Intensification of Treatment with Ustekinumab and Vedolizumab for Inflammatory Bowel Dis-Ease: A Real-World Study

Background: A significant proportion of patients with inflammatory bowel disease (IBD) treated with ustekinumab (UST) or vedolizumab (VDZ) experience an absence or loss of response with conventional treatment regimens. Available evidence on the intensification of these agents is limited. Aims: Main: To evaluate the frequency of intensification of UST and VDZ, the most frequent type of intensification, and its effectiveness, durability and safety. Secondary: Analyze predictors of response.Methods: Single-centre, retrospective, observational study including 101 patients with IBD who received UST and/or VDZ in an intensified regimen from its approval until June 2022. Efficacy was assessed at weeks 16 and 52 after intensification. Clinical response was considered to be a decrease of ≥3 points in clinical indices; and clinical remission as disappearance of symptoms. Results: Inten-sified treatment was given to 48.95% and 77.36% of patients on UST and VDZ, respective-ly. At 16 weeks, the rate of clinical response and remission for UST was 64.3% and 35.7%, respectively; and 46.3% and 20% for VDZ. At week 52 after UST intensification, 60% achieved a clinical response (43% remission); and 46.3% (31.7% remission) responded with VDZ. The likelihood of maintenance of intensified treatment was 79% for UST and 61% for VDZ (median follow-up 21 and 16 months, respectively). The use of corticoster-oids/ immunosuppressants was associated with a lack of response to short-term UST in-tensification (p=0.02). Conclusion: The frequency of intensification of UST and VDZ in real clinical practice is high. Short-term results of such strategy are acceptable and long-lasting, especially regarding UST.