Anti-IL 12/23 versus Anti-Tumor Necrosis Factor-α in Patients with Biologically Naïve Crohn's Disease: A Systematic Review and Meta-analysis.

Abstract

Introduction: Crohn's disease (CD) is a chronic inflammatory condition of the digestive tract, characterized by a noncontinuous pattern of transmural inflammation, leading to a significant decline in quality of life and productivity. For biologic-naïve patients, anti-tumor necrosis factor (TNF)-α and anti-interleukin (IL)-12/23 therapies are commonly recommended. This study compares anti-IL-12/23 and anti-TNF-α for clinical remission, corticosteroid-free remission, endoscopic remission, and endoscopic response in biologic-naïve patients.

Methods: We searched PubMed, Google Scholar, VHL, Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov for randomized clinical trials and cohort studies. Data were analyzed using odds ratios (ORs) with 95% confidence intervals (CIs). A random-effects model was applied for meta-analysis.

Results: Only 6 out of 5,401 articles were included, involving a total of 1,103 patients. Of these, 636 (57.6%) received anti-TNF-α therapy (infliximab or adalimumab), while 467 (42.4%) received anti-IL-12/23 (ustekinumab) therapy. Within 52 weeks, there were no statistically significant differences found between Ustekinumab and anti-TNF-α in terms of clinical remission (OR: 0.92, 95% CI: 0.55-1.54, p = 0.75), endoscopic remission (OR = 0.583, 95% CI: 0.289-1.176; p = 0.13), corticosteroid-free remission (OR: 1.19, 95% CI: 0.87-1.64, p = 0.28), or endoscopic response (OR = 0.48, 95% CI: 0.147-1.578; p = 0.23).

Conclusion: This meta-analysis found no significant differences in clinical remission, corticosteroid-free remission, endoscopic remission, or endoscopic response within 52 weeks between ustekinumab and anti-TNF-α agents in biologic-naïve CD patients. However, due to study limitations, further high-quality, head-to-head trials are needed to refine treatment selection and optimize outcomes.