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Abstract Number: 2797

Etanercept Biosimilar GP2015 Has Equivalent Efficacy and Safety to Etanercept Originator in Patients with Moderate to Severe Rheumatoid Arthritis: The Phase 3 Equira Study

Arthur Kavanaugh1, Yannick Allanore2, Eugeniusz J. Kucharz3 and Goran Babic4, 1Medicine, University of California, San Diego, La Jolla, CA, 2Department of Rheumatology, Cochin Hospital, Paris Descartes University, Paris, France, 3Department of Internal Medicine and Rheumatology, Medical University of Silesia, Katowice, Poland, 4Clinical development, Biopharmaceuticals, Hexal AG, a Sandoz company, Holzkirchen, Germany

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: biosimilars, etanercept and rheumatoid arthritis (RA)

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Session Information

Date: Tuesday, November 7, 2017

Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III: Biosimilars Therapy

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

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.

Table. Efficacy response over 24 weeks (per-protocol set)

Variables

Time

GP2015

N = 170

ETN

N = 156

DAS28-CRP, LS means difference (95% CI)

Week 24

-0.04 (-0.24, 0.15)

DAS28-CRP (mean change)

BL

5.42

5.54

Week 4

-1.61

-1.71

Week 12

-2.23

-2.21

Week 24

-2.78

-2.81

EULAR good response, n* (%)

Week 24

83 (48.8)

75 (48.1)

EULAR moderate response, n* (%)

83 (48.8)

77 (49.4)

ACR20 (% responders)

Week 4

48.8

53.5

Week 12

79.2

76.8

Week 24

88.8

93.6

ACR50 (% responders)

Week 4

15.5

19.4

Week 12

33.9

44.5

Week 24

63.9

71.2

ACR70 (% responders)

Week 4

4.8

5.2

Week 12

13.1

16.8

Week 24

33.7

42.9

*total number of patients achieving responses/remission

BL, baseline; ETN, etanercept originator product

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.


Disclosure: A. Kavanaugh, Sandoz, Merck, Boehringer Ingelheim, 5; Y. Allanore, Sandoz, Sanofi, Pfizer, Roche Genentech, 5,Sanofi, Pfizer, Roche Genentech, 2; E. J. Kucharz, Hexal AG, a Sandoz company, 5; G. Babic, Hexal AG, a Sandoz company, 3.

To cite this abstract in AMA style:

Kavanaugh A, Allanore Y, Kucharz EJ, Babic G. Etanercept Biosimilar GP2015 Has Equivalent Efficacy and Safety to Etanercept Originator in Patients with Moderate to Severe Rheumatoid Arthritis: The Phase 3 Equira Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). 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/. Accessed January 25, 2021.
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