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Omvoh ® ▼ (mirikizumab)
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Does Omvoh® (mirikizumab) cause injection-site pain?
Across all phase 2 and 3 studies, 160 of 4802 patients (3.3%) exposed to mirikizumab reported injection-site pain on the day of drug administration (incidence rate per 100 PY, 1.5; 95% CI, 1.3-1.8).
Content overview
Summary of Product Characteristics
Incidence of Injection-Site Pain From the Mirikizumab Clinical Trials For All Evaluated Indications
Treatment-Emergent Injection-Site Pain in the Phase 3 Crohn's Disease Clinical Trial: VIVID-1
- Injection-Site Pain in Induction Responders
- Injection-Site Pain in Delayed Responders
- Incidence of Injection-Site Pain by Injection Site
- Injection-Site Pain at 104 and 152 Weeks of Continuous Treatment With Mirikizumab in LUCENT-3
Clinical Study Using the Prefilled Syringe or Prefilled Pen in Healthy Participants
Citrate-Free Mirikizumab for Ulcerative Colitis and Crohn's Disease
Summary of Product Characteristics
Injection site reactions are listed as a known side effect of mirikizumab in the Omvoh Summary of Product Characteristics1
If a serious hypersensitivity reaction, including anaphylaxis, occurs, mirikizumab must be discontinued immediately and appropriate therapy must be initiated.1
For more information on the frequency and severity of local reactions, hypersensitivity reactions, and immunogenicity of mirikizumab, see the Omvoh Summary of Product Characteristics in the sections 1
- 4.3 Contraindications
- 4.4 Warnings and precautions
- 4.8 Undesirable effects
Incidence of Injection-Site Pain 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, 160 patients (3.3%) reported injection-site pain on the day of study drug administration (incidence rate per 100 PY, 1.5; 95% CI, 1.3-1.8).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 Injection-Site Pain in the Phase 3 Crohn's Disease Clinical Trial: VIVID-1
In the VIVID study, subcutaneous injections were administered every 4 weeks for mirikizumab and every 8 weeks for ustekinumab using prefilled manual syringes.3 Patients randomized to the mirikizumab treatment group received the classic formulation of mirikizumab which contained sodium citrate.2 For information on the citrate-free formulation, see Frequency of Injection-Site Pain in the VIVID-1 Clinical Trial.
During the 52-week VIVID-1 study, injection-site pain was reported in
- 3.2% of patients who received mirikizumab
- 3.6% of patients who received ustekinumab, and
- 3.8% of patients who received placebo (Frequency of Injection-Site Pain in the VIVID-1 Clinical Trial).2
The proportion of patients who reported injection-site pain was similar for mirikizumab and ustekinumab (Frequency of Injection-Site Pain in the VIVID-1 Clinical Trial). Most injection-site pain events were mild or moderate in severity.2
One patient in the mirikizumab treatment group discontinued from the study due to injection-site pain of moderate severity which occurred at the time of the patient's fourth maintenance dose. No patients in the ustekinumab and placebo treatment groups discontinued from the study due to injection-site pain.2
Eventa |
MIRI |
USTE |
PBO |
Injection-site pain |
20 (3.2) [3.4] |
11 (3.6) [3.8] |
8 (3.8) [7.0] |
Mild |
13 (2.1) |
9 (2.9) |
5 (2.4) |
Moderate |
5 (0.8) |
2 (0.6) |
2 (0.9) |
Severe |
2 (0.3) |
0 (0.0) |
1 (0.5) |
Abbreviations: EAIR = exposure-adjusted incidence rate; MIRI = mirikizumab; PBO = placebo; PYE = patient years of exposure; USTE = ustekinumab.
aData presented as n (%) [EAIR] or n (%), and from the safety population, which includes all patients who received ≥1 dose of study drug.
Treatment-Emergent Injection-Site Pain in the Phase 3 Ulcerative Colitis Clinical Trials: LUCENT-2 and LUCENT-3
In the LUCENT clinical trials, the prefilled syringe was used for patients randomized to maintenance treatment with the classic formulation of mirikizumab which contained sodium citrate.4 For information on the citrate-free formulation, see Incidence and Severity of Injection-Site Pain in Mirikizumab Induction Responders During the 40-Week Phase 3 LUCENT-2 Maintenance Study.
