Efficacy and safety data of subsequent entry biologics pertinent to nephrology practice: a systematic review

Canadian Journal of Kidney Health and Disease
Judith Genevieve MarinDaniel J Martinusen

Abstract

Subsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians. To compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic. Systematic review. Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials. Adult patients with chronic kidney disease (CKD). Our systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs), quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well. Only epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta) were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs ...Continue Reading

References

Jan 23, 2008·Current Medical Research and Opinion·Volker WizemannUNKNOWN Epoetin Zeta Study Group
Apr 9, 2008·Current Medical Research and Opinion·Stefan KrivoshievUNKNOWN Epoetin Zeta Study Group
Apr 7, 2010·Advances in Therapy·Stefan KrivoshievUNKNOWN Epoetin Zeta Study Group
Aug 2, 2012·Expert Opinion on Biological Therapy·Hans C EbbersHuub Schellekens
Aug 14, 2012·Expert Opinion on Drug Safety·Ivo Abraham, Karen MacDonald
Jan 1, 2014·Canadian Journal of Kidney Health and Disease·Daniel J MartinusenMarianna Leung

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