ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 0591 • ACR Convergence 2024

    Bimekizumab Maintained Efficacy Responses in Patients with Active Psoriatic Arthritis: Up to 2-Year Results from Two Phase 3 Studies

    Jessica A Walsh1, Joseph F. Merola2, Christopher T Ritchlin3, Yoshiya Tanaka4, Ennio Giulio Favalli5, Dennis McGonagle6, Diamant Thaçi7, Barbara Ink8, Rajan Bajracharya8, Jason Coarse9 and William Tillett10, 1Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT, 2UT Southwestern Medical Center, Dallas, TX, 3Allergy, Immunology & Rheumatology Division, University of Rochester Medical School, Rochester, NY, 4Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, 5ASST Gaetano Pini-CTO, Milan, Lombardia, Italy, 6National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC), Leeds Teaching Hospitals, Leeds, UK, Leeds, England, United Kingdom, 7Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, 8UCB Pharma, Slough, United Kingdom, 9UCB Pharma, Morrisville, NC, 10Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom

    Background/Purpose: PsA is a chronic disease, and patients (pts) can experience loss of response with sustained therapy; therefore, assessing long-term maintenance of response in pts…
  • Abstract Number: 0736 • ACR Convergence 2024

    Treatment of IgG4-Related Disease (IgG4-RD) with Elotuzumab, an Inhibitor of SLAM-F7: Report of a Phase 2 Clinical Trial

    John Stone1, Arezou Khosroshahi2, Shounak Majumder3, Cory Perugino4, Ana Fernandes4, Grace McMahon4, Isha Jha4, John Varghese2, Adriana Delgado3, Guy Katz4, Zachary Wallace5, Shiv Pillai4, William Barry6, Ashley Pinckney7, Ellen Goldmuntz8, Beverly Welch9 and Kaitlin McShea9, 1Massachusetts General Hospital , Harvard Medical School, Concord, MA, 2Emory University, Atlanta, GA, 3Mayo Clinic, rochester, MN, 4Massachusetts General Hospital, Boston, MA, 5Massachusetts General Hospital, Newton, MA, 6Rho, Durham, NC, 7Rho, St Louis Park, NC, 8NIAID/ NIH, Washington, DC, 9Rho, Washington, DC

    Background/Purpose: CD4+ cytotoxic T lymphocytes (CD4+ CTLs), plasmablasts, and selected other cells of the T and B cell lineages have been identified as cellular linchpins of…
  • Abstract Number: 1137 • ACR Convergence 2024

    Deucravacitinib, an Oral,Selective,Allosteric Tyrosine Kinase 2 Inhibitor, in Patients WithModerate to Severe Scalp Psoriasis: Efficacy and Safety Results of a Phase 3b/4, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial (PSORIATYK SCALP)

    Kristina Callis Duffin1, Christopher E. M. Griffiths2, Matthias Hoffmann3, Andrew Blauvelt4, Eugene Balagula5, Andrew Napoli5, Ying-Ming Jou5, Rachel Dyme5, Virginia Hala5, andreas pinter6 and Mark Lebwohl7, 1University of Utah, Salt Lake City, 2Dermatology Centre, University of Manchester, Manchester, and King’s College Hospital and King’s College London, London, United Kingdom, 3Private Practice, Witten, Germany, 4Oregon Medical Research Center, Portland, OR, 5Bristol Myers Squibb, Princeton, 6University Hospital of the Goethe University, Frankfurt am Main, Frankfurt, Germany, 7Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY

    Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in the US, EU, and other countries for treatment of adults with…
  • Abstract Number: 1413 • ACR Convergence 2024

    Pilot Trial of Ustekinumab for Primary Sjogren’s Syndrome

    Ummara Shah1 and Andrea Coca2, 1University of Rochester, Webster, NY, 2University of Pittsburgh, Pittsburgh, PA

