ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 0875 • ACR Convergence 2020

    Secukinumab Provides Sustained Improvements in Subgroup Analyses of Joint Tenderness and Swelling in Patients with Psoriatic Arthritis: 5‑Year Results from the Phase 3 FUTURE 2 Study

    Iain McInnes1, Hector Chinoy2, Darren Asquith3, Abigail White3 and Corine Gaillez4, 1Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, 2The University of Manchester, Manchester, United Kingdom, 3Novartis Pharmaceuticals UK Ltd., London, United Kingdom, 4Novartis Pharma AG, Basel, Switzerland

    Background/Purpose: Secukinumab, a fully human monoclonal antibody that neutralizes interleukin‑17A, has shown long-term efficacy and tolerability in patients with psoriatic arthritis (PsA) in FUTURE 2.…
  • Abstract Number: 1211 • ACR Convergence 2020

    Relationship Between Changes in Lipid Levels and Improvement in Disease Activity Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib Treatment: Pooled Analysis of Data from Two Phase 3 Studies

    Christina Charles-Schoeman1, Jon Giles2, Nancy Lane3, Ernest Choy4, Heidi Camp5, Yanna Song6, Samuel Anyanwu5 and Iain McInnes7, 1University of California, Los Angeles, Los Angeles, CA, 2Columbia University, New York, NY, 3University of California, Davis, Sacramento, CA, 4CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom, 5AbbVie Inc., North Chicago, IL, 6AbbVie Inc., North Chicago,, IL, 7Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom

    Background/Purpose: Upadacitinib (UPA) is an oral Janus kinase (JAK) inhibitor engineered to have greater selectivity for JAK1 vs JAK2, JAK3, and tyrosine kinase 2, and…
  • Abstract Number: 1630 • ACR Convergence 2020

    Long-term Safety of Tildrakizumab in Patients with Moderate to Severe Plaque Psoriasis: Incidence of Confirmed Major Adverse Cardiovascular Events Through 3 Years (148 Weeks) from Two Phase 3 Trials

    Lars Iversen1, Christopher EM Griffiths2, Andrea Peserico3, Ignasi Pau-Charles4, Andrew Blauvelt5, Diamant Thaçi6 and Kristian Reich7, 1Aarhus University Hospital, Aarhus, Denmark, 2The University of Manchester, Manchester, United Kingdom, 3DIMED University of Padua, Padua, Italy, 4Almirall R&D, Barcelona, Spain, 5Oregon Medical Research Center, Portland, OR, 6Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, 7Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation®, Hamburg, Germany

    Background/Purpose: Tildrakizumab (TIL) is a high-affinity anti–interleukin-23p19 monoclonal antibody that is approved for the treatment of moderate to severe plaque psoriasis. The objective of this…
  • Abstract Number: 1995 • ACR Convergence 2020

    Non-invasive Vagus Nerve Stimulation Improves Signs and Symptoms of Rheumatoid Arthritis: Results of a Pilot Study

    Sara Marsal1, Hector Corominas2, Juan Jose De Agustin De Oro3, Carolina Perez Garcia4, Maria Lopez Lasanta3, Helena Borrell3, Delia Reina5, Raimon Sanmartí6, Francisco Javier Narváez7, Clara Franco-Jarava8, Charles Peterfy9, Jose Antonio Narvaez10, Vivek Sharma11, Konstantinos Alataris11, Mark Genovese12 and Matthew Baker13, 1Hospital Universitari Vall d'Hebron, Barcelona, Spain, 2Institut Rec. Hospital de la Santa Creu I Sant Pau., Barcelona, Spain, 3Hospital Universitari Vall d’Hebron, Barcelona, Spain, 4Hospital Universitari Parc Salut Mar, Barcelona, Spain, 5Hospital Moises Broggi, Barcelona, Spain, 6Hospital Universitari Clínic de Barcelona, Barcelona, Catalonia, Spain, 7Hospital Bellvitge, BARCELONA, Spain, 81Hospital Universitari Vall d’Hebron, Barcelona, Spain, 9Spire Sciences, Inc., Boca Raton, FL, 10Clinica Diagonal, Barcelona, Spain, 11Vorso Corp, Redwood CIty, CA, 12Stanford University Medical Center, Palo Alto, CA, 13Stanford University, Menlo Park, CA

