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Tuesday Poster Session

Category: IBD

P3577 - Extended Induction of Mirikizumab Sustains Efficacy and Safety Over 104 Weeks for Patients With Moderately to Severely Active Ulcerative Colitis Refractory to Initial Induction

Tuesday, October 24, 2023
10:30 AM – 4:00 PM PT
Location: Exhibit Hall
Has Audio
Geert D'Haens, MD, PhD1, Seyedehsan Navabi, MD2, Faye Chan-Diehl, BS3, Richard E. Moses, DO, JD3, James Walter, MD4, Theresa Hunter Gibble, PhD, MPH3, David Laharie, 5, Javier P. Gisbert, MD, PhD6, Séverine Vermeire, MD, PhD7, Taku Kobayashi, MD, PhD8, Miguel Regueiro, MD9, Jordan Johns, PhD3, Aline Charabaty, MD10
1Amsterdam University Medical Center, Amsterdam, Noord-Holland, Netherlands; 2United Medical Doctors, Long Beach, CA; 3Eli Lilly and Company, Indianapolis, IN; 4Einstein Healthcare Network, Philadelphia, PA; 5Centre Hospitalier Universitaire de Bordeaux, Bordeaux, Centre, France; 6Hospital Universitario de La Princesa, Madrid, Madrid, Spain; 7UZ Leuven, Leuven, Vlaams-Brabant, Belgium; 8Kitasato University Kitasato Institute Hospital, Center for Advanced IBD Research and Treatment, Tokyo, Tokyo, Japan; 9Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH; 10Johns Hopkins School of Medicine, Potomac, MD

Introduction: Mirikizumab (miri), a p19-directed IL-23 antibody, was efficacious in inducing clinical remission at Week (W)12 (LUCENT-1) and maintaining clinical remission at W52 (LUCENT-2) in patients with moderately to severely active ulcerative colitis (UC). We present results from the ongoing open-label LUCENT-3 study evaluating efficacy and safety of miri in patients who received extended induction therapy.

Methods: We investigated patients who at W12 of LUCENT-1 had not responded to initial induction with miri but then received extended induction treatment of 3 doses of 300 mg IV miri, and subsequently responded at W24 (LUCENT-2). These delayed responders entered LUCENT-3 at W40, receiving 200 mg miri Q4W SC. Following 104W of miri treatment, we report clinical response and remission, corticosteroid-free (CSF) remission, endoscopic remission, histologic-endoscopic mucosal improvement (HEMI) and histologic-endoscopic mucosal remission (HEMR), symptomatic remission, bowel urgency (BU) clinical meaningful improvement (CMI) and remission scores, and induction baseline biologic failure status. Week numbers are shown as cumulative, i.e., W12 of LUCENT-2 is defined as W24 overall. Discontinuations or missing data were handled using non-responder imputation. All data were summarized as descriptive. Biologic Failed was defined as prior inadequate response, loss of response, or intolerance to biologic therapy or tofacitinib; otherwise, patients were categorized as Not Biologic Failed. Safety data were assessed.

Results: Among delayed responders (N=81) with clinical response at W52, 67.9% were still in clinical response at W104. Remission rates were: 34.6% clinical, 32.1% CSF, 45.7% endoscopic, 33.3% HEMR, 63.0% symptomatic, and 45.7% BU. Patients achieving HEMI and BU CMI were 40.7% and 59.7%, respectively. Biologic Failed/Not Failed subgroup data were similar (Figure 1). Severe TEAEs were reported in 3.3% of patients (LUCENT-3 safety population, N=123); 4.9% had serious AEs, and 4.1% discontinued treatment due to an AE. Most common TEAEs (≥4%) were COVID-19 (13.8%), UC (13.0%), diarrhea, headache and pyrexia (both 4.9%), nasopharyngitis, and upper respiratory tract infections (both 4.1%). One reported death was unrelated to miri treatment.

Discussion: Extended induction of miri sustained efficacy and safety over 104 wks for patients with moderately to severely active UC and refractory to initial induction. There were no new safety concerns.

Figure: Efficacy endpoint response rates for all patients and by biologic failure status


