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Tuesday Poster Session

Category: IBD

P4351 - Efficacy and Safety of Long-Term Mirikizumab Treatment in Patients With Moderate to Severe Crohn’s Disease

Tuesday, October 29, 2024
10:30 AM – 4:00 PM ET
Location: Exhibit Hall E
Has Audio
Bruce E.. Sands, MD, FACG1, Geert R. D'Haens, MD, PhD2, Tadakazu Hisamatsu, MD, PhD3, Vipul Jairath, MBChB4, Edward Barnes, MD, MPH, FACG5, Paola Pellanda, PhD6, Rebecca Hozak, PhD6, Zhantao Lin, PhD6, Guanglei Yu, 6, Marijana Protic, 6, Charles C. Owen, MD, MBA6, Monika Fischer, MD, MS7
1Icahn School of Medicine at Mount Sinai, New York, NY; 2Amsterdam University Medical Center, Amsterdam, Limburg, Netherlands; 3Kyorin University School of Medicine, Tokyo, Tokyo, Japan; 4Western University, London, ON, Canada; 5University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC; 6Eli Lilly and Company, Indianapolis, IN; 7Indiana University, Indianapolis, IN

Introduction: Mirikizumab (miri), an anti-IL-23p19 antibody, was efficacious and safe as a treatment for moderately-to-severely active Crohn's disease (CD) over 104 weeks in a Phase 2 study (AMAG; NCT02891226). Here we show continued activity through an additional 3 years (up to 6.5 years total) in a long-term extension study, AMAX (NCT04232553).

Methods: Data through Jan 20, 2024 are presented for all patients who enrolled in AMAX from AMAG; patients continued on open-label miri 300 mg subcutaneously every 4 weeks. Endoscopy was performed at 3 years in AMAX. Efficacy definitions were: endoscopic response, ≥50% reduction from AMAG baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) Total Score; endoscopic remission, SES-CD Total Score ≤4 and ≥2-point reduction from baseline with no subscore >1 for any individual variable; Crohn’s Disease Activity Score (CDAI) response, CDAI decrease from baseline ≥100 points and/or < 150; CDAI remission, CDAI < 150. Data are presented as-observed.

Results: 106 patients enrolled in AMAX; at database lock, median miri treatment duration (Q1, Q3) was 5.6 (5.3, 5.9) years. At Week 156 of AMAX, 18 patients (17.0%) had discontinued. For endoscopic results, 17 patients (16.0%) did not yet have data available for week 156. At Week 156 of AMAX, relative to AMAG baseline, the endoscopic response rate was 76.1% (n=54/71) and remission rate was 53.5% (n=38/71). For CDAI, 33 (31%) patients were ongoing but had missing data at Week 156; the CDAI response rate was 96.3% (n=52/54), and CDAI remission rate was 87.3% (n=48/55).

Summary safety data in AMAX (see table) showed that treatment emergent adverse events (TEAEs) were reported by 81.1% (n=86) of patients, with 9 (8.5%) patients reporting serious adverse events. Rates of TEAEs of special interest were as follows: any infection/infestation, 54.7% (n=58); opportunistic infections, 3.8% (n=4; 1 candidiasis; 3 herpes zoster [with concomitant azathioprine use in 2 of these cases]); malignancies, 0.9% (n=1 non-melanoma skin cancer [basal cell carcinoma]); and cerebro-cardiovascular events, 0.9% (n=1 bradycardia).

Discussion: Miri demonstrated durable efficacy up to >6 years in patients with moderately-to-severely active CD. Rates of endoscopic and clinical remission were generally maintained from the end of the AMAG maintenance period at Week 52. No unexpected safety events were reported and there were few discontinuations due to adverse events.


Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.