    Background/Purpose: Vagus nerve stimulation (VNS) has been shown to improve rheumatoid arthritis (RA) disease severity in patients with refractory disease (1,2). A multi-center pilot study…
  • Abstract Number: 0210 • ACR Convergence 2020

    Long-term Safety and Efficacy of Sarilumab over 5 Years in Patients with Rheumatoid Arthritis Refractory to Tumor Necrosis Factor Inhibitors

    Roy Fleischmann1, Karina Maslova2, Henry Leher3, Amy Praestgaard2 and Gerd Burmester4, 1Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, 2Sanofi, Cambridge, MA, 3Regeneron Pharmaceuticals, Inc, Tarrytown, NY, 4Charité University Hospital Berlin, Berlin, Germany

    Background/Purpose: Sarilumab is a human IL-6 receptor (IL-6R) inhibitor approved for the treatment of adults with moderate to severely active RA. In the TARGET study…
  • Abstract Number: 0348 • ACR Convergence 2020

    Biologics History and Sex Are Linked to Golimumab Discontinuation in Axial Spondyloarthritis: A Sub-Analysis of the Post-Registration GO-Practice Study

    Philippe Bertin1, Philippe Goupille2, Florence Tubach3, Eric Lespessailles4, Naoual Harid5, Saannya Sequeira6, Jean-Marie Fayette6, Bruno Fautrel7 and Rene-Marc Flipo8, 1Limoges University Hospital, Limoges, France, 2CHU Tours, department of rheumatology, Tours, France, 3Pierre Louis Institute of Epidemiology and Public Health, INSERM 1136, Sorbonne University and Centre of Pharmacoepidemiology, Pitié Salpêtrière Hospital, APHP.Sorbonne University, Paris, Ile-de-France, France, 4Regional Hospital and University of Orleans, Orléans, France, 5MSD France Puteaux, Puteaux, Ile-de-France, France, 6ClinSearch, Malakoff, Ile-de-France, France, 7Sorbonne University, INSERM, IPLES; Pitié-Salpêtrière Hospital, Paris, Ile-de-France, France, 8Lille University Hospital, Lille, France

    Background/Purpose: Golimumab (GLM) is the latest anti-TNFα to be indicated for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The post-registration GO-PRACTICE…
  • Abstract Number: 0677 • ACR Convergence 2020

    A Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled GOut Receiving Pegloticase (MIRROR): 12-Month Results of an Open-Label Study

    John Botson1, Paul Peloso2, Katie Obermeyer3, Brian LaMoreaux3, Lin Zhao3, Michael Weinblatt4 and Jeff Peterson5, 1Orthopedic Physicians Alaska, Anchorage, AK, 2Horizon Therapeutics plc, Gurnee, IL, 3Horizon Therapeutics plc, Lake Forest, IL, 4Brigham and Women's Hospital, Boston, MA, 5Western Washington Medical Group Arthritis Clinic, Bothell, WA

    Background/Purpose: Consistent, though limited, published data suggests that methotrexate (MTX) improves treatment response in patients treated with pegloticase for uncontrolled (refractory) gout. Recent case series1-3…
  • Abstract Number: 0877 • ACR Convergence 2020

    Improvements in Global Functioning and Health-related Quality of Life and Their Association with Disease Activity and Functional Improvement in Patients with Active Ankylosing Spondylitis Treated with Upadacitinib

