Real-world effectiveness and safety of Vedolizumab for the treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort.
Introduction: Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn’s disease and ulcerative colitis.
Aims: To establish the real-world efficacy and safety of vedolizumab in the treatment of inflammatory bowel disease.
Methods: Retrospective study involving six NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included a diagnosis ulcerative colitis or Crohn’s disease with objective evidence of active inflammation at baseline (HBI≥5 / Partial Mayo ≥2 plus CRP >5 g/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy / MRI) and at least one clinical follow up by 12 months. Kaplan-Meier survival analysis was used to establish 12-month cumulative rates of clinical remission (HBI <5 or Partial Mayo <2), mucosal healing (absence of ulceration/erosions on colonoscopy/MRI or Mayo score 0) and deep remission (clinical remission plus mucosal healing). Rates of serious adverse events were described quantitatively.
Results: Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn’s disease. Combined median follow up was 52 weeks (IQR 26-52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing and deep remission were 57.4%, 47.3% and 38.5% respectively. In Crohn’s disease, 12-month cumulative rates of clinical remission, mucosal healing and deep remission were 58.4%, 38.9% and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient years of follow up.
Conclusion: Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn’s disease.