P2109 - Efficacy and Safety of Mirikizumab in Patients With Crohn’s Disease: 104-Week Extension Results From a Phase 2 Randomized Controlled Trial

Monday, October 23, 2023

10:30 AM – 4:15 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Monika Fischer, MD, MSc, FACG

Indiana University
INDIANAPOLIS, IN

Arthur Kaser, ¹, Bruce E. Sands, MD, MS, FACG², Marijana Protic, MD, PhD³, Laurent Peyrin-Biroulet, MD, PhD⁴, Zhantao Lin, ³, Rebecca Hozak, ³, Vipul Jairath, MBChB, DPhil⁵, Hilde Carlier, ³, Emily Hon, ³, Monika Fischer, MD, MSc, FACG⁶
¹University of Cambridge, Cambridge, England, United Kingdom; ²Icahn School of Medicine at Mount Sinai, New York, NY; ³Eli Lilly and Company, Indianapolis, IN; ⁴Last Inserm U954 and CHU de Nancy, Lorraine University, Vandoeuvre-lès-Nancy, Lorraine, France; ⁵Western University, London, ON, Canada; ⁶Indiana University, Indianapolis, IN

Introduction: Here we report efficacy and safety of mirikizumab (miri) up to Week 104 in patients with moderately-to-severely active Crohn’s disease (CD).

Methods: At baseline, pts (N=191) were randomized 2:1:1:2 to 4 treatment arms (1000, 600, 200mg miri and placebo (PBO), intravenously (IV) every 4 weeks (Q4W) at W0, W4, and W8). Pts who received miri and achieved ≥1 point improvement in Simple Endoscopic Score for Crohn’s Disease (SES-CD) at W12 were rerandomized 1:1 into double-blind maintenance to either continue IV treatment Q4W (IV-C; N=41) or 300mg miri subcutaneous (SC) Q4W (IV-SC; N=46) up to W52. W12 endoscopic non-improvers and pts receiving PBO during induction received IV 1000mg miri Q4W from W12-W52. Subjects reported to experience clinical benefit received 300 mg SC from W52 to W104. All IV and SC arms were pooled for analysis.

Results: Overall, 68.5% (87/127) achieved endoscopic improvement at W12 and were rerandomized into maintenance. Of the W12 endoscopic improvers, 74 finished W52 maintenance and entered the extension period (W52-W104) where 68 completed treatment through W104. Among W12 miri induction endoscopic improvers, Crohn’s Disease Activity Index (CDAI) remission rates (CDAI Total Score < 150) were 39.0% (16/41) (IV-C) and 56.5% (26/46)(SC) and PRO remission (defined as SF ≤2.5 and AP ≤1 and no worse than baseline) rates were 46.3% (19/41)(IV-C) and 45.7% (21/46)(SC) at W52. At W104, CDAI remission rates were 66.7% (22/33)(IV-C) and 61.0% (25/41)(SC) and PRO remission rates were 63.6% (21/33)(IV-C) and 46.3% (19/41)(SC). Of the 74 endoscopic improvers who finished W52 maintenance, 6 discontinued between W52 to W104 (1 due to adverse events (AEs), 2 due to lack of efficacy, 1 due to lost to follow-up, and 2 due to withdrawal by subject). Among endoscopic improvers at W12, 4 pts were hospitalized due to CD in the SC group (2 from W12-W52 and 2 from W52-W104) as reported in Table 1. In all pts who received any miri treatment from W52 to W104 (endoscopic improvers, non-improvers, and PBO treated pts), 79.4% (108/136) experienced ≥ 1 treatment-emergent AEs.

Discussion: Miri demonstrated durable effectiveness among pts with moderately-to-severely active CD who showed early endoscopic improvement with continued miri dosing up to W104, and with no unexpected safety events. CDAI and PRO remission were sustained through W104, with no differences observed in pts who received either IV-C and SC miri treatments during maintenance and continued into the extension period.

Disclosures:

Arthur Kaser indicated no relevant financial relationships.

Bruce Sands: AbbVie – Consultant. Abivax – Consultant, Speaker’s fees. Adiso Therapeutics – Consultant. Alimentiv – Consultant. Amgen – Consultant. Arena pharmaceuticals – Consultant. Artizan Biosciences – Consultant. Artugen Therapeutics – Consultant. AstraZeneca – Consultant. Bacainn Therapeutics – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, speaking fees and other support. Calibr – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Connect Biopharm – Consultant. Cytoki Pharma – Consultant. Eli Lilly – Consultant, speaking fees and other support. Enthera – Consultant. Evommune – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. Gossamer Bio – Consultant. HMP Acquisition – Consultant. Imhotex – Consultant. Immunic – Consultant. InDex Pharmaceuticals – Consultant. Innovation Therapeutics – Consultant. Inotrem – Consultant. Ironwood Pharmaceuticals – Consultant. Janssen – Grant/Research Support, consulting and speaking fees and other support. Johnson & Johnson – Consultant. Kaleido Biosciences – Consultant. Kallyope – Consultant. Merck – Consultant. MiroBio – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. OSE Immunotherapeutics – Consultant. Pfizer Inc – Consultant, Grant/Research Support, speaking fees and other support. Progenity – Consultant. Prometheus Biosciences – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. RedHill Biopharma – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Synlogic Operating Company – Consultant. Takeda – Grant/Research Support, consulting and speaking fees and other support. Target RWE – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. USWM Enterprises – Consultant. Ventyx Biosciences – Consultant, personal fees and stock options for consulting. Viela Bio – Consultant.

