Effect of mirikizumab on bowel urgency clinically meaningful improvement and remission: results from the phase 3 LUCENT induction and maintenance studies

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Key messages

• Bowel urgency (BU) is a common and burdensome symptom in ulcerative colitis (UC), and was assessed in the mirikizumab LUCENT studies.
• The validated Urgency Numeric Rating Scale (UNRS) measures BU severity in the past 24 hours from 0 (no urgency) to 10 (worst possible urgency). 
• This analysis evaluated the proportions of patients in LUCENT studies achieving BU remission and clinically meaningful improvement (CMI).
• Significantly higher proportions of mirikizumab versus placebo patients achieved BU CMI (48.7% versus 32.2%) and BU remission (22.1% versus 12.3%) at Week 12 in the induction study. 
• Rates at Week 40 of maintenance were 65.2% versus 41.9% for BU CMI, and 43.3% versus 25.7% for BU remission compared to placebo among mirikizumab induction responders (both p<0.001).
• Mirikizumab had a highly significant and clinically meaningful benefit on reducing bowel urgency, one of the most disruptive UC symptoms.