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Tuesday Poster Session

Category: IBD

P3631 - Safety of Upadacitinib in IBD: Pooled Analysis of Phase 3 Maintenance Studies, U-ACHIEVE and U-ENDURE, In Patients with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease

Tuesday, October 24, 2023
10:30 AM – 4:00 PM PT
Location: Exhibit Hall
Has Audio
Remo Panaccione, MD1, Julian Panés, MD, PhD2, Laurent Peyrin-Biroulet, MD3, Jean-Frederic Colombel, MD4, James Lindsay, MD5, Filip Baert, MD6, Raja Atreya, MD7, Ana P.. Lacerda, MD, MSc8, Caroline Park, PharmD9, Samuel I.. Anyanwu, PhD, MS8, Justin Klaff, MD9, Jianzhong Liu, MD, MS8, Gweneth Levy, MD9, Benjamin Duncan, MS9, Ramona Vladea, PhD9, David T. Rubin, MD10
1University of Calgary, Calgary, AB, Canada; 2Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; 3University Hospital of Nancy, Lorraine University, Vandoeuvre, Lorraine, France; 4Icahn School of Medicine at Mount Sinai, New York, NY; 5Queen Mary University of London, London, England, United Kingdom; 6AZ Delta, Roeselare, West-Vlaanderen, Belgium; 7University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg, Erlangen, Schleswig-Holstein, Germany; 8AbbVie Inc., North Chicago, IL; 9AbbVie, North Chicago, IL; 10Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL

Introduction: Upadacitinib (UPA), an oral and reversible Janus kinase inhibitor, demonstrated significantly greater efficacy compared with placebo (PBO) for maintenance treatment in patients with moderate to severe ulcerative colitis (UC) or Crohn’s disease (CD) in two phase 3, double-blind, PBO-controlled trials, U-ACHIEVE1 (NCT02819635) and U-ENDURE2 (NCT03345823). UPA is approved for the treatment of patients with moderate to severe UC and CD.3-5 Safety analysis of UPA supports the benefit/risk assessment in the management of UC and CD patients. Reported here are adverse events (AEs) through week (wk) 52 of maintenance for the integrated intent-to-treat population from both studies, for patients treated with UPA 15 mg (UPA15), UPA 30 mg QD (UPA30) or PBO.

Methods: AEs were pooled among patients who responded to an induction dose of UPA 45 mg QD at wk 8 (UC) or wk 12 (CD) and then received at least one dose of PBO, UPA15 or UPA30 during maintenance. As the randomization ratios were identical for each study 1:1:1 there was no need to stratify the pooling by study.

Results: Overall, 1419 patients (U-ACHIEVE N=746; U-ENDURE N=673) were included in the analysis with 246.4 patient years (PY) of exposure in PBO, 353.1PY in UPA15, and 395.7PY in UPA30. At baseline of induction, demographics and disease characteristics were balanced across treatment arms (Table 1). Rates of serious AEs, AE leading to treatment discontinuation and serious infections were similar across both UPA doses, and lower than PBO; rates of herpes zoster were higher with UPA than PBO, with slightly more cases in UPA30. One gastrointestinal perforation was reported in each UPA treatment group (0.3/100PY), while 2 were reported in PBO (0.8/100PY). Adjudicated major adverse cardiovascular events were reported in 1 patient treated with UPA30 (0.3/100PY) and 1 with PBO (0.4/100PY), while 2 patients had adjudicated venous thromboembolic events among each of the UPA treatment groups (0.5-0.6/100PY) compared to none among PBO. Malignancies excluding non-melanoma skin cancer (NMSC) were reported in 2 patients on UPA15 (0.6/100PY), 4 patients on UPA30 (1.0/100PY), and 1 on PBO (0.4/100PY); NMSC was observed in 3 patients on UPA30 (0.8/100PY). No tuberculosis, lymphoma, or death occurred in any treatment group.

Discussion: UPA is generally well-tolerated and both maintenance doses have an acceptable safety profile in patients with moderate to severe UC and CD. No new safety signals were observed.


