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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Incidence of injection site pain
In LUCENT-2, the incidence of injection site pain was 4.4% in the mirikizumab-treated group and 3.1% in the placebo group.
Content overview
Injection site pain reactions in LUCENT-2 clinical trials
LUCENT-2 is a 40-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled, maintenance study that evaluated the safety and efficacy of mirikizumab, a p19-directed anti-IL-23 antibody, conducted in adult patients with moderately to severely active ulcerative colitis (UC) who completed the LUCENT-1 study.1
In the LUCENT clinical trials, the prefilled syringe was used for patients randomized to maintenance treatment with mirikizumab.1
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 to placebo (Incidence and Severity of Injection-Site Pain in Mirikizumab Induction Responders During the 40-Week Phase 3 LUCENT-2 Maintenance Study).1
Parametersb |
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 |
Abbreviations: MIRI = mirikizumab; PBO = placebo; SC = subcutaneous.
aRepresenting 52 weeks of continuous treatment.
bData are 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
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..
Parametersa |
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 are 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.
Clinical Study Using the Prefilled Syringe or Prefilled Pen in Healthy Participants
Study AMBE evaluated the pharmacokinetics, safety and tolerability, and pain associated with 125 mg of subcutaneous mirikizumab administered into the abdomen, thigh, or back of the arm using a prefilled syringe or prefilled pen in 66 healthy participants.3
The overall incidence of pain was not statistically significantly different between the prefilled syringe and the prefilled pen nor between devices at each injection site.2
Ways to potentially mitigate injection site pain
For a patient with injection site pain, based upon individual patient needs, the following options may be helpful before and/or after injection
- 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.4,5
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.
3A study of injections of LY3074828 in healthy participants. ClinicalTrials.gov identifier: NCT03886948. Updated February 20, 2024. Accessed March 4, 2024. https://clinicaltrials.gov/show/NCT03886948
4Thomaidou 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
5St 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
▼ 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: 04 March 2024