634 Transitioning From Vedolizumab IV to Vedolizumab SC in Patients With Ulcerative Colitis: Results From the VISIBLE Program

Abstract

INTRODUCTION: Vedolizumab (VDZ), a monoclonal antibody targeting α4β7 integrin, is approved as an intravenous (IV) formulation to treat ulcerative colitis (UC). In the first completed study with a new VDZ subcutaneous (SC) formulation (VISIBLE 1, NCT02611830, a randomized, double-blind, double-dummy, placebo-controlled, phase 3 trial assessing VDZ SC as maintenance treatment in adults with moderately to severely active UC), VDZ SC demonstrated statistically significant efficacy superior to placebo as maintenance treatment in patients with UC who had achieved a response to VDZ IV induction. The VDZ SC clinical program also includes an open-label extension (OLE, NCT02620046, ongoing). Analyses across these 2 studies allow for evaluation of efficacy when transitioning from VDZ IV to VDZ SC in patients who achieved clinical benefit with VDZ IV treatment for varying durations. METHODS: Efficacy of VDZ SC treatment after initial VDZ IV (300 mg) infusion was evaluated in 3 groups according to the duration of VDZ IV treatment before transitioning to VDZ SC (108 mg; Figure 1): (A) After 2 VDZ IV infusions (Week [W] 0 and 2) in patients who achieved clinical response at W6 and were randomized to VDZ SC maintenance treatment in VISIBLE 1; (B) After 3 VDZ IV infusions in patients who did not achieve clinical response at W6 who received a third VDZ IV infusion at W6 and had clinical response at W14 in VISIBLE 1 before enrolling in the OLE and transitioning to VDZ SC; (C) After 8 VDZ IV infusions (W0, W2, W6, and every 8 weeks thereafter until W52) in patients randomized to VDZ IV maintenance treatment in VISIBLE 1, completed 52 weeks of VDZ IV treatment, and transitioned to VDZ SC in the OLE. RESULTS: Patients who transitioned to VDZ SC after 2 infusions of VDZ IV (N = 106) had a clinical remission rate of 46.2% and a clinical response rate of 65.1% at W52. Among patients who received 3 VDZ IV infusions before transitioning to VDZ SC (N = 107), 39.2% achieved clinical remission and 48.0% achieved clinical response at W54 (14 weeks of IV; 40 weeks of SC). For patients who transitioned to VDZ SC after receiving 8 VDZ IV infusions over 52 weeks in VISIBLE 1 (N = 35), clinical remission and clinical response rates (both 76.9%) were maintained during the OLE on SC through W24 (Tables 1 and 2). CONCLUSION: Transitioning from initial VDZ IV treatment to VDZ SC maintenance treatment retains therapeutic benefit, independent of initial vedolizumab IV treatment duration.