A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study

Abstract

NCT01270997; Results.

Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis

“…IFX CT-P13 also demonstrated clinical efficacy in another RCT of MTX-IR RA 46. Efficacy was also formally proven in placebo-controlled RCTs with the ADA bsDMARDs ABP50147 and SB5,48 with the ETN bsDMARDs HD20349 and SB4,50 with the IFX bsDMARD SB251 and with the RTX bsDMARD BCD-020 52…”

Clinical trials of biosimilars should become more similar

“…SB2, another infliximab biosimilar, was granted marketing authorisation by the Korean MFDS on 4 December 2015 and by the EC on 26 May 2016, and is sold as Renflexis in South Korea and as Flixabi in the EU and EEA member states 5 7. In this issue, Bae et al 8 report the results of the phase III clinical trial of HD203 (etanercept biosimilar), Emery and colleagues report the results of the phase III clinical trial of SB4 (etanercept biosimilar)9 and Choe et al 10 report the results of the phase III clinical trial of SB2 (infliximab biosimilar).…”

“…Although their primary end points were similar, the phase III clinical trial of CT-P13 evaluated efficacy only at 14, 30 and 54 weeks,13 14 and that of HD203 evaluated efficacy only at 12, 24 and 48 weeks,8 each of which is a time point during the plateau phase of the time–response curve. In contrast, the studies of SB2 and SB4 also evaluated efficacy at several earlier time points 9 10.…”

“…For example, the study comparing HD203 to bio-originator etanercept used an equivalence margin of ±20%,8 whereas that of SB4 employed one of ±15% 9. A meta-analysis of the pivotal placebo-controlled clinical trials of bio-originator etanercept estimated δ ap =0.4049 (an absolute risk difference of 40.49% in the proportion of American College of Rheumatology (ACR)20 responders between bio-originator etanercept and placebo) 19.…”

Anti Etanercept and anti SB4 antibodies detection: impact of the assay method

“…In particular, some more details on the confirmatory test results to evaluate the specificity of detected ADAs, would be clarifying. A very recently published report comparing the immunogenicity of ETN and biosimilar HD203, found ADAs in 8/147 patients taking HD203 and in 3/147 patients taking ETN 9. So further studies are needed to better understand factors contributing to different immunogenicity of SB4 than ETN, with a bigger number of patients.…”