ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 2139 • ACR Convergence 2022

    Sustained Response to Guselkumab Regardless of Baseline Demographic, Disease, and Medication Characteristics in Patients with Active Psoriatic Arthritis and an Inadequate Response to TNF Inhibitors: Results from a Phase 3b Trial

    Iain B McInnes1, Philipp Sewerin2, Mohamed Sharaf3, Michela Efficace4, May Shawi5, Michelle Perate6, Miriam Zimmermann7 and Laura Coates8, 1Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom, 2Rheumazentrum Ruhrgebiet, Ruhr-Universität-Bochum, Herne, Germany, 3Johnson & Johnson, Middle East FZ LLC, Dubai, United Arab Emirates, 4Janssen Cilag SpA, Imperia, Italy, 5Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, 6Janssen Scientific Affairs, LLC, Horsham, PA, 7Janssen Scientific Affairs, LLC, Zug, Switzerland, 8Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom

    Background/Purpose: Guselkumab (GUS) is a human monoclonal antibody targeting the IL-23 p19 subunit. In the Phase 3b COSMOS trial (NCT03796858), GUS significantly improved disease signs/symptoms…
  • Abstract Number: 0036 • ACR Convergence 2022

    Patient-specific and Disease-related Determinants for Cardiovascular Disease (CVD) Risk Stratification in the APPLE (Atherosclerosis Prevention in Paediatric Lupus Erythematosus) Clinical Trial Cohort

    Junjie Peng1, George Robinson1, Stacy P Ardoin2, Laura Schanberg3, Elizabeth Jury1 and Coziana Ciurtin4, 1University College London, London, United Kingdom, 2Division of Rheumatology, Nationwide Children's Hospital and Department of Pediatrics, The Ohio State University, Columbus, OH, 3Duke University Medical Center, Durham, NC, 4Centre for Adolescent Rheumatology Versus Arthritis, Department of Medicine, University College London, London, United Kingdom

    Background/Purpose: The risk of developing cardiovascular disease (CVD) through atherosclerosis in juvenile-onset systemic lupus erythematosus (JSLE) patients is significantly increased. This study aimed to stratify…
  • Abstract Number: 0304 • ACR Convergence 2022

    Rheumatoid Arthritis Patients Who Switched Treatment from Adalimumab to Upadacitinib Demonstrate a Robust Reduction of Inflammation-related Biomarkers: Proteomics Analysis from the SELECT-COMPARE Phase 3 Study

    Thierry Sornasse1, Fang Cai2, Heidi Camp3, In-Ho Song4 and Iain B McInnes5, 1AbbVie, South San Francisco, CA, 2AbbVie, Redwood City, CA, 3Abbvie, Winnetka, IL, 4AbbVie, Inc., North Chicago, IL, 5Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom

    Background/Purpose: Upadacitinib 15 mg QD (UPA), an oral JAK inhibitor, showed greater efficacy compared to adalimumab (ADA) in patients (pts) with active rheumatoid arthritis (RA)…
  • Abstract Number: 0411 • ACR Convergence 2022

    Bimekizumab Improves Signs and Symptoms Including Inflammation in Patients with Active Ankylosing Spondylitis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo Controlled Study

    Désirée van der Heijde1, Xenofon Baraliakos2, Maxime Dougados3, Matthew Brown4, Denis Poddubnyy5, Filip Van den bosch6, Nigil Haroon7, Huji Xu8, Tetsuya Tomita9, Lianne Gensler10, Marga Oortgiesen11, Carmen Fleurinck12, Natasha de Peyrecave13, Thomas Vaux14, Alexander Marten15 and Atul Deodhar16, 1Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Leiden, Netherlands, 2Rheumazentrum Ruhrgebiet Herne, Herne, Germany, 3Department of Rheumatology, Hôpital Cochin, Paris, France, Paris, France, 4Genomics England, London, United Kingdom, 5Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, 6Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium, 7Schroeder Arthritis Institute, University Health Network; University of Toronto, Toronto, ON, Canada, 8Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China, 9Department of Orthopaedic Biomaterial Science, Osaka University Graduate School of Medicine, Osaka, Japan, Suita Osaka, Japan, 10Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, 11UCB Pharma, Raleigh, NC, 12UCB Pharma, Brussels, Belgium, Oosterzele, Belgium, 13UCB Pharma, Brussels, Belgium, 14UCB Pharma, Slough, United Kingdom, 15UCB Pharma, Monheim am Rhein, Germany, 16Oregon Health & Science University, Portland, OR, USA, Portland, OR

    Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. In a phase 2b study, BKZ showed rapid and…
  • Abstract Number: 0890 • ACR Convergence 2022

    Long Term Efficacy of a 2-year MRI Treat-to-target Treatment Strategy on Disease Activity, MRI Inflammation and Physical Function in Rheumatoid Arthritis Patients in Clinical Remission: Five Year Follow-up of the IMAGINE-RA Cohort

