Mirikizumab improves IBD outcomes during induction, maintenance periods

Treatment with mirikizumab results in significant improvements in clinical, endoscopic, and histologic outcomes during induction and maintenance phases in patients with Crohn’s disease (CD) or ulcerative colitis (UC), according to an updated meta-analysis of randomized controlled trials (RCTs).

“Previous meta-analysis of mirikizumab for inflammatory bowel disease (IBD) had methodological limitations,” said lead study author Dr Hyun Hee Sul, internal medicine resident at Jersey City Medical Center in New Jersey, US.

“We aim to update evidence by including a recent RCT and analysing outcomes not yet explored in reviews, including subgroup analysis of biologic previous failure,” she added.

Sul and colleagues performed a systematic search across the databases of PubMed, Embase, and Cochrane Library to identify RCTs that compared mirikizumab with placebo in adult patients with CD or UC. They analysed binary endpoints using risk ratios (RRs), with 95 percent confidence intervals (CIs).

In addition, a subgroup analysis was conducted to compare CD with UC and biologic-naïve with biologic-failed patients. R software (version 4.4.3) was used to carry out all analyses.

Five RCTs and five corresponding post hoc analyses, with non-overlapping populations for each outcome, met the eligibility criteria for this study. A total of 2,380 patients, with 1,760 treated with mirikizumab and 620 with placebo, were included in the meta-analysis.

Participants were followed for 12 weeks during induction and for 40 weeks during the maintenance period. [Inflamm Bowel Dis 2026;doi:10.1093/ibd/izag006.019]

Remission

More patients treated with mirikizumab than with placebo achieved clinical remission during induction (RR, 1.83, 95 percent CI, 1.14‒2.95) and maintenance (RR, 2.37, 95 percent CI, 1.27‒4.43), clinical response during induction (RR, 1.58, 95 percent CI, 1.14‒2.19), and endoscopic remission during induction (RR, 2.13, 95 percent CI, 0.99‒4.58) and maintenance (RR, 2.03, 95 percent CI, 1.59‒2.69).

Treatment with mirikizumab also resulted in higher rates of endoscopic response during induction (RR, 2.83, 95 percent CI, 1.86‒4.3) and maintenance (RR, 5.1, 95 percent CI, 3.34‒7.78), histologic remission during induction (RR, 1.92, 95 percent CI, 1.1‒3.35) and maintenance (RR, 1.72, 95 percent CI, 1.12‒2.63), and histologic response during induction (RR, 1.93, 95 percent CI, 1.42‒2.63) and maintenance (RR, 1.5, 95 percent CI, 1.01‒2.22) compared with placebo.

Notably, no significant difference was observed across all endpoints between CD and UC, but a significant difference was seen for clinical response in biologic subgroup analysis. Specifically, higher effect estimates were noted in biologic-failed (RR, 1.75, 95 percent CI, 1.35‒2.28) than biologic-naïve patients (RR, 1.33, 95 percent CI, 1.08‒1.64).

In analyses of other outcomes, there was no significant difference observed in biologic subgroup. Moreover, mirikizumab demonstrated an acceptable safety profile in both induction and maintenance periods, according to Sul and colleagues.

“Our findings suggest that mirikizumab improves clinical, endoscopic, and histologic outcomes during induction and maintenance phases in both CD and UC with a safe profile,” Sul said.