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Omvoh ® ▼ (mirikizumab)
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Does Omvoh® (mirikizumab) cause infusion-site reactions?
In phase 2 and 3 studies that included 4802 patients with 11,003.1 patient-years (PY) of exposure to mirikizumab, 8 patients (0.2%) reported an infusion site reaction (incidence rate per 100 PY, 0.1; 95% CI, 0.0-0.1).
Content overview
Incidence of Infusion Site 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, 8 patients (0.2%) reported at least one treatment-emergent infusion site reaction (incidence rate per 100 PY, 0.1; 95% CI, 0.0-0.1).1
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.1
Treatment-Emergent Infusion Site Reactions in the Phase 3 Crohn's Disease Clinical Trial: VIVID-1
During the VIVID-1 study, infusion site reaction was reported in
- 0.2% of patients who received mirikizumab
- 1.3% of patients who received ustekinumab, and
- 0% patients who received placebo (Frequency of Infusion Site Reactions in the VIVID-1 Clinical Trial).2
All infusion site reactions were mild to moderate in severity, no infusion site reactions were classified as serious, and no participants discontinued from the study due to an infusion site reaction.1
Eventa |
Mirikizumab |
Ustekinumab |
Placebo |
Infusion site reactionb |
1 (0.2) [0.7]c |
4 (1.3) [8.2] |
0 (0.0) [0.0] |
Infusion site pruritus |
1 (0.2) |
0 |
0 |
Infusion site bruising |
0 |
1 (0.3) |
0 |
Infusion site erythema |
0 |
1 (0.3) |
0 |
Infusion site hematoma |
0 |
1 (0.3) |
0 |
Infusion site edema |
0 |
1 (0.3) |
0 |
Abbreviations: EAIR = exposure-adjusted incidence rates; MedDRA = Medical Dictionary for Regulatory Activities; PYE = patient-years of exposure.
aData for the high-level term "infusion site reaction" presented as n (%) [EAIR], and data for the lower-level terms presented as n (%). Data derived from the safety population, which includes all patients who received ≥1 dose of study drug.
bThe infusion site reactions query captures all adverse events with a MedDRA coded high level term of infusion site reactions excluding joint-related preferred terms.
cThe estimated rate difference (95% CI) for mirikizumab vs ustekinumab is -7.6 (-15.7 to 0.6) and for mirikizumab vs placebo is 0.7 (-0.6 to 2).
Treatment-Emergent Infusion Site Reactions in the Phase 3 Ulcerative Colitis Clinical Trials: LUCENT-1 and LUCENT-2
During the 12-week induction phase (LUCENT-1), infusion site reaction was reported in
- 0.4% of patients who received mirikizumab, and
- 0.3% of patients who received placebo.3
All infusion site reactions were mild in severity, and no infusion site reactions were classified as serious. Three patients (0.3%) who received mirikizumab discontinued from the study due to an infusion reaction.1
One patient who received open-label extended induction experienced an infusion site reaction. The event was not reported as serious and the patient did not discontinue from the study due to the event.1,3
Frequency of Infusion Site Reactions in the LUCENT Clinical Trial Program provides additional information on infusion site 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 |
||
Infusion site reactionb |
4 (0.4) |
1 (0.3) |
Infusion site erythema |
1 (0.1) |
0 |
Infusion site pain |
1 (0.1) |
0 |
Infusion site paresthesia |
1 (0.1) |
1 (0.3) |
Infusion site pruritus |
1 (0.1) |
0 |
LUCENT-2 MIRI Induction Delayed Responders |
OL Extended Induction |
|
LUCENT-2 Week 12 |
||
Infusion site reactionb |
1 (0.3) |
|
Infusion site warmth |
1 (0.3) |
|
Abbreviations: IV = intravenous; MedDRA = Medical Dictionary for Regulatory Activities; MIRI = mirikizumab; OL = open-label; PBO = placebo; Q4W = every 4 weeks.
aData derived from the safety population, which includes all patients who received ≥1 dose of study drug, are presented as n (%).
bThe infusion site reactions query captures all adverse events with a MedDRA coded high level term of infusion site reactions excluding joint-related preferred terms.
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Ferrante 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
3D'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
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.
Date of Last Review: 15 January 2025