Background
Despite randomized controlled trials (RCTs) and trial-based meta-analyses, the optimal rescue therapy for patients with acute glucorticosteroid-refractory ulcerative colitis (UC), to avoid colectomy and improve long-term outcomes, remains unclear. We conducted a network meta-analysis examining this issue.
Methods
We searched MEDLINE, EMBASE, EMBASE Classic, and the Cochrane central register to June 2020. We included RCTs comparing ciclosporin and infliximab, either with each other, or with placebo, in patients with glucorticosteroid-refractory UC.
Results
We identified seven RCTs containing 534 patients (415 in head-to-head trials of ciclosporin versus infliximab). Risk of colectomy at ≤1 month was reduced significantly with both treatments, compared with placebo (relative risk (RR) of colectomy with infliximab versus placebo = 0.37; 95% CI 0.21-0.65, RR with ciclosporin versus placebo = 0.40; 95% CI 0.21-0.77). In terms of colectomy between >1 month and <1 year both drugs ranked equally (P-score 0.75). Neither treatment was more effective than placebo in reducing risk of colectomy at ≥1 year. Both ciclosporin and infliximab were significantly more efficacious than placebo in achieving a response. Neither treatment was more effective than placebo for inducing remission, nor more likely to cause serious adverse events than placebo.
Conclusions
Both ciclosporin and infliximab were superior to placebo in terms of response to therapy and avoiding colectomy up to 1 year, with no significant differences in efficacy or safety between the two. Ciclosporin is still a valid option to treat refractory UC patients, especially those who do not respond to previous treatment with infliximab, or as a bridge to other biologic therapies.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)