Mirikizumab is associated with rapid and sustained improvements in novel measures of bowel urgency in moderately-to-severely active ulcerative colitis: 28-week results from the LUCENT-URGE trial

INTRODUCTION: LUCENT-URGE (NCT05767021) was a Phase 3b, multicenter, open-label, single-arm study investigating bowel urgency (BU) in patients with moderately-to-severely active ulcerative colitis (UC) and BU at baseline, treated with mirikizumab. METHODS: Patients without prior mirikizumab exposure received intravenous mirikizumab 300 mg at weeks (W)0, 4, and 8, followed by subcutaneous mirikizumab 200 mg at W12, 16, 20, and 24. The primary objective was improvement in the validated BU severity measure (Urgency Numeric Rating Scale [UNRS]) at W12. Secondary objectives included improvement in BU at W28, novel measures of stool deferral time (SDT), bowel urgency frequency (BUF), and associations between BU measures. UNRS, BUF, and SDT were collected using a daily diary; the shortest weekly SDT was used for analysis. Baseline observation carried forward was used as the response for the corresponding visit for all missing observations. Missing continuous data were treated as having no change from baseline. RESULTS: All three BU measures at W12 were sustained or improved through W28. With mirikizumab treatment, 52.2% improved BU severity, 55.1% improved BUF, and 40.7% improved shortest weekly SDT. Patients with shortest weekly SDT ≥ 15 min or no urgency increased from 4.1% at baseline to 29.7% at W28. At W12, 36 (20.9%) achieved clinical remission and 54 (31.4%) achieved endoscopic remission, improving to 62 (36.1%) and 76 (44.2%) at W28, respectively. The safety profile was generally consistent with the known profile. CONCLUSION: In the first comprehensive approach assessing complex BU symptoms in UC, mirikizumab was associated with improvements in several BU and clinically related measures through W28. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov, NCT05767021.