Disclosures:
Bruce Sands: AbbVie – Consultant. Abivax – Consultant, Speakers Bureau. Adiso Therapeutics – Consultant. Agomab – Consultant. Alimentiv – Consultant. Amgen – Consultant. AnaptysBio – Consultant. Arena Pharmaceuticals – Consultant. Artugen Therapeutics – Consultant. AstraZeneca – Consultant. Biolojic Design – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, Other support, Speakers Bureau. Calibr – Consultant. Celgene – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Enthera – Consultant. Envied Biosciences – Consultant. Equilium – Consultant. Evommune – Consultant. Ferring – Consultant. Fiat – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech (Roche) – Consultant. Gilead Sciences – Consultant. Glaxo SmithKline – Consultant. Gossamer Bio – Consultant. Imhotex – Consultant. Index Pharmaceuticals – Consultant. Innovation Pharmaceuticals – Consultant. Inotrem – Consultant. Janssen – Consultant, Grant/Research Support, Other support, Speakers Bureau. Kaleido – Consultant. Kallyope – Consultant. Lilly – Consultant, other support, Speakers Bureau. Merck & Co., Inc., Rahway, NJ, USA – Consultant. Microba – Consultant. Mobius Care – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. Nexus Therapeutics – Consultant. Nimbus Discovery – Consultant. Odyssey Therapeutics – Consultant. Pfizer Inc – Consultant, Grant/Research Support, Other support, Speakers Bureau. Progenity – Consultant. Prometheus Biosciences – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. Rasayana Therapeutics – Consultant. Recludix Therapeutics – Consultant. Reistone Biopharma – Consultant. Sanofi – Consultant. Spyre Therapeutics – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Takeda – Consultant, Grant/Research Support, Other support, Speakers Bureau. Target RWE – Consultant. Teva – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. Tr1X – Consultant. Union Therapeutics – Consultant. Ventyx Biopharma – Consultant, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Geert D'Haens: AbbVie – Advisor or Review Panel Member, Speakers Bureau. Agomab Therapeutics – Advisor or Review Panel Member. Alimentiv – Advisor or Review Panel Member. Allergan – Advisor or Review Panel Member. Alphabiomics – Advisor or Review Panel Member. AstraZeneca – Advisor or Review Panel Member. Boehringer Ingelheim – Advisor or Review Panel Member. Bristol Myers Squibb – Advisor or Review Panel Member, Speakers Bureau. Celltrion – Advisor or Review Panel Member, Grant/Research Support. Eli Lilly – Advisor or Review Panel Member, Speakers Bureau. Ferring – Advisor or Review Panel Member. Galapagos – Advisor or Review Panel Member, Speakers Bureau. GlaxoSmithKline – Advisor or Review Panel Member. Immunic – Advisor or Review Panel Member. Johnson & Johnson – Advisor or Review Panel Member, Speakers Bureau. Pfizer Inc – Advisor or Review Panel Member, Grant/Research Support, Speakers Bureau. Seres – Advisor or Review Panel Member. Takeda – Advisor or Review Panel Member, Speakers Bureau. Tillotts – Advisor or Review Panel Member, Speakers Bureau. Ventyx – Advisor or Review Panel Member.
Tadakazu Hisamatsu: AbbVie – Grant/Research Support, lecture fees. Bristol Myers Squibb – Consultant. Daiichi-Sankyo – Grant/Research Support. EA Pharma – Consultant, Grant/Research Support, lecture fees. Gilead Sciences – Consultant. Janssen – Consultant. JIMRO – Grant/Research Support. Mitsubishi Tanabe Pharma Corporation – Grant/Research Support, lecture fees. Mochida Pharmaceutical – Grant/Research Support. Nippon Kayaku – Grant/Research Support. Pfizer – Grant/Research Support. Takeda Pharmaceutical – Grant/Research Support, lecture fees.
