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Omvoh ® ▼ (mirikizumab)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk
Can a patient get vaccinated while taking Omvoh® (Mirikizumab)?
Avoid use of live vaccines in patients treated with mirikizumab.
Management of Vaccinations With Omvoh Therapy
Prior to initiating therapy with mirikizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. For complete information, please refer to the Omvoh Summary of Product Characteristics, in particular, the section1
- 4.4 Special warnings and precautions for use
Below, you will find more information on the vaccination procedure used in the clinical trials for Crohn's disease and ulcerative colitis.
Vaccinations Allowed in the LUCENT and VIVID Clinical Trial Programs
Nonlive Vaccinations
Live Vaccinations
Patients were excluded from the phase 3 clinical trials of mirikizumab for the treatment of ulcerative colitis or Crohn's disease if they
Published Literature on Vaccinations in Patients With Inflammatory Bowel Disease
Patients with inflammatory bowel disease are at an increased risk of infection and many patients will begin immunosuppressive therapy. Therefore, an assessment of a patient's vaccination history and completion of age-appropriate immunizations are recommended.4-6
The following are key considerations for this patient population from the published literature.
- Vaccinations should ideally be administered at least 4 weeks before starting an immunosuppressive therapy.4,5
- Patients who have already started treatment should still receive appropriate nonlive vaccines although there is evidence that the vaccine response may be reduced by certain immunosuppressive agents.4-6
- If the immunosuppressive therapy has been started, administering the nonlive vaccines during disease remission and when the patient is receiving the lowest possible dose of the immunosuppressive therapy may increase response.4
- Live vaccines should generally be avoided if the patient is considered to be immunocompromised.4,5
- The published literature suggests that booster vaccines may be affected less by immunosuppressive therapies than the primary vaccine dose, and the use of conjugate vaccines may provide more robust immune responses than polysaccharide vaccines.4
- Ensure that vaccinations are current for the patient's close contacts and household members.4
Immunization recommendations for patients with inflammatory bowel disease have been published by the
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands. (GB)
2D'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
3Ferrante 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
4Manser CN, Maillard MH, Rogler G, et al; Swiss IBDnet, an official working group of the Swiss Society of Gastroenterology. Vaccination in patients with inflammatory bowel diseases. Digestion. 2020;101(suppl 1):58-68. https://doi.org/10.1159/000503253
5Crosby S, Schuh MJ, Caldera F, Farraye FA. Vaccination of patients with inflammatory bowel disease during the COVID-19 pandemic. Gastroenterol Hepatol. 2021;17(1):18-30. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8132679/
6Jones JL, Tse F, Carroll MW, et al. Canadian Association of Gastroenterology clinical practice guideline for immunizations in patients with inflammatory bowel disease (IBD)-part 2: inactivated vaccines. Gastroenterology. 2021;161(2):681-700. https://dx.doi.org/10.1053/j.gastro.2021.04.034
7Farraye FA, Melmed GY, Lichtenstein GR, Kane SV. ACG clinical guideline: preventive care in inflammatory bowel disease. Am J Gastroenterol. 2017;112(2):241-258. https://doi.org/10.1038/ajg.2016.537
8Kucharzik T, Ellul P, Greuter T, et al; European Crohn’s and Colitis Organisation (ECCO). ECCO guidelines on the prevention, diagnosis, and management of infections in inflammatory bowel disease. J Crohns Colitis. 2021;15(6):879-913. https://dx.doi.org/10.1093/ecco-jcc/jjab052
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: 22 November 2024