    Signe Møller-Bisgaard1, Kim Hørslev-Petersen2, Daniel Glinatsi3, Bo Ejbjerg4, Merete Lund Hetland5, Jakob Møllenbach Møller6, Robin Christensen7, Sabrina Mai Nielsen8, Mikael Boesen9, Kristian Stengaard-Pedersen10, Ole Rintek Madsen11, Bente Jensen12, Jan Alexander Villadsen13, Ellen Margrethe Hauge10, Oliver Hendricks2, Hanne Merete Lindegaard14, Niels Steen Krogh15, Anne Grethe Jurik16, Henrik Thomsen17 and Mikkel Østergaard18, 1Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, 2Department of Rheumatology, Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark, 3Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, 4Department of Rheumatology, Slagelse Hospital, Slagelse, Denmark, 5Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark, 6Department of Radiology, Herlev-Gentofte Hospital, Copenhagen, Denmark, 7Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Denmark, 8The Parker Institute, Section for Biostatistics and Evidence-Based Research, Bispebjerg-Frederiksberg Hospital, Frederiksberg, Denmark, 9Department of Radiology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark, 10Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, 11Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Herlev-Gentofte, Copenhagen, Denmark, 12Center for Rheumatology and Spine Diseases, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark, 13Department of Rheumatology, Silkeborg Hospital, Silkeborg, Denmark, 14Department of Rheumatology, Odense University Hospital, Odense, Denmark, 15ZiteLab ApS, Frederiksberg, Denmark, 16Department of Radiology, Aarhus University Hospital, Aarhus, Denmark, 17Department of Radiology, Herlev and Gentofte Hospital, Copenhagen, Denmark, 18Rigshospitalet, University of Copenhagen, Glostrup, Denmark

    Background/Purpose: Targeting MRI remission in rheumatoid arthritis (RA) patients in clinical remission may improve long term clinical, functional and MRI outcomes. The purpose of the…
  • Abstract Number: 1077 • ACR Convergence 2022

    Safety of Avacopan in ANCA-Associated Vasculitis: Combined Data from Three Clinical Trials

    Pirow Bekker1, Peter Merkel2 and David Jayne3, 1ChemoCentryx, San Juan Capistrano, CA, 2U of Pennsylvania, Philadelphia, PA, 3University of Cambridge, Cambridge, United Kingdom

    Background/Purpose: Avacopan is approved as adjunctive treatment for adults with ANCA-associated vasculitis (AAV). This study aimed to combine and report on data of the safety…
  • Abstract Number: 1579 • ACR Convergence 2022

    The TICOG Study: Tight Control of Gout – A Randomized, Controlled Trial of Targeted versus Conventional Treatment for Gout Including Ultrasonography

    Sarah Black, Natalie McKee, Jonathan McKnight, Annmarie McShane, Adrian Pendleton, Taggart Alister and Gary Wright, Musgrave Park Hospital, Belfast Health and Social Care Trust, Belfast, Northern Ireland, United Kingdom

    Background/Purpose: Gout is a common inflammatory arthritis triggered by deposition of monosodium urate crystals in joints, bone and soft tissues, with a prevalence of 1-4%…
  • Abstract Number: 1832 • ACR Convergence 2022

    Efficacy and Safety Similarity of Biosimilar Adalimumab-aqvh to Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Phase III Study

    Barbara Finck, Helen Tang, Kathy Jensen, Francesca Civoli and Suzanna Tatarewicz, Coherus BioSciences, Redwood City, CA

    Background/Purpose: This study aimed to demonstrate that there were no clinically meaningful differences between adalimumab-aqvh, a US Food and Drug Administration–approved biosimilar, and adalimumab in…
  • Abstract Number: 2008 • ACR Convergence 2022

    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of Dazodalibep (VIB4920/HZN4920) in Patients with Rheumatoid Arthritis Having Inadequate Response to Conventional/Biological DMARDs

    Alan Kivitz1, Liangwei Wang2, Ilias Alevizos2, Michele Gunsior2, Judith Falloon2 and Gabor Illei3, 1Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, 2Horizon Therapeutics, Gaithersburg, MD, 3Horizon Therapeutics, Rockville, MD

    Background/Purpose: Dazodalibep (DAZ), a non-antibody biologic antagonist of CD40L, led to higher/durable response rates vs. placebo (PBO) in a double-blind, Phase 1b trial of patients…
  • Abstract Number: 2142 • ACR Convergence 2022

    Strong Correlation Between Short- vs Long-form Composite Measures of Psoriatic Arthritis Disease Activity in a TNFi-IR Population Treated with Guselkumab: Data from the Phase 3b COSMOS Trial

    William Tillett1, Laura Coates2, Mohamed Sharaf3, Marlies Neuhold4, Elke Theander5, Paul Bergmans6, May Shawi7, Michelle Perate8, Christine Contré9 and Philip Helliwell10, 1Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, 2Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom, 3Johnson & Johnson, Middle East FZ LLC, Dubai, United Arab Emirates, 4Takeda Europe & Canada Business Unit (EUCAN) Medical Affairs, Zurich, Switzerland; formerly at Janssen Scientific Affairs, LLC, Zug, Switzerland, 5Formerly at Janssen Scientific Affairs, LLC, Solna, Sweden, 6Formerly at Janssen, Breda, Netherlands, 7Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, 8Janssen Scientific Affairs, LLC, Horsham, PA, 9Formerly at Janssen Scientific Affairs, LLC, Issy-les-Moulineaux, France, Issy-les-Moulineaux, France, 10Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom

