Background/Purpose: The biosimilarity of GP2015 and etanercept originator product (ETN) has been previously demonstrated in patients with chronic plaque-type psoriasis.¹ The randomized, double-blind, phase 3 study, EQUIRA (NCT02638259) compared the efficacy and safety of GP2015 versus ETN in patients with moderate-to-severe RA and an inadequate response to DMARDs. Here, we present the 24-week results (TP1).

Methods: Patients (aged ≥ 18 years) with active RA (diagnosed according to the ACR 1987 or ACR/EULAR 2010 criteria for ≥ 6 months before baseline and active disease defined as DAS28-CRP ≥ 3.2, and CRP >5 mg/L or ESR ≥28 mm/h), who had an inadequate clinical response to MTX at a dose of 10 – 25 mg/week, were randomized 1:1 to self-administer 50 mg GP2015 or ETN subcutaneously, once weekly, for 24 weeks. All patients continued to receive concomitant MTX (10 – 25 mg/week), at a stable dose throughout the study and folic acid (≥ 5 mg/week until end of study). The primary endpoint was change from baseline in DAS28-CRP at week 24.

Results: The baseline demographic and disease characteristics were comparable between the GP2015 (n=170) and ETN (n=156) groups. In the per-protocol set, GP2015 was determined to be equivalent to ETN in the LS mean change from baseline to week 24 in DAS28-CRP, as the 95% CI was within the pre-specified equivalence margin of -0.6; 0.6 (LS means difference between GP2015 vs ETN: -0.04, 95% CI: -0.24, 0.15). At week 24, the ACR 20/50/70 response rates and the mean change from baseline in DAS28-CRP scores were comparable between GP2015 and ETN groups (Table). In the GP2015 (n=186) vs ETN (n=190) groups (safety set), treatment-emergent adverse events (AEs) occurred in 43.5% vs 49.5% patients, respectively; SAEs occurred in 0.5% vs 3.2% patients, respectively. One patient died in the ETN group. Injection site reactions, as a part of all AEs, were reported in 7.0% of patients in GP2015 and 17.9% of patients in ETN group. Using a very sensitive assay, very low titers of ADAs were transiently detected, however at week 24 none of the patients had significant levels detected.

Conclusion: GP2015 demonstrated equivalent efficacy to ETN in patients with RA who had an inadequate response to DMARDs. Overall, the safety profile was comparable between GP2015 and ETN.

Reference: 1. Griffiths CEM, et al. Br J Dermatol. 2017;176:928–38.

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/etanercept-biosimilar-gp2015-has-equivalent-efficacy-and-safety-to-etanercept-originator-in-patients-with-moderate-to-severe-rheumatoid-arthritis-the-phase-3-equira-study/