Efficacy and Safety of Tofacitinib in Pediatric Ulcerative Colitis Patients: A Systematic Review

Introduction: Ulcerative colitis (UC), an inflammatory Bowel Disease (IBD), is a chronic illness of unknown mechanism affecting the colonic mucosa, mainly causing diarrhea and bleeding. It can potentially disrupt the quality of life. Tofacitinib, a Janus Kinase inhibitor, showed a promising effect in inducing remission in IBD patients. In this study, we aim to assess the efficacy and safety of Tofacitinib in treating children with ulcerative colitis. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA), we searched four electronic databases (PubMed, Scopus, Cochrane Library, Embase, and Web of Science) to identify eligible studies reported up to July 2024. We reported outcomes as frequencies and proportions in our study. Results: We identified five studies encompassing 83 children diagnosed with IBD, of which 57 children had ulcerative colitis. The proportion of patients achieving a clinical response across one included study was 66.67%. The proportion of patients achieving clinical remission was 38.46%. Also, the proportion of patients achieving steroid-free remission across the three studies was 48.57%. The rate for serious adverse events was 25.53% across the three included studies. Conclusion: Tofacitinib could be useful in achieving clinical remission in children with UC and reducing colectomy rates. Also, a low infection rate and the incidence of serious adverse events were observed. Future randomized controlled trials with larger samples and longer follow-up periods are needed to support these findings.