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Omvoh ® ▼ (mirikizumab)
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Have hypersensitivity reactions been reported with Omvoh® (mirikizumab)?
In phase 2 and 3 studies that included 4802 patients with 11,003.1 patient years (PY) of exposure to mirikizumab, 124 patients (2.6%) reported a potential immediate hypersensitivity reaction (incidence rate per 100 PY, 1.1; 95% CI, 1.0-1.4).
Content overview
Management of Hypersensitivity Reactions
Treatment-Emergent Hypersensitivity Reactions in the Phase 3 Crohn's Disease Clinical Trial: VIVID-1
Note: Information on infusion or injections site reactions is not included as a part of this response.
Management of Hypersensitivity Reactions
Hypersensitivity reactions are listed as an uncommon side effect of mirikizumab in the Summary of Product Characteristics.1
In the event of serious reactions or anaphylaxis, Mirikizumab must be discontinued immediately and appropriate therapy initiated.2
For more information on the frequency and severity of hypersensitivity reactions and the immunogenicity of mirikizumab, see the Omvoh Summary of Product Characteristics in sections1
- 4.3 Contraindications
- 4.4 Warnings and precautions
- 4.8 Undesirable effects
Below is more information about the hypersensitivity reactions reported in the clinical trials.
Incidence of Hypersensitivity Reactions From the Mirikizumab Clinical Trials For All Evaluated Indications
Across all phase 2 and 3 studies that included 4802 patients with 11,003.1 patient years (PY) of exposure to mirikizumab,
- 124 patients (2.6%) reported a potential immediate hypersensitivity reaction (incidence rate per 100 PY, 1.1; 95% CI, 1.0-1.4), and
- 442 patients (9.2%) reported a potential nonimmediate hypersensitivity reaction (incidence rate per 100 PY, 4.3; 95% CI, 3.9-4.7).2
The integrated safety dataset includes all patients from phase 2 and 3 studies of mirikizumab for psoriasis, ulcerative colitis, and Crohn's disease who received at least one dose of study drug. This includes all treatment periods and posttreatment follow-up through October 4, 2023. Over half of the patients (58.6%) received mirikizumab for at least 2 years.2
Treatment-Emergent Hypersensitivity Reactions in the Phase 3 Crohn's Disease Clinical Trial: VIVID-1
During the 52-week VIVID-1 study, an immediate hypersensitivity reaction was reported in
- 3.8% of patients who received mirikizumab
- 2.3% of patients who received ustekinumab, and
- 2.4% patients who received placebo (Frequency of Hypersensitivity Reactions in the VIVID-1 Clinical Trial,).3
A nonimmediate hypersensitivity reaction was reported in
- 7.9% of patients who received mirikizumab
- 5.8% of patients who received ustekinumab, and
- 5.2% patients who received placebo (Frequency of Hypersensitivity Reactions in the VIVID-1 Clinical Trial,).3
Eventb |
Mirikizumab |
Ustekinumab |
Placebo |
Immediate hypersensitivity reaction, narrowc |
24 (3.8) [4.1]d |
7 (2.3) [2.4] |
5 (2.4) [4.2] |
Nonimmediate hypersensitivity reaction, narrowe |
50 (7.9) [8.9]f |
18 (5.8) [6.4] |
11 (5.2) [9.6] |
Abbreviations: EAIR = exposure-adjusted incidence rate; PYE = patient years of exposure.
aIncludes all patients who received at least one dose of study drug.
bData presented as n (%) [EAIR].
cDefined as an event that occurred on the day of study treatment administration.
dThe estimated rate difference (95% CI) for mirikizumab vs ustekinumab was 1.7 (-0.7 to 4.1) and for mirikizumab vs placebo was ‑0.1 (‑4.2 to 4.0).
eDefined as an event that occurred after the day of study treatment administration.
fThe estimated rate difference (95% CI) for mirikizumab vs ustekinumab is 2.5 (-1.4 to 6.3) and for mirikizumab vs placebo is -0.7 (‑6.9 to 5.5).
