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Omvoh ® ▼ (mirikizumab)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk
What are the Most Common Infections With Omvoh® (Mirikizumab)?
The most commonly reported infections were upper respiratory tract infections, especially nasopharyngitis. Herpes zoster has also been reported.
Managing Patients Receiving Omvoh with Concurrent Infections or Elevated Infection Risk
Mirikizumab may increase the risk of serious infections, which should be taken into account in patients with infections or at risk of infections. For complete information, please refer to the Omvoh Summary of Product Characteristics, in particular the sections1
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.8 Undesirable effects
Below you will find more information on the frequency of infections in the clinical trials of ulcerative colitis.
Treatment-emergent infections in the phase 3 ulcerative colitis clinical trials: LUCENT-1, LUCENT-2, and LUCENT-3
During the 12-week induction phase (LUCENT-1), at least 1 treatment-emergent infection was reported in
- 15.1% of patients who received mirikizumab, and
- 14.0% of patients who received placebo.2
During the 40-week maintenance phase (LUCENT-2), at least 1 treatment-emergent infection was reported in
- 23.9% of patients who received mirikizumab, and
- 22.9% of patients who received placebo.2
Most of the infections during the induction and maintenance phases were mild or moderate in severity.3
In patients who received extended induction treatment with mirikizumab, 12.8% reported a treatment-emergent infection.2
In patients who received open-label maintenance dosing with mirikizumab, 18.1% reported a treatment-emergent infection.2
Through the first 100 weeks of LUCENT-3 (week 52 to week 152 of continuous mirikizumab treatment), 144 patients (42.5%) reported an infection.4
Frequency of Infections in the LUCENT Clinical Trial Program provides a summary of the infections in the LUCENT studies.
Eventa |
Treatment Group |
|
LUCENT-1 MIRI Induction |
MIRI 300 mg IV Q4W (n=958) |
PBO IV Q4W (n=321) |
LUCENT-1 Week 12 |
||
All infections |
145 (15.1) |
45 (14.0) |
Severityb |
||
Mild |
108 (11.3) |
24 (7.5) |
Moderate |
32 (3.3) |
20 (6.2) |
Severe |
5 (0.5) |
1 (0.3) |
Serious infections |
7 (0.7) |
2 (0.6) |
Pneumonia |
2 |
0 |
Cytomegalovirus colitis |
1 |
0 |
Gastroenteritis viral |
1 |
0 |
Intestinal sepsis |
1 |
0 |
Klebsiella infection |
1 |
0 |
Viral infection |
1 |
0 |
Acute sinusitis |
0 |
1 |
Sinusitis |
0 |
1 |
Opportunistic infections |
5 (0.5) |
1 (0.3) |
Cytomegalovirus colitis |
2c |
0 |
Herpes zoster |
1 |
1 |
Intestinal tuberculosis |
1 |
0 |
Esophageal candidiasis |
1 |
0 |
LUCENT-2 MIRI Induction Responders |
MIRI 200 mg SC Q4W (n=389) |
PBO SC Q4W (n=192) |
LUCENT-2 Week 40 |
||
All infections |
93 (23.9) |
44 (22.9) |
Severityb |
||
Mild |
70 (18.0) |
31 (16.1) |
Moderate |
20 (5.1) |
9 (4.7) |
Severe |
3 (0.8) |
4 (2.1) |
Serious infections |
3 (0.8) |
3 (1.6) |
Gastroenteritis |
1 |
0 |
COVID-19 pneumonia |
1 |
0 |
Diverticulitis |
1 |
0 |
COVID-19 |
0 |
1 |
Large intestine infection |
0 |
1 |
Subcutaneous abscess |
0 |
1 |
Opportunistic infections |
5 (1.3) |
0 (0.0) |
Herpes zoster |
4c |
0 |
Oral candidiasis |
1 |
0 |
LUCENT-2 MIRI Induction Delayed Respondersd |
OL Extended Induction |
OL Maintenance of Delayed Responders |
LUCENT-2 Week 12 |
LUCENT-2 Week 40 |
|
All infections |
40 (12.8) |
31 (18.1) |
Serious infections |
5 (1.6) |
2 (1.2) |
Opportunistic infections |
2 (0.6) |
0 (0.0) |
Gastrointestinal candidiasis |
1 |
0 |
Cytomegalovirus esophagitis |
1 |
0 |
LUCENT-3 |
OL Maintenance of MIRI Induction Responders |
|
Week 100e |
||
All infections |
144 (42.5) |
|
Commonly reported infectionsf |
||
COVID-19 |
76 (22.4) |
|
Nasopharyngitis |
28 (8.3) |
|
Upper respiratory tract infection |
15 (4.4) |
|
Opportunistic infectionsg |
6 (1.8) |
|
Herpes zoster |
4 (1.2) |
|
Esophageal candidiasis |
2 (0.6) |
|
Oral candidiasis |
1 (0.3) |
|
Serious infections |
8 (2.4) |
|
Abbreviations: IV = intravenous; MIRI = mirikizumab; OL = open-label; PBO = placebo; Q4W = every 4 weeks; SC = subcutaneous.
aData presented as n (%) or n.
bPatients with multiple occurrences of the same event are counted under the highest severity.
cOne case was severe.
dThree out of 148 patients (2.0%) who were nonresponders to placebo induction in LUCENT-1 and received open-label mirikizumab induction therapy in LUCENT-2 reported opportunistic infections, including one case each of oral candidiasis, cytomegalovirus enteritis, and herpes zoster.
eRepresents 152 weeks of continuous mirikizumab treatment.
fAffecting ≥3% of patients.
gNarrow.
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands. (GB)
2D'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
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Sands 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.
Date of Last Review: 21 March 2024