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Omvoh ® ▼ (mirikizumab)
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Does Omvoh® (mirikizumab) increase the risk of infection in patients with ulcerative colitis?
Mirikizumab may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
Content overview
Information on infections in the Omvoh label
Mirikizumab is contraindicated in clinically important active infections (active tuberculosis).1
Mirikizumab may increase the risk of severe infection.1
- Treatment with mirikizumab should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.
- The risks and benefits of treatment should be considered prior to initiating use of mirikizumab in patients with a chronic infection or a history of recurrent infection.
- Patients should be instructed to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur.
Upper respiratory tract infections are reported as common adverse reactions (≥ 1/100 to < 1/10) associated to mirikizumab treatment. These include:1
- acute sinusitis,
- nasopharyngitis,
- oropharyngeal discomfort,
- oropharyngeal pain,
- pharyngitis,
- rhinitis,
- sinusitis,
- tonsillitis,
- upper respiratory tract infection, and
- viral upper respiratory tract infection.
Also, herpes zoster is reported as an uncommon (≥ 1/1000 to < 1/100) adverse reaction associated to mirikizumab treatment.1
If a serious infection develops, discontinuation of mirikizumab should be considered until the infection resolves.1
Pre-treatment evaluation for tuberculosis
Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection.1
Patients receiving mirikizumab should be monitored for signs and symptoms of active TB during and after treatment.1
Anti‑TB therapy should be considered prior to initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.1
Infections in LUCENT-1 and LUCENT-2 Studies
Induction Period
During the 12-week induction period of LUCENT-1 in patients with ulcerative colitis, at least 1 treatment-emergent infection was reported by
- 15.1% of patients who received mirikizumab, and
- 14.0% of patients who received placebo (Infections in the LUCENT-1 and LUCENT-2 Studies in Patients With Ulcerative Colitis).2
Most of the infections were mild or moderate in severity.3 Treatment-emergent adverse events reported by severity from the 12-week LUCENT-1 study are summarized in All Infections by Maximum Severity in the LUCENT-1 Study in Patients With Ulcerative Colitis.
All Infections, n (%) |
MIRI 300 mg IV Q4W (N=958) |
PBO IV Q4W (N=321) |
Mild |
108 (11.3) |
24 (7.5) |
Moderate |
32 (3.3) |
20 (6.2) |
Severe |
5 (0.5) |
1 (0.3) |
Abbreviations: IV = intravenous; MIRI = mirikizumab; PBO = placebo; Q4W = every 4 weeks.
aPatients with multiple occurrences of the same event are counted under the highest severity.
Maintenance Period of Induction Responders
Patients who responded to induction treatment with mirikizumab in LUCENT-1 were rerandomized to treatment with either mirikizumab or placebo in LUCENT-2. During the 40-week maintenance period in LUCENT-2, at least 1 treatment-emergent infection was reported by
- 23.9% of patients who received mirikizumab, and
- 22.9% of patients who received placebo (Infections in the LUCENT-1 and LUCENT-2 Studies in Patients With Ulcerative Colitis).2
Most of the infections were mild or moderate in severity.3 Treatment-emergent adverse events reported by severity from the 40-week LUCENT-2 study are summarized in All Infections by Maximum Severity in the LUCENT-2 Study in Patients With Ulcerative Colitis.
All Infections, n (%) |
MIRI 200 mg SC Q4W (N=389) |
PBO SC Q4W (N=192) |
Mild |
70 (18.0) |
31 (16.1) |
Moderate |
20 (5.1) |
9 (4.7) |
Severe |
3 (0.8) |
4 (2.1) |
Abbreviations: MIRI = mirikizumab; PBO = placebo; Q4W = every 4 weeks; SC = subcutaneous.
aPatients with multiple occurrences of the same event are counted under the highest severity.
Extended Induction Period
Of the patients who did not respond to mirikizumab induction therapy in LUCENT-1 and received extended induction with mirikizumab IV 300 mg every 4 weeks for 12 weeks in LUCENT-2, 12.8% reported a treatment-emergent infection (Infections in the LUCENT-1 and LUCENT-2 Studies in Patients With Ulcerative Colitis).2
Open-Label Maintenance Period of Delayed Responders
At week 40 of LUCENT-2, 18.1% of delayed responders to mirikizumab who received maintenance therapy with mirikizumab 200 mg injected subcutaneously reported a treatment-emergent infection (Infections in the LUCENT-1 and LUCENT-2 Studies in Patients With Ulcerative Colitis).2
Infectiona |
Treatment Arm |
|
LUCENT-1 MIRI Induction |
MIRI 300 mg IV Q4W (N=958) |
PBO IV Q4W (N=321) |
LUCENT-1 Week 12 |
||
All infections, n (%) |
145 (15.1) |
45 (14.0) |
Serious infections, n (%) |
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, n (%) |
5 (0.5) |
1 (0.3) |
Cytomegalovirus colitis |
2b |
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, n (%) |
93 (23.9) |
44 (22.9) |
Serious infections, n (%) |
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, n (%) |
5 (1.3) |
0 |
Herpes zoster |
4c |
0 |
Oral candidiasis |
1 |
0 |
LUCENT-2 MIRI Induction Nonresponders |
OL Induction MIRI 300 mg IV (N=313) |
OL Maintenance of Delayed Responders |
LUCENT-2 Week 12 |
LUCENT-2 Week 40 |
|
All infections, n (%) |
40 (12.8) |
31 (18.1) |
Serious infections, n (%) |
5 (1.6) |
2 (1.2) |
Opportunistic infections, n (%) |
2 (0.6) |
0 |
Gastrointestinal candidiasis |
1 |
0 |
Cytomegalovirus esophagitis |
1 |
0 |
Abbreviations: IV = intravenous; MIRI = mirikizumab; OL = open-label; PBO = placebo; Q4W = every 4 weeks; SC = subcutaneous.
Note: Three 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.
aData are presented as n unless otherwise indicated.
bOne case of cytomegalovirus was severe.
cOne case of herpes zoster was severe.
References
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
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.
4Winthrop KL, Novosad SA, Baddley JW, et al. Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance. Ann Rheum Dis. 2015;74(12):2107-2116. http://dx.doi.org/10.1136/annrheumdis-2015-207841
▼ 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