Marijana Protic: Eli Lilly and Company – Employee.

Laurent Peyrin-Biroulet: AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Allergan – personal fees. Alma – personal fees. Amgen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Applied Molecular Transport – personal fees. Arena – personal fees. Biogaran – Advisory Committee/Board Member, Consultant, Speakers Bureau. Biogen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant, Speakers Bureau. Bristol Myers Squibb – personal fees. Celgene – Advisory Committee/Board Member, Consultant, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. CTMA – Stock Options. Eli Lilly – Advisory Committee/Board Member, Consultant, Speakers Bureau. Enterome – personal fees. Enthera – personal fees. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Forward Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. Fresenius – personal fees. Genentech – Advisory Committee/Board Member, Consultant, Speakers Bureau. Gilead – personal fees. H.A.C. Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. Hikma – personal fees. Hospira/Pfizer – Advisory Committee/Board Member, Consultant, Speakers Bureau. Index Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speakers Bureau. Janssen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Lycera – Advisory Committee/Board Member, Consultant, Speakers Bureau. Merck – Advisory Committee/Board Member, Consultant, Speakers Bureau. Mitsubishi – Advisory Committee/Board Member, Consultant, Speakers Bureau. MSD – Grant/Research Support, personal fees. Mylan – personal fees. Nestlé – personal fees. Norgine – Advisory Committee/Board Member, Consultant, Speakers Bureau. Oppilan Pharma – personal fees. OSE Immunotherapeutics – personal fees. Pfizer – personal fees. Pharmacosmos – personal fees. Roche – personal fees. Samsung Bioepis – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sandoz – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sterna – personal fees. Sublimity Therapeutics – personal fees. Takeda – Advisory Committee/Board Member, Consultant, Speakers Bureau. Theravance – Advisory Committee/Board Member, Consultant, Speakers Bureau. Tillots – Advisory Committee/Board Member, Consultant, Speakers Bureau. Vifor – Advisory Committee/Board Member, Consultant, Speakers Bureau.

Zhantao Lin: Eli Lilly and Company – Employee.

Rebecca Hozak: Eli Lilly and Company – Employee, Stock Options.

Vipul Jairath: AbbVie – Advisory Committee/Board Member, consulting/advisory board fees, speaker’s fees. Alimentiv Inc – consulting/advisory board fees. Arena pharmaceuticals – consulting/advisory board fees. Asahi Kasei Pharma – consulting/advisory board fees. Asieris – consulting/advisory board fees. Astra Zeneca – consulting/advisory board fees. Bristol Myers Squibb – consulting/advisory board fees, speaker’s fees. Celltrion – consulting/advisory board fees. Eli Lilly and Company – consulting/advisory board fees. Ferring – consulting/advisory board fees, speaker’s fees. Flagship Pioneering – consulting/advisory board fees. Fresenius Kabi – consulting/advisory board fees, speaker’s fees. Galapagos – consulting/advisory board fees, speaker’s fees. Genentech – consulting/advisory board fees. Gilead – consulting/advisory board fees. GlaxoSmithKline – consulting/advisory board fees. Janssen – consulting/advisory board fees, speaker’s fees. Merck – consulting/advisory board fees. Metacrine – consulting/advisory board fees. Mylan – consulting/advisory board fees. Pandion – consulting/advisory board fees. Pendopharm – consulting/advisory board fees. Pfizer – consulting/advisory board fees, speaker’s fees. Prometheus – consulting/advisory board fees. Protagonist – consulting/advisory board fees. Reistone Biopharma – consulting/advisory board fees. Roche – consulting/advisory board fees. Sandoz – consulting/advisory board fees. Second Genome – consulting/advisory board fees. Shire – speaker’s fees. Sorriso pharmaceuticals – consulting/advisory board fees. Takeda – consulting/advisory board fees, speaker’s fees. Teva – consulting/advisory board fees. Topivert – consulting/advisory board fees. Ventyx – consulting/advisory board fees. Vividion – consulting/advisory board fees.

Hilde Carlier: Eli Lilly and Company – Employee.

Emily Hon: Eli Lilly and Company – Employee.

Monika Fischer: AbbVie – Advisor or Review Panel Member. Bristol Myers Squibb – Advisor or Review Panel Member, Speakers Bureau. Eli Lilly and Company – Advisor or Review Panel Member. Ferring – Advisor or Review Panel Member, DSMB. Janssen – Speakers Bureau. Pfizer – Advisor or Review Panel Member. Rebiotix – DSMB. scioto – Advisor or Review Panel Member. Seres – Advisor or Review Panel Member.

Arthur Kaser, ¹, Bruce E. Sands, MD, MS, FACG², Marijana Protic, MD, PhD³, Laurent Peyrin-Biroulet, MD, PhD⁴, Zhantao Lin, ³, Rebecca Hozak, ³, Vipul Jairath, MBChB, DPhil⁵, Hilde Carlier, ³, Emily Hon, ³, Monika Fischer, MD, MSc, FACG⁶. P2109 - Efficacy and Safety of Mirikizumab in Patients With Crohn’s Disease: 104-Week Extension Results From a Phase 2 Randomized Controlled Trial, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.