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Omvoh ® ▼ (mirikizumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Switching a patient from another biologic to Omvoh® (mirikizumab)
Eli Lilly and Company has not sponsored any studies on how to switch or the effects of switching between biologic agents for the treatment of moderately to severely active ulcerative colitis.
Healthcare providers should follow their clinical judgment, taking into account the patient’s individual circumstances, when deciding how to transition from one biologic to another.
Phase 3 clinical study exclusion criteria
LUCENT-1 is a 12-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study of mirikizumab, a p19-directed anti-interleukin-23 (anti-IL-23) antibody. The study was conducted to evaluate efficacy and safety in adult patients with moderately to severely active ulcerative colitis (UC), with a modified Mayo score of 4 to 9 points and centrally read Mayo endoscopic subscore ≥2, who had an inadequate response, loss of response, or an intolerance to corticosteroids, immunosuppressants, biologic therapies, or tofacitinib.1
LUCENT-2 is a 40-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled, maintenance study that evaluated the safety and efficacy of mirikizumab, a p19-directed anti-IL-23 antibody, conducted in adult patients with moderately to severely active UC who completed the LUCENT-1 study.1
The following medications used for the treatment of ulcerative colitis were prohibited within the specified time frames.1
- Anti-tumor necrosis factor (TNF) antibodies (eg, infliximab, adalimumab, or golimumab) or anti-integrin antibodies (eg, vedolizumab) within 8 weeks prior to screening endoscopy.
- Agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab) within 12 months of baseline. Patients remain excluded if there is evidence of persistent targeted lymphocyte depletion at the time of screening endoscopy.
- Any investigational biologic therapy within 8 weeks prior to the screening endoscopy or within 5 half-lives prior to the screening endoscopy, whichever is longer.
Patients were also excluded if they had
- ever received anti-IL12p40 antibodies (eg, ustekinumab) or anti–IL-23p19 antibodies (eg, risankizumab [BI-655066], brazikumab [MEDI-2070], guselkumab [CNTO1959], or tildrakizumab [MK-3222]) for any indication, including investigational use, or
- failed 3 or more biologic therapies for ulcerative colitis.1
1D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. Published online June 29, 2023. https://doi.org/10.1056/NEJMoa2207940
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 30 May 2023