Effectiveness of vedolizumab dose escalation in inflammatory bowel disease in a large-scale, Canadian real-world cohort

Background and Aims This study explores the effectiveness of vedolizumab dose escalation among patients with ulcerative colitis or Crohn’s disease who experienced a suboptimal or loss of clinical response in a Canadian real-world cohort. Methods Patients with moderately to severely active ulcerative colitis or Crohn’s disease treated with vedolizumab were prospectively followed in a patient support program in Canada from 2015 to 2023. In patients who dose escalated to every 4 weeks from every 8 weeks intravenous maintenance dosing, Harvey-Bradshaw Index and Partial Mayo Scores were assessed 12 and 52 weeks after dose escalation. Clinical remission was defined as Harvey-Bradshaw Index < 5 or Partial Mayo Score < 3. Results This study included 924 patients with Crohn’s disease (45% bio-naïve) and 1816 patients with ulcerative colitis (71% bio-naïve). Of patients with Crohn’s disease, 39% bio-naïve and 54% bio-experienced dose-escalated within the first 2 years. Of patients with ulcerative colitis, 39% bio-naïve and 50% bio-experienced dose escalated within the first 2 years. For Crohn’s disease patients receiving every 8 weekly intravenous maintenance dosing who were not in clinical remission, 50% bio-naïve and 23% bio-experienced patients were in clinical remission 12 weeks after dose escalation, while for ulcerative colitis, 43% bio-naïve and 35% bio-experienced patients were in clinical remission 12 weeks after dose escalation, which was sustained through 52 weeks. Conclusions For patients who experienced a suboptimal or loss of clinical response to vedolizumab, this study supports the real-world effectiveness of intravenous vedolizumab dose escalation in improving clinical response and clinical remission rates among patients with ulcerative colitis or Crohn’s disease.