Comparative efficacy of ustekinumab and vedolizumab in anti-TNF–naive and anti-TNF–exposed patients with Crohn’s disease: a matched cohort study

Background Ustekinumab and vedolizumab are used in patients with Crohn’s disease (CD). However, comparative studies evaluating their long-term efficacy in anti-TNF–naïve and anti-TNF–exposed populations remain limited.Methods A retrospective cohort study utilizing the TriNetX US Collaborative Network database was conducted to compare the real-world efficacy of ustekinumab and vedolizumab in adult patients with CD. Patients were stratified into anti-TNF–naïve and anti-TNF–exposed cohorts, and 1:1 propensity score matching was employed. The primary outcome was rate of corticosteroid use at 12 and 24 months. Secondary outcomes included all-cause hospitalization rates and emergency department visits.Results In the anti-TNF–naïve cohort (n = 2800 per group after matching), ustekinumab was associated with significantly lower steroid use at 12 months (29.8% vs 39.0%; adjusted hazard ratio [aHR] 0.71, 95% confidence interval [CI] 0.65–0.78; P < 0.001) and 24 months (36.1% vs 45.3%; aHR 0.73, 95% CI 0.68–0.80; P < 0.001). Ustekinumab was also associated with fewer emergency department visits, while hospitalization rates were slightly higher at 12 months but not significantly different at 24 months. In the anti-TNF–exposed cohort (n = 1234 per group after matching), ustekinumab was associated with lower steroid use at 12 months (43.7% vs 53.2%; aHR 0.73, 95% CI 0.66–0.82; P < 0.001) and 24 months (35.8% vs 45.3%; aHR 0.72, 95% CI 0.63–0.81; P < 0.001). Ustekinumab was also associated with fewer emergency department visits and reduced hospitalization rates at both time points.Conclusions Ustekinumab use was associated with lower corticosteroid exposure and reduced healthcare utilization compared to vedolizumab in anti-TNF–naïve and anti-TNF–exposed CD patients.