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FRI0129 Switch between reference etanercept (ETN) and gp2015, an etanercept biosimilar, did not impact efficacy and safety in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase 3 equira study
  1. M. Matucci-Cerinic1,
  2. H. Schulze-Koops2,
  3. M. Buch3,
  4. A. Kavanaugh4,
  5. Y. Allanore5,
  6. E.J. Kucharz6,
  7. G. Babic7
  1. 1University of Florence, Florence, Italy
  2. 2Ludwig-Maximilians-University, Munich, Germany
  3. 3University of Leeds, Leeds, UK
  4. 4UC San Diego School of Medicine, La Jolla, California, USA
  5. 5Cochin Hospital, Paris Descartes University, Paris, France
  6. 6Medical University of Silesia, Katowice, Poland
  7. 7Hexal AG, a Sandoz company, Holzkirchen, Germany

Abstract

Background GP2015 is an etanercept biosimilar. It has shown an equivalent efficacy, and comparable safety and immunogenicity to ETN in patients with chronic plaque-type psoriasis.1

Objectives To compare the efficacy and safety of GP2015 versus ETN in patients with moderate-to-severe rheumatoid arthritis (RA) and evaluate the effects of switching from ETN to GP2015.

Methods EQUIRA was a 48 week, randomised, double-blind, Phase 3 study. The primary endpoint was equivalent change from baseline (BL) in DAS28-CRP at Week 24. Patients≥18 years with active RA ACR 1987 or ACR/EULAR 2010 criteria for ≥6 months before BL and active disease defined as DAS28-CRP≥3.2 and CRP >5 mg/L or ESR ≥28 mm/h) and inadequate response to methotrexate (MTX) were randomised 1:1 to 50 mg GP2015 or ETN subcutaneously once weekly for 24 weeks (Treatment period 1). Patients with at least moderate EULAR response at Week 24 either continued GP2015 treatment or, in the ETN group, were switched to receive 50 mg GP2015 up to 48 weeks (Treatment period 2 [TP2]). All patients continued to receive concomitant MTX (10–25 mg/week) at a stable dose and folic acid. Efficacy outcome measures included change in DAS28-CRP, EULAR and ACR20/50/70 responses.

Results Baseline characteristics were comparable between the GP2015 (n=186) and ETN (n=190) groups. The primary endpoint for equivalence was met.2 The mean change in DAS28-CRP from BL to Week 48 was comparable between the continued and switched to GP2015 groups (TP2 per-protocol set; figure 1). At Week 48, the EULAR and ACR 20/50/70 response rates were comparable between the two groups (table 1). In TP2, treatment-emergent adverse events (AEs) occurred in 42.9% vs 38.0% patients in the continued GP2015 (n=175) vs the switched (n=166) groups; serious AEs occurred in 2.3% vs 2.4% patients (TP2 safety set). Injection site reactions occurred in 6 (3.6%) patients in the switched group but none in the continued GP2015 group. In TP2, 4 (2.4%) patients in the continued GP2015 group had single-event, very low titer, non-neutralising antidrug antibodies detected.

Abstract FRI0129 – Table 1

Efficacy response over 48 weeks, TP2 per-protocol set (W=week)

Abstract FRI0129 – Figure 1

Change from Baseline in DAS28-CRP up to Week 48 (TP2 per-protocol set)

Conclusions The efficacy of GP2015 was comparable to that of ETN. Moreover, the switch from ETN to GP2015 did not impact on efficacy and safety of etanercept in patients with moderate-to-severe RA.

References [1] Griffiths CEM, et al. Br J Dermatol2017;176:928–38.

[2] Kavanaugh A, et al. Arthritis Rheumatol2017;69(suppl 10).

Disclosure of Interest M. Matucci-Cerinic Grant/research support from: Actelion, Beyer, BMS, Chemomab, Inventiva, Pfizer and Sandoz, H. Schulze-Koops: None declared, M. Buch Grant/research support from: Abbvie, AstraZeneca, Eli Lilly, Pfizer, Roche, Sandoz and UCB, Consultant for: Abbvie, AstraZeneca, Eli Lilly, Pfizer, Roche, Sandoz and UCB, A. Kavanaugh Consultant for: Sandoz, Merck and Boehringer-Ingelheim, Y. Allanore Grant/research support from: Pfizer and Sandoz, Consultant for: Pfizer and Sandoz, E. J. Kucharz Consultant for: AbbVie, Berlin Chemie, Biogen, Celgene, Egis, Eli Lilly Polska, MSD, Novartis, Pfizer, Polpharma, Roche, Sandoz and UCB Biopharma, G. Babic Employee of: Hexal AG

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