Supplementary Material for: Long-term outcome of ciclosporin and infliximab as rescue therapy in steroid-refractory acute severe ulcerative colitis

Background: Ciclosporin and infliximab have equal short-term efficacy in treating acute severe ulcerative colitis (ASUC). However, data about long-term outcome and switching to a second rescue therapy is limited.

Methods: Patients with steroid-refractory ASUC treated at a tertiary center in Switzerland were retrospectively analysed regarding the outcome of different rescue therapies. Colectomy-free survival rates at 1, 3 and 5 years were estimated through Kaplan-Meier method. Furthermore, predictors of colectomy, the presence of adverse events at 1 year and mortality during the entire follow-up were assessed.

Results: We analysed a total of 46 patients who were treated initially with either ciclosporin (n=31) or infliximab (n=15) due to steroid-refractory ASUC between January 2010 and July 2021. 13% of patients received a second rescue therapy. In sum, 78%, 67% and 48% were colectomy-free at 1, 3 and 5 years, respectively. Although there was a significant difference between the three arms in colectomy-free survival (p = 0.026), a post-hoc analysis could not demonstrate a difference between each individual therapy compared to another. The post-hoc analysis indicated a non-significant benefit with sequential therapy in comparison to CsA regarding the colectomy-free survival (p = 0.087). The outcome between infliximab and ciclosporin was not statistically different (p = 0.149). The number of previous advanced therapies was negatively associated with 1-year colectomy-free survival (p = 0.049). Other variables such as age at hospitalisation, sex, dose of steroids, disease duration and albumin did not correlate with a higher risk of 1-year colectomy.

Conclusions: This real-world single center analysis confirms the equal efficacy and safety of infliximab and ciclosporin over a follow-up of 5 years. Patients not responding to the first may benefit of a second rescue therapy without increasing the risk of complication or mortality.