Treatment-Emergent Hypersensitivity Reaction in the Phase 3 Ulcerative Colitis Clinical Trials: LUCENT-1, LUCENT-2, and LUCENT-3
Immediate hypersensitivity reactions were reported in 1.0% of patients who received mirikizumab and 0.3% of those who received placebo in LUCENT-1, and in 1.8% of patients rerandomized to mirikizumab and 1.0% of those rerandomized to placebo in LUCENT-2.2,4
Nonimmediate hypersensitivity reactions were reported in 2.5% of patients who received mirikizumab and 2.2% of those who received placebo in LUCENT-1, and in 6.9% of patients rerandomized to mirikizumab and 2.6% of those rerandomized to placebo in LUCENT-2.2,4
Frequency of Hypersensitivity Reaction in the LUCENT Clinical Trial Program provides additional information on hypersensitivity reactions in the clinical trial program.
Eventa |
Treatment Group |
|
LUCENT-1 MIRI Induction |
MIRI 300 mg IV Q4W (n=958) |
PBO IV Q4W (n=321) |
LUCENT-1 Week 12 |
||
Immediate hypersensitivity reactionb |
10 (1.0) |
1 (0.3) |
Nonimmediate hypersensitivity reaction |
24 (2.5)c |
7 (2.2) |
LUCENT-2 MIRI Induction Responders |
MIRI 200 mg SC Q4W (n=389) |
PBO SC Q4W (n=192) |
LUCENT-2 Week 40 |
||
Immediate hypersensitivity reaction |
7 (1.8) |
2 (1.0)d |
Nonimmediate hypersensitivity reaction |
27 (6.9) |
5 (2.6) |
LUCENT-2 MIRI Induction Delayed Responders |
OL Extended Induction |
OL Maintenance of Delayed Responders |
LUCENT-2 Week 12 |
LUCENT-2 Week 40 |
|
Immediate hypersensitivity reaction |
2 (0.6) |
1 (0.6) |
Nonimmediate hypersensitivity reaction |
7 (2.2) |
5 (2.9) |
LUCENT-3 |
OL Maintenance of MIRI Induction Responders |
|
Week 100e |
||
Immediate hypersensitivity reaction |
4 (1.2)f |
|
Abbreviations: IV = intravenous; MIRI = mirikizumab; OL = open-label; PBO = placebo; Q4W = every 4 weeks; SC = subcutaneous.
Note: Events that occurred on the day of study treatment administration were classified as immediate hypersensitivity reactions, while those that occurred after the day of study administration were classified as nonimmediate hypersensitivity reactions.
aData presented as n (%).
bOf the 11 patients who reported immediate hypersensitivity reactions, infusion-related hypersensitivity reactions were reported by 4 patients (0.4%) who received mirikizumab and 1 patient (0.3%) who received placebo. All cases of infusion related hypersensitivity reactions in LUCENT-1 were mild to moderate in severity.
cThree patients who experienced infusion related hypersensitivity reactions discontinued from the study.
dOne of the events in the placebo group was an anaphylactic reaction.
eRepresents 152 weeks of continuous mirikizumab treatment.
fIncluded one patient each with allergic sinusitis, eczema, injection site hypersensitivity, and injection site urticaria.
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands. (GB)
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Ferrante M, D'Haens G, Jairath V, et al; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn’s disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436. https://doi.org/10.1016/S0140-6736(24)01762-8
4D'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
5Sands BE, D'Haens G, Clemow DB, et al. Three-year efficacy and safety of mirikizumab following 152 weeks of continuous treatment for ulcerative colitis: results from the LUCENT-3 open-label extension study. Inflamm Bowel Dis. Published online October 25, 2024. https://doi.org/10.1093/ibd/izae253
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
▼ 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.
Appendix
Definitions of Immediate and Nonimmediate Hypersensitivity Reactions
The clinical trials used the term 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 angioedema.2
An immediate hypersensitivity reaction is defined as an event that occurs on the day of study drug administration. This includes any event with a known start time that begins on or after the administration and up to 24 hours after it ends, or any event with an unknown start time but known to have started on the day of administration.2
A nonimmediate hypersensitivity reaction is defined as an event that occurs after the day of study drug administration, excluding any dates when the study drug was administered.2
Date of Last Review: 15 January 2025