    Uta Kiltz1, Joachim Sieper2, Atul Deodhar3, Patrick Zueger4, In-Ho Song4, Naijun Chen4 and Désirée van der Heijde5, 1Rheumazentrum Ruhrgebiet, Herne, and Ruhr-University Bochum, Herne, Germany, 2Charité Universitätsmedizin Berlin, Berlin, Germany, 3Oregon Health & Science University, Portland, OR, 4AbbVie Inc., North Chicago, IL, 5Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: Upadacitinib (UPA) has been shown to be effective and well tolerated in patients with active ankylosing spondylitis (AS) [1]. However, improvements in global functioning…
  • Abstract Number: 1213 • ACR Convergence 2020

    Discrepancy Between the Multi-biomarker Disease Activity Score and Clinical Disease Activity Scores in a 2‑Part, Multicenter Study of Repository Corticotropin Injection (Acthar® Gel) for Patients with Persistently Active Rheumatoid Arthritis

    Roy Fleischmann1, Jingyu Liu2, Julie Zhu2, Oscar Segurado3 and Daniel Furst*4, 1Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, 2Mallinckrodt Pharmaceuticals, Bedminster, NJ, 3SSI Strategy, San Jose, CA, 4Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA, Los Angeles, CA

    Background/Purpose: Assessment of disease activity in RA with validated measures, such as the Disease Activity Score with 28 joint count and erythrocyte sedimentation rate (DAS28-ESR)…
  • Abstract Number: 1639 • ACR Convergence 2020

    Preliminary Baseline Subject Demographics and Disease Characteristics in a Phase 3 Clinical Trial of the Safety and Efficacy of Lenabasum in Dermatomyositis (DETERMINE)

    Victoria Werth1, Chester Oddis2, David Fiorentino3, Nancy Dgetluck4, Quinn Dinh5, Michael Tillinger6, Barbara White5 and Ingrid Lundberg7, 1University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, 2Department of Medicine, Division of Rheumatology, University of Pittsburgh, Pittsburgh, PA, 3Department of Dermatology, Stanford University, Redwood City, CA, 4Corbus Pharmaceuticals, Inc., Norwood, MA, 5Corbus Pharmaceuticals, Norwood, MA, 6Corbus Pharmaceuticals Inc., Norwood, MA, 7Division of Rheumatology, Department of Medicine, Karolinska Institutet,, Stockholm, Sweden

    Background/Purpose: There is significant unmet need for new treatments to achieve disease control in dermatomyositis (DM), because of limited efficacy or toxicity of immunosuppressive agents…
  • Abstract Number: 2002 • ACR Convergence 2020

    Incidence and Risk Factors for Herpes Zoster in Rheumatoid Arthritis Patients Receiving Upadacitinib

    Kevin Winthrop1, Peter Nash2, Kunihiro Yamaoka3, Eduardo Mysler4, Leonard Calabrese5, Nasser Khan6, Jeffrey Enejosa6, Yanna Song7, Jessica Suboticki6 and Jeffrey Curtis8, 1Oregon Health & Science University, Portland, OR, 2School of Medicine Griffith University, Brisbane, Queensland, Australia, 3Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan, 4Organización Medica de Investigación, Buenos Aires, Argentina, 5Cleveland Clinic, Cleveland, OH, 6AbbVie Inc., North Chicago, IL, 7AbbVie Inc., North Chicago,, IL, 8Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: Upadacitinib (UPA) is an oral JAK inhibitor approved for the treatment of rheumatoid arthritis (RA). The background rate of herpes zoster (HZ) in patients…
  • Abstract Number: 0211 • ACR Convergence 2020

    Efficacy and Safety of Upadacitinib in Patients from China, Brazil, and South Korea with Rheumatoid Arthritis Who Have Had Inadequate Response to Conventional Synthetic Disease-modifying Antirheumatic Drugs

    Xiaofeng Zeng1, Dongbao Zhao2, Sebastiao Radominski3, Mauro Keiserman4, Chang Keun Lee5, Sebastian Meerwein6, Jeffrey Enejosa7, Yunxia Sui7, Mohamed-Eslam Mohamed7 and Won Park8, 1Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China (People's Republic), 2Shanghai Changhai Hospital, Shanghai, China (People's Republic), 3Universidade Federal do Paraná, Curitiba, Brazil, 4Pontificial Catholic University, Porto Alegre, Brazil, 5Asan Medical Center, Seoul, Republic of Korea, 6Pharmaceutical Development, AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany, 7AbbVie Inc., North Chicago, IL, 8Inha University, Incheon, Republic of Korea

