Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naïve Patients With Early or Late Crohn's Disease: Results From the EVOLVE Expansion Study.

Background: We evaluated the real-world effectiveness and safety of vedolizumab and ustekinumab as first-line biologics in patients with Crohn's disease (CD), by disease duration.

Methods: EVOLVE Expansion (ClinicalTrials.gov, NCT05056441) was a retrospective medical chart review study in Australia, Belgium, and Switzerland. Biologic-naïve patients with CD (≥18 years old) initiated first-line biologic treatment with vedolizumab or ustekinumab. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were assessed over 36 months. Outcomes were compared between patients with early (≤2 years) and late (>2 years) disease at biologic initiation. Serious adverse events (SAEs), serious infections (SIs), and healthcare resource use (HCRU) were evaluated.

Results: In early (n = 249) and late (n = 371) CD subgroups, there were no significant differences over 36 months between vedolizumab and ustekinumab in the cumulative rates of clinical response (early CD, 81.6% vs 80.7%; P = .31; late CD, 83.7% vs 86.5%; P = .31) or clinical remission (early CD, 87.9% vs 85.0%; P = .74; late CD, 91.1% vs 90.6%; P = .96). In patients with early CD, mucosal healing rates were significantly higher with vedolizumab than ustekinumab at both 24 (P = .02) and 36 months (P = .03). Treatment persistence was significantly higher with ustekinumab versus vedolizumab over 36 months in patients with late CD, but similar in patients with early CD. There were no significant differences in SAEs, SIs, or HCRU.

Conclusions: Both vedolizumab and ustekinumab are effective treatment options for early- and late-stage CD. Over 36 months, mucosal healing rates in patients with early CD were significantly higher with vedolizumab than with ustekinumab.