Cure8 research brief
This study summarizes early postmarketing safety reports for mirikizumab in UC and highlights injection-site reactions as the clearest signal, while flagging rare reports involving thromboembolism and pregnancy that need further validation.
Patients and clinicians using a newly approved biologic may want to be aware of reported adverse-event patterns and the limits of passive-reporting data.
Clinicians prescribing or monitoring mirikizumab, researchers and pharmacovigilance teams, and patients with ulcerative colitis receiving or considering mirikizumab (adults; those planning pregnancy should discuss exposure risks with their clinician).
A postmarketing analysis of FAERS reports for mirikizumab used for ulcerative colitis (2023–2025) identified 408 UC-specific reports, most submitted by consumers.
Injection site pain was the most commonly reported preferred term and showed the strongest disproportionality signal; several other signals that met strict statistical correction included injection site bruising, pulmonary embolism, spontaneous abortion, maternal exposure during pregnancy (an exposure circumstance), and flushing.
Most non–injection-site findings were based on fewer than 10 reports and therefore are hypothesis-generating rather than definitive. The authors note that these disproportionality signals cannot establish causality, incidence, or comparative safety, and that time-to-onset analyses were limited to reports with complete dates.
If you use or prescribe mirikizumab, this paper supports continued pharmacovigilance and the need for validation in adjudicated, denominator-based studies.
FAERS disproportionality analyses detect reporting patterns but cannot prove causation or provide incidence rates. Many signals were based on small counts and consumer reports; maternal "exposure" is an exposure circumstance, not an adverse event. The authors recommend further study using clinically adjudicated, denominator-based designs.
Review the original publication for the complete reporting, methods, and context.
Conflict statement: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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