosimilars in CKD included 30 RCTs with 7843 patients (21/30 studies included dialysis patients). Compared with ESA biosimilars, epoetin alfa did not statistically differ for any of the measured outcomes like prevention of blood transfusion, reduction of fatigue, breathlessness and mortality or cardiovascular events (low quality evidence). In the comparison between epoetin alfa vs. darbepoetin alfa, no differences were observed for all outcomes, but blood transfusions showed favorable results for darbepoetin alfa (RR 2.18, 95% CI 1.31 to 3.62; low quality evidence). No differences were observed between epoetin beta and methoxy polyethylene glycol-epoetin beta, and between darbepoetin alfa and methoxy polyethylene glycol-epoetin beta (low to moderate quality of evidence).

A Cochrane review [Abstract] 3 included 117 studies invovling a total of 25 237 participants. There were no difference in blood transfusions or death in comparison between epoetin/darpoetin/biosimilars and placebo.