ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: L02 • ACR Convergence 2022

    Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study

    Christopher Ritchlin1, Laura Coates2, Iain McInnes3, Philip J. Mease4, Joseph Merola5, Yoshiya Tanaka6, Akihiko Asahina7, Laure Gossec8, Alice Gottlieb9, Diamant Thaci10, Barbara Ink11, Deepak Assudani11, Rajan Bajracharya11, Vish Shende11, Jason Coarse12 and Robert Landewé13, 1University of Rochester Medical Center, Rochester, NY, 2Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, United Kingdom, 3College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom, 4Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, 5Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, 6University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 7Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, 8Sorbonne Universités, UPMC Univ Paris 06, GRC-UPMC 08 (EEMOIS); AP-HP, Hôpital Pitié Salpêtrière, Rheumatology Department, Paris, France, Paris, France, 9Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, 10Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, 11UCB Pharma, Slough, United Kingdom, 12UCB Pharma, Raleigh, NC, 13Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, and Zuyderland MC, Heerlen, Netherlands

    Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy in joints and…
  • Abstract Number: L06 • ACR Convergence 2022

    Risk of Extended Major Adverse Cardiovascular Event Endpoints with Tofacitinib vs TNF Inhibitors in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of a Phase 3b/4 Randomized Safety Study

    Maya H. Buch1, Deepak L. Bhatt2, Christina Charles-Schoeman3, Jon T. Giles4, Ted R. Mikuls5, Gary Koch6, Steven Ytterberg7, Edward Nagy8, Hyejin Jo9, Kenneth Kwok9, Carol A. Connell10, Karim R. Masri11 and Arne Yndestad12, 1Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, 2Division of Cardiovascular Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, 3Division of Rheumatology, Department of Medicine, University of California, Los Angeles, CA, 4Division of Rheumatology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, 5Division of Rheumatology, University of Nebraska Medical Center and VA Nebraska-Western Iowa Health Care System, Omaha, NE, 6Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, 7Division of Rheumatology, Mayo Clinic, Rochester, MN, 8Pfizer Ltd, Tadworth, Surrey, United Kingdom, 9Pfizer Inc, New York, NY, 10Pfizer Inc, Groton, CT, 11Pfizer Inc, Collegeville, PA, 12Pfizer Inc, Oslo, Norway

    Background/Purpose: ORAL Surveillance (NCT02092467; a post-authorization safety study of tofacitinib 5 and 10 mg twice daily [BID] vs TNF inhibitors [TNFi]) found higher risk of…
  • Abstract Number: L07 • ACR Convergence 2022

    Telitacicept, a Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Systemic Lupus Erythematosus (SLE): Results of a Phase 3 Study

    Di Wu1, Jing Li1, Dong Xu1, Li Wang1, Jianmin Fang2, Dan Ross3 and Fengchun Zhang4, 1Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China, Beijing, China, 2Shanghai Tongji Hospital, Tongji University, Shanghai 200065, China School of Life Science and Technology, Tongji University, Shanghai 200092, China, Shanghai, China, 3RemeGen Co., San Diego, CA, 4Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China; Key Laboratory of Rheumatology & Clinical Immunology, Ministry of Education, Beijing, China, Beijing, China

    Background/Purpose: Telitacicept is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor…
  • Abstract Number: L14 • ACR Convergence 2022

    Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies

    Xenofon Baraliakos1, Atul Deodhar2, Désirée van der Heijde3, Marina Magrey4, Walter Maksymowych5, Tetsuya Tomita6, Huji Xu7, Marga Oortgiesen8, Ute Massow9, Carmen Fleurinck10, Alicia M Ellis8, Tom Vaux11, Julie Shepherd-Smith11, Alexander Marten9 and Lianne S Gensler12, 1Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, 2Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, 3Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 4Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, US, Richfield, OH, 5Department of Medicine, University of Alberta, Edmonton, AB, Canada, 6Graduate School of Health Science, Morinomiya University of Medical Science, Osaka City, Osaka City, Osaka, Japan, 7Department of Rheumatology and Immunology, Shanghai Changzheng Hospital, Affiliated to Second Military Medical University, Shanghai, China (People's Republic), 8UCB Pharma, Morrisvile, NC, 9UCB Pharma, Monheim am Rhein, Nordrhein-Westfalen, Germany, 10UCB Pharma, Brussels, Brussels Hoofdstedelijk Gewest, Belgium, 11UCB Pharma, Slough, United Kingdom, 12Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA

    Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL‑17A. In the phase 3 BE MOBILE 1 and 2…
  • 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: 1549 • ACR Convergence 2022

    Toward Safer Glucocorticoid Therapy

    Xingyu Pan1, Qiongqiong Hou1, Jiahui Xu1, Yake Ma1, Jiawen Li1, Min Li1, Jing Su1, Xuerou Shi1, William Bracken2 and David Katz2, 1WuXi AppTec, Nantong, China, 2Sparrow Pharmaceuticals, Portland, OR

    Background/Purpose: SPI-62 is a potent 11b-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor entering Phase 2 development as adjunctive therapy to prednisolone in polymyalgia rheumatica, as well…
  • Abstract Number: 1831 • ACR Convergence 2022

    Establishing a Scientific Bridge to Historic VIOXX to Enable a Reintroduction of Rofecoxib: Pharmacokinetic Evaluation of TRM‑201 (Rofecoxib)

    Judith Boice1, Travis Helm1, Maria Bermudez2, Mark Corrigan1 and Bradford Sippy1, 1Tremeau Pharmaceuticals, Inc, Concord, MA, 2Clinical Pharmacology of Miami, LLC, Miami, FL

    Background/Purpose: TRM-201 (rofecoxib) is a cyclooxygenase-2 (COX-2) selective inhibitor being developed for the treatment of hemophilic arthropathy (HA) and acute migraine. Previously marketed as VIOXX,…
  • Abstract Number: 2000 • ACR Convergence 2022

    Tapering of Long-term, Low Dose Glucocorticoids in Senior Rheumatoid Arthritis Patients: Follow up of the Pragmatic, Multicentre, Placebo-controlled GLORIA Trial

    Abdullah Almayali1, Maarten Boers2, Linda Hartman3, Daniela OPRIS-BELINSKI4, Reinhard Bos5, Marc Kok6, Jose Pereira da Silva7, Eduard N Griep8, Ruth Klaasen9, CF Allaart10, Paul Baudoin11, Hennie Raterman12, Zoltan Szekanecz13, Frank Buttgereit14, Pavol MASARYK15, Willem Lems16, Maurizio Cutolo17 and Marieke ter Wee3, 1Amsterdam University Medical Centers, Vrije Universiteit, Purmerend, Noord-Holland, Netherlands, 2Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, 3Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands, 4Carol Davila University, Bucharest, Romania, 5Medical Centre Leeuwarden, Department of Rheumatology, Leeuwarden, Netherlands, 6Department of Rheumatology and Clinical immunology, Maasstad Hospital, Rotterdam, Netherlands, 7University of Coimbra, Rheumatology, Columbia, Portugal, 8Department of Rheumatology, Antonius Hospital, Leeuwarden, Netherlands, 9Department of Rheumatology, Meander Medical Center, Amersfoort, Netherlands, 10Leiden University Medical Center, Leiden, Netherlands, 11Reumazorg Flevoland, Almere, Netherlands, 12Department of Rheumatology, Northwest Clinics, Alkmaar, Netherlands, 13Division of Rheumatology, Faculty of Medicine, Debrecen, Hungary, 14Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin / DRFZ Berlin, Berlin, Germany, 15National Institute for the Rheumatic Diseases, Piešťany, Slovakia, 16Amsterdam University Medical Centers, Amsterdam, Netherlands, 17Laboratory of Experimental Rheumatology and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy

    Background/Purpose: Guidelines suggest glucocorticoids (GC) should be used as bridge therapy in rheumatoid arthritis (RA), but many patients are on chronic treatment, and the effects…
  • 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: 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…
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