Disclosures:
Geert D'Haens: AbbVie – Consultant, Speakers Bureau. Alimentiv – Consultant, Speakers Bureau. Boehringer Ingelheim – Consultant, Speakers Bureau. Cellitrion – Consultant, Speakers Bureau. Ferring – Consultant, Speakers Bureau. Galapagos – Consultant, Speakers Bureau. GlaxoSmithKline – Consultant, Speakers Bureau. Gossamerbio – Consultant, Speakers Bureau. Janssen – Consultant, Speakers Bureau. Lilly – Consultant, Speakers Bureau. MSD – Consultant, Speakers Bureau. Pfizer – Consultant, Speakers Bureau. Progenity – Consultant, Speakers Bureau. Prometheus Biosciences – Consultant, Speakers Bureau. Prometheus Laboratories – Consultant, Speakers Bureau. Takeda – Consultant, Speakers Bureau. Tillotts – Consultant, Speakers Bureau.
Seyedehsan Navabi: Eli Lilly and Company – Advisory Committee/Board Member.
Faye Chan-Diehl: Eli Lilly – Employee.
Richard E. Moses: Eli Lilly and Company – Employee, Stock-privately held company.
James Walter: Eli Lilly – Advisor or Review Panel Member. Medtronic – Consultant.
Theresa Hunter Gibble: Eli Lilly and Company – Employee, stockholder.
David Laharie: Abbvie – Advisory Committee/Board Member. Galapagos – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member. Lilly – Advisor or Review Panel Member, Advisory Committee/Board Member. MSD – Advisory Committee/Board Member. Takeda – Advisory Committee/Board Member.
Javier Gisbert: Abbvie – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Biogen – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Casen Fleet – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Celgene/Bristol Myers – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Chiesi – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Dr. Falk Pharma – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Eli Lilly – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Faes Farma – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Ferring – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Gebro Pharma – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Gilead/Galapagos – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Janssen – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Kern Pharma – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. MSD – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Mylan – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Norgine – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Otsuka Pharmaceutical – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Pfizer – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Roche – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Sandoz – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Shire Pharmaceuticals – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Tillotts Pharma – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau. Vifor Pharma – Advisor or Review Panel Member, Consultant, Grant/Research Support, Speakers Bureau.
Séverine Vermeire: AbbVie – Consultant, Grant/Research Support. AbolerIS Pharma – Grant/Research Support. AgomAb – Grant/Research Support. Alimentiv – Consultant. Arena Pharmaceuticals – Consultant. AstraZeneca – Consultant. Avaxia Biologics – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. CVasThera – Consultant, Speakers Bureau. Cytoki Pharma – Consultant, Speakers Bureau. Dr. Falk Pharma – Consultant, Speakers Bureau. Eli Lilly – Consultant, Speakers Bureau. Ferring Pharmaceuticals – Consultant, Speakers Bureau. Galapagos – Consultant, Grant/Research Support, Speakers Bureau. Genentech/Roche – Consultant, Speakers Bureau. Gilead – Consultant, Speakers Bureau. GSK – Consultant, Speakers Bureau. Hospira – Consultant, Speakers Bureau. IMIDomics – Consultant, Speakers Bureau. Janssen Pharmaceuticals – Consultant, Speakers Bureau. Johnson & Johnson – Consultant, Grant/Research Support, Speakers Bureau. Materia Prima – Consultant, Speakers Bureau. MiroBio – Consultant, Speakers Bureau. Morphic – Consultant, Speakers Bureau. MRM Health – Consultant, Speakers Bureau. MSD – Consultant, Speakers Bureau. Mundipharma – Consultant, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. ProDigest – Consultant, Speakers Bureau. Progenity – Consultant, Speakers Bureau. Prometheus – Consultant, Speakers Bureau. Robarts Clinical Trials – Consultant, Speakers Bureau. Second Genome – Consultant, Speakers Bureau. Shire – Consultant, Speakers Bureau. Surrozen – Consultant, Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau. Theravance Biopharma – Consultant, Speakers Bureau. Tillotts Pharma – Consultant, Speakers Bureau. Zealand Pharma – 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.
Miguel Regueiro: AbbVie – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Alfasigma – Advisory Committee/Board Member, Consultant. Allergan – Advisory Committee/Board Member, Consultant. Amgen – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Celgene – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Eli Lilly – Advisory Committee/Board Member, Consultant. Genentech – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Gilead Sciences – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Janssen – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Miraca Labs – Advisory Committee/Board Member, Consultant. Pfizer Inc – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Prometheus – Advisory Committee/Board Member, Consultant. Salix – Advisory Committee/Board Member, Consultant. Seres – Advisory Committee/Board Member, Consultant. Takeda – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Target RWE – Advisory Committee/Board Member, Consultant. UCB – Advisory Committee/Board Member, Consultant, Unrestricted educational grants. Wolters Kluwer Health – Royalties.
Jordan Johns: Eli Lilly and Company – Employee, stockholder.
Aline Charabaty: Abbvie – Advisory Committee/Board Member, Consultant. BMS – Advisory Committee/Board Member, Consultant. Eli Lilly – Advisory Committee/Board Member, Consultant. Janssen – Advisory Committee/Board Member, Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Takeda – Advisory Committee/Board Member, Consultant.


Geert D'Haens, MD, PhD1, Seyedehsan Navabi, MD2, Faye Chan-Diehl, BS3, Richard E. Moses, DO, JD3, James Walter, MD4, Theresa Hunter Gibble, PhD, MPH3, David Laharie, 5, Javier P. Gisbert, MD, PhD6, Séverine Vermeire, MD, PhD7, Taku Kobayashi, MD, PhD8, Miguel Regueiro, MD9, Jordan Johns, PhD3, Aline Charabaty, MD10. P3577 - Extended Induction of Mirikizumab Sustains Efficacy and Safety Over 104 Weeks for Patients With Moderately to Severely Active Ulcerative Colitis Refractory to Initial Induction, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.