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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.
How effective is Omvoh™ (mirikizumab-mrkz) for the long-term control of symptoms of ulcerative colitis?
Patients had sustained stool frequency remission, rectal bleeding remission, bowel urgency remission, and improvement in abdominal pain after 52 weeks of continuous mirikizumab therapy (p<.001 vs placebo for all).
LUCENT-2 Study Design
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
A total of 544 patients who received mirikizumab in LUCENT-1 and achieved a clinical response were rerandomized in a 2:1 ratio to receive subcutaneous mirikizumab 200 mg or placebo every 4 weeks for 40 weeks. Randomization was stratified by
- biologic or tofacitinib failure status
- induction remission status
- baseline corticosteroid use, and
- geographic region (North America/Europe/other).1
Appendix shows definitions for the symptom endpoints, as mentioned in the following sections.
Stool Frequency Remission
At week 40 of LUCENT-2, 75.1% of patients who received mirikizumab had achieved stool frequency remission compared with 44.7% of patients who received placebo (p<.001) ().2
The proportion of patients with stool frequency remission was significantly higher in the mirikizumab group than in the placebo group at each time point from weeks 8 through 40 of LUCENT-2 (p<.05) ().2
Rectal Bleeding Remission
At week 40 of LUCENT-2, 79.7% of patients who received mirikizumab had achieved rectal bleeding remission compared with 49.7% of patients who received placebo (p<.001) ().2
The proportion of patients with rectal bleeding remission was significantly higher in the mirikizumab group than in the placebo group at each time point from weeks 8 through 40 of LUCENT-2 (p<.01) ().3
Symptomatic Remission
At week 40 of LUCENT-2, 71.0% of patients who received mirikizumab had achieved symptomatic remission compared with 39.7% of patients who received placebo (p<.001) ().3
At week 40 of LUCENT-2, 69.7% of patients who received mirikizumab had stable maintenance of symptomatic remission compared with 38.4% of patients who received placebo (p<.001) ().2
The proportion of patients with symptomatic remission was significantly higher in the mirikizumab group than in the placebo group at each time point from weeks 8 through 40 of LUCENT-2 (p<.05) ().2
Bowel Urgency Improvement and Remission
The least-squares mean improvement from baseline in the Urgency Numeric Rating Scale (NRS) was significantly greater in the mirikizumab group than in the placebo group at each time point from weeks 12 through 40 of LUCENT-2 (p<.05) ().2
Of the patients with an Urgency NRS of at least 3 at induction baseline, the proportion of patients with bowel urgency remission was significantly higher in the mirikizumab group than in the placebo group at each time point from weeks 8 through 40 of LUCENT-2 (p<.05) ().2
Abdominal Pain Improvement
The proportion of patients with abdominal pain improvement was significantly higher in the mirikizumab group than in the placebo group at each time point from weeks 16 through 40 of LUCENT-2 (p<.05) ().2
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 Divergence Between US Prescribing Information and Data Disclosures in Mirikizumab Ulcerative Colitis Studies. 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.4
Bowel Urgency
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
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;388:2444-2455. https://doi.org/10.1056/NEJMoa2207940
2Dignass A, Danese S, Matsuoka K, et al. Sustained symptom control with mirikizumab in patients with moderately to severely active ulcerative colitis in the LUCENT-2 maintenance trial. Abstract presented at: United European Gastroenterology Week (UEGW); October 8-11, 2022.
3Dignass A, Danese S, Matsuoka K, et al. Sustained symptom control with mirikizumab in patients with moderately to severely active ulcerative colitis in the LUCENT-2 maintenance trial. Poster presented at: United European Gastroenterology Week (UEGW); October 8-11, 2022.
4Omvoh [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
5Danese S, Dignass A, Matsuoka K, et al. Early symptom control with mirikizumab in patients with moderately to severely active ulcerative colitis in the LUCENT-1 induction trial. Abstract presented at: United European Gastroenterology Week (UEGW); October 8-11, 2022.
6Dubinsky MC, Irving PM, Panaccione R, et al. Incorporating patient experience into drug development for ulcerative colitis: development of the Urgency Numeric Rating Scale, a patient-reported outcome measure to assess bowel urgency in adults. J Patient Rep Outcomes. 2022;6(1):31. https://dx.doi.org/10.1186/s41687-022-00439-w
7Dubinsky MC, Delbecque L, Lewis JD, et al. Psychometric validation and interpretation of a patient-reported outcomes instrument to assess bowel urgency among adults with moderate to severe ulcerative colitis. Abstract presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO Virtual); February 16-19, 2022. Accessed June 15, 2022. https://www.ecco-ibd.eu/publications/congress-abstracts/item/p138-psychometric-validation-and-interpretation-of-a-patient-reported-outcomes-instrument-to-assess-bowel-urgency-among-adults-with-moderate-to-severe-ulcerative-colitis.html
8D'Haens G, Kobayashi T, Morris N, et al. Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-1 study. J Crohns Colitis. 2022;16(suppl 1):i028-i029. European Crohn's and Colitis Organisation abstract OP26. https://doi.org/10.1093/ecco-jcc/jjab232.025
9US National Library of Medicine. ClinicalTrials.gov. February 29, 2000. Accessed August 31, 2023. https://clinicaltrials.gov/
10US 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
Definitions of Efficacy Outcomes in Mirikizumab Ulcerative Colitis Studies
Outcome |
Definition |
Clinical response |
Decrease in the MMS of ≥2 points with ≥30% decrease from baseline, and either a decrease of ≥1 point in the rectal bleeding subscore from baseline or a rectal bleeding subscore of 0 or 1. |
Clinical remission |
Stool frequency subscore of 0, or stool frequency subscore of 1 with ≥1-point decrease from baseline, rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1 (excluding friability). |
Stool frequency remission |
Stool frequency subscore of 0, or stool frequency subscore of 1 with ≥1-point decrease from baseline. |
Rectal bleeding remission |
Rectal bleeding subscore of 0. |
Symptomatic response |
Reduction ≥30% from baseline in the sum of stool frequency and rectal bleeding subscores. |
Symptomatic remission |
Stool frequency subscore of 0, or stool frequency subscore of 1 with ≥1-point decrease from baseline, and rectal bleeding subscore of 0. |
Stable maintenance of symptomatic remission |
Symptomatic remission for at least 7 of 9 visits from weeks 4 to 36 and also at week 40, among patients in symptomatic remission and clinical response at the end of LUCENT-1. |
Bowel urgency NRS |
The bowel urgency NRS is an 11-point scale ranging from
|
Bowel urgency remission |
Defined as Urgency NRS=0 or 1 among patients induced into clinical response with mirikizumab in LUCENT-1 and had Urgency NRS ≥3 at induction baseline. |
Bowel urgency CMI |
Improvement ≥3 points in the Urgency NRS in patients with a baseline Urgency NRS ≥3. |
Endoscopic remission |
Endoscopic subscore of 0 or 1 excluding friability. |
Improvement in abdominal pain |
Improvement ≥30% from induction baseline in patients with a baseline abdominal pain NRS ≥3. |
Abbreviation: CMI = Clinically Meaningful Improvement; MMS = Modified Mayo score; NRS = Numeric Rating Scale.
Divergence Between US Prescribing Information and Data Disclosures in Mirikizumab Ulcerative Colitis Studies
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.1,9
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-2.1,4,10
Date of Last Review: May 30, 2023