C0401 - Sustained Symptom Control With Mirikizumab in Patients With Moderately-to-Severely Active Ulcerative Colitis in the LUCENT-2 Maintenance Trial

Axel Dignass, MD, PhD¹, Silvio Danese, 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, Xingyuan Li, PhD⁷, Nathan Morris, PhD⁷, Catherine Milch, MD, MS⁷, Maria T. Abreu, MD^8
1Agaplesion Markus Hospital / Goethe University, Frankfurt, Hessen, Germany; ²Vita-Salute San Raffaele University - IRCCS San Raffaele Scientific Institute, Milan, Lombardia, Italy; 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) 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). 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.

Methods: 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.

Results: 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< 0.001). Pts in the miri-treatment group had a significantly greater mean reduction in BU NRS change from induction BL starting at W12 (p=0.034) onwards compared to PBO (Table). Pts assigned to miri accrued an additional 13.6 percentage-point benefit in BU Remission during the first 8W of maintenance therapy and achieved a significant greater improvement at W40 compared to PBO (p< 0.001, Table). Similarly, AP was significantly improved for the miri-treated group starting at W16 (p=0.034) onwards compared to PBO.

Discussion: Miri provides sustained control of UC symptoms including BU, RB, and SF compared to PBO in pts with moderately to severely active UC.



Disclosures:


Axel Dignass, MD, PhD¹, Silvio Danese, 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, Xingyuan Li, PhD⁷, Nathan Morris, PhD⁷, Catherine Milch, MD, MS⁷, Maria T. Abreu, MD⁸. C0401 - Sustained Symptom Control With Mirikizumab in Patients With Moderately-to-Severely Active Ulcerative Colitis in the LUCENT-2 Maintenance Trial, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.