Long-Term Safety of Mirikizumab Remains Stable Across UC and Crohn’s Disease
Mirikizumab, an interleukin-23p19 monoclonal antibody, demonstrated a consistent and stable safety profile over up to four years of treatment in patients with ulcerative colitis (UC) and Crohn’s disease (CD), according to a pooled analysis of phase 3 trials presented at Digestive Disease Week 2026. The findings provide long-term safety data across both indications.
Investigators analyzed pooled data from 2,404 adults with moderately to severely active UC or CD enrolled in the LUCENT and VIVID trial programs. Patients were followed for a cumulative 5,967.9 patient-years of exposure, allowing assessment of safety outcomes over time using exposure-adjusted incidence rates.
Across the integrated inflammatory bowel disease (IBD) population, treatment-emergent adverse events occurred at a rate of 114.6 events per 100 patient-years. Notably, event rates declined over time, decreasing from 165.3 events per 100 patient-years in the first year to 79.2 events per 100 patient-years by year 4. Rates of serious adverse events also decreased over the same period.
Key safety outcomes remained low and stable. Incidence rates of serious infections, major adverse cardiovascular events, malignancies, and hepatic events did not increase with longer exposure. The safety profile was similar between patients with UC and those with CD.
The authors reported that “no new safety signals were found in this integrated study,” and noted that “the safety profile of mirikizumab…through 4 years of treatment is reassuring and consistent across both UC and CD indications.”
These findings address an important gap in long-term safety data for IL-23 inhibitors in IBD. Sustained therapy did not appear to introduce cumulative risk, supporting continued use in patients requiring maintenance treatment.
Reference
Roghani, RS Roghani S, Jalili F, et al. Saffron as an adjuvant therapy improves ulcerative colitis: a multicenter clinical trial assessing inflammatory and clinical outcomes. Presented at: Digestive Disease Week; May 2–5, 2026; Chicago, Illinois.
