Effectiveness and Safety of Vedolizumab Induction Therapy for Patients With Inflammatory Bowel Disease.

Background & Aims Phase 3 trials have demonstrated the efficacy of vedolizumab, which binds to integrin α4β7, in patients with Crohn’s disease (CD) or ulcerative colitis (UC). We investigated the effectiveness and safety of vedolizumab in a patients who failed anti-tumor necrosis factor (TNF) therapy. Methods From June through December 2014, 173 patients with Crohn’s disease (CD) and 121 with ulcerative colitis (UC) were included in a multicenter nominative compassionate early-access program granted by French regulatory agencies. This program provided patients access to vedolizumab before it was authorized for marketing. Vedolizumab (300 mg) was administered intravenously at weeks 0, 2, and 6 and then every 8 weeks. Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. We report results obtained after the 14 week induction phase. Results Among the 294 patients treated with vedolizumab (mean age, 39.5 ± 14.0 years; mean disease duration, 10.8 ± 7.6 years; concomitant steroid in 44% of cases), 276 completed the induction period whereas 18 discontinued vedolizumab because of lack of response (n=14), infusion-related reaction (n=2), or infections (n=2). At week 14, 31% of patients with CD were in steroid-free clinical remission and 51% had a response; among patients with UC, 36% were in steroid-free clinical remission and 50% had a response. No deaths were reported. Severe adverse events occurred in 24 patients (8.2%), including 15 (5.1%) that led to vedolizumab discontinuation (1 case of pulmonary tuberculosis and 1 rectal adenocarcinoma). Conclusion In a cohort of patients with CD or UC who failed previous anti-TNF therapy, about one third of patients achieved steroid-free clinical remission following 14 weeks induction therapy with vedolizumab. This agent had an acceptable safety profile in these patients