Disclosures:
Remo Panaccione: Abbivax – Consultant. Abbott – Consultant. AbbVie – Consultant. Alimentiv – Consultant. Amgen – Consultant. Arena – Consultant. AstraZeneca – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Celltrion – Consultant. Cosmos Technology – Consultant. Eisai – Consultant. Elan – Consultant. Eli Lilly – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. JAMP Bio – Consultant. Janssen – Consultant. Merck – Consultant. Mylan – Consultant. Novartis – Consultant. Oppilan Pharma – Consultant. Organon – Consultant. Pandion Pharma – Consultant. Pendopharm – Consultant. Pfizer Inc – Consultant. Progenity – Consultant. Prometheus – Consultant. Protagonist Therapeutics – Consultant. Roche – Consultant. Sandoz – Consultant. Satisfai Health – Consultant. Shire – Consultant. Sublimity Therapeutics – Consultant. Takeda Pharmaceuticals – Consultant. Theravance Biopharma – Consultant. Trellus – Consultant. UCB – Consultant. Ventyx – Consultant. Viatris – Consultant.
Julian Panés: AbbVie – Grant/Research Support, Personal fees. Arena – Consultant. Athos – Consultant. Atomwise – Consultant. Boehringer Ingelheim – Consultant. Celgene – Consultant. Celltrion – Consultant. Ferring – Consultant, Speakers Bureau. Galapagos – Consultant. Genentech/Roche – Consultant. GlaxoSmithKline – Consultant. Immunic – Personal fees. Janssen – Consultant, payment for development of educational presentations. Mirum – Consultant. Morphic – Consultant. Origo – Consultant. Pandion – Consultant. Pfizer Inc – Grant/Research Support, payment for development of educational presentations. Progenity – Consultant. Revolo – Consultant. Takeda – payment for development of educational presentations. Theravance – Consultant. Wasserman – Consultant.
Laurent Peyrin-Biroulet: AbbVie – Consultant, Speaker's fees. Abivax – Consultant. Alimentiv – Consultant. Alma Bio Therapeutics – Consultant. Amgen – Consultant, Speaker's fees. Applied Molecular Transport – Consultant. Arena – Consultant, Speaker's fees. Biogen – Consultant, Speaker's fees. Bristol Myers Squibb – Consultant. Celltrion – Consultant, Grant/Research Support, Speaker's fees. CONNECT Biopharm – Consultant. Cytoki Pharma – Consultant. Eli Lilly – Consultant, Speaker's fees. Enthera – Consultant. Ferring – Consultant, Speaker's fees. Fresenius Kabi – Consultant, Grant/Research Support. Galapagos – Consultant, Speaker's fees. Genentech – Consultant, Speaker's fees. Gilead – Consultant, Speaker's fees. GlaxoSmithKline – Consultant. Gossamer Bio – Consultant. HAC-Pharma – Consultant. IAG Image Analysis – Consultant. Index Pharmaceuticals – Consultant. Inotrem – Consultant. Janssen – Consultant, Speaker's fees. Medac – Consultant, Speaker's fees. Mopac – Consultant. Moprhic – Consultant. MSD – Consultant, Speaker's fees. Norgine – Consultant. Novartis – Consultant. OM Pharma – Consultant. ONO Pharma – Consultant. OSE Immunotherapeutics – Consultant. Pandion Therapeutics – Consultant. Par’Immune – Consultant. Pfizer – Consultant, Speaker's fees. Prometheus – Consultant. Prometheus – Consultant. Protagonist – Consultant. Roche – Consultant. Roivant – Consultant. Samsung – Consultant. Sandoz – Consultant, Speaker's fees. Sanofi – Consultant. Takeda – Consultant, Grant/Research Support, Speaker's fees. Theravance – Consultant. Thermo Fisher – Consultant. Tigenix – Consultant. Tillots – Consultant, Speaker's fees. Vectivbio – Consultant. Ventyx – Consultant. Viatris – Consultant, Speaker's fees. Vifor – Consultant, Speaker's fees. Ysopia – Consultant.
Jean-Frederic Colombel: AbbVie – Consultant, Grant/Research Support, Speaker's fees. Allergan – Consultant. Amgen – Consultant. AnaptysBio – Consultant. Arena Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support. Celgene Corporation – Consultant. Celltrion – Consultant. Eli Lilly – Consultant. Ferring Pharmaceuticals – Consultant. Galmed Research – Consultant. Genentech (Roche) – Consultant. Glaxo Smith Kline – Consultant. Immunic – Consultant. Intestinal Biotech Development – Stock Options. Invea – Consultant. Iterative Scopes – Consultant. Janssen Pharmaceuticals – Consultant, Grant/Research Support. Kaleido Biosciences – Consultant. Landos – Consultant. Merck – Consultant. Microba Life Science – Consultant. Novartis – Consultant. Otsuka Pharmaceutical – Consultant. Pfizer – Consultant. Prometheus – Consultant. Protagonist Therapeutics – Consultant. Sanofi – Consultant. Seres – Consultant. Takeda – Consultant, Grant/Research Support, Speaker's fees. Teva – Consultant. TiGenix – Consultant. Vifor – Consultant.
