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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 soon does Omvoh™ (mirikizumab-mrkz) start working for the symptoms of ulcerative colitis?
As early as week 2, mirikizumab was associated with significantly greater improvements in stool frequency, rectal bleeding, bowel urgency, and fatigue as well as higher stool frequency remission rates than placebo.
LUCENT-1 Study Design
LUCENT-1 is a 12-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study of mirikizumab, a p19-directed anti-interleukin-23 (anti-IL-23) antibody. The study was conducted to evaluate efficacy and safety in adult patients with moderately to severely active ulcerative colitis (UC), with a modified Mayo score of 4 to 9 points and centrally read Mayo endoscopic subscore ≥2, who had an inadequate response, loss of response, or an intolerance to corticosteroids, immunosuppressants, biologic therapies, or tofacitinib.1
A total of 1281 patients were randomized in a 3:1 ratio to receive intravenous (IV) mirikizumab 300 mg or placebo every 4 weeks. Randomization was stratified by
- biologic or tofacitinib failure status
- baseline corticosteroid use
- baseline disease activity as measured by the modified Mayo score, and
- world region.1
Ulcerative Colitis Symptom Control During the 12-Week LUCENT-1 Induction Study
Appendix shows definitions for the symptom endpoints and outcomes, as mentioned in the following sections.
Improvement in Stool Frequency
Improvement in Rectal Bleeding
Improvement in Bowel Urgency
Stool Frequency Remission
Rectal Bleeding Remission
Symptomatic Response
Symptomatic Remission
Bowel Urgency Clinically Meaningful Improvement
Bowel Urgency Remission
Fatigue Numeric Rating Scale
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
2Danese 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.
3Danese 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. Poster presented at: United European Gastroenterology Week (UEGW); October 8-11, 2022.
4Dignass 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.
5Dubinsky 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
6Dubinsky 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
7D'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
Appendix
Symptom Control Endpoint Definitions
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.
Patient-Reported Outcomes Scales
Patient-reported outcomes assessed in the daily patient eDiary included the... |
which ranges in scores from... |
to... |
stool frequency Mayo subscore |
0 (normal number of stools/day for the patient) |
4 (≥5 stools/day more than normal for the patient). |
rectal bleeding Mayo subscore |
0 (no blood) |
3 (blood alone passed). |
bowel urgency severity NRS |
0 (no urgency) |
10 (worst possible urgency). |
abdominal pain NRS |
0 (none) |
10 (worst possible pain). |
fatigue NRS |
0 (none) |
10 (worst possible fatigue). |
Abbreviation: NRS = Numeric Rating Scale.
Note: Patient-reported outcomes were recorded daily in the patient eDiary then averaged by week. For stool frequency and rectal bleeding, weekly assessments were calculated by averaging the 3 most recent available diary days in a 7-day period. For bowel urgency, abdominal pain, and fatigue, all available diary days in a 7-day period were averaged.
Date of Last Review: May 30, 2023