A184 EARLY SYMPTOM CONTROL WITH MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN THE LUCENT-1 INDUCTION TRIAL

Abstract Background Mirikizumab (miri), an anti-IL23/p19 monoclonal antibody, demonstrated efficacy compared with placebo (PBO) in the Phase 3, multicentre, randomized, double-blind LUCENT-1 induction study patients moderately to severely active ulcerative colitis (UC, NCT03518086). Purpose This analysis assessed early onset of symptomatic improvement and control during induction. Method During 12-week (W) study, 1162 adult (pts) inadequate response, loss or were intolerant conventional therapy biologic tofacitinib for UC, received miri IV Q4W (N=868) PBO (N=294). We evaluated symptoms stool frequency (SF), rectal bleeding (RB) bowel movement urgency (BU), abdominal pain fatigue. BU Numeric Rating Scale (NRS) change from baseline (BL), Clinical Meaningful Improvement (CMI), Remission, Fatigue NRS BL, Abdominal Pain Improvement, as well SF RB Symptomatic Response Remission assessed. Result(s) As W2, miri-treated pts achieved a significantly greater reduction subscores (p=0.001) (p=0.035). From W2 W4, percentage respectively PBO. A (p=0.003) W4 (p<0.001). Miri-treated showed mean scores (p=0.004). CMI versus (p=0.044). W7 onwards, (p=0.002). The (p=0.014). significant at least 30% score BL was observed (p=0.007). At W12, proportion Response, (Table). Image Conclusion(s) Miri provides rapid UC symptoms, including fatigue, UC. Please acknowledge all funding agencies by checking applicable boxes below Other indicate your source funding; Eli Lilly Company Disclosure Interest S. Danese Consultant of: AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr. Falk Pharma, Company, Enthera, Ferring Pharmaceuticals, Gilead Sciences, Hospira, Inotrem, Janssen, Johnson & Johnson, Merck Sharp Dohme, Mundipharma, Mylan, Pfizer, Roche, Sandoz Sublimity, Takeda, TiGenix, UCB Vifor Speakers bureau A. Dignass Abivax, Arena Squibb (Celgene), Fresenius Kabi, Galapagos, Novartis, Pharmacosmos, Sandoz/Hexal, Tillotts Pharma AG, High5Md, Materia, Sandoz, K. Matsuoka Grant / Research support from: EA JIMRO, Kissei Pharmaceutical, Kyowa Kyorin, Mitsubishi Tanabe, Mochida Zeria Pharmaceutical Nippon, M. Ferrante Janssen Cilag, Viatris, Medtronic, Regeneron, Thermo Fisher Scientific, Lamepro, Samsung Bioepis, Long Calibr, Genentech, Prometheus Biosciences, TARGET PharmaSolutions, Theravance Biopharma, I. Redondo Employee T. Gibble R. Moses N. Morris X. Li C. Milch former employee, employed time Abreu Microba Life WebMD, Intellisphere LLC (HCP Live Institutional Perspectives GI), Prime CME, J. Jones: None Declared