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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 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) |
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.
Two patients in the mirikizumab group and 0 patients in the placebo group reported injection site pain as a severe treatment-emergent adverse event.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.
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.3,4
References
1D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. Published online June 29, 2023. https://doi.org/10.1056/NEJMoa2207940
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Thomaidou 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
4St 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.
Date of Last Review: 30 May 2023