ACR Meeting Abstracts

ACR Meeting Abstracts

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Abstracts tagged "Randomized Trial"

  • Abstract Number: L15 • ACR Convergence 2022

    Effect of Secukinumab versus Adalimumab Biosimilar on Radiographic Progression in Patients with Radiographic Axial Spondyloarthritis: A Randomized Phase IIIb Study

    Xenofon Baraliakos1, Mikkel Østergaard2, Denis Poddubnyy3, Désirée van der Heijde4, Atul Deodhar5, Pedro M. Machado6, Victoria Navarro-Compán7, Kay Geert Hermann8, Mitsumasa Kishimoto9, Eun Young Lee10, Lianne S Gensler11, Uta Kiltz1, Marco Eigenmann12, Patricia Pertel13, Aimee Readie14, Hanno B. Richards12, Brian Porter15 and Juergen Braun1, 1Rheumazentrum Ruhrgebiet, Herne, Ruhr-Universität Bochum, Bochum, Nordrhein-Westfalen, Germany, 2Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark, 3Charité - Universitätsmedizin Berlin and German Rheumatism Research Centre, Berlin, Germany, 4Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 5Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, 6Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, 7Department of Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, 8Department of Radiology, University Hospital Charité - Campus Mitte, Charitéplatz, Berlin, Germany, 9Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, 10Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea, 11Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, CA, 12Novartis Pharma AG, Basel, Switzerland, 13Novartis Pharma AG, Reinach, Switzerland, 14Novartis Pharmaceuticals Corporation, East Hanover, NJ, 15Novartis Pharmaceuticals Corporation, Far Hills, NJ

    Background/Purpose: Biologics are clinically efficacious in patients (pts) with axial spondyloarthritis (axSpA) including radiographic axSpA (r-axSpA). Limited data exist on the effect of biologics in…
  • Abstract Number: L05 • ACR Convergence 2022

    Effect of Denosumab on Structure Modification in Erosive Hand Osteoarthritis: Results of a 48-Week, Monocentric, Randomized, Placebo-controlled, Double-blind Phase 2 Study and Open Label Extension Phase

    Ruth Wittoek1, August Verbruggen2, Tine Vanhaverbeke2 and Dirk Elewaut3, 1Dept. of Rheumatology, Ghent University Hospital, Ghent University, Ghent, Oost-Vlaanderen, Belgium, 2Ghent University Hospital, Ghent, Belgium, 3Ghent University and VIB Center for Inflammation Research, Ghent, Belgium

    Background/Purpose: Erosive hand osteoarthritis (OA) is a disabling disease with limited therapeutic options. Denosumab, a Receptor Activator of Nuclear Factor kappa-b Ligand inhibitor, affects bone…
  • 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: 0763 • ACR Convergence 2022

    Immunogenicity Analysis from the VOLTAIRE Trials in Patients with Rheumatoid Arthritis, Crohn’s Disease, and Chronic Plaque Psoriasis

    Vibeke Strand1, Shaun Bender2 and Dorothy McCabe3, 1Stanford University School of Medicine, Stanford, CA, 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, 3Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT

    Background/Purpose: The VOLTAIRE trials program compared the safety, efficacy, and immunogenicity of biosimilar BI 695501 with adalimumab reference product (RP) for indications including moderate-severely active…
  • Abstract Number: 1894 • ACR Convergence 2022

    A Phase 2, 104-Week Study of Repeat Lorecivivint Injections Evaluating Safety, Efficacy, and Bone Health Utilizing Quantitative Computed Tomography (qCT) in Knee Osteoarthritis (OA-06)

    Yusuf Yazici1, Christopher Swearingen2, Heli Ghandehari3, Jon Britt4, ismail simsek5, Mark Fineman6, Sarah Kennedy2, Jeyanesh Tambiah7 and Nancy Lane8, 1New York University School of Medicine, La Jolla, CA, 2Biosplice Therapeutics, Inc, San Diego, CA, 3Biosplice Therapeutics, Inc., San Diego, CA, 4Biosplice Therapeutics, Inc., Los Angeles, CA, 5Alpine Immunesciences, San Diego, CA, 6Biosplice Therapeutics, San Diego, CA, 7Biosplice Ther Inc., San Diego, CA, 8University of California Davis, Hillsborough, CA

    Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There is a large unmet need for safe and…
  • Abstract Number: 0997 • ACR Convergence 2022

    Withdrawal of Maintenance Glucocorticoid versus Other Immunosuppressants Among Patients with Systemic Lupus Erythematosus in Long Term Clinical Remission: Interim Analysis of a Non-inferiority Randomised Controlled Trial

