POS0592 BIOSIMILAR INFLIXIMAB THERAPY IN RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS AND PSORIATIC ARTHRITIS: A LONG-TERM FOLLOW-UP STUDY ON INFLIXIMAB-NAÏVE PATIENTS AND PATIENTS SWITCHED FROM THE ORIGINATOR TO THE BIOSIMILAR CT-P13
Authors: B. Fautrel, M. Assing, N. Mammar, H. Marotte
Journal: Annals of the Rheumatic Diseases (2021)

Objectives: The ReFLECT study was carried out to investigate real life use of CT-P13, the first monoclonal antibody biosimilar to infliximab originator. Methods: ReFLECT is a multicentre, prospective, observational study conducted in France to determine the characteristics of patients (pts) receiving CT-P13, its effectiveness and safety in a real-life setting. Eligible were both pts who had been switched from infliximab originator (IFX S ) and infliximab-naïve pts started on CT-P13 (IFX N ). Intermediate results in pts with rheumatic diseases using descriptive statistical analyses from inclusion to a 24-month-follow-up period are described here. Results: Among the 1370 adult pts included between October 2016 and April 2019, data were analysed for 142 pts with rheumatoid arthritis (RA; 23.9% males; mean age: 61.5±10.9 years; 80 IFX N /61 IFX S ), 411 with ankylosing spondylitis (AS; 58.9% males; 48.1±13.1 years; 228 IFX N /179 IFX S ), and 96 with psoriatic arthritis (PsA; 41.7% males; 53.4±14.1 years; 55 IFX N /40 IFX S ) after a median of between 8.7 and 12.9 years since diagnosis. At inclusion, 66.9%, 24.3% and 50% had one concomitant treatment, mainly methotrexate. At the time of the first administration of CT-P13, disease had been active in 94.2%, 76.6% and 83.3% of the IFX N pts compared with 45.3%, 24.0% and 32.0% of the IFX S pts. After 24 months of follow-up, both CRP levels and disease activity remained stable compared to baseline in the IFX S pts: median ΔCRP/RA S = 1, ΔCRP/AS S = 0, ΔCRP/PsA S = 0 and median ΔDAS28/RA S = 0, ΔBASDAI/AS S = 0, ΔDAS28/PsA S = 1. As expected, improvement was observed in the IFX N pts: median ΔCRP/RA N = -2, ΔCRP/AS N = -2, ΔCRP/PsA N = 0 and median ΔDAS28/RA N = -1, ΔBASDAI/AS N = -2, ΔDAS28/PsA N = -1. In naïve pts, CT-P13 brought both CRP and disease activity down to levels comparable to those seen in patients switched from the IFX originator: median [Q1;Q3] CRP/RA N = 5 [2;9] vs CRP/RA S = 5 [2;8]; CRP/AS N = 3 [2;9] vs CRP/AS S = 3 [2;5]; CRP/PsA N = 2 [1;4] vs CRP/PsA S = 2 [1;3] and median [Q1;Q3] DAS28/RA N = 3 [3;4] vs DAS28/RA S = 2 [2;3]; BASDAI/AS N = 3 [1;4] vs BASDAI/AS S = 2 [1;3]; DAS28/PsA N = 3 [2;3] vs DAS28/PsA S = 3 [2;3], (Figure 1). At 24 months, 62.7%, 74.9% and 75.0% remained on treatment with CT-P13 in RA, AS and PsA pts respectively. The reasons for treatment withdrawing and safety results are reported in Table 1. Figure 1. Disease activity at the time of first administration of CT-P13 and after 24 months Table 1. Reasons for treatment withdrawing and safety results Reasons for treatment withdrawing IFX pts, n (% ) RA N , 37 RAs, 15 AS N, 64 ASs, 38 PsA N, 11 PsAs, 12 Missing 1 0 0 0 0 1 Remission 0 2 (13.3) 2 (3.1) 0 0 0 Therapeutic failure * 25 (69.4) 8 (53.3) 41 (64.1) 23 (60.5) 5 (45.5) 6 (54.5) Intolerance 5 (13.9) 1 (6.7) 5 (7.8) 2 (5.3) 1 (9.1) 1 (9.1) Other 6 (16.7) 4 (26.7) 16 (25.0) 13 (34.2) 5 (45.5) 4 (36.4) Safety data, n (% ) RA, 142 AS, 411 PsA, 96 Pts with ≥ 1 adverse event (AE) 67 (47.2) 222 (54.0) 48 (50.0) Pts with ≥ 1 AE related to CT-P13 33 (23.2) 84 (20.4) 19 (19.8) Pts with ≥ 1 serious AE 19 (13.4) 42 (10.2) 9 (9.4) Pts with ≥ 1 allergic infusion reaction † 4 (2.8) 11 (2.7) 1 (1.0) Pts with ≥ 1 infection ‡ 10 (7.0) 18 (4.4) 3 (3.1) * Encompassing primary failure in IFX N pts and loss of efficacy in IFX N and IFX S pts † Including acute and delayed hypersensitivity reactions ‡ Including severe infections, tuberculosis, opportunistic infections, hepatitis Conclusion: Year 2 follow-up data indicate that CT-P13 effectively induced improvement in disease activity in pts with RA, AS and PsA receiving infliximab for the first time and maintained stable disease activity in pts switched from IFX originator to CT-P13. This real-life study did not highlight any new safety concerns. Disclosure of Interests: Bruno Fautrel Speakers bureau: Lilly, SOBI, Roche-Chugaï, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Roche-Chugaï, Sanofi Aventis, SOBI and UCB, Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Maryse Assing Employee of: Pfizer, Nadir Mammar Employee of: Pfizer, Hubert MAROTTE Speakers bureau: Sanofi-Aventis, Paid instructor for: Sanofi-Aventis, Consultant of: AbbVie, Biogen, Bristol Myers Squibb, Gilead, Lilly France, MSD, Medac, Nordic Pharma, Novartis, Pfizer, Sanofi-Aventis, UCB, Grant/research support from: Bristol Myers Squibb, Lilly France, MSD, Novartis, Nordic Pharma, Pfizer, Sanofi Aventis