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Omvoh ™ (mirikizumab-mrkz) injection
300 mg/15 mL, 100 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the effect of Omvoh™ (mirikizumab-mrkz) on bowel urgency in patients with ulcerative colitis?
Patients with ulcerative colitis who received mirikizumab had shown more significant improvements in bowel urgency as early as week 2 compared with placebo (p=.004), and the improvements were maintained through 52 weeks of continuous treatment (p<.001).
Bowel Urgency Efficacy in LUCENT-1 and LUCENT-2
Change From Baseline in Bowel Urgency
In LUCENT-1, patients with ulcerative colitis were randomized in a 3:1 ratio to receive either mirikizumab 300 mg (N=868) or placebo (N=294) infused intravenously every 4 weeks for the 12-week induction period.1
Patients who received mirikizumab and achieved a clinical response after the 12-week induction period (LUCENT-1) were rerandomized in a 2:1 ratio to receive either mirikizumab 200 mg (N=365) or placebo (N=179) injected subcutaneously every 4 weeks for 40 weeks during the maintenance period (LUCENT-2).1
The least-squares mean change from baseline in the urgency numeric rating scale (NRS) was significantly greater for patients who received mirikizumab than for patients who received placebo as early as week 2 (p=.004), and the difference remained significant at weeks 12 (p<.0001) and 40 (p<.001) ().1
Clinically Meaningful Improvement in Bowel Urgency and Bowel Urgency Remission
According to a psychometric evaluation of the validated urgency NRS, in patients with an induction baseline urgency NRS score of at least 3, a clinically meaningful improvement (CMI) in bowel urgency correlates with at least a 3-point change from baseline in the urgency NRS, and an urgency NRS score of 0 or 1 represents bowel urgency remission.1
At weeks 12 and 52, a significantly greater proportion of overall patients who received mirikizumab achieved a CMI in bowel urgency and bowel urgency remission than did patients who received placebo (p<.001) (). The difference was significant as early as week 4 for bowel urgency CMI (p=.044).1
Endpoint |
LUCENT-1 Induction |
LUCENT-2 Maintenance |
||
MIRI 300 mg IV Q4W (N=868) |
PBO IV Q4W (N=294) |
MIRI 200 mg SC Q4W (N=365) |
PBO SC Q4W (N=179) |
|
Week 12 |
Week 40b |
|||
Change from BL in urgency NRS, LSM (SE) |
||||
Overall patients |
-2.59 (0.08)c |
-1.63 (0.14) |
-3.80 (0.14)c |
-2.74 (0.20) |
Biofailed patientsd |
-2.46 (0.13)c |
-0.95 (0.23) |
-3.60 (0.23)c |
-2.66 (0.35) |
Bowel urgency CMI,e n (%) |
||||
Overall patients |
395/811 (48.7)c |
89/276 (32.2) |
219/336 (65.2)c |
72/172 (41.9) |
Biofailed patientsd |
157/344 (45.6)c |
22/115 (19.1) |
73/122 (59.8)f |
22/63 (34.9) |
Bowel urgency remission,e n (%) |
||||
Overall patients |
179/811 (22.1)c |
34/276 (12.3) |
144/336 (42.9)c |
43/172 (25.0) |
Biofailed patientsd |
67/344 (19.5)c |
5/115 (4.3) |
43/122 (35.2)g |
12/63 (19.0) |
Abbreviations: BL = baseline; CMH = Cochran-Mantel-Haenszel; CMI = clinically meaningful improvement; IV = intravenous; LSM = least-squares mean; MIRI = mirikizumab; mITT = modified intent-to-treat; MMRM = mixed-effects model for repeated measures; NRS = numeric rating scale; PBO = placebo; Q4W = every 4 weeks; SC = subcutaneous; TNF = tumor necrosis factor; UC = ulcerative colitis.
Treatment comparison for urgency NRS change from baseline was made using MMRM; model included treatment, baseline value, treatment by visit interactions, baseline value by visit interactions, and stratification factors.
Treatment comparison for bowel urgency CMI and remission was made using CMH tests adjusting for stratification factors; missing data were considered as nonresponse.
aIncludes patients who received ≥1 dose of randomized treatment.
bRepresenting a total of 52 weeks of continuous therapy.
cp<.001 vs PBO.
dThe biofailed patients included patients who had inadequate response to, loss of response to, or were intolerant to a biologic therapy for UC (such as anti-TNFs or anti-integrins) or to the Janus kinase inhibitor tofacitinib.
eBowel urgency CMI and remission were assessed in mITT patients with baseline urgency NRS ≥3 in LUCENT-1 and mirikizumab induction responders with baseline urgency NRS ≥3 in LUCENT-2.
fp=.002 vs PBO.
gp=.027 vs PBO.
Patient Population With Modified Mayo Score of 5 to 9
The United States Prescribing Information (USPI) presents data that differs from the information in data disclosures, reflecting adjustments made in accordance with FDA guidance on inclusion criteria and endpoints for ulcerative colitis clinical studies. Supplementary details can be found in the Appendix. The information below originates from the USPI.
LUCENT-2
LUCENT-2 is the maintenance study that evaluated 506 patients who achieved clinical response at week 12 in the LUCENT-1 study. These patients were randomized 2:1 to receive either 200 mg mirikizumab or placebo subcutaneously every 4 weeks for 40 weeks in LUCENT-2. The total length of treatment for LUCENT-1 and LUCENT-2 was 52 weeks.2
Bowel Urgency
Bowel urgency was assessed during LUCENT-1 and LUCENT-2 with an Urgency NRS of 0 to 10.2
A greater proportion of subjects with a baseline Urgency NRS weekly average score ≥3 treated with mirikizumab compared to placebo reported an Urgency NRS weekly average score of 0 or 1 (39% versus 23%) at week 40.2
Urgency NRS weekly average scores of 0 to 1 were also observed in a greater proportion of subjects treated with mirikizumab compared to placebo at Week 12.2
Enclosed Prescribing Information
Reference
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Dubinsky MC, Clemow DB, Gibble TH, et al. Clinical effect of mirikizumab treatment on bowel urgency in patients with moderately to severely active ulcerative colitis and the clinical relevance of bowel urgency improvement for disease remission. Crohns Colitis 360. 2023;5(1):otac044. https://doi.org/10.1093/crocol/otac044
2Omvoh [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
3D'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;388:2444-2455. https://doi.org/10.1056/NEJMoa2207940
4US National Library of Medicine. ClinicalTrials.gov. February 29, 2000. Accessed August 31, 2023. https://clinicaltrials.gov/
5US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Ulcerative colitis: developing drugs for treatment. Guidance for industry. April 2022. Accessed August 31, 2023. https://www.fda.gov/media/158016/download
Appendix
The mirikizumab clinical development program for ulcerative colitis began in 2015 with specific criteria for eligible patients: those with moderately to severely active ulcerative colitis, defined by a modified Mayo score (MMS) of 4 to 9 and an endoscopic subscore (ES) of at least 2, based on endoscopy within 14 days before baseline. Throughout data disclosures, this patient group has consistently been used.3,4
In April 2022, the FDA issued draft guidance, stipulating that clinical studies evaluating drug candidates for moderately to severely active ulcerative colitis treatment should involve patients with an MMS of 5 to 9, including an ES of at least 2. As a result, the United States prescribing information contains data only from patients meeting this revised criteria. This adjustment led to 100 fewer patients evaluated in LUCENT-1 and 38 fewer mirikizumab induction responders evaluated in LUCENT-2.2,3,5
Date of Last Review: May 30, 2023