    Aishwarya Gopal1, Chengappa Kavadichanda2, Devender Bairwa3, Molly Mary Thabah4 and Vir Singh Negi5, 1Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, Puducherry, India, 2JIPMER, Pondicherry, Puducherry, India, 3Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, Puducherry, India, 4JIPMER, Puducherry, Puducherry, India, 5AIIMS Bilaspur, Puducherry, Puducherry, India

    Background/Purpose: Attempts to stop glucocorticoids among Systemic Lupus Erythematosus(SLE) patients in long term remission have been successful. Continuing other immunosuppressive (IS) agents indefinitely is currently…
  • Abstract Number: 1899 • ACR Convergence 2022

    A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (OA-10) to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

    Yusuf Yazici1, Christopher Swearingen2, Heli Ghandehari3, Victor Lopez4, ismail simsek5, Mark Fineman6, Sarah Kennedy7, Jeyanesh Tambiah8 and Timothy McAlindon9, 1New York University School of Medicine, La Jolla, CA, 2Samumed LLC, San Diego, CA, 3Biosplice Therapeutics, Inc., San Diego, CA, 4Biosplice Therapeutics, Santa Clarita, CA, 5Alpine Immunesciences, San Diego, CA, 6Biosplice Therapeutics, San Diego, CA, 7Biosplice Therapeutics, Inc, San Diego, CA, 8Biosplice Ther Inc., San Diego, CA, 9Tufts Medical Center, Arlington, MA

    Background/Purpose: Knee osteoarthritis (OA) is a common joint disorder associated with pain, disability, and joint damage. There remains a large unmet need for treatments that…
  • Abstract Number: 1001 • ACR Convergence 2022

    Effect of Atacicept on Renal Function in Patients with Systemic Lupus Erythematosus (SLE)

    David Isenberg1, Celia Lin2, Amy Kao3, Aida Aydemir4 and Caroline Gordon5, 1University College London, London, United Kingdom, 2Vera Therapeutics, Inc, Burlingame, CA, 3EMD Serono, Billerica, MA, 4EMD Serono Research & Development Institute, Inc, Billerica, MA, 5Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom

    Background/Purpose: Atacicept is a fusion protein that blocks B-lymphocyte stimulator and a proliferation-inducing ligand, which are increased in patients with SLE. APRIL-SLE was a double-blind,…
  • Abstract Number: 1960 • ACR Convergence 2022

    Impact of Delaying Initiation of Methotrexate by One Month on the Outcome of RA at One Year

    Theresa Than1, Emmanuelle Dernis2, Olivier BROCQ3, Bruno Fautrel4, Helena HUGUET5, Liana Euller-Ziegler6, Lindsay BUSTAMENTE-CENCI6, Olivier Vittecoq7, Marie-christine PICOT5, Cédric Lukas8, Claire DAIEN9, Charlotte Hua10, Marlène Genty5, Helene Che5, Anouck REMY-MOULARD11, Frederic LIOTE12, Martin Soubrier13, Cécile GAUJOUX-VIALA14, Arnaud Constantin15, Alain Saraux16, Emilie Ducourau17, Stephanie RIST18, CARINE SALLIOT19, Nada IBRAHIM-NASSER18, Clara qUINTEN18, Vincent Goeb20 and Jacques Morel1, 1University and CHU Montpellier, Montpellier, France, 2LE MANS general hospital, LE MANS, France, 3Centre hospitalier Princesse-Grace, Monaco, France, 4Sorbonne University Paris, France and Pierre Louis Institute of Epidemiology and Public Health, Paris, France, Paris, France, 5CHU Montpellier, Montpellier, France, 6CHRU Nice, Nice, France, 7CHU de Rouen, ROUEN, France, 8University Hospital Centre Montpellier, University of Montpellier, Montpellier, France, 9University Hospital, Saint-Gély-du-Fesc, France, 10La Lettre du Rhumatologue, Paris, France, 11CHU Montpellier, Montpellier, Chad, 12University of Paris, Paris, France, 13Gabriel-Montpied Hospital, Clermont-Ferrand, France, 14CHU Nîmes, Univ Montpellier (IDESP), Nîmes, France, 15Toulouse University Hospital, Toulouse, France, 16CHU Brest, Brest, France, 17CH Orleans, Chambray Les Tours, France, 18CH orleans, Orleans, France, 19CHR orleans, Orleans, France, 20CHU Amiens, Amiens, France

    Background/Purpose: It is recommended that vaccinations should be performed prior to start methotrexate (MTX) knowing that delaying initiation of background therapy may have an impact…
  • Abstract Number: 0173 • ACR Convergence 2022

    Cutaneous Manifestations, Clinical Trials, Safety Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis

