P1149 - Mirikizumab Sustains Improvement in Fatigue, Abdominal Pain, and Stool Frequency Following 104 Weeks of Continuous Treatment for Crohn’s Disease: Results From the VIVID-2 Open-Label Extension Study

Peter Bossuyt, ¹, Ashwin Ananthakrishnan, ², Aisha Vadhariya, ³, Na Lu, ⁴, Guanglei Yu, PhD⁵, Jianmin Wu, ³, Jessica R.. Allegretti, MD, MPH⁶, Minhu Chen, MD, PhD⁷
1Imelda General Hospital, Bonheiden, Antwerpen, Belgium; 2Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; 3Eli Lilly and Company, Indianapolis, IN; 4Precision Statistics Consulting Inc, Woodbury, Woodbury, MN; 5Eli Lilly and Company, Indianapolis, Indiana, USA, Indianapolis, IN; 6Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; 7The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Introduction: Mirikizumab (MIRI), a p19-directed antibody against interleukin-23, demonstrated improvements in fatigue, abdominal pain (AP) and stool frequency (SF) at Week (W) 12 and W52 in the VIVID-1 clinical trial.

Methods: This analysis shows the effect of MIRI on fatigue, AP, SF and achievement of clinical remission by Patient-Reported Outcome (PRO; SF ≤3 and AP ≤1 and neither worse than baseline) in the VIVID-2 open-label extension study through W104. This analysis includes data from primary analysis set in patients with Crohn’s disease (CD) randomized to the MIRI treatment arm in VIVID-1 who achieved endoscopic response (≥50% reduction from baseline in Simple endoscopic score for CD) at W52 and continued the MIRI subcutaneous dosing (300 mg) in VIVID-2. Change from VIVID-1 baseline was measured for continuous endpoints. Endpoints: fatigue measured using FACIT-Fatigue (measured as change from baseline, and clinically-meaningful improvement of ≥6-points among patients with baseline ≤46), AP improvement (measured as change from baseline, and achievement of ≤1 among patients with baseline >1), SF improvement (measured as change from baseline, and achievement of ≤3 among patients with baseline >3) and clinical remission by PRO, assessed at W64 and 104. Missing data were handled using observed case (OC) and modified non-responder imputation (mNRI) for response rates, while using modified baseline observation carried forward (mBOCF) for change from baseline. Response rates were presented as unadjusted proportions with 2-sided 95% confidence intervals using the Rubin's Rules (mNRI). ANCOVA models were used for continuous variables, adjusting for baseline values and intervention group.

Results: Fatigue mean (standard error [SE]) change from baseline was 10.7 (0.56) at W64; 9.4 (0.59) at W104, (observed response, n [%]: 152 [67.6%] at W64; 136 [64.8%] at W104; Table). AP improved (mean [SE] change: −1.5 [0.04] at W64; −1.6 [0.05] at W104), with response rates increasing from 174 (77.3%) to 161 (84.7%). SF showed sustained improvement (mean [SE] change: −4.3 [0.14] at W64; −4.3 [0.16] at W104), with response rates reaching 155 (89.6%) at W104. Similar rates of achievement of clinical remission by PRO were observed (178 [73.6%] at W64; 165 [80.1%] at W104) (Table).

Discussion: MIRI sustained improvement in fatigue, AP, SF and clinical remission by PRO through 104 weeks of continuous treatment. These consistent findings support the long-term treatment with MIRI to address key symptoms of CD.


Figure: Improvement in Fatigue, Abdominal Pain, Stool Frequency and Achievement of Clinical Remission by PRO up to Week 104

Disclosures:
Peter Bossuyt: AbbVie – Advisory Committee/Board Member, Grant/Research Support, Lecture fees. Amgen – Grant/Research Support. Bristol Myers Squibb – Advisory Committee/Board Member, Lecture fees. CAG – Lecture fees. Celltrion – Advisory Committee/Board Member, Lecture fees. CIRC – Advisory Committee/Board Member. Dr. Falk Pharma Benelux – Advisory Committee/Board Member. Eli Lilly and Company – Advisory Committee/Board Member, Lecture fees. EPGS – Lecture fees. Galapagos NV – Advisory Committee/Board Member, Lecture fees. Globalport – Lecture fees. Janssen – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member, Grant/Research Support, Lecture fees. Janssen – Lecture fees. Materia Prima – Lecture fees. Pentax – Advisory Committee/Board Member, Lecture fees. Pfizer – Grant/Research Support. PSI-CRO – Advisory Committee/Board Member. Roche – Advisory Committee/Board Member. Scope – Lecture fees. Takeda – Advisory Committee/Board Member, Lecture fees. Tetrameros – Advisory Committee/Board Member. Viatris – Grant/Research Support.
Ashwin Ananthakrishnan: Takeda – Grant/Research Support.
Aisha Vadhariya: Eli Lilly and Company – Employee, Stock Options.
Na Lu: Precision Statistics Consulting – Employee.
Guanglei Yu: Eli Lilly and Company – Employee, Stock Options.
Jianmin Wu: Eli Lilly and Company – Employee, Stock Options.
Jessica Allegretti: Abbvie – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Speaker, Speakers Bureau. Adiso – Consultant. Bristol Myer Squibb – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Speaker. Celltrion – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. Ferring – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. Finch – Consultant. Genentech – Advisory Committee/Board Member, Consultant. GlaxoSmithKline – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. Iterative Scopes – Consultant. Janssen – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Speakers Bureau. Johnson & Johnson – Consultant, Grant/Research Support, Speaker. Merck – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support. Pfizer – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant, Grant/Research Support. Roivant – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. Roivant Adiso – Consultant. Seres Therapeutics – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. Shattuck Labs – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. TRXBio – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant. Vedanta – Advisor or Review Panel Member, Advisory Committee/Board Member, Consultant.
Minhu Chen: AbbVie – Provided Educational Activities. Boehringer Ingelheim – Advisory Committee/Board Member. China Medical System – Provided Educational Activities. IPSEN – Provided Educational Activities. Johnson & Johnson – Advisor or Review Panel Member, Grant/Research Support, Speakers Bureau. Takeda – Grant/Research Support, Provided Educational Activities.

Peter Bossuyt, ¹, Ashwin Ananthakrishnan, ², Aisha Vadhariya, ³, Na Lu, ⁴, Guanglei Yu, PhD⁵, Jianmin Wu, ³, Jessica R.. Allegretti, MD, MPH⁶, Minhu Chen, MD, PhD⁷. P1149 - Mirikizumab Sustains Improvement in Fatigue, Abdominal Pain, and Stool Frequency Following 104 Weeks of Continuous Treatment for Crohn’s Disease: Results From the VIVID-2 Open-Label Extension Study, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.