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The following is a summary of “Efficacy and safety of Mirikizumab for ulcerative colitis: a systematic review and meta-analysis of randomized controlled trials,” published in the April 2025 issue of BMC Gastroenterology by Elainein et al. 

Ulcerative colitis (UC) was a widespread, incurable chronic inflammation of the colon mucosa, with treatments including oral small-molecule medications and monoclonal antibodies targeting various pathways, but up to 50% of patients either failed to respond or lost response over time, highlighting the need for innovative therapies like Mirikizumab, a humanized Immunoglobulin (Ig) G4-variant monoclonal antibody targeting interleukin-23 (IL-23)subunit p19.  

Researchers conducted a retrospective study to assess the efficacy of Mirikizumab compared to placebo in treating moderate-to-severe active UC.  

They systematically reviewed the literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and applied the Population, Intervention, Comparison, Outcome, Study design (PICOS) model for inclusion and exclusion criteria. Randomized controlled trials (RCTs) were included assessing Mirikizumab efficacy in treating UC across demographics. The Cochrane Risk of Bias tool (RoB1) evaluated bias within the included studies across 7 domains. Statistical analysis was executed using Review Manager (RevMan) Version 5 software.  

The results showed that 4 studies compared patients treated with Mirikizumab to placebo groups. All intravenous doses of Mirikizumab induced clinical remission, with the 200 mg and 300 mg doses demonstrating significant efficacy, showing risk ratios (RR) of 4.74 (95% (Confidence Interval (CI) [1.43, 15.69]) and 1.82 (95% CI [1.33, 2.50]), respectively. During the maintenance phase of extension trials, symptoms improved with a subcutaneous 200 mg dose (RR = 1.46, 95% CI [0.47, 4.51], P= 0.51).  

Investigators concluded that mirikizumab demonstrated significant efficacy in treating UC, substantially improving clinical, endoscopic, and histological outcomes. 

Source: bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-03627-2