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Omvoh ® ▼ (mirikizumab)
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Does Omvoh® (mirikizumab) cause infusion or injection-site reactions?
Infusion reactions were reported by 0.4% of patients who received mirikizumab induction therapy, and injection site reactions were reported by 8.7% of mirikizumab induction responders who received 40-week maintenance therapy with mirikizumab.
Content overview
Infusion site reactions in the LUCENT-1 induction study
The phase 3 induction study of mirikizumab for the treatment of moderately-to-severely active ulcerative colitis, LUCENT-1, randomized patients to receive either
- mirikizumab 300 mg (N=958) or
- placebo (N=321)
infused intravenously (IV) every 4 weeks for 12 weeks (at weeks 0, 4, and 8).1
Infusion site reactions were reported by
- 4 (0.4%) patients who received mirikizumab, and
- 1 (0.3%) patient who received placebo.1
Three patients (0.3%) who received mirikizumab discontinued from the study due to an infusion reaction.2
Infusion and injection site reactions in the LUCENT-2 maintenance study
In the LUCENT clinical trials, the prefilled syringe was used for patients randomized to maintenance treatment with mirikizumab.1,2
Mirikizumab induction responders
The phase 3 maintenance study of mirikizumab for the treatment of moderately to severely active ulcerative colitis, LUCENT-2, rerandomized patients who responded to induction therapy with mirikizumab in LUCENT-1 to receive either
- mirikizumab 200 mg (N=389) or
- placebo (N=192)
injected subcutaneously (SC) via prefilled syringe every 4 weeks for 40 weeks.1
Injection site reactions were reported by
- 34 (8.7%) patients who received mirikizumab, and
- 8 (4.2%) patients who received placebo.1
One patient (0.3%) who received mirikizumab and none of the patients who received placebo discontinued from the study due to the event.2
Mirikizumab induction nonresponders
Open-Label Extended Induction
Patients who did not achieve a clinical response to either mirikizumab or placebo during the 12-week induction phase of LUCENT-1 received 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-2.1
Open-Label Maintenance of Delayed Responders
Patients who achieved a clinical response with extended induction therapy compared with LUCENT-1 baseline received open-label maintenance dosing with mirikizumab 200 mg injected subcutaneously via prefilled syringe every 4 weeks through week 40 of LUCENT-2.1
References
1D'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
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
▼ 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: 01 December 2023