    Background/Purpose: This Phase 3, randomized, double-blind, placebo (PBO)-controlled study assessed the efficacy and safety of upadacitinib (UPA) in combination with csDMARDs in patients with rheumatoid…
  • Abstract Number: 0349 • ACR Convergence 2020

    Pooled Safety Results from Two Phase-3 Trials of Guselkumab in Patients with Psoriatic Arthritis Through 1 Year

    Christopher Ritchlin1, Proton Rahman2, Philip Helliwell3, Wolf-Henning Boehncke4, Iain McInnes5, Alice Gottlieb6, Shelly Kafka7, Alexa Kollmeier8, Elizabeth Hsia9, Xie Xu10, May Shawi11, Shihong Sheng12, Prasheen Agarwal12, Bei Zhou12, Paraneedharan Ramachandran13 and Philip Mease14, 1Department of Medicine, University of Rochester Medical Center, Rochester, NY, 2Memorial University of Newfoundland, Department of Medicine, St John's, Canada, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 4Geneva University Hospitals, Geneva, Switzerland, 5Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, 6Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 7Janssen Scientific Affairs, LLC, Horsham, PA, 8Janssen Research & Development, LLC, La Jolla, CA, 9Janssen Research & Development, LLC and University of Pennsylvania Medical Center, Spring House, PA, 10Janssen Research & Development, LLC, San Marcos, CA, 11Janssen Global Services, LLC, Toronto, ON, Canada, 12Janssen Research & Development, LLC, Spring House, PA, 13Janssen Research & Development, LLC, Horsham, 14Seattle Rheumatology Associates, P.L.L.C., Seattle, WA

    Background/Purpose: DISCOVER 1 & 2, two double-blind, phase 3, psoriatic arthritis (PsA) trials of guselkumab (GUS, an IL-23 inhibitor), demonstrated significant improvement with GUS vs…
  • Abstract Number: 0683 • ACR Convergence 2020

    Pharmacokinetics of Pegloticase and Methotrexate Polyglutamate(s) in Patients with Uncontrolled Gout Receiving Pegloticase and Co-treatment of Methotrexate

    Yang Song1, Yan Xin1, Michael Weinblatt2, Jason Chamberlain1, Katie Obermeyer3, Lin Zhao3, Colleen Canavan3, Paul Peloso4 and Srini Ramanathan1, 1Horizon Therapeutics plc, South San Francisco, CA, 2Brigham and Women's Hospital, Boston, MA, 3Horizon Therapeutics plc, Lake Forest, IL, 4Horizon Therapeutics plc, Gurnee, IL

    Background/Purpose: In an open-label trial in adult patients with uncontrolled gout (MIRROR open-label [OL] trial) evaluating pegloticase co-treatment with methotrexate (MTX), 78.6% patients maintained serum…
  • Abstract Number: 0880 • ACR Convergence 2020

    Ixekizumab Improves Signs and Symptoms of Patients with Radiographic and Non-radiographic Axial Spondyloarthritis and Extra-articular Manifestation of Enthesitis Through 16 Weeks

    Georg Schett1, Filip Van den Bosch2, Xenofon Baraliakos3, David Sandoval4, Vladimir Geneus4, Rebecca Bolce4, Soyi Liu-Leage5, Andris Kronbergs4 and Philip Mease6, 1Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany, 2Ghent University Hospital, Ghent, Belgium, 3Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany, 4Eli Lilly and Company, Indianapolis, 5Eli Lilly and Company, Indianapolis, IN, 6Seattle Rheumatology Associates, P.L.L.C., Seattle, WA

    Background/Purpose: Axial SpA (axSpA) is a chronic inflammatory disease affecting the spine and sacroiliac (SI) joints and has two subtypes that represent the spectrum of…
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