Injection-Site Pain in Induction Responders
At the end of the 40-week maintenance period (representing 52 weeks of continuous treatment), the incidence of injection-site pain was numerically higher in patients receiving subcutaneous mirikizumab 200 mg via prefilled syringe compared with placebo (Incidence and Severity of Injection-Site Pain in Mirikizumab Induction Responders During the 40-Week Phase 3 LUCENT-2 Maintenance Study).4
Eventb |
MIRI Induction Respondersc |
|
MIRI 200 mg SCd |
PBO SCd |
|
Injection-site pain |
17 (4.4) |
6 (3.1) |
Milde |
12 (3.1) |
4 (2.1) |
Moderatef |
3 (0.8) |
2 (1.0) |
Severeg |
2 (0.5) |
0 (0.0) |
Abbreviations: MIRI = mirikizumab; PBO = placebo; SC = subcutaneous.
aRepresenting 52 weeks of continuous treatment.
bData presented as n (%).
cDefined as patients who received 12-week mirikizumab induction therapy and achieved 1) a decrease in the modified Mayo score of ≥2 points and ≥30% decrease from baseline, and 2) a decrease of ≥1 point in the rectal bleeding subscore from baseline or a rectal bleeding score of 0 or 1.
dAdministered using a prefilled syringe.
eMild severity means the event does not interfere with activity or require local therapy.
fModerate severity means that the event interferes with activity or leads to repeated use of non-narcotic pain reliever for longer than 24 hours.
gSevere means the event prevents activity or leads to use of narcotic pain reliever.
Most injection-site pain events were mild or moderate in severity.2
See Reports of Injection-Site Pain in Patients Treated With Mirikizumab in LUCENT-2 in the Appendix for details on all injection-site pain events. See below for additional information on the 2 patients with severe injection-site pain.2
- A 68-year-old white male who responded to induction therapy with mirikizumab was rerandomized to receive mirikizumab 200 mg injected subcutaneously (SC) in LUCENT‑2. At the time of his first SC maintenance dose (study day 1 of LUCENT-2), the patient reported mild pain at the injection site in the right arm and severe pain at the injection site in the left arm. For the second maintenance dose (study day 32), the patient received the injection in the right arm and the right abdomen, and he reported moderate pain at both injection sites. The third maintenance dose (study day 60) was administered in the patient's right and left abdomen and he reported mild injection-site pain. The patient did not report injection-site pain at subsequent visits until study day 256, when he reported mild injection-site pain which was further described as burning in the right and left abdomen. Each of the events resolved and the patient did not discontinue from the study due to the events.2
- A 26-year-old male American Indian/Alaska Native who responded to induction therapy with mirikizumab was rerandomized to received mirikizumab 200 mg injected SC in LUCENT-2. The patient received each dose in the right and left abdomen. At the time of administration of each of the first 8 maintenance doses, the patient reported injection-site pain which was further described as burning and lasted approximately 10 seconds. The severity of the event was severe for the first 3 doses (study days 1, 29, and 57), moderate for the next 2 doses (study days 92 and 119), and mild for the last 3 doses (study days 147, 176, and 204). Each of the events resolved and the patient did not discontinue from the study due to the events.2
Injection-Site Pain in Delayed Responders
The incidence of injection-site pain for open-label mirikizumab delayed responders can be found in Incidence of Injection-Site Pain in Open-label Mirikizumab Delayed Responders During the 40-Week Phase 3 LUCENT-2 Maintenance Study.
Eventa |
OL MIRI Delayed Respondersb |
MIRI 200 mg SCc |
|
Injection-site pain |
6 (3.5) |
Abbreviations: IV = intravenous; MIRI = mirikizumab; OL = open-label; Q4W = every 4 weeks; SC = subcutaneous.
aData presented as n (%).
bDefined as patients who received 12-week mirikizumab induction therapy plus OL extended induction therapy with an additional 3 doses of IV mirikizumab 300 mg Q4W. After the extended induction period, these patients had achieved 1) a decrease in the modified Mayo score of ≥2 points and ≥30% decrease from induction baseline, and 2) a decrease of ≥1 point in the rectal bleeding subscore from induction baseline or a rectal bleeding score of 0 or 1.
cAdministered using a prefilled syringe.
