- Omvoh (mirikizumab-mrkz), an IL‑23p19 antagonist, sustained disease clearance through four years in LUCENT‑3: 63.5% maintained clearance from year 1 to year 4 (61.3% for stringent remission).
- With modified non‑responder imputation, sustained rates at four years were 49.7% (disease clearance) and 42.8% (stringent clearance).
- Safety: 12% of long‑term patients reported serious adverse events and 7% discontinued due to adverse events; common AEs included upper respiratory infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.
- Lilly is testing mirikizumab combinations with eltrekibart and zotemtegrast in COMMIT‑UC/CD trials and running pediatric studies; Omvoh is approved in 47 countries and has a U.S. single‑injection maintenance regimen.
Key findings
In LUCENT-3, an open-label extension of the Phase 3 LUCENT program, 63.5% of patients who achieved disease clearance at one year sustained simultaneous symptomatic, endoscopic and histologic remission at four years; 61.3% sustained stringent remission defined by endoscopic normalization.
Study details
Disease clearance was assessed among patients who achieved clinical remission in LUCENT-2 and continued on Omvoh in LUCENT-3 (single-arm extension up to four years); using modified non-responder imputation sustained rates at four years were 49.7% (disease clearance) and 42.8% (stringent clearance).
Safety and outcomes
The long-term safety profile was consistent with prior data: 12% of patients reported serious adverse events and 7% discontinued for adverse events; common reactions included upper respiratory tract infections, injection site reactions, arthralgia, rash, headache and herpes viral infection; LUCENT-3 recorded one UC-related hospitalization and no UC-related surgeries in the extension.
Ongoing development and approvals
Mirikizumab combinations with eltrekibart and zotemtegrast are being studied in COMMIT‑UC and COMMIT‑CD trials, pediatric trials are under way, and Omvoh is approved for adult UC and Crohn's disease in 47 countries with a U.S. single-injection maintenance option.
