DOP034Infliximab and Glucocorticoids as First-Line Treatment Strategy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Prospective, Real-World Cohort Study (INSURE Study)

Background The optimal first-line treatment strategy for moderate-to-severe ulcerative colitis (UC) remains controversial. High-quality evidence directly comparing infliximab and glucocorticoids as initial therapies is limited. This study aimed to evaluate the short-term efficacy, long-term effectiveness, and safety of infliximab versus glucocorticoids as initial treatment strategies in a real-world clinical setting. Methods This multicenter, prospective, observational, long-term, real-world cohort study enrolled patients with moderate-to-severe UC initiating first-line infliximab or glucocorticoids based on shared decision-making between physicians and patients. The primary endpoint was clinical remission at week 14; secondary endpoints included endoscopic remission, deep remission, treatment outcomes during up to three years of follow-up, treatment durability, and safety profile. Inverse probability treatment weighting (IPTW) was applied to adjust for baseline covariates, with sensitivity analyses conducted via propensity score matching (PSM) and multivariable logistic regression. Statistical analyses were performed using the weighted pseudo-population. Results A total of 278 patients were enrolled across six tertiary centers (infliximab group: 188; glucocorticoids group: 90). After IPTW adjustment, all baseline covariates were effectively balanced. The weighted pseudo-population satisfied the assumptions for comparative analyses. At week 14, infliximab demonstrated superior induction effectiveness compared to glucocorticoids: clinical remission (55.6% vs. 25.8%, P < 0.001; adjusted odds ratio = 3.589, 95% confidence interval: 2.098–6.298), endoscopic remission (48.7% vs. 33.9%, P = 0.020), and deep remission (39.0% vs. 23.3%, P = 0.010). Long-term outcomes consistently favored infliximab, with higher clinical remission rates at week 52 (57.8% vs. 29.8%, P < 0.001), week 104 (40.0% vs. 17.9%, P < 0.001), and week 156 (19.6% vs. 6.9%, P = 0.008). PSM analysis confirmed robust consistency in effectiveness outcomes. Infliximab showed better treatment durability (adjusted hazard ratio = 0.508, 95% confidence interval: 0.330–0.781, P = 0.002). The incidence of adverse events was lower in the infliximab group (6.4% vs. 16.7%, P = 0.007). Conclusion In this real-world cohort, compared to a glucocorticoid-based induction strategy, infliximab as an initial treatment strategy demonstrated superior efficacy in achieving rapid induction and maintaining long-term remission, along with a more favorable safety profile. The study was registered on ClinicalTrials.gov (NCT04879966). Conflict of interest: Lin, Lang: No conflict of interest Chao, Kang: Gao, Xiang: No conflict of interest Tang, Jian: No conflict of interest