Incidence of Injection-Site Pain by Injection Site
Of the total number of injections administered in LUCENT-2, injection-site pain was reported with the administration of
- 169 (2.3%) mirikizumab injections, including
- 3.0% of doses injected into the abdomen
- 1.6% of doses injected into the arm, and
- 0.8% of doses injected into the thigh, and
- 77 (2.5%) placebo injections, including
- 1.7% of doses injected into the abdomen
- 3.4% of doses injected into the arm, and
- 4.5% of doses injected into the thigh.2
Incidence of Injection-Site Pain by Injection Site in Mirikizumab Induction Responders During the 40-Week Phase 3 LUCENT-2 Maintenance Study shows additional data for injection-site reactions and injection-site pain by injection site for the 2 treatment groups.
|
MIRI Induction Respondersa |
|||||||
MIRI 200 mg SCb |
PBO SCb |
|||||||
Administration Site |
Abdomen |
Arm |
Thigh |
Total |
Abdomen |
Arm |
Thigh |
Total |
Total number of injections, Nx (%) |
4087 (56.0) |
2503 (34.3) |
709 (9.7) |
7301 (100) |
1729 (56.6) |
1082 (35.4) |
242 (7.9) |
3053 (100) |
Any TE injection-site reactions, nx (%) |
166 (4.1) |
62 (2.5) |
7 (1.0) |
235 (3.2) |
31 (1.8) |
39 (3.6) |
11 (4.5) |
81 (2.7) |
Injection-site pain, nx (%) |
123 (3.0) |
40 (1.6) |
6 (0.8) |
169 (2.3) |
29 (1.7) |
37 (3.4) |
11 (4.5) |
77 (2.5) |
Abbreviations: MIRI = mirikizumab; Nx = number of injections; nx = number of injection-site events in the specific category; PBO = placebo; SC = subcutaneous; TE = treatment-emergent.
aDefined as patients who received 12-week mirikizumab induction therapy and achieved 1) a decrease in the modified Mayo score of ≥2 points and ≥30% decrease from baseline, and 2) a decrease of ≥1 point in the rectal bleeding subscore from baseline or a rectal bleeding score of 0 or 1.
bAdministered using a prefilled syringe.
Injection-Site Pain at 104 and 152 Weeks of Continuous Treatment With Mirikizumab in LUCENT-3
Clinical Study Using the Prefilled Syringe or Prefilled Pen in Healthy Participants
Study AMBE evaluated the pharmacokinetics, safety and tolerability, and pain associated with subcutaneous mirikizumab 125 mg administered into the abdomen, thigh, or arm using a prefilled syringe or prefilled pen in 66 healthy participants.7
The overall incidence of pain was not significantly different between the prefilled syringe and the prefilled pen or between devices at each injection site.2
Citrate-Free Mirikizumab for Ulcerative Colitis and Crohn's Disease
The approval and availability of a citrate-free formulation of mirikizumab in a prefilled pen or syringe for ulcerative colitis may differ by country. For information regarding availability, please reach out to your local Eli Lilly and Company affiliate.
A total of 3 phase 1 studies were conducted and supported the bioequivalence and safety of the citrate-free formulation of mirikizumab compared with the classic formulation.8
Ways to Potentially Mitigate Injection-Site Pain
For a patient who has experienced injection-site pain, based upon individual patient needs, it may be helpful to
- place a cold ice pack, gel pack, or water bottle on the injection site
- let mirikizumab warm to room temperature before injecting
- pinch and hold the skin while injecting
- use local anesthetic cream such as lidocaine or prilocaine on the injection site, and
- use anti-pain medication such as acetaminophen.9,10
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands. (UK)
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. 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. 2024;30(12):2245-2258. https://doi.org/10.1093/ibd/izae024
6Sands 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. 2025;31(7):1876-1890. https://doi.org/10.1093/ibd/izae253
7A study of injections of LY3074828 in healthy participants. ClinicalTrials.gov identifier: NCT03886948. Updated February 20, 2024. Accessed May 20, 2025. https://clinicaltrials.gov/show/NCT03886948
8Otani Y, Feagan B, D'Haens G, et al. Pharmacokinetic comparability and safety between original and citrate-free mirikizumab formulations for subcutaneous injections: results from three clinical trials in healthy participants. Poster presented at: 20th Congress of the European Crohn's and Colitis Organisation; February 19-22, 2025; Berlin, Germany.
