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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): most common adverse events in LUCENT clinical trials
In the 12-week induction study of mirikizumab for the treatment of ulcerative colitis, the most commonly reported adverse events (≥3%) in the mirikizumab treatment group were nasopharyngitis, anemia, and headache.
Frequency of Adverse Events in LUCENT-1 and LUCENT-2
In the 12-week induction study of mirikizumab 300 mg infused intravenously every 4 weeks for the treatment of ulcerative colitis, LUCENT-1, the frequency of treatment-emergent adverse events (TEAEs) was similar between patients who received mirikizumab (44.5%) and patients who received placebo (46.1%).1
Of the patients who responded to induction therapy with mirikizumab and participated in the 40-week maintenance study, a TEAE was reported in 1
- 64.5% of patients who received mirikizumab 200 mg injected subcutaneously every 4 weeks and
- 68.8% of patients who received placebo
Of the patients who did not respond to mirikizumab induction therapy in LUCENT-1 and received extended induction with mirikizumab 300 mg infused intravenously every 4 weeks for 12 weeks in LUCENT-2, 38.3% reported a TEAE.1
At week 40 of LUCENT-2, 57.9% of delayed responders to mirikizumab reported a TEAE.1
Common Adverse Events Reported in ≥3% of Patients in LUCENT-1 and LUCENT-2
Most Commonly Reported Treatment-Emergent Adverse Events in LUCENT-1 and LUCENT-2 lists the most commonly reported adverse events in LUCENT-1 and LUCENT-2.
Adverse Eventb |
Treatment Arm |
|
LUCENT-1 MIRI Induction |
MIRI 300 mg IV Q4W (N=958) |
PBO IV Q4W (N=321) |
LUCENT-1 Week 12 |
||
All TEAEs |
426 (44.5) |
148 (46.1) |
Nasopharyngitis |
39 (4.1) |
10 (3.1) |
Arthralgia |
20 (2.1) |
4 (1.2) |
Ulcerative colitis |
17 (1.8) |
24 (7.5) |
Headache |
32 (3.3) |
9 (2.8) |
Rash |
5 (0.5) |
2 (0.6) |
Pyrexia |
14 (1.5) |
3 (0.9) |
Anemia |
32 (3.3) |
19 (5.9) |
LUCENT-2 MIRI Induction Responders |
MIRI 200 mg SC Q4W (N=389) |
PBO SC Q4W (N=192) |
LUCENT-2 Week 40 |
||
All TEAEs |
251 (64.5) |
132 (68.8) |
Nasopharyngitis |
28 (7.2) |
11 (5.7) |
Arthralgia |
26 (6.7) |
8 (4.2) |
Ulcerative colitis |
26 (6.7) |
40 (20.8) |
Injection site pain |
17 (4.4) |
6 (3.1) |
Headache |
16 (4.1) |
2 (1.0) |
Rash |
14 (3.6) |
0 |
Pyrexia |
13 (3.3) |
5 (2.6) |
Anemia |
8 (2.1) |
9 (4.7) |
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 TEAEs |
120 (38.3) |
99 (57.9) |
Arthralgia |
14 (4.5) |
13 (7.6) |
Nasopharyngitis |
8 (2.6) |
9 (5.3) |
Ulcerative colitis |
8 (2.6) |
11 (6.4) |
Anemia |
6 (1.9) |
8 (4.7) |
Headache |
5 (1.6) |
7 (4.1) |
Diarrhea |
2 (0.6) |
6 (3.5) |
Injection site pain |
N/A |
6 (3.5) |
Abbreviations: IV = intravenous; MIRI = mirikizumab; N/A = not applicable; OL = open-label; PBO = placebo; Q4W = every 4 weeks; SC = subcutaneous; TEAE = treatment-emergent adverse event.
Note: A TEAE is defined as an event that first occurred or worsened in severity after baseline.
aAdverse events occurred in at least 3% of patients in either treatment group.
bData are presented as n (%).
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
2Sandborn WJ, Ferrante M, Bhandari BR, et al. Efficacy and safety of mirikizumab in a randomized phase 2 study of patients with ulcerative colitis. Gastroenterology. 2020;158(3):537-549.e10. https://doi.org/10.1053/j.gastro.2019.08.043
▼ 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