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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).
Use of vaccines with Omvoh® (mirikizumab)
The vaccine response in patients receiving mirikizumab has not been evaluated. Patients with IBD are at an increased risk of infection. It is up to an HCP’s discretion to assess a patient's vaccination history and complete age-appropriate immunizations.
Mirikizumab label information
Prior to initiating therapy with mirikizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines.1
Avoid use of live vaccines in patients treated with mirikizumab.1
No data are available on the response to live or non‑live vaccines.1
Vaccinations allowed in the LUCENT clinical trial program
In the LUCENT-1 clinical trial, patients were permitted to receive nonlive (killed, inactivated, or subunit) vaccinations. However, their efficacy in patients receiving mirikizumab is unknown.2
Patients were excluded from the phase 3 clinical trials of mirikizumab for the treatment of ulcerative colitis if they had received a BCG vaccination within 12 months of baseline or intended to receive one during the study.3
Patients who participated in the LUCENT clinical trials were prohibited from receiving a BCG vaccination for 12 months after discontinuation of study drug.3
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
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
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
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;161:681-700. 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
9Advisory Committee on Immunization Practices (ACIP). ACIP vaccine recommendations and guidelines. Centers for Disease Control and Prevention. Updated July 16, 2013. Accessed November 15, 2022. https://www.cdc.gov/vaccines/hcp/acip-recs/index.html
10Canadian Immunization Guide. Public Health Agency of Canada. Updated October 31, 2022. Accessed November 15, 2022. https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html
▼ 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