    Background/Purpose: Accurate assessment of psoriatic arthritis (PsA) disease activity in clinical practice requires a feasible, continuous, multidimensional composite instrument to assess key domains of this…
  • Abstract Number: 0089 • ACR Convergence 2022

    Racial Disparities in Rheumatology Clinical Trials

    Pushti Khandwala1, Anila Hussain2 and Irene Tan3, 1Einstein Medical Center Philadelphia, Glen Mills, PA, 2Crozer Chester Medical Center, Glen Mills, PA, 3Einstein Medical Center Philadelphia, Philadelphia, PA

    Background/Purpose: Healthcare disparities exist in patients living with rheumatologic diseases. Factors contributing to disparities include age, sex, race, or sociodemographic variables, each playing a crucial…
  • Abstract Number: 0305 • ACR Convergence 2022

    Effect of Upadacitinib on Bone Erosion Repair in Rheumatoid Arthritis: A Pilot Study

    Ho SO1, Isaac Cheng1, Vivian Hung2 and Lai-shan Tam1, 1The Chinese University of Hong Kong, Hong Kong, China, 2The Chinese University of Hong Kong, Hong Kong, Hong Kong

    Background/Purpose: Blockade of JAK, preferably JAK1, by upadacitinib is a feasible approach to achieve erosion repair as it 1) is approved for the treatment of…
  • Abstract Number: 0419 • ACR Convergence 2022

    Efficacy of Upadacitinib in Patients with Non-Radiographic Axial Spondyloarthritis Stratified by Objective Signs of Inflammation at Baseline

    Walter P Maksymowych1, Xenofon Baraliakos2, Atul Deodhar3, Denis Poddubnyy4, Fabiana Ganz5, Tianming Gao6, Jayne Stigler6, Anna K Shmagel6, Peter Wung6 and Filip Van den bosch7, 1Department of Medicine, University of Alberta, Edmonton, AB, Canada, 2Rheumazentrum Ruhrgebiet Herne, Herne, Germany, 3Oregon Health & Science University, Portland, OR, USA, Portland, OR, 4Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, 5AbbVie, Inc., Luzern, Switzerland, 6AbbVie, Inc., North Chicago, IL, 7Department of Internal Medicine and Paediatrics, Ghent University and VIB Centre for Inflammation Research, Ghent, Belgium

    Background/Purpose: The Phase 3 SELECT-AXIS 2 trial (NCT04169373) assessed the efficacy and safety of upadacitinib (UPA) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Here, we…
  • Abstract Number: 0911 • ACR Convergence 2022

    Peer Coach Intervention to Improve Primary Cardiovascular Disease Screening for Patients with Rheumatoid Arthritis

    Iris Navarro-Millan1, Mackenzie Brown2, Yuliana Domínguez Páez3, Geyanne Lui4, Joan Weiner1, Shelley fritz1, Tien Sydnor-Campbell5, Aberdeen Allen6, Assem Jabri1, Shilpa Venkatachalam7, Kelly Gavigan8, William Benjamin Nowell9, Jeffrey Curtis10, Liana Fraenkel11 and Monika Safford1, 1Weill Cornell Medicine, New York, NY, 2Weill Cornell Medicine, Brooklyn, NY, 3Weill Cornell Medicine, Bronx, NY, 4Albert Einstein College of Medicine, New York, NY, 5Weill Cornell Medicine, Philedelphia, 6Weill Cornell Medicine, Parlin, 7Global Healthy Living Foundation, New York, NY, 8Global Healthy Living Foundation, Upper Nyack, NY, 9Global Healthy Living Foundation, Nyack, NY, 10University of Alabama at Birmingham, Hoover, AL, 11Berkshire Medical Center, Lenox, MA

    Background/Purpose: Only 37% of patients with rheumatoid arthritis (RA) receive screening for cardiovascular disease (CVD) despite their high risk. To improve CVD prevention, we designed…
  • Abstract Number: 1078 • ACR Convergence 2022

    Glucocorticoid Use and Related Adverse Events in ADVOCATE Trial of Avacopan in ANCA-Associated Vasculitis

    Emil De Gomma1, Peter Merkel2, Michael George3, Rennie Rhee3, Andreas Kronbichler4, David Jayne5, Huibin Yue1 and Pirow Bekker1, 1ChemoCentryx, San Juan Capistrano, CA, 2U of Pennsylvania, Philadelphia, PA, 3University of Pennsylvania, Philadelphia, PA, 4Cambridge University, Sale Creek, TN, 5University of Cambridge, Cambridge, United Kingdom

    Background/Purpose: Although the 2021 ACR/VF guidelines for ANCA-associated vasculitis (AAV) recommend reduced-dose glucocorticoids (GCs) over standard-dose GCs (1), this approach still leads to substantial toxicity,…
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