The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis

Abstract

SummaryBackground GP2015 is a proposed etanercept biosimilar. Objectives To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and the etanercept originator (ETN, Enbrel â ) in patients with

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

“…SB4 was approved in regions including Australia, Canada, and the EU based on a submission containing data from a comparative trial in patients with RA, 106,121 while GP2015 has been approved in various markets, including the US, following an application encompassing the results of a trial in psoriasis. 101,122–125 In both cases, approval was granted for other eligible indications of the originator. 125,126 In early 2018, a third etanercept biosimilar, LBEC0101, gained approval in both Japan and the Republic of Korea.…”

“…Data on switching from the originator product to its biosimilar have been provided in the extension phases of comparative clinical studies and in the randomized NOR-SWITCH study, and have not identified any significant safety or efficacy concerns. 122,140–142 …”

The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar

“…Therefore, a confirmatory study was conducted to demonstrate equivalent efficacy and similar safety and immunogenicity between GP2015 and reference etanercept in patients with moderate-to-severe chronic plaque-type psoriasis (ClinicalTrials.gov Identifier: NCT01891864) 57 . Patients (n ¼ 531) were randomized 1:1 to receive either GP2015 50 mg or reference etanercept 50 mg twice weekly for 12 weeks.…”

“…At Week 12, patients who achieved at least a PASI 50 response were re-randomized to either continue the same treatment on a once-weekly dosing schedule, or to undergo a sequence of treatment switches between GP2015 and reference etanercept until Week 30 ( Figure 5). In the extension phase of the study, patients continued to receive the last treatment that they had received at Week 30 for the remainder of the study until Week 52 57 . The primary efficacy endpoint was the PASI 75 response rate at Week 12, since this measure is well understood and considered clinically meaningful 55 .…”

“…The key secondary efficacy endpoint was the percentage change from baseline in PASI score up to Week 12. Additional secondary endpoints included PASI 50, 75, and 90 response rates over time, and the Investigator's Global Assessment of psoriasis, among others, which allows regulators to evaluate multiple endpoints taking the totality-of-the-evidence into consideration 57 . The PASI 75 response rate after 12 weeks of treatment was 73.4% with GP2015 and 75.7% with reference etanercept.…”