Efficacy and safety of Mirikizumab in the treatment of moderate to severe active ulcerative colitis: a systematic review
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Ajay Kumar Shukla
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Ravi Kant Narayan
Abstract
Introduction
Ulcerative colitis in the second or third decade is characterised by haematochezia, stomach pain, faecal urgency, and tenesmus. On October 26, 2023, the US-FDA approved Mirikizumab for the treatment of moderate-to-severe ulcerative colitis in adults.
Content
This systematic review evaluated the safety and effectiveness of Mirikizumab for the treatment of ulcerative colitis by analysing data from available clinical trials. We performed a thorough search across databases such as PubMed, Cochrane, Embase, Scopus, Google Scholar, and ClinicalTrials.gov, covering records from their inception up to June 30, 2025, in accordance with PRISMA guidelines. Thorough investigation identified five relevant studies: four randomised controlled trials and one observational study. All Mirikizumab doses achieved complete healing of the inflamed lumen. Except for the 50 mg dose, they also showed superior histological remission compared to placebo. Most adverse effects likely stem from the condition itself rather than the drug, supported by a higher dropout rate among placebo patients. Additionally, in patients with prior treatment failures, Mirikizumab demonstrated improved outcomes by week 40.
Summary and Outcome
Mirikizumab improves clinical, endoscopic, and histological results in ulcerative colitis. This study highlights the clinical importance of Mirikizumab and its potential to change treatment standards for ulcerative colitis.
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Research ethics: The local institutional review board deemed the study exempt from review.
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Informed consent: Not applicable.
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Author contributions: Dr Ajay Kumar Shukla (AKS)—Concept, Data collection, data analysis, Writing the article, final editing, Dr Saurav Misra (SM)—Concept, Idea, Data collection, data analysis, Writing the article, final editing, Submission, Dr Ravi Kant Narayan (RKN)—Data collection, data analysis, Writing the article, final editing, Dr. Shahnawaz Ahmed—Data collection, data analysis, Writing the article, final editing.
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Use of Large Language Models, AI and Machine Learning Tools: None used.
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Conflict of interest: None.
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Research funding: None.
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Data availability: Yes.
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