    Background/Purpose: Sjogren’s Syndrome (SS) is a chronic autoimmune disease characterized by keratoconjunctivitis sicca and xerostomia. Currently there is no approved systemic treatment for primary SS. …
  • Abstract Number: 1552 • ACR Convergence 2024

    Kinetics of Mucocutaneous and Musculoskeletal Responses to Deucravacitinibin Patients with Active SLE in the Phase 2 PAISLEY Trial

    Ronald Van Vollenhoven1, Joseph Merola2, Kathryn H. Dao3, Piotr Leszczynski4, Marilyn Pike5, Samantha Pomponi6, Coburn Hobar6, Matthew J. Colombo6, Ravi Koti6, Subhashis Banerjee6, Thomas Wegman7 and Eric Morand8, 1Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands, 2UT Southwestern Medical Center, Newton, MA, 3Department of Internal Medicine, Division of Rheumatology, The University of Texas Southwestern Medical Center, Dallas, 4Department of Internal Medicine, Poznań University of Medical Sciences, Poznań, Poland, 5Rheumatology, MedPharm Consulting, Inc., Raleigh, NC, 6Bristol Myers Squibb, Princeton, NJ, 7Bristol Myers Squibb, Beaver Falls, PA, 8School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia

    Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of moderate to severe plaque…
  • Abstract Number: 2005 • ACR Convergence 2024

    Impact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional Therapy

    Puja Khanna1, Vibeke Strand2, Atul Singhal3, Herbert Baraf4, Rehan Azeem5, Wesley DeHaan6, Sheldon Leung5, Hugues Santin-Janin7, Aletta Falk8 and Alan Kivitz9, 1University of Michigan, Ann Arbor, MI, 2Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 3Southwest Arthritis Research Group, Mesquite, TX, 4Center for Rheumatology and Bone Research, Wheaton, MD, 5Sobi Inc., Waltham, MA, 6Sobi, Inc, Waltham, MA, 7Sobi, BETTENDORF (68560), France, 8Sobi, Stockholm, Sweden, 9Altoona Center for Clinical Research, Duncansville, PA

    Background/Purpose: SEL-212 is a once-monthly, investigational, two-component infusion therapy consisting of pegadricase (SEL-037, a pegylated uricase) and immune-tolerizing nanoparticles containing sirolimus (SEL-110), for the treatment…
  • Abstract Number: 2252 • ACR Convergence 2024

    Long-term Efficacy of Filgotinib Monotherapy and Combination Therapy: Interim Results from a Post Hoc Analysis of the FINCH 4 Study

    Maya H. Buch1, Patrick Verschueren2, Roberto Caporali3, Thomas Huizinga4, Edmund V. Ekoka Omoruyi5, Dick de Vries6, Jeffrey Ritsema7, Francesco De Leonardis8 and Daniel Aletaha9, 1Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, 2Department of Rheumatology, University Hospital Leuven and KU Leuven, Leuven, Belgium, 3Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, 4Department of Rheumatology, Leiden University, Leiden, Netherlands, 5Biostatistics, Galapagos NV, Mechelen, Belgium, 6Clinical Development, Galapagos BV, Leiden, Netherlands, 7Medical Affairs, Galapagos BV, Leiden, Netherlands, 8Medical Affairs, Galapagos GmbH, Basel, Switzerland, 9Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Wien, Austria

    Background/Purpose: Filgotinib (FIL) is a preferential Janus kinase 1 inhibitor for the treatment of moderate to severe RA. FINCH 4 (NCT03025308) is an ongoing, open-label,…
  • Abstract Number: 2478 • ACR Convergence 2024

    Avacopan versus a Prednisone Taper in Patients with ANCA-Associated Vasculitis Without Kidney Involvement in a Phase 3 Trial

    Christian Pagnoux1, Antoine Neel2, Sarah Bray3, Rachel E. Gurlin4, Darcy Trimpe5, David Jayne6 and Peter Merkel7, and ADVOCATE Study Group, 1Mount Sinai Hospital, Toronto, ON, Canada, 2Department of Internal Medicine, CHU Nantes, Nantes, France, 3Amgen Ltd, Cambridge, United Kingdom, 4Amgen Inc., Mountain View, CA, 5Amgen Inc., Thousand Oaks, CA, 6University of Cambridge, Cambridge, United Kingdom, 7University of Pennsylvania, Philadelphia, PA

