Millie D Long, Stefan Schreiber, Toshifumi Hibi, Theresa Hunter Gibble, Deborah A Fisher, Gina Park, Richard E Moses, Peter D R Higgins, James O Lindsay, Scott D Lee, Rodrigo Escobar, Vipul Jairath

Association of bowel urgency with quality-of-life measures in patients with moderately-to-severely active ulcerative colitis: Results from phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies

  • Gastroenterology

Abstract Background Improvement in bowel urgency (BU) was associated with better clinical outcomes in phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies in moderately-to-severely active ulcerative colitis (UC). We assessed association of BU with quality of life (QoL) outcomes. Methods LUCENT-1: 1162 patients randomized 3:1 to intravenous mirikizumab 300mg or placebo every 4 weeks (Q4W) for 12 weeks. LUCENT-2: 544 mirikizumab induction responders re-randomized 2:1 to subcutaneous mirikizumab 200mg or placebo Q4W through Week (W) 40 (W52 of continuous treatment). Patients reported BU severity in the past 24 hours using a validated Urgency Numeric Rating Scale (NRS). In patients with baseline Urgency NRS ≥3, association between BU Clinically Meaningful Improvement (CMI; ≥3-point decrease) and remission (score 0 or 1) with patient-reported outcomes was assessed at W12 and W52. Results A significantly greater proportion of patients with versus without BU Remission achieved IBDQ remission (W12: 87.3% vs 42.7%, p<0.0001; W52: 91.4% vs 45.5%, p<0.0001). Similarly, BU Remission was associated with more patients achieving CMI in SF-36 Physical Component Summary (W12: 69.0% vs 44.4%, p<0.0001; W52: 77.5% vs 42.1%, p<0.0001) and Mental Component Summary (W12: 53.5% vs 41.0%, p=0.0019; W52: 62.0% vs 38.3%, p<0.0001) scores. At W12 and W52, patients with BU CMI or Remission showed significant improvements in EQ-5D-5L and Work Productivity and Activity Impairment:UC scores. Significant improvements were also seen in fatigue, abdominal pain, and nocturnal stool. Conclusions In patients with moderately-to-severely active UC, improvement in BU was associated with improved QoL in phase 3 LUCENT-1 and LUCENT-2 studies.

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