P0869Comparison of effectiveness between subcutaneous infliximab as monotherapy or combined with an immunosuppressant in patients with Crohn’s disease: interim results from the REMONO-CD study.

Abstract Background We aimed to demonstrate the non-inferiority of subcutaneous infliximab monotherapy (SC IFX mono) compared with combination therapy (SC IFX + IS) in patients with Crohn’s disease (CD). Methods In this multicenter (22 centers) retrospective study, we consecutively included all patients ≥18 years-old with symptomatic CD according to PRO-2 (abdominal pain subscore 1 or stool frequency 3) who started SC infliximab 120 mg every 2 weeks, from week 6 or W10 after an IV induction regimen (2 or 3 IV infusions at 5 mg/kg at week 0, W2 ± W6). The primary endpoint was clinical remission (abdominal pain subscore ≤1 and stool frequency ≤3) without steroid (CFREM) and is expressed as % of months (4-week periods) spent in CFREM (month being the statistical unit). The non-inferiority margin was predefined at -10% according to IOIBD recommendations. A priori sample-size calculation (considering hypothesis of 55% of months spent in CFREM in reference group, 90% power, one-sided 95% confidence interval due to non-inferiority design, and imbalance between groups), indicated that 2,160 months were required, i.e 210 patients. We present here the results of an interim analysis while data from half of participating centers have been collected. Secondary endpoints considered the patient as the statistical unit. All comparisons were performed using propensity-score adjustment (IPTW) Results To date, 196 patients (1,954 months) have been included (SC IFX mono = 62 and SC IFX +IS = 134 patients). The two groups were comparable except for higher complicated phenotypes and shorter disease duration in SC IFX+IS group (Table 1), which has been taken into account in propensity score analyses. Analysis on primary endpoint including 1,954 months, showed that 73.6% and 61.5% of months were spent in CFREM in SC IFX and SC IFX + IS groups, respectively, giving an absolute difference of + 12.1% lower bound = +8.4%, upper bound = +15.6%, confirming the non-inferiority of SC IFX mono. After IPTW (N = 196 patients), no difference of CFREM at W12 (67.1% vs 59.8%;p=0.32), W24 (71.5% vs 64.2%;p=0.28), and W52 (65.4% vs 61.9%;p=0.66) was seen between SC IFX mono and SC IFX + IS, respectively, (Table 2) with no difference in subgroups such as bio-exposed, B2/B3 phenotypes, and prior exposure to IS. SC IFX mono was not associated with a higher risk of SC IFX dose optimization (HR = 0.81 0.41–1.60, p = 0.55), IFX discontinuation (HR = 1.87 0.96-3.65, progression of bowel damage (HR = 0.660.15–2.96), bowel resection (HR = 0.150.02–1.15), or hospitalization (HR = 0.800.30–2.10) (median follow-up=19.4 months). Conclusion In this real-world multicenter study, SC infliximab monotherapy appeared non-inferior to combination therapy in CD at both short and mid-terms. Conflict of interest: Prof. Dr. Buisson, Anthony: Consulting fees from : Abbvie, AlfaSigma, Amgen, Arena, Biogen, Celltrion, CTMA, Ferring, Galapagos, Guty Care, Janssen, Hikma, Lilly, Mylan, Nexbiome, Pfizer, Roche, Takeda, Tillotts Lecture fees from: Abbvie, AlfaSigma, Amgen, Biogen, Celltrion, Ferring, Galapagos, Hikma, Janssen, Lilly, Mayoli-Spindler, MSD, Pfizer, Roche, Sanofi-Aventis, Takeda, Tillotts, Vifor-Pharma Research fundings from: Abbvie, AlfaSigma, Celltrion, Janssen, Lessaffre, Lilly, Pfizer, Takeda Caron, Bénédicte: No conflict of interest Le Berre, Catherine: Abbvie, Amgen, Celltrion, Ferring, Fresenius Kabi, Galapagos, Gielad, Janssen, Lilly, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda. Le Cosquer, Guillaume: consultant/lecture, transport fees from AbbVie, Amgen, Johnson & Johnson, Lilly, Takeda, Fresenius Kabi, Celltrion, and Pfizer. Serrero, Melanie: fees from Pfizer, Abbvie, Takeda, Janssen, MSD, Amgen, Ferring, Tillotts, Celltrion Nachury, Maria: Abbvie, Alfa Sigma, Biosynex, Celltrion, Galapagos, Janssen, Lilly, MSD, Pfizer, Takeda Altwegg, Romain: Advisory boards from Abbvie, Takeda, Johnson and Johnson, Lilly, Alphasigma, Celltrion, Pfizer, Amgen, Biogen, Sandoz, Ferring Boschetti, Gilles: No conflict of interest Vuitton, Lucine: No conflict of interest Uzzan, Mathieu: Grant: ECCO-IOIBD, Fondation pour la Recherche Medicale (FRM), SNFGE Personal Fees: Abbvie, Takeda, Celltrion, Janssen, Amgen, Alfasigma, Pfizer Tretón, Xavier: Personal Fees: Lectures and advisory board : Abbvie, Celltrion, MSD, johnson & Johnson, Takeda, Amgen, Alphasigma, Lilly, Pfizer Other: participations: Thabor Therapeutics Fumery, Mathurin: Grant: Pfizer Personal Fees: Abbvie, Janssen, Takeda, MSD, Biogen, Amgen, Sandoz, Fresenius, Gilead, Celgene, Galapagos, Mylan, Tillots, Ferring, Pfizer, Hospira, CTMA, Boehringer, Lilly, Arena Non-financial Support: Abbvie, Janssen, Takeda, MSD, Galapagos, Ferring, Pfizer Peyrin-Biroulet, Laurent: CONSULTING Abbvie, Abivax, Adacyte, Alimentiv, Alfasigma, Amgen, Apini, Banook, BMS, Celltrion, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Iterative Health, Janssen, Lilly, LifeMine, Medac, Morphic, MSD, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeuthics, Par’ Immune, Pfizer, Prometheus, Roche, Roivant, Samsung, Sandoz, Sanofi, Sorriso, Spyre, Takeda, Teva, ThirtyfiveBio, Tillots, Vectivbio, Vedanta, Ventyx. LECTURE Abbvie, Alfasigma, Amgen, Biogen, Celltrion, Ferring, Galapagos, Genentech, Gilead, Iterative Health, Janssen, Lilly, Medac, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda, Tillots Gilletta de Saint Joseph, Cyrielle: Speaker/ consultant fees from Abbvie, AlfaSigma, Amgen, Celltrion, Ferring, Fresenius, Janssen, Lilly, Pfizer, Takeda and Tillots Guillo, Lucas: No conflict of interest Nancey, Stéphane: board membership and lecturing fees from Abbvie, Takeda, Celltrion Healthcare, Pfizer, Galapagos, Johnson & Jonshon, Lilly, Fresenius, Amgen, Medac, MSD. Domas, Quentin: No conflict of interest Pereira, Bruno: No conflict of interest