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Omvoh ® ▼ (mirikizumab)
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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 and mirikizumab. There are no specific recommendations. The switch is at the discretion of the treating physician.
Content Overview
Description of Pivotal studies for Omvoh in Crohn's disease and Ulcerative colitis
The VIVID-1 study evaluated the efficacy and safety of mirikizumab in adult patients with moderate to severe active Crohn's disease and LUCENT in adult patients with moderate to severe active ulcerative colitis. A complete description of these studies and the results can be found in the Omvoh Summary of Product Characteristics section
- 5.1 Clinical efficacy and safety
Patients undergoing biologic therapy had to switch treatments. The following describes the washout periods used in the study and the previous treatments that excluded patients from participating in the study.
Transition considerations
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.
Crohn`s Disease: Exclusion Criteria and Washout Periods for the Phase 3 VIVID-1 Study
VIVID-1 was a 52-week, phase 3, multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled, treat-through study in patients with moderately to severely active Crohn's disease.1
Prohibited Biologics During the VIVID-1 Clinical Trial and Conditions for Washout shows the required washout periods for select biologics before a patient could participate in the VIVID-1 clinical trial. Prior exposure to certain biologics, including anti-interleukin (IL)-23p19 and anti-IL-12/23p40 antibodies, disqualified patients from participating in the study.2
Drug Class |
Examples |
Conditions for Washouta |
Anti-TNF antibodies |
Infliximab, adalimumab, or certolizumab pegol |
Discontinue ≥4 weeks prior to screening endoscopy. |
Anti-integrin antibodies |
Natalizumab |
Discontinue ≥12 months prior to screening endoscopy. |
Other anti-integrin antibodies such as vedolizumab |
Discontinue ≥4 weeks prior to screening endoscopy. |
|
Agents that deplete B or T cells |
Rituximab, alemtuzumab, or visilizumab |
Discontinue ≥12 months prior to baseline. Participants were excluded from the study if there was evidence of persistent targeted lymphocyte depletion at the time of the screening endoscopy. |
Anti–IL-23p19 antibodies |
Risankizumab (BI-655066), brazikumab (MEDI-2070), guselkumab (CNTO1959), or tildrakizumab (MK-3222) |
Participants with any previous exposure for any indication, including investigational use, were excluded. |
Anti-IL-12/23p40 antibodies |
Ustekinumab |
Participants with any previous exposure were excluded. |
Any investigational biologic or nonbiologic therapy |
Discontinue ≥4 weeks, or 5 half-lives, whichever is longer, prior to screening endoscopy. |
|
Abbreviations: IL = interleukin; TNF = tumor necrosis factor.
aThe medications were also prohibited throughout the duration of the study.
Ulcerative colitis: Phase 3 clinical study exclusion criteria in the LUCENT studies
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 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.3
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.3
The following medications used for the treatment of ulcerative colitis were prohibited within the specified time frames.3
- 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.3
References
1Ferrante M, D'Haens G, Jairath V, et al; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436. https://doi.org/10.1016/S0140-6736(24)01762-8
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3D'Haens G, Dubinsky M, Kobayashi T, et al; LUCENT Study Group. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. https://doi.org/10.1056/NEJMoa2207940
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
▼ 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