P529 Year-two follow-up results of an observational study conducted in Crohn’s disease and ulcerative colitis patients treated with infliximab biosimilar CT-P13 in a real-life setting

Abstract

Abstract Background ReFLECT study has been carried out to investigate real life use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) originator. Aims: describe the profile of inflammatory bowel disease (IBD) patients (pts) treated with CT-P13 in a real-world setting and the treatment durability over time. Methods ReFLECT is a multicentre, prospective, observational study conducted in France. Eligible pts were IFX naive pts (IFX-N) starting CT-P13 and those who have been switched from infliximab originator to CT-P13 (IFX-S). Treatment maintenance was described indirectly and expressed as the percentage of pts without treatment failure during the 2 years of follow-up; treatment failure was defined as a permanent discontinuation of CT-P13 due to lack or loss of response and/or intolerance or death. Two years of follow-up final results of adult IBD pts using descriptive statistical analyses, are presented here. Results Among the 1400 adult pts included from Oct 2016 to April 2019, 751 had an IBD and 649 had a rheumatic disease; 530 pts with Crohn’s disease (CD; 51.5% females; mean age±SD: 38.1±13.9 years old; 327 IFX-N / 188 IFX-S) and 221 with ulcerative colitis (UC; 44.8% females; 43.5±17.3 years old; 152 IFX-N / 59 IFX-S), with a median disease duration since diagnosis of 7.5 and 6.2 years respectively. Nearly 80% of pts were already under CT-P13 before inclusion, and 35.3% of CD and 32.6% of UC pts had a concomitant treatment with AZA. At first CT-P13 administration, 54.3% of CD pts had an HBI>4 and 60.6% of UC pts had a Mayo score>6 in IFX-N pts compared with, 15.8% and 23.1% in IFX-S pts respectively. From first administration of CT-P13 to 24 months of follow-up, a higher proportion of pts without treatment failure was observed in IFX-S than in IFX-N pts: 83.7% [95%CI:78.0;89.9] vs 65.7% [58.6;73.7] in CD and 91.2% [81.7;100.0] vs 53.4% [43.0;66.2] in UC pts respectively (Figures 1 and 2). Main reason for CT-P13 withdrawing was treatment failure in IFX-N and IFX-S: 14.7% and 7.4% of CD, 21.7% and 5.1% of UC pts respectively. Withdrawing for intolerance involved 9.2% and 7.4% of CD, 7.2% and 3.4% of UC naive and switched pts respectively. Regarding safety (Table 1), 51.3% CD pts and 45.2% UC pts reported at least one adverse event (AE). AEs with suspected relationship with CT-P13 were described in 18.5% and 17.6% and serious AEs in 13.2% and 12.7% of CD and UC pts respectively. AEs were balanced between IFX-N and IFX-S. Conclusion 2 year follow-up data indicate that CT-P13 induce effective therapeutic maintenance in pts with CD and UC receiving IFX for the first time, and maintain a sustained disease control in pts having switched from IFX originator to CT-P13. This real-life study did not highlight any new safety concerns.