Abstracts tagged "clinical trial"

Abstract Number: 1990 • ACR Convergence 2020
Janus Kinase (JAK) Inhibition with Baricitinib in Refractory Juvenile Dermatomyositis
Hanna Kim¹, Lylan Bergeron², Samantha Dill², Michelle O'Brien², Laura Vian³, Minal Jain⁴, Manuk Manukyan², Xiaobai Li⁵, Shajia Lu³, Wanxia L. Tsai³, Kalyani Mishra Thakur⁶, Yinghui Shi⁶, Massimo Gadina⁷, April Brundidge², Michelle Millwood², Lisa G. Rider⁸ and Robert Colbert², ¹Juvenile Myositis Pathogenesis and Therapeutics Unit / NIAMS / National Institutes of Health, Bethesda, MD, ²Pediatric Clinical Trials Unit and Office of Clinical Director, NIAMS, NIH, Bethesda, MD, ³Translational Immunology Section, NIAMS, NIH, Bethesda, MD, ⁴Rehabilitation Medicine Department, Physical Therapy Section, Clinical Research Center, NIH, Bethesda, MD, ⁵Biostatistics and Clinical Epidemiology Service, Clinical Center, NIH, Bethesda, MD, ⁶Office of Clinical Director, NIAMS, NIH, Bethesda, MD, ⁷National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, Bethesda, MD, ⁸Environmental Autoimmunity Group, Clinical Research Branch, NIEHS, NIH, Garrett Park, MD
Background/Purpose: Juvenile dermatomyositis (JDM) is a systemic autoimmune disease with a prominent interferon (IFN) signature. Treatment often requires prolonged high-dose steroids and other immunosuppressive medications.…
Abstract Number: 0209 • ACR Convergence 2020
Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks
Josef Smolen¹, Paul Emery², William Rigby³, Yoshiya Tanaka⁴, Juan Vargas⁵, Nemanja Damjanov⁶, Manish Jain⁷, Yanna Song⁸, Nasser Khan⁹, Jeffrey Enejosa⁹ and Stanley Cohen¹⁰, ¹Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK, Leeds, United Kingdom, ³Dartmouth College, Norwichi, VT, ⁴The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Quantum Research, Puerto Varas, Chile, ⁶University of Belgrade Medical School, Belgrade, Serbia, ⁷Great Lakes Clinical Trials, Chicago, IL, ⁸AbbVie Inc., North Chicago,, IL, ⁹AbbVie Inc., North Chicago, IL, ¹⁰Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In the SELECT-MONOTHERAPY trial, upadacitinib (UPA), an oral JAK inhibitor, demonstrated significantly greater efficacy compared to continuing methotrexate (MTX) when used as monotherapy over…
Abstract Number: 0347 • ACR Convergence 2020
In Two Phase-3 Trials, Guselkumab Reduced Fatigue over 52 Weeks in Patients with Psoriatic Arthritis and Demonstrated Independent Treatment Effects on Fatigue After Adjustment for Clinical Response (ACR20)
Proton Rahman¹, Philip Helliwell², Atul Deodhar³, Alexa Kollmeier⁴, Elizabeth Hsia⁵, Bei Zhou⁶, Xiwu Lin⁶, Chenglong Han⁶ and Philip Mease⁷, ¹Memorial University of Newfoundland, Department of Medicine, St John's, Canada, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Oregon Health & Science University, Portland, OR, ⁴Janssen Research & Development, LLC, La Jolla, CA, ⁵Janssen Research & Development, LLC and University of Pennsylvania Medical Center, Spring House, PA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Seattle Rheumatology Associates, P.L.L.C., Seattle, WA
Background/Purpose: DISCOVER 1 & 2 are phase-3 trials of guselkumab (GUS, an IL-23 inhibitor) in patients with psoriatic arthritis (PsA). In both trials, treatment with…
Abstract Number: 0649 • ACR Convergence 2020
A Multicenter, Open-Label, Efficacy and Safety Study of Pegloticase in Patients with Uncontrolled Gout Who Have Undergone Kidney Transplantation: Early Data Report
Abdul Abdellatif¹, Lin Zhao², Paul Peloso³, Katya Cherny², Brad Marder², John Scandling⁴ and Kenneth Saag⁵, ¹Baylor College of Medicine, Division of Nephrology, Houston, TX, ²Horizon Therapeutics plc, Lake Forest, IL, ³Horizon Therapeutics plc, Gurnee, IL, ⁴Stanford Medicine, Department of Nephrology, Stanford, CA, ⁵University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, Birmingham, AL
Background/Purpose: Gout’s high prevalence in kidney transplant (KT) recipients has been associated with heavy residual urate burden, decreased urate excretion related to reduced renal function,…
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…

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