Comparative Effectiveness of Infliximab vs Ustekinumab for Endoscopic and Transmural Remission in Biologic Naïve Crohn's Disease.

Objective: Active-comparator studies are important to clinical decision-making. We compared the effectiveness of infliximab vs ustekinumab for endoscopic and transmural remission in biologic-naïve Crohn's disease (CD).

Methods: This was a prospective real-world cohort study that included biologic-naïve patients with CD initiating infliximab or ustekinumab therapy. We compared endoscopic remission, endoscopic response, transmural remission, transmural response, clinical remission, and C-reactive protein (CRP) remission at weeks 14 to 26 and 44 to 56, using multiple logistic regression and propensity score matching to adjust for confounders.

Results: In total, 429 patients were included (283 infliximab and 146 ustekinumab). At weeks 14 to 26 and 44 to 56, no significant differences were found between infliximab and ustekinumab groups in the rates of endoscopic remission (37.5% vs 30.8%; adjusted odds ratio [aOR], 1.42; 95% confidence interval [CI], 0.89-2.25; 37.5% vs 35.6%; aOR, 1.10; 95% CI, 0.71-1.72), endoscopic response (60.8% vs 55.5%; aOR, 1.27; 95% CI, 0.83-1.95; 52.7% vs 49.3%; aOR, 1.14; 95% CI, 0.75-1.76), transmural remission (16.7% vs 14.7%; aOR, 1.23; 95% CI, 0.64-2.38; 30.0% vs 28.7%; aOR, 1.10; 95% CI, 0.65-1.87), transmural response (40.1% vs 34.1%; aOR, 1.23; 95% CI, 0.76-2.00; 47.6% vs 42.6%; aOR, 1.19; 95% CI, 0.75-1.90), and clinical remission (73.2% vs 62.3%; aOR, 1.54; 95% CI, 0.96-2.48; 73.5% vs 71.2%; aOR, 1.14; 95% CI, 0.71-1.85). The infliximab group had a higher CRP remission rate at weeks 14 to 26 (60.1% vs 61.6%; aOR, 1.85; 95% CI, 1.17-2.93), but rates were similar at weeks 44 to 56 (72.8% vs 71.4%; aOR, 0.99; 95% CI, 0.65-1.52). By week 56, treatment discontinuation rates were also comparable between the infliximab and ustekinumab groups (24.4% vs 20.5%; P = .372). Similar results were replicated in the propensity-matched cohort.

Conclusions: Infliximab and ustekinumab demonstrated similar effectiveness in achieving clinical, endoscopic, and transmural remission in biologic-naïve patients with CD.