Anti-tumor necrosis factor-α monotherapy versus combo therapy with immunosuppressant in pediatric inflammatory bowel disease: A real-life study

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.