9Thomaidou E, Ramot Y. Injection site reactions with the use of biological agents. Dermatol Ther. 2019;32(2):e12817. https://doi.org/10.1111/dth.12817
10St Clair-Jones A, Prignano F, Goncalves J, et al. Understanding and minimising injection-site pain following subcutaneous administration of biologics: a narrative review. Rheumatol Ther. 2020;7(4):741-757. https://doi.og/10.1007/s40744-020-00245-0
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
Patient |
Study Day |
Description |
Severity |
Action Taken and Event Outcome |
Related to Study Treatment |
Treatment Discontinuation |
1 |
1 |
Paresthesia at the injection site (right/left abdomen) |
Mild |
DNC; recovered/resolved |
Yes |
No |
28 |
Pain at the injection site (right/left abdomen) with erythema on right side |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
56 |
Injection-site pain, further described as a little burning (right/left abdomen) |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
167 |
Injection-site pain, further described as a little burning (right/left abdomen) |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
196 |
Paresthesia at the injection site (right/left abdomen) |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
224 |
Injection-site hematoma |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
2 |
1 |
Injection-site pain, further described as burning (right/left arm) |
Moderate |
DNC; recovered resolved |
Yes |
No |
1 |
Injection-site erythema approximately 30 minutes post injection (left arm) |
Mild |
DNC; recovered resolved |
Yes |
No |
|
29 |
Injection-site pain, further described as burning (right/left arm) |
Mild |
DNC; recovered resolved |
Yes |
No |
|
29 |
Injection-site erythema approximately 30 minutes post injection (left arm) |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
59 |
Injection-site pain (right/left arm) |
Moderate |
DNC; recovered/resolved |
Yes |
No |
|
85 |
Injection-site pain (right/left arm) |
Moderate |
DNC; recovered/resolved |
Yes |
No |
|
85 |
Injection-site erythema (left arm) |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
3 |
1 |
Injection-site pain (right arm) |
Mild |
DNC; recovered/resolved |
Yes |
No |
1 |
Injection-site pain (left arm) |
Severe |
DNC; recovered/resolved |
No |
No |
|
32 |
Injection-site pain (right arm/right abdomen) |
Moderate |
DNC; recovered/resolved |
Yes |
No |
|
60 |
Injection-site pain (right/left abdomen) |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
256 |
Injection-site pain, further described as burning (right/left abdomen) |
Mild |
DNC; recovered/resolved |
Yes |
No |
|
4a |
87 |
Injection-site pain, further described as burning |
Mild |
DNC; recovered/resolved |
Yes |
No |
114 |
Injection-site pain, further described as burning (right/left injection site)b |
Mild |
DNC; recovered/resolved |
No |
No |
|
140 |
Injection-site pain (right/left injection site) |
Mild |
DNC; recovered/resolved |
No (R)/Yes (L)c |
No |
|
5 |
1 |
Injection-site pain, further described as burning which lasted 10 seconds (right/left abdomen) |
Severe |
DNC; recovered/resolved |
Yes |
No |
29 |
Injection-site pain, further described as burning which lasted 10 seconds (right/left abdomen) |
Severe |
DNC; recovered/resolved |
Yes |
No |
|
57 |
Injection-site pain, further described as burning which lasted 10 seconds (right/left abdomen) |
Severe |
DNC; recovered/resolved |
Yes |
No |
|
92 |
Injection-site pain, further described as burning which lasted 10 seconds (right/left abdomen) |
Moderate |
DNC; recovered/resolved |
Yes |
No |
|
119 |
Injection-site pain, further described as burning which lasted 10 seconds (right/left abdomen) |
Moderate |
DNC; recovered/resolved |
Yes |
No |
|
147 |
Injection-site pain, further described as burning which lasted 10 seconds (right/left abdomen) |
Mild |
DNC; recovered/resolved |
No |
No |
|
176 |
Injection-site pain, further described as burning which lasted 10 seconds (right/left abdomen) |
Mild |
DNC; recovered/resolved |
No |
No |
|
204 |
Injection-site pain, further described as burning which lasted 10 seconds (right/left abdomen) |
Mild |
DNC; recovered/resolved |
No |
No |
Abbreviations: DNC = dose not changed; L = left injection site; R = right injection site.
aThis patient was a mirikizumab induction nonresponder.
bThe patient had a mild hematoma at the injection site approximately 2 weeks later which resolved.
cThe injection-site pain on the right injection site was marked as not related to study treatment, and the injection-site pain on the left injection site was marked as related to study treatment.
Date of Last Review: 20 May 2025