Vipul Jairath: AbbVie – Consultant, Grant/Research Support, Speakers Bureau. Alimentiv – Consultant, Employee, Grant/Research Support, Speakers Bureau. Arena Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. Asahi Kasei Pharma – Consultant, Grant/Research Support, Speakers Bureau. Asieris Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. AstraZeneca – Consultant, Grant/Research Support, Speakers Bureau. Avoro Capital – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, Speakers Bureau. Celltrion – Consultant, Grant/Research Support, Speakers Bureau. Eli Lilly and Company – Consultant, Grant/Research Support, Speakers Bureau. Endpoint Health – Advisory Committee/Board Member, Consultant. Enthera – Advisory Committee/Board Member, Consultant. Ferring Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. Flagship Pioneering – Consultant, Grant/Research Support, Speakers Bureau. Fresenius Kabi – Consultant, Grant/Research Support, Speakers Bureau. Galapagos NV – Consultant, Grant/Research Support, Speakers Bureau. Genentech – Consultant, Grant/Research Support, Speakers Bureau. Gilde Healthcare – Advisory Committee/Board Member, Consultant. Gilead Sciences – Consultant, Grant/Research Support, Speakers Bureau. GlaxoSmithKline – Consultant, Grant/Research Support, Speakers Bureau. Innomar – Advisory Committee/Board Member, Consultant. JAMP – Advisory Committee/Board Member, Consultant. Janssen – Consultant, Grant/Research Support, Speakers Bureau. London Health Sciences Centre – Employee. Merck – Consultant, Grant/Research Support, Speakers Bureau. Metacrine – Consultant, Grant/Research Support, Speakers Bureau. Mylan – Consultant, Grant/Research Support, Speakers Bureau. Pandion Therapeutics – Consultant, Grant/Research Support, Speakers Bureau. Pendopharm – Consultant, Grant/Research Support, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Prometheus Therapeutics and Diagnostics – Consultant, Grant/Research Support, Speakers Bureau. Protagonist Therapeutics – Consultant, Grant/Research Support, Speakers Bureau. Reistone Biopharma – Consultant, Grant/Research Support, Speakers Bureau. Roche – Consultant, Grant/Research Support, Speakers Bureau. Roivant – Advisory Committee/Board Member, Consultant. Sandoz – Consultant, Grant/Research Support, Speakers Bureau. SCOPE – Advisory Committee/Board Member, Consultant. Second Genome – Consultant, Grant/Research Support, Speakers Bureau. Shire – Speakers Bureau. Sorriso Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. Synedgen – Advisory Committee/Board Member, Consultant. Takeda – Consultant, Grant/Research Support, Speakers Bureau. TD Securities – Advisory Committee/Board Member, Consultant. Teva – Consultant, Grant/Research Support, Speakers Bureau. Topivert – Consultant, Grant/Research Support, Speakers Bureau. Ventyx Biosciences – Consultant, Grant/Research Support, Speakers Bureau. Vividion Therapeutics – Consultant, Grant/Research Support, Speakers Bureau.
Edward Barnes: AbbVie, Inc. – Consultant. Boomerang – Consultant. Bristol-Meyers Squibb – Consultant. Direct Biologics – Consultant. Eli Lilly and Company – Advisor or Review Panel Member. Pfizer – Consultant. Target RWE – Consultant.
Paola Pellanda: Eli Lilly and Company – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Rebecca Hozak: Eli Lilly and Company – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Zhantao Lin: Eli Lilly and Company – Employee, Stock Options.
Guanglei Yu: Eli Lilly and Company – Employee, Stock Options.
Marijana Protic: Eli Lilly and Company – Employee, Stock Options.
Charles C. Owen: Eli Lilly and Company – Employee, Stock Options.
Monika Fischer: AbbVie – Consultant. Bristol Myers Squibb – Consultant. Eli Lilly and Company – Consultant. Ferring Pharmaceuticals – Consultant. Janssen – Consultant. Pfizer – Consultant. Rebiotix – Consultant. Scioto Biosciences – Consultant. Seres Therapeutics – Consultant.


Bruce E.. Sands, MD, FACG1, Geert R. D'Haens, MD, PhD2, Tadakazu Hisamatsu, MD, PhD3, Vipul Jairath, MBChB4, Edward Barnes, MD, MPH, FACG5, Paola Pellanda, PhD6, Rebecca Hozak, PhD6, Zhantao Lin, PhD6, Guanglei Yu, 6, Marijana Protic, 6, Charles C. Owen, MD, MBA6, Monika Fischer, MD, MS7. P4351 - Efficacy and Safety of Long-Term Mirikizumab Treatment in Patients With Moderate to Severe Crohn’s Disease, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.