FRI0518 BIOSIMILAR INFLIXIMAB THERAPY IN RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS AND PSORIATIC ARTHRITIS: A LONG-TERM FOLLOW-UP STUDY
Authors: H. Marotte, A. Tamzali, B. Fautrel
Journal: Annals of the Rheumatic Diseases (2020)

Background: Objectives: REFLECT study has been carried out to assess in real life the use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) approved in France. Long-term real-life data on CT-P13 use are limited in patients (pts) suffering from rheumatic diseases and inflammatory bowel diseases. Methods: REFLECT is a multicenter, prospective, observational study conducted in France which aims to describe characteristics of pts’ receiving CT-P13 and to assess its safety and effectiveness in real-life conditions. Eligible pts for inclusion were pts (≥ 6 years old) with RA, axSpA, PsA, and inflammatory bowel disease treated with CT-P13. IFX naive pts (IFX-N) or those having switched from IFX originator to CT-P13 were enrolled (IFX-S). An intermediate result in pts with rheumatic diseases using descriptive statistical analyses from inclusion after 18-month-follow-up period are described below. Results: From 19 October 2016 to 31 January 2019, 1321 pts were included by 70 centres, and 616 pts with rheumatic diseases were analysed: 132 RA (25.0% males; mean age: 61.5 ± 10.5; median time since diagnosis: 12.9 years), 398 axSpA (59.0%; 48.0 ± 13.1 years; 10.7 years, respectively), and 86 PsA (41.9%; 53.0 ± 14.1 years; 10.3 years). Previous bDMARDs other than IFX were reported in 40.1%, 42.1% and 47.4% of RA, axSpA and PsA pts, respectively. More than ⅓ of pts switched from the IFX originator to CT-P13 (40.2% of RA, 42.7% of axSpA and 35.5% of PsA). At the first administration of CT-P13, the majority of IFX-N pts had active disease (92.0% of RA, 76.4% of axSPA and 55.0% of PsA) compared to IFX-S pts (39.5% of RA, 23.1% of axSPA and 26.3% of PsA). At the first infusion of CT-P13, the median DAS28 scores were 4.8 and 2.4 for RA pts in IFX-N and INF-S pts, and 4 and 2.2 for PsA pts, respectively. In axSpA pts, the median BASDAI at baseline were 5.6 and 2.4 and the median BASFI was 5.3 and 2.8 in IFX-N and IFX-S pts, respectively. From the first administration of CT-P13 to 18 months follow-up the median DAS 28 decreased (-1 point) in both IFX-N pts and IFX-S for RA pts; for axSPA pts the BASFI and BASDAI scores decreased by -2 and -1, respectively in IFX-N and remained stable in IFX-S. The analysis of pts suffering from PsA has not been reported due to the small number of patients with a follow-up at 18 months (4 IFX-N pts and 1 IFX-S pts). 78,8%, 82,9% and 87,2% remain on treatment with CT-P13 in RA, AxSpa and PsA pts respectively. The reasons for treatment withdrawing are reported in table 1. Table 1. Reasons for treatment withdrawing RA Ax Spa PsA IFX pts (N) IFXn (N=16) IFXs (N=9) IFXn (N=28) IFXs (N=30) IFXn (N=5) IFXs (N=6) Missing 0 0 1 0 0 0 Remission 0 (0.0%) 2 (22.2%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Therapeutic failure 9 (56.3%) 3 (33.3%) 18 (56.3%) 19 (63.3%) 3 (60.0%) 4 (66.7%) Intolerance 2 (12.5%) 1 (11.1%) 3 (11.1%) 2 (6.7%) 0 (0.0%) 0 (0.0%) Other 5 (31.3%) 3 (33.3%) 6 (22.2%) 9 (30.0%) 2 (40.0%) 2 (33.3%) The safety data are presented in Table 2. Table 2. Safety data RA (N=132) ax Spa (N=398) PsA (N=86) Patients with at least one adverse event (AE) 49 (37.1%) 141 (35.4%) 25 (29.1%) Patients with at least one serious AE 11 (8.3%) 19 (4.8%) 1 (1.2%) Patients with at least one allergic infusion reaction† 3 (2.3%) 9 (2.3%) - Patients with at least one infection‡ 3 (2.3%) 4 (1.0%) 1 (1.2%) † Including acute and delayed hypersensitivity reactions ‡ Including severe infections, tuberculosis, opportunistic infections, hepatitis. Conclusion: The results from this long-term follow-up period show that CT-P13 was effective in inducing and maintaining remission in both naive and switched patients. This real-life study did not highlight any new safety concerns. Disclosure of Interests: Hubert MAROTTE Grant/research support from: Bristol Myers Sqibb, Lilly France, MSD, Novartis, Nordic Pharma, Pfizer, SanofiAventis, Consultant of: AbbVie, Amgen, Bristol Myers Sqibb, Lilly France, MSD, Novartis, Nordic Pharma, Pfizer, SanofiAventis, Paid instructor for: Sanofi-Aventis, Speakers bureau: Sanofi-Aventis, amel tamzali Employee of: Pfizer, Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB