Objectives: The aim of the study is to evaluate the efficacy of anti-tumor necrosis factor (TNF)-α monotherapy versus combination anti-TNF-α and immunosuppressive therapy.
Methods: A single-center, retrospective, observational study was conducted on inflammatory bowel disease (IBD) children. Patients with at least 6 months of follow-up were enrolled and divided into two groups based on therapy. Combo group included children on combination anti-TNF-α and immunosuppressant therapy; children undergoing anti-TNF-α monotherapy were assigned to Mono group.
Results: One hundred and seventeen children were enrolled, of whom 74 (63.2%) were affected by Crohn's disease (CD) and 43 (36.8%) by ulcerative Colitis (UC) (median age at diagnosis: 11.6 years; range 2.1-16.9; M/F: 56/61). Eighty patients (68.4%) were included in combo group and 37 (31.6%) in mono group. The median follow-up was 2.6 years (0.5-11.3). Twenty-three patients out of 80 (28.7%) in Group 1 showed therapy failure compared with 21/37 (56.8%) children in Mono group (p = 0.04). CD patients in monotherapy showed a significantly increased risk of therapy failure than those treated with combination therapy (p < 0.001). Conversely, no difference was found in UC children (p = 0.7). Children undergoing a reactive approach showed more frequent therapy failure compared to proactive in both groups (combo group: 41.7% vs. 4.3%; p = 0.01; mono group: 87.5% vs. 20%; p = 0.01). In a multivariate regression model, the use of a proactive approach and combination therapy was independently associated with anti-TNF-α durability (odds ratio [OR] = 22.1, OR = 12.9).
Conclusion: Combination therapy reduced overall anti-TNF-α failure in CD children, but not in UC patients. Additionally, a proactive approach was associated with increased anti-TNF-α durability.
Keywords: anti‐TNF therapy; children; immunosuppressive therapy; therapeutic drug monitoring.
© 2025 The Author(s). Journal of Pediatric Gastroenterology and Nutrition published by Wiley Periodicals LLC on behalf of European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.