Efficacy and safety of cyclosporine in colitis: An updated meta-analysis of randomized control trials (1998 to 2024).

BACKGROUND

Ulcerative colitis (UC) is a chronic inflammatory condition affecting the large intestine that can progress to colorectal cancer if left untreated. Different therapeutic approaches are used for its treatment and cyclosporine is one of them. It has been investigated as a rescue treatment option in cases when patients are unresponsive to steroidal therapy. However, its efficacy and safety remain uncertain. This study aims to conduct a comprehensive analysis of clinical evidence on cyclosporine safety and efficacy for the treatment of UC.

METHODS

Electronic databases, Cochrane Library, and PubMed were searched from 1998 till December 2024 to screen the relevant studies. A systematic approach was followed to pool and analyze the studies following the PICOS framework (population, intervention, comparison, outcome, and study design). Data was extracted systematically and analyzed using Comprehensive Meta-analysis software (CMA version 3), with the risk of bias evaluated using the RoB-2 tool, heterogeneity measured using I2 statistic, and Publication bias was evaluated using funnel plots and Egger's test.

RESULTS

Out of 27 studies initially identified, 6 studies meeting the eligibility criteria were included in the final analysis. The risk of bias was high in four studies for all the outcomes except for colectomy rates. Heterogeneity between studies was not significant for all outcomes. Analysis results demonstrated that there was no statistically significant difference between the clinical response (OR = 1.290, 95%CI 0.552-3.012, P = 0.557), colectomy rates (OR = 1.171, 95%CI 0.776-1.767, P = 0.452), and serious adverse events (OR = 0.592, 95%CI 0.313-1.120, P = 0.107) of cyclosporine in comparison with control group.

CONCLUSION

There is no statistically significant difference between cyclosporine compared to the control group in improving clinical outcomes for patients with ulcerative colitis. Future studies with larger sample sizes can explore its role with combination therapy in targeted patient sub-groups.