Long-term safety of vedolizumab in patients with ulcerative colitis/Crohn's disease: A prospective observational study.

Background and aims: This post-authorization safety study compared long-term safety of vedolizumab or other biologics in patients with ulcerative colitis (UC) or Crohn's disease (CD).

Methods: This was a prospective, observational, multicentre, cohort study in patients with UC or CD starting treatment with vedolizumab or other biologics (NCT02674308, EUPAS6469). The primary safety outcome was serious infections compared between cohorts using a Cox proportional hazards model adjusted by propensity score. Clinical effectiveness was a secondary outcome.

Results: The full analysis set comprised 5,008 pts (vedolizumab=2,502; other biologic=2,506) and mean (standard deviation) follow-up duration was 37.4 (14.1) months. Patients in the vedolizumab group had greater age, duration of disease, and concomitant medication use at baseline, indicating more advanced disease. In patients with UC, the incidence rate per 100 person-years of serious infections was: 5.5 (95% CI: 4.7, 6.5) [vedolizumab] and 7.0 (5.8, 8.5) [other biologic], with an adjusted hazard ratio (HR) of 0.89 (0.69, 1.15), p=0.38. In patients with CD, corresponding findings were 7.9 (95% CI: 6.8, 9.1) [vedolizumab] and 6.5 (95% CI: 5.7, 7.3) [other biologic] with adjusted HR of 1.15 (0.95, 1.40), p=0.16. There were no safety issues relating to pregnancy and no cases of progressive multifocal leukoencephalopathy were observed. There were 18 deaths in the vedolizumab group and 13 in the other biologic group. Clinical effectiveness was comparable between cohorts and was similar to the levels seen in other prospective observations of vedolizumab.

Conclusion: There was no new safety signal identified in relation to vedolizumab. Results regarding safety and effectiveness were consistent with the known profile of vedolizumab.