November 01, 2018
The efficacy of biosimilar GP2015 was comparable to that of etanercept over 48 weeks.
CHICAGO — The efficacy of etanercept biosimilar GP2015 was comparable to the etanercept reference product for patients with moderate to severe rheumatoid arthritis (RA) over the course of 48 weeks, and switching patients from etanercept to the biosimilar did not affect safety or efficacy, according to research presented at the 2018 ACR/ARHP Annual Meeting, held October 19-24, in Chicago, Illinois.
The 2-treatment period, confirmatory EQUIRA study was a randomized, phase 3, double-blind, 48-week study with an end point of equivalent change from baseline in 28-joint count Disease Activity Score based on C-reactive protein (DAS28-CRP) at 24 weeks. Participants ≥18 years with active RA who had an inadequate treatment response to methotrexate were randomly assigned to receive etanercept or the biosimilar 50 mg once weekly for 24 weeks (treatment period 1). Patients with moderate or better European League Against Rheumatism (EULAR) response after treatment period 1 either continued with the biosimilar or switched from etanercept to the biosimilar for another 24 weeks (treatment period 2). All participants received a concomitant stable dose of 10 to 25 mg/wk of methotrexate and folic acid. Primary outcome measures included change in American College of Rheumatology criteria (ACR20/50/70), EULAR response, and DAS28-CRP response.
Baseline characteristics between the etanercept (n=190) and biosimilar (n=186) groups were comparable, and the primary end point for treatment period 1 equivalence change was met. At the end of treatment period 2 (48 weeks), ACR20 response rates for patients who had continued on the biosimilar after 24 weeks were comparable to those who had switched to the drug.
In treatment period 2, 42.9% of continuing participants (n=175) experienced treatment-emergent adverse events compared with 38.0% of patients who switched (n=166), with 13.1% and 11.4%, respectively, of these considered to be drug-related. Serious adverse events were seen in 2.3% vs 2.4% of participants in treatment period 2. Six (3.6%) participants who had switched to the biosimilar experienced injection site reactions compared with none in the continued group. Four (2.4%) of the participants who continued the biosimilar showed very low titer, single-event, non-neutralizing antidrug antibodies.
Several researchers disclose connections to Merck & Co., Bristol-Myers Squibb, Pfizer, Eli Lilly, Sandoz, Biogen, Celgene, Novartis, Roche, and others. See original reference for full disclosure list.
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Kavanaugh A, Matucci-Cerinic M, Schulze-Koops H, et al. Phase 3 EQUIRA 48 week study results demonstrated no impact on efficacy and safety when patients with moderate-to-severe rheumatoid arthritis were switched between reference etanercept (ETN) and GP2015, an etanercept biosimilar. Presented at: 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, Illinois. Abstract 2550.
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