Transition to subcutaneous vedolizumab is effective and safe in adults with inflammatory bowel disease who are in clinical remission, including those on dose-escalated intravenous vedolizumab: a prospective cohort study

Background We present a prospective evaluation of the effectiveness and safety of subcutaneous (SC) vedolizumab in patients with inflammatory bowel disease (IBD) who transitioned from standard or dose-escalated intravenous (IV) maintenance to SC vedolizumab and those who started SC vedolizumab following IV induction. Methods We prospectively evaluated adults with IBD treated with SC vedolizumab at the University of Chicago from September 2023 to December 2025. We examined the following outcomes: treatment persistence, maintenance of clinical and biochemical remission in those in remission at time of switch, and adverse events (AEs). Outcomes were stratified by baseline IV vedolizumab dosing and clinical disease activity. Results We included 86 patients who switched from IV maintenance to SC vedolizumab, of whom 25 were on dose-escalated IV therapy. One-year treatment persistence was 82.6%, regardless of IV dosing or clinical disease activity. Of those in clinical remission, 97.5% remained in clinical remission at 1 year. Of those with biochemical data available, 95.8% maintained normalization of C-reactive protein (CRP) and 100% maintained normalization of fecal calprotectin (FCP). We included a second exploratory group with 18 patients who received SC vedolizumab after 2 IV induction doses. Forty-five patients across Groups 1 and 2 experienced 51 AEs, most commonly IBD flare (n = 19) and injection site reactions (ISRs) (n = 18). Conclusion Transitioning from IV to SC vedolizumab was associated with high treatment persistence (82.6%) and sustained clinical remission (97.5%) at 1 year. The findings were similar in a small cohort of patients on prior dose-escalated IV vedolizumab. Potential risks include ISRs and relapse of IBD.