Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
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 (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Omvoh® (mirikizumab): Use in patients undergoing medical procedure or surgery
The decision to stop mirikizumab therapy for patients undergoing a medical procedure or surgery should be up to the health care provider's clinical judgment. In phase 3 clinical studies for UC, patients would pause mirikizumab therapy for major surgery.
LUCENT-1 and LUCENT-2
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 antibody. The study was conducted to evaluate efficacy and safety in adult patients with moderately to severely active ulcerative colitis, 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, conducted in adult patients with moderately to severely active ulcerative colitis who completed the LUCENT-1 study.2
Temporarily holding mirikizumab for major surgery
During LUCENT-1 and -2, patients who required major surgery would temporarily stop taking study drug.3
After surgery and adequate wound healing, patients were allowed to start taking study drug again.3
Exclusion criteria for surgery
Summary of LUCENT-1 and LUCENT-2 Exclusion Criteria Related to Surgeries summarizes the LUCENT-1 and LUCENT-2 exclusion criteria related to surgeries.
Exclusion Criteria |
|
Gastrointestinal criteria |
|
Additional exclusion criteria for LUCENT-2 |
|
Abbreviation: UC = ulcerative colitis.
aSome patients with limited colonic surgery, eg, segmental colonic resection, may have been allowed in the study if it would not affect assessment of efficacy.
Study drug discontinuation for surgery
Patients discontinued study drug if they required a colectomy, proctocolectomy, or partial colectomy during LUCENT-1 or LUCENT-2.3
Mirikizumab on label information
Pharmacokinetic properties
There was no apparent accumulation in serum mirikizumab concentration over time when given subcutaneously every 4 weeks.4
Following subcutaneous dosing of mirikizumab, peak serum concentrations were achieved 2 ‑ 3 days post dose with an estimated absolute bioavailability of 44 %.4
Injection site location did not significantly influence absorption of mirikizumab.4
In the population PK analysis,4
- mean apparent clearance was 0.0229 L/hr and
- the mean elimination half‑life is approximately 9.3 days in patients with ulcerative colitis.
- Clearance is independent of dose.4
Population pharmacokinetic analysis showed that age, sex, weight, or race/ethnicity did not have a clinically meaningful effect on the pharmacokinetics of mirikizumab.4
Infections
Mirikizumab may increase the risk of severe infection.4
- Treatment with mirikizumab should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.
- The risks and benefits of treatment should be considered prior to initiating use of mirikizumab in patients with a chronic infection or a history of recurrent infection.
-
Patients should be instructed to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur.
If a serious infection develops, discontinuation of mirikizumab should be considered until the infection resolves.4
Pre-treatment evaluation for tuberculosis
Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection.4
Patients receiving mirikizumab should be monitored for signs and symptoms of active TB during and after treatment.4
Anti‑TB therapy should be considered prior to initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.4
References
1D'Haens G, Kobayashi T, Morris N, et al. Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-1 study. J Crohns Colitis. 2022;16(suppl 1):i028-i029. European Crohn's and Colitis Organisation abstract OP26. https://doi.org/10.1093/ecco-jcc/jjab232.025
2Dubinsky MC, Irving PM, Li X, et al. Efficacy and safety of mirikizumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-2 study. Abstract presented at: Digestive Disease Week; May 24, 2022; San Diego, CA.
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
▼ 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