James Lindsay: AbbVie – Consultant, Grant/Research Support, Speaker's fees. Allergan (Warner Chilcott) – Consultant, Speaker's fees. Atlantic Healthcare – Consultant, Speaker's fees. Bristol Myers Squibb – Consultant, Speaker's fees. Celgene – Consultant, Speaker's fees. Celltrion – Consultant, Speaker's fees. Eli Lilly – Consultant, Speaker's fees. Ferring Pharmaceuticals – Consultant, Speaker's fees. Galapagos – Consultant, Speaker's fees. Gilead – Consultant, Grant/Research Support, Speaker's fees. GSK – Consultant, Speaker's fees. Janseen – Consultant, Speaker's fees. MSD – Consultant, Speaker's fees. Napp Pharmaceuticals – Consultant, Speaker's fees. Pfizer – Consultant, Grant/Research Support, Speaker's fees. Shire – Consultant, Grant/Research Support, Speaker's fees. Takeda – Consultant, Grant/Research Support, Speaker's fees. Vifor Pharma – Consultant, Speaker's fees.
Filip Baert: Abbvie – Consultant, Speakers Bureau. Amgen – Consultant, Grant/Research Support. Arena Pharmaceuticals – Consultant, Speakers Bureau. Celltrion – Consultant, Speakers Bureau. Ferring – Consultant, Speakers Bureau. Fresenius Kabi – Consultant. Galapagos – Speakers Bureau. Janssen – Consultant, Speakers Bureau. Pfizer Inc – Consultant. Sandoz – Consultant. Takeda – Grant/Research Support.
Raja Atreya: AbbVie – Consultant, Grant/Research Support. Amgen – Consultant, Speaker's fees. Arena Pharmaceuticals – Consultant, Speaker's fees. AstraZeneca – Consultant, Speaker's fees. Biogen – Consultant, Grant/Research Support, Speaker's fees. Boehringer Ingelheim – Consultant, Speaker's fees. Bristol Myers Squibb – Consultant, Speaker's fees. Celgene – Consultant, Speaker's fees. Celltrion Healthcare – Consultant, Speaker's fees. DrFalk Pharma – Consultant, Speaker's fees. Eli Lilly – Consultant, Speaker's fees. Ferring – Consultant, Speaker's fees. Fresenius Kabi – Consultant, Speaker's fees. Galapagos – Consultant, Speaker's fees. Gilead – Consultant, Speaker's fees. GlaxoSmithKline – Consultant, Speaker's fees. Index Pharmaceuticals – Consultant, Grant/Research Support, Speaker's fees. Janssen-Cilag – Consultant, Speaker's fees. Kliniksa Pharmaceuticals – Consultant, Speaker's fees. MSD Sharp & Dohme – Consultant, Speaker's fees. Novartis – Consultant, Speaker's fees. Pandion Therapeutics – Consultant, Speaker's fees. Pfizer – Consultant, Speaker's fees. Roche – Consultant, Speaker's fees. Samsung Bioepsis – Consultant, Speaker's fees. Stelic Institute – Consultant, Speaker's fees. Takeda Pharmaceuticals – Consultant, Grant/Research Support, Speaker's fees. Tillotts Pharma AG – Consultant, Grant/Research Support, Speaker's fees. Viatris – Consultant, Speaker's fees.
Ana Lacerda: AbbVie – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Caroline Park: AbbVie – Stock Options, Stock-publicly held company(excluding mutual/index funds).
Samuel Anyanwu: AbbVie – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Justin Klaff: AbbVie – Stock Options, Stock-publicly held company(excluding mutual/index funds).
Jianzhong Liu: AbbVie – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Gweneth Levy: AbbVie – Stock Options, Stock-publicly held company(excluding mutual/index funds).
Benjamin Duncan: AbbVie – Stock Options, Stock-publicly held company(excluding mutual/index funds).
Ramona Vladea: AbbVie – Stock Options, Stock-publicly held company(excluding mutual/index funds).
David Rubin: AbbVie – Consultant, personal fees. AltruBio – Consultant, personal fees. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant, personal fees. Bristol Myers Squibb – Consultant. Celgene Chronicles – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Corp/Syneos – Consultant. Eco R1 – Consultant. GastroIntestinal Research Foundation – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant, personal fees. Helmsley Charitable Trust – Grant/Research Support. Iterative Health – Consultant. Janssen Pharmaceuticals – Consultant, personal fees. Kaleido Biosciences – Consultant. Lilly – Consultant. Pfizer – Consultant, personal fees. Prometheus Biosciences – Consultant. Reistone Biopharma – Consultant, personal fees. Seres Therapeutics – Consultant. Takeda – Consultant, Grant/Research Support, Personal fees. Target RWE – Consultant. Trellus Health – Consultant.


Remo Panaccione, MD1, Julian Panés, MD, PhD2, Laurent Peyrin-Biroulet, MD3, Jean-Frederic Colombel, MD4, James Lindsay, MD5, Filip Baert, MD6, Raja Atreya, MD7, Ana P.. Lacerda, MD, MSc8, Caroline Park, PharmD9, Samuel I.. Anyanwu, PhD, MS8, Justin Klaff, MD9, Jianzhong Liu, MD, MS8, Gweneth Levy, MD9, Benjamin Duncan, MS9, Ramona Vladea, PhD9, David T. Rubin, MD10. P3631 - Safety of Upadacitinib in IBD: Pooled Analysis of Phase 3 Maintenance Studies, U-ACHIEVE and U-ENDURE, In Patients with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.