C0400 - Early Symptom Control With Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis in the LUCENT-1 Induction Trial

Silvio Danese, MD, PhD¹, Axel Dignass, MD, PhD², Katsuyoshi Matsuoka, MD, PhD³, Marc Ferrante, MD, PhD⁴, Millie Long, MD, MPH, FACG⁵, Isabel Redondo, MD⁶, Theresa Hunter Gibble, PhD⁷, Richard Moses, DO, JD⁷, Nathan Morris, PhD⁷, Xingyuan Li, PhD⁷, Catherine Milch, MD, MS⁷, Maria T. Abreu, MD^8
1Vita-Salute San Raffaele University - IRCCS San Raffaele Scientific Institute, Milan, Lombardia, Italy; ²Agaplesion Markus Hospital / Goethe University, Frankfurt, Hessen, Germany; ³Toho University Sakura Medical Center, Sakura, Chiba, Japan; ⁴University Hospitals Leuven, Leuven, Brabant Wallon, Belgium; ⁵UNC Chapel Hill, Chapel Hill, NC; ⁶Eli Lilly Portugal, Produtos Farmacêuticos, Lda, Lisbon, Lisboa, Portugal; ⁷Eli Lilly and Company, Indianapolis, IN; ⁸The University of Miami Health System, Miami, FL

Introduction: 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 in patients with moderately to severely active ulcerative colitis (UC, NCT03518086)). This analysis assessed early onset of symptomatic improvement and symptomatic control during induction.

Methods: During the 12-week (W) induction study, 1162 adult patients (pts) with inadequate response, loss of response, or were intolerant to conventional therapy or biologic or tofacitinib therapy for UC, received miri IV Q4W (N=868) or PBO (N=294). We evaluated improvement for symptoms of stool frequency (SF), rectal bleeding (RB) and bowel movement urgency (BU), abdominal pain and fatigue. BU Numeric Rating Scale (NRS) change from baseline (BL), BU Clinical Meaningful Improvement (CMI), BU Remission, Fatigue NRS change from BL, Abdominal Pain Improvement, as well as SF Remission, RB Remission, Symptomatic Response and Symptomatic Remission were assessed.

Results: As early as W2, miri-treated pts achieved a significantly greater reduction in RB subscores (p=0.001) and in SF subscores (p=0.035). From W2 and W4, a significantly greater percentage achieved SF Remission and RB Remission, respectively compared to PBO. A significantly greater percentage of miri-treated pts achieved Symptomatic Response compared to PBO from W2 (p=0.003) and of Symptomatic Remission compared with PBO from W4 (p< 0.001). Miri-treated pts showed a significantly greater mean reduction in BU NRS scores as early as W2 compared to PBO (p=0.004). From W4, a significantly greater percentage of miri-treated pts achieved BU CMI versus PBO (p=0.044). From W7 onwards, a significantly greater percentage achieved BU Remission (p=0.002). The pts showed a significantly greater mean reduction in Fatigue NRS scores from W2 compared to PBO (p=0.014). As early as W4, a significant reduction of at least 30% in Abdominal Pain NRS score from BL was observed in the miri-treated pts compared with PBO (p=0.007). At W12, a significantly greater proportion of miri-treated pts achieved Symptomatic Response, Symptomatic Remission, RB Remission, SF Remission, BU change from BL, BU CMI and Remission, as well as Fatigue and Abdominal Pain Improvement, compared to PBO (Table).

Discussion: Miri provides rapid control of UC symptoms, including BU and fatigue, as early as W2 compared with PBO in pts with moderately to severely active UC.



Disclosures:


Silvio Danese, MD, PhD¹, Axel Dignass, MD, PhD², Katsuyoshi Matsuoka, MD, PhD³, Marc Ferrante, MD, PhD⁴, Millie Long, MD, MPH, FACG⁵, Isabel Redondo, MD⁶, Theresa Hunter Gibble, PhD⁷, Richard Moses, DO, JD⁷, Nathan Morris, PhD⁷, Xingyuan Li, PhD⁷, Catherine Milch, MD, MS⁷, Maria T. Abreu, MD⁸. C0400 - Early Symptom Control With Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis in the LUCENT-1 Induction Trial, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.