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Mirikizumab
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.
What is the effect of mirikizumab 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) (Bowel Urgency Improvement and Remission at Weeks 12 and 40 in the Phase 3 LUCENT-1 and LUCENT-2 Clinical Trials, mITT Population).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) (Bowel Urgency Improvement and Remission at Weeks 12 and 40 in the Phase 3 LUCENT-1 and LUCENT-2 Clinical Trials, mITT Population). 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.
Additional Information
Additional safety and efficacy data from the mirikizumab ulcerative colitis registration studies are available in the following document:
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):1-13. https://doi.org/10.1093/crocol/otac044
Date of Last Review: November 29, 2022