Comparative efficacy and safety in ESA biosimilars vs. originators in adults with chronic kidney disease: a systematic review and meta-analysis

摘要: Several Erythropoiesis-stimulating agents (ESAs) are available to treat anemia in patients with chronic kidney disease (CKD). Questions about the comparability of such therapeutic options not purely a regulatory or economical matter. Appropriate use originator biosimilar these need be supported by clinical data. Regarding prevention blood transfusion, reduction fatigue, breathlessness and mortality cardiovascular events, summary comparative efficacy safety data drugs is lacking. We performed systematic literature search CENTRAL, PubMed, Embase through November 11, 2015. Our inclusion criteria encompassed randomized, controlled trials that evaluated effectiveness different ESAs originators and/or biosimilar. The considered participants were adults aged 18 years older due CKD. overall quality evidence was assessed using GRADE system. identified 30 eligible studies including 7843 CKD, 21/30 included hemodialysis peritoneal dialysis. Compared ESA biosimilars, epoetin α did statistically differ for any ten measured outcomes. varied from low very low. In comparison between vs. darbepoetin α, no differences observed all outcomes, but transfusions showed favorable results α: RR 2.18 (1.31–3.62). No β methoxy polyethylene glycol-epoetin β, moderate Data 31 allowed pool meta-analysis related four comparisons eleven outcome measures. Nevertheless, only one result significant favor concerning transfusions. For other outcomes comparisons, we find terms security EPO considered. quite low, further research could change results. Further high examining conducted.