A POOLED ANALYSIS OF 1-YEAR CLINICAL OUTCOMES AMONG 6-MONTH RESPONDERS AND NON-RESPONDERS FROM THREE RANDOMISED CONTROLLED STUDIES OF TNF INHIBITOR BIOSIMILARS IN PATIENTS WITH RHEUMATOID ARTHRITIS

Background: SB4, SB2, and SB5 are biosimilars of etanercept, infliximab, and adalimumab. Phase III randomised, double-blind studies were conducted to compare efficacy and safety between biosimilars and reference products. Objectives: Assess and compare 1-year outcomes among 6-month responders and non-responders. Methods: Patients who had 6-month data from each phase III study were pooled and categorised, based on their disease status at 6 months (week 24 for etanercept and adalimumab and week 30 for infliximab) and 1 year (week 52 for etanercept and adalimumab and week 54 for infliximab). Responders included patients who achieved an ACR20 response or low disease activity (including remission) by DAS28, SDAI, or CDAI at 6 months. Those who did not or dropped out were considered non-responders. Primary outcome was the proportion of responders who maintained responses from 6 months to 1 year or non-responders at 6 months who achieved responses at 1 year. Results: Data from 1461 patients were included in the analysis. For all treatments combined, 81.1% of ACR20 responders, 69.6%, 77.8%, and 77.0% of responders with DAS28, SDAI, and CDAI low disease activity (LDA) at 6 months maintained their responses at 1 year, and 33.9%, 18.8%, 26.7%, and 24.9% of 6-month non-responders achieved responses at 1 year, respectively. The proportions of patients maintaining or achieving an ACR20 response or DAS28, SDAI, and CDAI LDA at 1 year were similar across different treatment groups ( Table 1 ). Conclusion: A pooled analysis of TNF inhibitor biosimilars and reference products showed that about 20-30% of responders lost their response, while about 20-30% gained it. Thus, the overall stability of disease fluctuation in our 1-year phase III studies is a consequence of a similar success and failure rate. The validity of these data can be seen by the similarities in these outcomes between different types of TNF-inhibitors and similarity between biosimilars and respective reference products. REFERENCES: [1] Emery, et al. Rheumatology. 2017 Dec;56(12):2093-2101. [2] Smolen, et al. Ann Rheum Dis. 2018 Feb;77(2):234-240. [3] Weinblatt, et al. Arthritis Rheumatol. 2018 Jan;70(1):40-48. Disclosure of Interests: Josef S. Smolen Grant/research support from: AbbVie, Eli Lilly, Janssen, MSD, Pfizer Inc, Roche, Consultant for: AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, Eli Lilly, GlaxoSmithKline, ILTOO, Janssen, Medimmune, MSD, Novartis-Sandoz, Pfizer Inc, Roche, Samsung, Sanofi, UCB, Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, Eli Lilly, GlaxoSmithKline, ILTOO, Janssen, Medimmune, MSD, Novartis-Sandoz, Pfizer Inc, Roche, Samsung, Sanofi, UCB, Michael E. Weinblatt Shareholder of: Stock option: CanFite, Lycera, Scipher, Inmedix, Grant/research support from: Crescendo Bioscience, Bristol Myers Squibb, Sanofi, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, CanFite, Corrona, Crescendo, GlaxoSmithKline, Gilead, Horizon, Lilly, Lycera, Merck, Novartis, Pfizer, Roche, Samsung, Scipher, Set Point, Paul Emery Grant/research support from: Pfizer, MSD, AbbVie, Bristol-Myers Squibb, Roche, Consultant for: Pfizer, MSD, AbbVie, Bristol-Myers Squibb, UCB, Roche, Novartis, Gilead,Samsung, Sandoz and Lilly, Jung-Yoon Choe: None declared, Jonathan Kay Grant/research support from: Gilead Sciences, Pfizer, UCB Pharma, Consultant for: AbbVie, Boehringer Ingelheim GmbH, Celltrion Healthcare, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals, Pfizer, Samsung Bioepis, Sandoz, UCB Pharma, Jieun Lee Employee of: Samsung Bioepis, Gihyun Myung Employee of: Samsung Bioepis, Hyoryeong Seo Employee of: Samsung Bioepis, Jeehoon Ghil Employee of: Samsung Bioepis DOI: 10.1136/annrheumdis-2019-eular.6611Citation: Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1153Session: Rheumatoid arthritis - biological DMARDs (Scientific Abstracts)