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Omvoh ® ▼ (mirikizumab)
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What is the dose regimen of Omvoh® (mirikizumab)?
The recommended mirikizumab dose regimen is described in the SmPC. It has 2 parts: induction and maintenance dose.
Approved Dosage of Omvoh for Ulcerative Colitis
The recommended mirikizumab dose regimen for ulcerative colitis has 2 parts and consists of an induction phase and a maintenance phase. For complete information, please refer to the Omvoh Summary of Product Characteristics, in particular, the section1
- 4.2 Dosage and method of administration
Dosing Regimens in the Phase 3 LUCENT-1 and LUCENT-2 Clinical Trials
Induction Therapy
In the 12-week, phase 3 induction study of mirikizumab for the treatment of ulcerative colitis, LUCENT-1, patients received either mirikizumab 300 mg or placebo infused intravenously every 4 weeks, at weeks 0, 4, and 8. Infusions occurred over at least 30 minutes, and patients were monitored for at least 1 hour after dosing.2
Maintenance Therapy
In the phase 3 maintenance study of mirikizumab for the treatment of ulcerative colitis, LUCENT-2, patients who responded to induction therapy with mirikizumab in LUCENT-1 were rerandomized to receive either mirikizumab 200 mg or placebo injected subcutaneously every 4 weeks for 40 weeks.2
Extended Induction
Patients who did not achieve a clinical response to either mirikizumab or placebo during the 12-week induction phase of LUCENT-1 had the option to receive open-label extended induction treatment with an additional 3 doses of mirikizumab 300 mg infused intravenously every 4 weeks for the first 12 weeks of LUCENT-2.2
Patients who achieved a clinical response compared with LUCENT-1 baseline with extended induction therapy received open-label maintenance dosing with mirikizumab 200 mg injected subcutaneously every 4 weeks through week 40 of LUCENT-2.2
Patients who did not achieve a clinical response with extended induction therapy were discontinued from the study.2
Loss of Response With Mirikizumab Maintenance Therapy
Patients who achieved a clinical response with mirikizumab or placebo during the 12-week induction phase of LUCENT-1 but subsequently had a loss of response at or after week 12 of maintenance therapy in LUCENT-2 had the option to receive open-label rescue therapy with 3 doses of mirikizumab 300 mg infused intravenously every 4 weeks.2
Dosing Regimen in the Phase 3 LUCENT-3 Clinical Trial
Patients who completed week 40 of LUCENT-2 on blinded subcutaneous mirikizumab treatment, and whom the investigator believed would benefit from ongoing treatment with mirikizumab, were allowed to rollover into LUCENT-3.3
All patients in LUCENT-3 received mirikizumab 200 mg subcutaneously every 4 weeks.3
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
3Sands BE, D'Haens G, Clemow DB, et al. Two-year efficacy and safety of mirikizumab following 104 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflamm Bowel Dis. Published online March 9, 2024. https://doi.org/10.1093/ibd/izae024
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▼ 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: 16 February 2024