P0736 - The Addition of Bowel Urgency Improvement to the Achievement of Clinical Response and Remission Was Associated with Better Quality of Life in Patients with Ulcerative Colitis from Mirikizumab Phase 3 Trials

David T. Rubin, MD¹, Jianmin Wu, PhD², Simin Baygani, MS², Nathan Morris, ², Theresa Hunter Gibble, PhD, MPH², Stefan Schreiber, MD^3
1Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL; ²Eli Lilly and Company, Indianapolis, IN; ³University Hospital Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany

Introduction: This analysis evaluated if the addition of BU improvement to the achievement of clinical response or remission was associated with better quality of life (QoL) from mirikizumab (miri) Phase 3 LUCENT-1 and LUCENT-2 trials in patients with moderately-to-severely active ulcerative colitis (UC).

Methods: In LUCENT-1, patients were randomized 3:1 to miri 300mg intravenous or placebo every four weeks (Q4W). Miri-treated patients achieving clinical response at week 12 (W12) were re-randomized 2:1 to subcutaneous miri 200mg or placebo Q4W for 40 weeks in LUCENT-2 (continuous treatment up to W52). Clinical remission was defined as stool frequency subscore=0 or 1 with a ≥1-point decrease in modified Mayo Score (MMS) from baseline (BL); rectal bleeding (RB) subscore=0; and endoscopic subscore=0 or 1. Clinical response was defined as ≥2-point and ≥30% decrease in MMS from BL, RB=0 or 1, or ≥1-point decrease from BL. Patients’ QoL was measured using the Inflammatory Bowel Disease Questionnaire (IBDQ): IBDQ response (≥16-point improvement from baseline in IBDQ total score) and IBDQ remission (IBDQ total score ≥170). BU was assessed using the Urgency Numeric Rating Scale (UNRS), with both BU CMI (≥3-point change) and BU remission (UNRS score= 0 or 1), measured in patients with a baseline UNRS of ≥3. The association between BU improvement (CMI or remission) and IBDQ (response or remission) was evaluated using the chi-square test of association among patients with baseline UNRS ≥3 who achieved clinical response. This analysis was repeated among patients who achieved clinical remission.

Results: Among patients achieving clinical response, a significantly higher proportion achieved IBDQ response and IBDQ remission when they also achieved BU CMI or BU remission vs those who did not both at W12 and W52 (p< 0.005)(Table 1). Among patients who achieved clinical remission, achievement of BU CMI was significantly associated with IBDQ response (p< 0.005) but not IBDQ remission, and achievement of BU remission was significantly associated with IBDQ remission (p< 0.005) but not IBDQ response at W12; achieving BU remission was significantly associated with better IBDQ response and IBDQ remission at week 52 (p< 0.05).

Discussion: Among patients with UC from miri phase 3 trials, the additional improvement of BU (CMI or remission) to the achievement of clinical response or remission was associated with greater QoL assessed by IBDQ response and remission.



Disclosures:


David T. Rubin, MD¹, Jianmin Wu, PhD², Simin Baygani, MS², Nathan Morris, ², Theresa Hunter Gibble, PhD, MPH², Stefan Schreiber, MD³. P0736 - The Addition of Bowel Urgency Improvement to the Achievement of Clinical Response and Remission Was Associated with Better Quality of Life in Patients with Ulcerative Colitis from Mirikizumab Phase 3 Trials, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.