Real-World Effectiveness and Patient Stratification for Vedolizumab Treatment in Crohn's Disease: A Multicenter Retrospective Study.

Background: Although selecting the appropriate patients for vedolizumab (VDZ) treatment was challenging, this multicenter, retrospective study evaluated the real-world effectiveness of VDZ and identified the patients who would benefit from VDZ therapy. Methods: A total of 264 patients from three tertiary care centers specializing in inflammatory bowel disease were treated with VDZ. The outcomes assessed included steroid-free remission, clinical remission, objective response, and remission at Weeks 26 and 52. Least Absolute Shrinkage and Selection Operator regression and multivariate analyses were performed to identify independent predictors, and a nomogram was developed to predict steroid-free remission at Week 26. Results: The rates of steroid-free remission and clinical remission were 46.6% and 47.0% at Week 26, and both were 38.6% at Week 52. Objective response and remission were achieved in 41.5% and 14.8% of patients at Week 26, compared with 20.7% and 11.4% at Week 52. Bio-naïve patients without active intestinal fistula, and with low inflammation burden (Crohn's Disease Activity Index ≤ 220 and C-reactive protein ≤ 10 mg/L) showed the highest rates of steroid-free remission and objective remission at both time points (all Conclusions: VDZ was effective and safe in treating Crohn's disease. Patients who were bio-naïve, without active intestinal fistulas, and who had milder baseline disease activity were more likely to benefit from VDZ therapy.