A185 SUSTAINED SYMPTOM CONTROL WITH MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN THE LUCENT-2 MAINTENANCE TRIAL

• Published in: Journal of the Canadian Association of Gastroenterology 2023-03, Vol.6 (Supplement_1), p.29-31
• Main Authors: Dignass, A, Danese, S, Matsuoka, K, Ferrante, M, Long, M, Redondo, I, Gibble, T H, Moses, R, Li, X, Morris, N, Milch, C, Abreu, M, Jones, J
• Format: Article
• Language: English
• Subjects: Poster Presentations
• ISSN: 2515-2084; 2515-2092
• DOI: 10.1093/jcag/gwac036.185

Abstract Background Mirikizumab (miri) improved symptom control in a Phase 3, multicenter, randomized, double-blind, parallel, placebo-controlled induction study at Week (W)12, in patients (pts) with moderately-to-severely active ulcerative colitis (UC; LUCENT-1). Purpose This analysis assessed sustained symptom control during the maintenance phase through W40 (W52 of continuous therapy), among pts who were induced into clinical response with miri. Method During the 40W maintenance study (LUCENT-2), pts (N=544) who achieved clinical response to miri 300mg Q4W by W12 of induction, were re-randomized 2:1 to subcutaneous (SC) miri 200mg (n=365) or PBO Q4W (n=179). We evaluated sustained control of stool frequency (SF), rectal bleeding (RB), bowel movement urgency (BU) and abdominal pain (AP). The proportion of pts achieving SF Remission (defined as SF=0, or SF=1 with a ≥1-point decrease from induction baseline [BL]), RB Remission (RB=0), Symptomatic Remission (both SF and RB Remission), Stable Maintenance of Symptomatic Remission (defined as pts in Symptomatic Remission for at least 7 out of 9 visits from W4 to W36 and also at Week 40 among pts in Symptomatic Remission and Clinical Response at the end of LUCENT-1), and AP Improvement (Numeric Rating Scale [NRS] pain score ≥30% improvement from BL in pts with baseline AP NRS ≥3) were assessed. BU NRS change from baseline, and the proportion of pts achieving BU Remission (NRS 0 or 1 in pts with BU NRS ≥3 at baseline) were evaluated. Result(s) A greater proportion of miri-treated pts achieved SF Remission, RB Remission and Symptomatic Remission compared to PBO at W40 (Table), with significant differences observed from W8 of LUCENT-2 (p=0.042; p=0.004; p=0.036, respectively) and maintained through W40. Miri-treated pts had a significantly higher percentage of Stable Maintenance of Symptomatic Remission (p