    Victoria Werth1, Barbara White2, Josef Concha3, Josh Dan1, Nancy Dgetluck2, Kathleen Hally2, Scott Constantine2, Rohit Aggarwal4, David Fiorentino5, Ingrid Lundberg6 and Chester Oddis7, 1Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, 2Corbus Pharmaceuticals, Norwood, MA, 3Universiity of Pennsylvania/Dermatology, Philadelphia, PA, 4University of Pittsburgh, Division of Rheumatology, Pittsburgh, PA, 5Stanford university/Department of Dermatology, Palo Alto, CA, 6Karolinska Institute, Stockholm, Sweden, 7University of Pittsburgh, Pittsburgh, PA

    Background/Purpose: Safe and effective treatments are of significant unmet need in DM. Lenabasum, a CB2 agonist that activates resolution of inflammation, improved skin disease, patient-reported…
  • Abstract Number: 1007 • ACR Convergence 2022

    Metabolic Disorders and Abnormal Dietary Patterns and Their Association with Psoriatic Arthritis Activity: The Dietary Intervention in PsA (DIPSA) Study

    Lihi Eder1, Charlene Compher2, Helen Emanoilidis3, Ryan F. Quinn2, Dafna Gladman4, Vinod Chandran5, Jose Scher6 and Alexis Ogdie7, 1Women’s College Research Institute, Department of Medicine, University of Toronto, Toronto, ON, Canada, 2University of Pennsylvania, Philadelphia, PA, 3Women's College Hospital, Toronto, ON, Canada, 4Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, 5Departments of Medicine and Laboratory Medicine and Pathobiology, University of Toronto/ Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, ON, Canada, 6New York University School of Medicine, New York, NY, 7Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

    Background/Purpose: Psoriatic Arthritis (PsA) is associated with obesity and its related metabolic abnormalities. The role of diet as an adjunct therapy in PsA remains unclear.…
  • Abstract Number: 1985 • ACR Convergence 2022

    The BEGIN Study: A Double-blind, Multi-center, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks of Treatment with AP1189 in Early Rheumatoid Arthritis (RA) Patients with Active Joint Disease

    Thomas Jonassen1, Irene Sandholdt2, Birgitte Telmer2 and Ellen-Margrethe Hauge3, 1SynAct Pharma, Holte, Denmark, 2CroxxMed, Hørsholm, Denmark, 3Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark

    Background/Purpose: Melanocortin (MC) type 1 and type 3 receptor stimulation is associated with anti-inflammatory activity and the promotion of inflammatory resolution. AP1189 is novel biased…
  • Abstract Number: 0199 • ACR Convergence 2022

    Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes – 16-Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis

    Peter Taylor1, Frank Behrens2, Philip J Mease3, Dieter Wetzel4, Paul Peloso5, Nicolai Brun4, Brian Wiens6, Jan Brandt-Juergens7, Edit Drescher8, Eva Dokoupilova9, Anna Rowińska-Osuch10, Nadia Abdel- Kader Martin11 and Kurt de Vlam12, 1University of Oxford, Oxford, United Kingdom, 2Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany, 3Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, 4Affibody AB, Solna, Sweden, 5ACELYRIN, Naples, FL, 6ACELYRIN, Inc., Los Angeles, CA, 7Rheumatologische Schwerpunktpraxis, Berlin, Germany, 8Veszprem Megyei Csolnoky Ferenc Korhaz, Budapest, Hungary, 9Medical Plus, s.r.o. & Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Brno, Prague, Czech Republic, 10ETG Network - Rheumatology, Warsaw, Poland, 11Hospital Infanta Luisa Quiron, Rheumatology, Sevilla, Spain, 12University Hospitals Leuven, Leuven, Belgium

    Background/Purpose: Izokibep is a unique IL-17A inhibitor with high potency and small molecular size designed to overcome the limitations of monoclonal antibodies. IL-17 is a…
  • Abstract Number: 1036 • ACR Convergence 2022

    Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by History of Cigarette Smoking

    Alexis Ogdie1, Lars Erik Kristensen2, Enrique R Soriano3, Servet Akar4, Yanhui Sun5, David Gruben6, Lara Fallon7, Cassandra D Kinch8 and Dafna Gladman9, 1Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 2The Parker Institute, Copenhagen University Hospital, Copenhagen, Denmark, 3Rheumatology Unit and University Institute, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, 4Izmir Katip Celebi University School of Medicine, Izmir, Turkey, 5Pfizer CRDC, Shanghai, China, 6Pfizer Inc, Groton, CT, 7Pfizer Inc, Montréal, QC, Canada, 8Pfizer Canada ULC, Kirkland, Canada, 9Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada

    Background/Purpose: In patients (pts) with PsA and AS, smoking may be associated with an increased comorbidity burden, and greater responses to TNF inhibitors (TNFi) are…
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