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Mirikizumab
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Can patients taking mirikizumab for ulcerative colitis discontinue corticosteroids and stay in remission?
After 40 weeks of maintenance treatment with mirikizumab (for a total of 52 weeks of mirikizumab treatment), 49.9% of patients were in clinical remission and 97.8% of those patients were in corticosteroid-free remission.
Corticosteroid-Free Remission at Week 40 of LUCENT-2
After the 12-week induction period of mirikizumab for the treatment of ulcerative colitis (LUCENT-1), patients who received mirikizumab and achieved a clinical response were rerandomized to receive either mirikizumab 200 mg or placebo injected subcutaneously every 4 weeks for 40 weeks during the maintenance period (LUCENT-2). A key secondary objective of LUCENT-2 was corticosteroid-free remission, defined as
- clinical remission at week 40
- symptomatic remission at week 28, and
- no corticosteroid use for at least 12 weeks prior to week 40.1
Compared with placebo, a significantly greater proportion of patients who were rerandomized to maintenance treatment with mirikizumab achieved clinical remission and corticosteroid-free remission at week 40 (p<.001 for both endpoints) (Clinical Remission and Corticosteroid-Free Remission at Week 40 in Mirikizumab Induction Responders).1
Endpoint |
MIRI 200 mg SC (N=365) |
PBO SC (N=179) |
Clinical remission,a n (%) |
182 (49.9)b |
45 (25.1) |
Common risk difference (95% CI) |
23.2 (15.2, 31.2) |
|
Corticosteroid-free clinical remission,c n (%) |
164 (44.9)b |
39 (21.8) |
Common risk difference (95% CI) |
21.3 (13.5, 29.1) |
|
Abbreviations: ES = Endoscopic Subscore; MIRI = mirikizumab; MMS = Modified Mayo Score; PBO = placebo; RB = rectal bleeding; SC = subcutaneous; SF = stool frequency.
Note: Includes the modified intent-to-treat population.
aClinical remission is based on the MMS and defined as 1) an SF = 0, or an SF = 1 with a ≥1-point decrease from baseline, 2) a RB subscore = 0, and 3) an ES = 0 or 1 (excluding friability).
bp<.001 vs PBO.
cCorticosteroid-free remission is defined as 1) clinical remission at week 40, 2) symptomatic remission at week 28, and 3) no corticosteroid use for ≥12 weeks prior to week 40.
Reference
1Dubinsky MC, Irving PM, Li X, et al. Efficacy and safety of mirikizumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-2 study. Abstract presented at: Digestive Disease Week; May 24, 2022; San Diego, California.
Date of Last Review: May 24, 2022