    Background/Purpose: Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are subtypes of ANCA-associated vasculitis that frequently involve the kidneys. However, a subset of patients with…
  • Abstract Number: 0303 • ACR Convergence 2024

    Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis: FRONTIER-2

    Laura K. Ferris1, Jerry Bagel2, Yu-Huei Huang3, Andrew E. Pink4, Stephen K. Tyring5, Georgios Kokolakis6, Amy M. DeLozier7, Daniel Kakaley8, Shu Li9, Yaung-Kaung Shen10, Takayuki Ota7 and Robert Bissonnette11, 1University of Pittsburgh, Pittsburgh, PA, 2Psoriasis Treatment Center of Central NJ, East Windsor, NJ, 3Chang Gung Memorial Hospital and Chang Gung University, Linkou, Taoyuan City, Taiwan (Republic of China), 4NHS Foundation Trust Great Maze Pond, London, United Kingdom, 5Center for Clinical Studies, Webster, TX, 6Psoriasis Research and Treatment Center, Department of Dermatology, Venereology and Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, 7Janssen Research & Development, LLC, San Diego, CA, 8Janssen Scientific Affairs, LLC, Horsham, PA, 9Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, 10Janssen Research & Development, LLC, Spring House, PA, 11Innovaderm Research, Montreal, QC, Canada

    Background/Purpose: JNJ-77242113, a targeted oral peptide, inhibits IL-23 signaling by binding the IL-23 receptor. At all doses, JNJ-77242113 showed superior efficacy at Week 16 versus…
  • Abstract Number: 0593 • ACR Convergence 2024

    Value of the Routine Assessment of Patient Index Data 3 in Assessing Disease Severity and Treatment Effect in Patients with Early Oligoarticular Psoriatic Arthritis Treated with Apremilast

    Alvin F. Wells1, Arthur Kavanaugh2, William Tillett3, Philip S. Helliwell4, Marijn Vis5, Yuri Klyachkin6, Cynthia Deignan7, Lichen Teng7, Rebecca Wang7 and Alexis Ogdie8, 1Rheumatology and Immunotherapy Center, Franklin, WI, 2University of California San Diego, La Jolla, CA, 3Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, 4Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK, Leeds, United Kingdom, 5Erasmus MC, Rotterdam, Netherlands, 6Amgen, Lexington, KY, 7Amgen Inc., Thousand Oaks, CA, 8Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

    Background/Purpose: The Routine Assessment of Patient Index Data 3 (RAPID3) score is a composite of 3 patient-reported outcomes (PROs): Health Assessment Questionnaire (HAQ), pain visual…
  • Abstract Number: 0747 • ACR Convergence 2024

    Clofutriben to Improve the Benefit-Risk Profile of Prednisolone in Patients with Polymyalgia Rheumatica

    FRANK HARTMUT DR. BUTTGEREIT1, Andrea Everding2, Ioana Andreica3, Herbert Kellner4, Florian Schuch5, Tonya K Marmon6, Frank S Czerwiec7, Ketan Desai8 and David A Katz9, 1Charité University Medicine Berlin, Berlin, Germany, 2Hamburger Rheuma Forschungszentrum II, Hamburg, Germany, 3Rheumazentrum Ruhrgebiet, Bochum, Germany, 4Schwerpunktpraxis f�r Rheumatologie und Gastroenterologie, Munich, Germany, 5PGRN, Erlangen, Germany, 6Marmon Biostatistics, Seattle, WA, 7Sparrow Pharmaceuticals, Portand, OR, 8IMC, Easton, PA, 9Sparrow Pharmaceuticals, Portland, OR

