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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Hypersensitivity reactions in LUCENT clinical trials
Immediate hypersensitivity reactions occurred more frequently in patients who received mirikizumab than in patients who received placebo. None of the patients who received mirikizumab experienced serious hypersensitivity reactions or anaphylaxis.
Note: Information on infusion or injections site reactions is not included as a part of this response.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions were those occurring
- within 24 hours of drug administration, or
- on the day of administration if the time is not recorded.1
The study used the term immediate hypersensitivity reactions to describe those systemic events that likely had an allergic or hypersensitivity etiology, and used the narrow MedDRA (Standardised Medical Dictionary for Regulatory Activities) Query terms
- anaphylactic reactions
- hypersensitivity, and
Hypersensitivity Reactions in the LUCENT-1 Induction Study
In the phase 3 induction study of mirikizumab for the treatment of moderately to severely active ulcerative colitis, LUCENT-1, 1281 patients were randomized to receive either mirikizumab 300 mg or placebo infused intravenously every 4 weeks for 12 weeks.1
Infusion-Related Hypersensitivity Reactions in the LUCENT-1 Induction Study
Of the 11 patients who reported immediate hypersensitivity reactions, Infusion related hypersensitivity reactions were reported by
- 4 (0.4%) patients who received mirikizumab, and
- 1 (0.3%) patient who received placebo.2
All cases of infusion related hypersensitivity reactions in LUCENT-1 were mild to moderate in severity. Additionally, 3 patients who experienced infusion related hypersensitivity reactions discontinued from the study.2
Hypersensitivity Reactions in the LUCENT-2 Maintenance Study
Mirikizumab Induction Responders
The phase 3 maintenance study of mirikizumab for the treatment of moderately-to-severely active ulcerative colitis, LUCENT-2, rerandomized 544 patients who responded to induction therapy with mirikizumab in LUCENT-1 to receive either mirikizumab 200 mg or placebo injected subcutaneously every 4 weeks for 40 weeks.3
Immediate hypersensitivity reactions were reported by
- 7 (1.8%) patients who received mirikizumab, and
- 2 (1.0%) patients who received placebo.3
One of the events in the placebo group was an anaphylactic reaction.3
No patients who received mirikizumab in the LUCENT-2 study experienced anaphylaxis or a serious hypersensitivity reaction. Additionally, no mirikizumab-treated patients discontinued from the study due to an immediate hypersensitivity event.3
Management of Infusion-Related Hypersensitivity Reactions
Mirikizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.4
Serious hypersensitivity reactions including anaphylaxis may occur with mirikizumab administration. If a serious hypersensitivity reaction occurs, discontinue mirikizumab immediately and initiate appropriate therapy.2
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. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO Virtual); February 16-19, 2022.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Dubinsky 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. Poster presented at: Digestive Disease Week; May 24, 2022; San Diego, CA.
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