P0986Higher persistence with subcutaneous infliximab compared to vedolizumab in stable IBD patients switching from maintenance intravenous therapy confirmed in an independent multicentre validation cohort

Abstract Background Subcutaneous (SC) formulations of infliximab and vedolizumab have been approved for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). A previous single-centre study involving 140 patients who switched from maintenance intravenous (IV) to SC therapy reported higher treatment persistence with infliximab compared to vedolizumab1. The current study aimed to validate this finding in an independent cohort. Methods We conducted a multicentre retrospective study from May 2021 through January 2025 enrolling patients with inflammatory bowel disease (IBD) on maintenance IV infliximab or vedolizumab who switched to SC formulations with a minimum follow-up of 34 weeks. All patients had stable disease based on physician’s global assessment. Demographics, disease characteristics, treatment history, and outcomes after switch were collected. The primary endpoint was SC treatment persistence. Secondary endpoints included reasons for treatment discontinuation and the need for SC dose escalation. A multivariate Cox proportional hazards model identified independent predictors of SC treatment discontinuation. Results A total of 400 patients (median age 40 y, 52.8% female, 39.5% UC, 60.5% CD, 46.5% infliximab, 53.5% vedolizumab) were included (Table 1). No patients received concomitant steroids, while 28 patients (7.0%) used concomitant immunosuppressants. Seventy-six patients (19.0%) had elevated biomarkers (C-reactive protein 5 mg/L and/or faecal calprotectin 250 mg/kg) at switch. Thirteen patients (3.3%) initiated weekly SC dosing directly after switch. Over a median follow-up of 124 (IQR 76-160) weeks, 82.8% of patients remained on SC formulation (86.0% infliximab, 80.0% vedolizumab). Reasons for discontinuation were disease flare (n = 23), adverse events (n = 20), injection site reactions (n = 7), disease remission (n = 7), patient preference (n = 7), non-compliance (n = 5), and increased symptoms (n = 1). Female sex (HR 2.54 95% CI 1.15-3.23, p = 0.014) and vedolizumab use (2.08 1.02-2.93, p = 0.042) were associated with SC treatment discontinuation (Figure 1). Forty-eight patients (12.0%) needed escalation to weekly SC dosing after switch. Reasons for dose escalation were disease flare (n = 31), increased symptoms without objective signs of disease activity (n = 14), ongoing endoscopic disease activity (n = 2), and subtherapeutic serum levels (n = 3). Conclusion This validation cohort confirmed higher SC treatment persistence with infliximab compared to vedolizumab in stable IBD patients after switching from maintenance IV therapy. Discontinuation was mainly related to disease activity or adverse events, and was more frequent in women and vedolizumab users. Reference: 1. Outtier A, Hoffert Y, De Dycker E, et al. Treatment persistence, clinical, and biological outcomes following an elective switch from intravenous to subcutaneous infliximab and vedolizumab abstract. J Crohns Colitis. 2025;19(Suppl 1):i1431–i1432. Conflict of interest: Dr. Outtier, An: No conflicts Truyens, Marie: No conflict of interest Pouillon, Lieven: Lieven Pouillon received advisory board fees from AbbVie, Alphasigma, Celltrion, Galápagos, Janssen-Cilag, Sandoz and Takeda consultancy fees from Ipsos NV and Ismar Healthcare funded by Viatris presentation fees from AbbVie, Alphasigma, Celltrion, Eli Lilly, Ferring, Galápagos and Pfizer and personal fees (congress support) from AbbVie, EG, Ferring, Galápagos, Janssen-Cilag, Norgine and Takeda. Baert, Filip J.: Grant: AbbVie, Amgen, EG, J&J, Takeda. Personal Fees: AbbVie, Abivax, Alpha Sigma, Arena, BMS,,Celltrion, Eli Lilly, Falk, Ferring, Fresenius, Galapagos, J&J, Pfizer, Sandoz, Takeda, Vifor. Cremer, Anneline: No conflict of interest Van Moerkercke, Wouter: No conflict of interest D’hooghe, Anna-Teresa: No conflicts. Taelman, Thibault: None Liefferinckx, Claire: Consultancy/speaker fees: Takeda, Janssen, Abbvie, Alfasigma, Celltrion Bossuyt, Peter: Grant support for research from AbbVie, EG Consulting fee from AbbVie, Bristol Meyers Squibb, CIRC, Galapagos, Janssen, Jeito capital, Lilly, Pentax, Pfizer, PSI-CRO, Roche, Takeda, Tetrameros Speakers fee from AbbVie, AMC ICP, Amgen, Bristol Myers Squibb, Celltrion, Dr Falk Benelux, EG, Galapagos, Globalport, Lilly, Medtalks, Materia Prima, Pentax, Springer Media Lobatón Ortega, Triana: Grant: Abbvie, Ferring, Viatris, MSD, EG, Mundipharma, Biogen, Janssen, Pfizer, Takeda, Galapagos, Afasigma and Sandoz. Personal Fees: Speaker fees from MSD, Abbvie, Janssen, Amgen, Fresenius Kabi, Galapagos, Viatris, Ferring, Celltrion, Alfasigma, Lilly and Takeda. Consultancy fee from Janssen, Galapagos, Alfasigma, Amgen, Bristol Myers, Squibb Fresenius Kabi, Takeda and Abbvie Ferrante, Marc: Research grants from AbbVie, EG Pharma, Celltrion, Janssen, Pfizer, Takeda and Viatris Consultancy fees from AbbVie, AgomAb Therapeutics, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Janssen-Cilag, MRM Health, Merck Sharp and Dohme, Pfizer, Takeda and ThermoFisher Speakers’ fees from AbbVie, Biogen, Boehringer Ingelheim, Dr Falk Pharma, Ferring, Janssen-Cilag, Merck Sharp and Dohme, Pfizer, Takeda, Truvion Healthcare and Viatris