P2204 - Endoscopic and Histologic Remission After 2 Years Treatment With Mirikizumab in Patients With Moderately-to-Severely Active Ulcerative Colitis

Monday, October 23, 2023

10:30 AM – 4:15 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Bruce E. Sands, MD, MS, FACG

Icahn School of Medicine at Mount Sinai
New York, New York

Fernando Margo, ¹, Laurent Peyrin-Biroulet, MD, PhD², Taku Kobayashi, MD, PhD³, Vipul Jairath, MBChB, DPhil⁴, Alissa Walsh, ⁵, Britt Christensen, MD⁶, Jianmin Wu, PhD⁷, Gina Park, ⁸, Isabel Redondo, ⁷, Bruce E. Sands, MD, MS, FACG⁹
¹Clinical Pharmacology Unit, São João University Hospital Center, Porto, Porto, Portugal; ²Last Inserm U954 and CHU de Nancy, Lorraine University, Vandoeuvre-lès-Nancy, Lorraine, France; ³Kitasato University Kitasato Institute Hospital, Center for Advanced IBD Research and Treatment, Tokyo, Tokyo, Japan; ⁴Western University, London, ON, Canada; ⁵NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, England, United Kingdom; ⁶University of Melbourne and Royal Melbourne Hospital, Melbourne, Victoria, Australia; ⁷Eli Lilly and Company, Indianapolis, IN; ⁸TechData Service, King of Prussia, PA; ⁹Icahn School of Medicine at Mount Sinai, New York, NY

Introduction: Mirikizumab (miri), a p19-directed IL-23 antibody, has shown efficacy in achieving clinical, endoscopic and histological response and remission after 52 weeks of therapy in patients with moderately-to-severely active ulcerative colitis (UC) in Phase 3 trials (LUCENT-1,; LUCENT-2). Histological healing in UC can indicate remission depth. Here, we report from LUCENT-3 the proportion of patients with and without prior biologic or tofacitinib failure who achieved histologic and endoscopic remission after 2 years of miri treatment.

Methods: LUCENT-3 is an ongoing, single-arm, outpatient, multicenter, long-term extension Phase 3 study evaluating the efficacy and safety of miri in patients with moderately-to-severely active UC. All enrolled patients received open-label subcutaneous miri 200 mg every 4 weeks. This analysis focused on miri responders at Week (W)52 (patients who were responders at W12, were re-randomized to miri maintenance and were in response at the end of LUCENT-2) who were enrolled in the long-term extension and continued to receive miri for additional 52 weeks. Endpoints of interest are the proportions of patients with histologic improvement, endoscopic remission, endoscopic normalization, histologic-endoscopic mucosal improvement (HEMI), histologic-endoscopic mucosal remission (HEMR), and alternate HEMR (histologic remission and endoscopic normalization) at W104. P-values were calculated using Pearson chi-square test. Missing response data were imputed as non-response.

Results: Among the Week 52 miri responders (N=239), 60.3% were male, with mean age of 43.9. Mean baseline modified Mayo Score was 6.7, and 33.5% had prior biologic or tofacitinib exposure. After 2 years of miri treatment, 65.3% patients achieved endoscopic remission and 51.9% achieved histologic remission. HEMI and HEMR were achieved by 53.1% and 47.7% of patients, respectively. A similar proportion of patients achieved histologic improvement, histologic remission, endoscopic remission, HEMI, and HEMR irrespective of prior biologic or tofacitinib failure, with only endoscopic normalization and alternate HEMR showing statistically significant higher rates for patients who didn´t have prior biologic or tofacitinib failure (Table 1).

Discussion: In LUCENT-3, sustained histologic and endoscopic remission were observed in patients with moderately-to-severely active UC who were treated with mirikizumab for 2 years, regardless of previous biologic or tofacitinib failure.

Disclosures:

Fernando Margo: Abbvie – Speakers Bureau. Arena – Speakers Bureau. Biogen – Speakers Bureau. Bristol-Myers Squibb – Speakers Bureau. Falk, Ferring, Hospira, Janssen – Speakers Bureau. Laboratórios Vitoria, Pfizer, Lilly, Merck Sharp & Dohme, – Speakers Bureau. Sandoz, Takeda, UCB, Vifor. – Speakers Bureau.

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.

Taku Kobayashi: , Nippon Kayaku, Otsuka, Pfizer Japan K.K., Takeda and Zeria Pharmaceutical – Grant/Research Support. ., Takeda, Thermo Fisher Scientific and Zeria Pharmaceutical – Speakers Bureau. – Bristol Myers Squibb, EA Pharma, Eli Lilly and Company and Janssen – Advisory Committee/Board Member. AbbVie, ActivAid, Alfresa Pharma, Bristol Myers Squibb, EA Pharma, Eli Lilly Japan K.K., Gilead Sciences, Google Asia Pacific – Grant/Research Support. AbbVie, ActivAid, Alfresa Pharma, EA Pharma, Janssen Pharmaceutical K.K., Kissei, Kyorin, Mitsubishi Tanabe Pharma, – Payment for expert testimony. AbbVie, ActivAid, Alfresa Pharma, Galapagos NV, Janssen Pharmaceutical K.K., JIMRO, Kyorin, Mitsubishi Tanabe Pharma, Nippon Kayaku, Pfizer Japan K.K – Speakers Bureau. Janssen Pharmaceutical K.K., JIMRO, JMDC, Kyorin, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, – Grant/Research Support. Mochida Pharmaceutical, Nippon Kayaku, Pfizer Japan K.K. and Takeda – Payment for expert testimony.

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.

Alissa Walsh: Ferring Pharmaceuticals, Janssen and Takeda – personal fees outside the submitted work.

Britt Christensen: AbbVie – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. BMS – Advisory Committee/Board Member, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Falk – Advisory Committee/Board Member, Speakers Bureau. Ferring – Advisory Committee/Board Member, Speakers Bureau. Fresenius Kabi – Advisory Committee/Board Member, Speakers Bureau. Gilead – Advisory Committee/Board Member, Speakers Bureau. Janssen – Grant/Research Support. Janssen-Cilag – Advisory Committee/Board Member, Speakers Bureau. MSD – Advisory Committee/Board Member, Speakers Bureau. Pfizer – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Sandoz – Advisory Committee/Board Member, Speakers Bureau. Takeda – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau.

Jianmin Wu: Eli Lilly and Company – Employee, Stock Options.

Gina Park: TechData Service – Employee.

Isabel Redondo: Eli Lilly and Company – Employee.

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.

Fernando Margo, ¹, Laurent Peyrin-Biroulet, MD, PhD², Taku Kobayashi, MD, PhD³, Vipul Jairath, MBChB, DPhil⁴, Alissa Walsh, ⁵, Britt Christensen, MD⁶, Jianmin Wu, PhD⁷, Gina Park, ⁸, Isabel Redondo, ⁷, Bruce E. Sands, MD, MS, FACG⁹. P2204 - Endoscopic and Histologic Remission After 2 Years Treatment With Mirikizumab in Patients With Moderately-to-Severely Active Ulcerative Colitis, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.