DOP090Persistence and treatment patterns of vedolizumab subcutaneous maintenance therapy in patients with Inflammatory Bowel Disease: data from a Canadian cohort

Abstract Background The subcutaneous (SC) formulation of vedolizumab was approved in Canada as a maintenance therapy for adults with moderate to severe ulcerative colitis (UC) in 2020 and Crohn’s disease (CD) in 2021. The VISIBLE 2 trial (NCT02611817) and VISIBLE open-label extension study (NCT02620046) demonstrated the safety and efficacy of vedolizumab SC, while VISIBLE 1 (NCT02611830) further supported its comparable profile to the intravenous (IV) formulation. Real-world evidence from European centres shows that a substantial proportion of patients switch from IV maintenance therapy to SC maintenance therapy; however, data on the use of vedolizumab SC maintenance therapy following IV induction remain limited. Methods This retrospective study used data from the cross-Canada patient support programme between 1 January 2015 and 31 March 2025, including adult patients receiving maintenance therapy with vedolizumab for UC or CD. Following IV induction of up to 14 weeks after 1 January 2021, patients were stratified by vedolizumab administration route into the SC maintenance cohort or the new IV maintenance (received vedolizumab for the first time during the study period) cohort. Follow up was until discontinuation or 31 March 2025. First index date was defined as the date of the first IV induction dose; second index date was defined as the date of the first SC or IV maintenance dose after IV induction. Baseline characteristics, treatment characteristics, and dosing frequency patterns were analysed by cohort using descriptive statistics; time to first discontinuation of vedolizumab SC and IV was analysed using Kaplan–Meier analyses. Results In total, 10,853 patients were included in the new IV maintenance cohort and 1,977 patients in the SC maintenance cohort. At second index date, baseline characteristics were similar between the new IV maintenance and SC maintenance cohorts (Table 1). During a 200-week follow-up period, similar proportions of patients in each cohort discontinued vedolizumab treatment (new IV maintenance: UC 30.5%, CD 33.0%; SC maintenance: UC 22.6%, CD 24.6%; Table 1). Kaplan–Meier analyses showed comparable treatment persistence across cohorts, with similar proportions of patients remaining on vedolizumab at 200 weeks (Figures 1A–B). In the SC maintenance cohort, a low proportion of patients dose-escalated from once every 2 weeks to once every week (UC, 4.2%; CD, 4.1%; Table 1). Conclusion In a real-world setting, patients who received vedolizumab SC maintenance after IV induction demonstrated similar persistence to those who received IV maintenance, with approximately 4 years of follow-up, consistent with clinical trial findings. Only a small proportion of the patients in the SC maintenance cohort required dose escalation. Conflict of interest: Bressler, Brian: Personal Fees: Janssen, Abbvie, Takeda, Pfizer, Alimentiv, Pendopharm, Genentech, Merck, CSL. Stock Options: Qu Biologics, Dova Health Intelligence. Other: This study was funded by Takeda Pharmaceuticals U.S.A., Inc. Medical writing support was provided by Hera Wong of PharmaGenesis Cardiff, Cardiff, UK, and funded by Takeda Pharmaceuticals U.S.A., Inc.. Moulson, Ruth: Ruth Moulson is an employee of Pentavere Research Group. Yang, Zimo: Employee of Pentavere Research Group. Pettengell, Christopher: Employee of Pentavere Research Group Inc Brown, Joshua: Employee and hold stock/stock options in Takeda Pharmaceuticals U.S.A., Inc. Barfield, Elaine: Employee and hold stock/stock options in Takeda Pharmaceuticals U.S.A., Inc. Gift, Thais: Employee and hold stock/stock options in Takeda Pharmaceuticals U.S.A., Inc. Liu, Yiyan: Employee and hold stock/stock options at Takeda Pharmaceuticals U.S.A., Inc. Power, G Sarah: Former employee of Takeda Canada Inc. Horst, Sara: Consultant for Johnson & Johnson, Takeda, AbbVie, Lilly, Biocon, Mirador, Celltrion. Educational Grant from AbbVie, Takeda.