Real-world clinical effectiveness and safety of vedolizumab and ustekinumab in biologic-naive patients with noncomplicated or complex Crohn’s disease: results from the EVOLVE Expansion study

BACKGROUND: Real-world effectiveness/safety of vedolizumab and ustekinumab as first-line biologics in Crohn's disease were evaluated by disease complexity. METHODS: EVOLVE Expansion (NCT05056441) was a retrospective chart review in Australia, Belgium, and Switzerland. Biologic-naive patients with Crohn's disease (≥18 years) initiated first-line biologic treatment with vedolizumab or ustekinumab. Complex Crohn's disease was defined as active fistula at treatment initiation, any prior Crohn's disease-related surgery since, or any Crohn's disease-related hospitalization within 12 months prior to treatment initiation. Baseline characteristics were balanced using inverse probability of treatment weighting. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were estimated over 36 months. Serious adverse events (SAEs), serious infections, and health care resource use (HCRU) were evaluated. RESULTS: Overall, 427 patients had noncomplicated Crohn's disease (vedolizumab, n = 245; ustekinumab, n = 182) and 196 had complex Crohn's disease (vedolizumab, n = 102; ustekinumab, n = 94). In both subgroups, cumulative rates (vedolizumab vs. ustekinumab) of clinical response (noncomplicated, 85.1 vs. 85.7%; complex, 79.7 vs. 81.3%), clinical remission (noncomplicated, 93.5 vs. 91.3%; complex, 82.9 vs. 80.8%), mucosal healing (noncomplicated, 91.1 vs. 91.5%; complex, 87.8 vs. 80.2%), and treatment persistence (noncomplicated, 72.2 vs. 83.7%; complex, 71.8 vs. 71.3%) over 36 months were not significantly different in patients who initiated vedolizumab or ustekinumab. In both subgroups, the risks of SAEs, Crohn's disease exacerbations, Crohn's disease-related surgeries, and Crohn's disease-related hospitalizations were similar between patients treated with vedolizumab or ustekinumab during 36 months. CONCLUSION: Vedolizumab and ustekinumab demonstrated similar rates of clinical outcomes, treatment persistence, safety, and HCRU in patients with complex and noncomplicated Crohn's disease during 36 months of treatment.