FRI0518 BIOSIMILAR INFLIXIMAB THERAPY IN RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS AND PSORIATIC ARTHRITIS: A LONG-TERM FOLLOW-UP STUDY

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. The safety data are presented in Table 2. 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