    Background/Purpose: 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) differentially regulates intracellular glucocorticoid levels in the immune system and glucocorticoid toxicity target organs. Clofutriben is a potent HSD-1…
  • Abstract Number: 1169 • ACR Convergence 2024

    Efficacy of Intravenous Immunoglobulin (Octagam 10%) on Pulmonary Manifestations in Patients with Dermatomyositis: Results from the ProDERM Study

    Rohit Aggarwal1, christina Charles-Schoeman2 and Joachim Schessl3, and the ProDERM Investigators, 1Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, USA, Pittsburgh, PA, 2UCLA Medical Center, Santa Monica, CA, 3Friedrch-Baur-Institut; Ludwig-Maximilians University of Munich, Munich, Germany

    Background/Purpose: Interstitial lung disease (ILD) and other pulmonary manifestations are a major cause of mortality and morbidity in patients with dermatomyositis (DM). The ProDERM study…
  • Abstract Number: 1427 • ACR Convergence 2024

    Observed and Simulated Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Fully Human FcRn Blocking Monoclonal Antibody, in Adults with Sjögren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study

    Sophia G. Liva1, fudan Zheng1, Jocelyn H. Leu2, Kathy Sivils3, Keying Ma1, He Li4, Steven Leonardo5, Kim Lo1, Jada Idokogi1, Kim Campbell1 and Jonathan J. Hubbard1, 1Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, 2Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, PA, 3Johnson & Johnson Innovative Medicine, Edmond, OK, 4Janssen Research & Development, LLC, Therapeutics Discovery, Spring House, PA, 5Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA

    Background/Purpose: Sjögren’s disease (SjD) is a chronic, progressive autoimmune disease characterized by aberrant B lymphocyte activity, elevated IgG production, and the presence of IgG autoantibodies…
  • Abstract Number: 1596 • ACR Convergence 2024

    Efficacy of Eosinophil-Targeting Therapies According to Disease Severity in Patients with Eosinophilic Granulomatosis with Polyangiitis

    Bernhard Hellmich1, Peter Merkel2, David Jayne3, Benjamin Terrier4, Florence Roufosse5, Parameswaran Nair6, Nader Khalidi6, David J. Jackson7, Shunsuke Furuta8, Lena Börjesson Sjö9, Sofia Necander9, Anat Shavit10, Claire Walton11 and Michael Wechsler12, 1Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, 2University of Pennsylvania, Philadelphia, PA, 3University of Cambridge, Cambridge, United Kingdom, 4Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, 5Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, 6McMaster University and St Joseph’s Healthcare, Hamilton, ON, Canada, 7Guy’s Severe Asthma Centre, Guy’s and St Thomas’ NHS Trust; School of Immunology and Microbial Sciences, King’s College London, London, United Kingdom, 8Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan, 9Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, 10BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, 11Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, 12National Jewish Health, Denver, CO

    Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by asthma, eosinophilia, and small-to-medium size vessel vasculitis, with individual manifestations widely ranging…
  • Abstract Number: 2008 • ACR Convergence 2024

    A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Dose of ABP-671 in Participants with Chronic Kidney Disease (CKD)

    ullrich schwertschlag1, william dongfang Shi2, rOBERT PERRY3, Kwabena Ayesu4, rOY WU5, jerry liu6, JinSying Lin7 and Adam Jin8, 1Atombio Science, PALO ALTO, CA, 2Jiangsu Atom Bioscience,, Suzhou, Jiangsu, China (People's Republic), 3Panax Clin Res, Miami Lakes, FL, 4OMEGARLLC, ORLANDO, FL, 5Atom Bioscience, SAN FRANCISCO, CA, 6atombio, San Diego, CA, 7Biostatconsulting, Wuzhong, Suzhou, Jiangsu, China (People's Republic), 8atom biosciences, Wuzhong, Suzhou, Jiangsu, China (People's Republic)

    Background/Purpose: In this open-label Phase 1 study, 22 participants were enrolled in 3 cohorts, 10 participants with normal kidney function (eGFR ≥90 ml/min/1.73m2 and no…
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