Authors: Marianne Heibert Arnlind Linda Fryklund Sigurd Vitols Göran Bertilsson
Publish Date: 2016/07/21
Volume: 72, Issue: 10, Pages: 1161-1169
Abstract
We systematically reviewed published observational studies and randomized controlled trials RCT reports of clinical trials on erythropoiesisstimulating agents ESA’s Only studies evaluating the risk of developing antidrug antibodies ADA of both original and biosimilar drugs were chosenTwentyone publications were included The overall prevalence of ADA in the studies was about 02 to 05 Most studies were not designed to monitor the development of ADA and often the study duration was too short less than 6 months and the patient population too small Moreover in many studies the assays used only determined the presence of ADA and did not measure therapy failure due to ADA In one RCT as many as 13 cases 4 of ADA were identifiedADA development seems to be low in shortterm studies with ESA None of the efficacy and safety issues for ESA biosimilars were judged to be adequately addressed in the evaluated literature with respect to ADA formation due to the study design and the assay method usedGB contributed to study concept analysis interpretation of data and drafting the manuscript GB is responsible for the content and writing of the paper and approved the final manuscript MHA contributed to study concept analysis interpretation of data and drafting the manuscript MHA is responsible for the content and writing of the paper and approved the final manuscript LF contributed to study concept analysis interpretation of data and drafting the manuscript LF is responsible for the content and writing of the paper and approved the final manuscript SV contributed to study concept analysis interpretation of data and drafting the manuscript SV is responsible for the content and writing of the paper and approved the final manuscript All authors contributed equally
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