Abstracts tagged "Randomized Trial"

Abstract Number: L14 • ACR Convergence 2023
Efficacy and Safety of Benralizumab Compared with Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Patients Receiving Standard of Care Therapy: Phase 3 MANDARA Study
Michael Wechsler¹, Parameswaran Nair², Benjamin Terrier³, Bastian Walz⁴, Arnaud Bourdin⁵, David Jayne⁶, David Jackson⁷, Florence Roufosse⁸, Lena Börjesson Sjö⁹, Ying Fan¹⁰, Maria Jison¹⁰, Christopher McCrae¹¹, Sofia Necander⁹, Anat Shavit¹², Claire Walton¹² and Peter Merkel¹³, ¹National Jewish Health, Denver, CO, ²McMaster University, Hamilton, ON, Canada, ³Cochin Hospital, Paris, France, ⁴University of Tübingen, Kirchheim-Teck, Germany, ⁵University of Montpellier, CHU Montpellier, INSERM, Montpellier, Montpellier, France, ⁶Addenbrooke's Hospital, Cambridge, United Kingdom, ⁷Guy's Severe Asthma Centre, School of Immunology & Microbial Sciences, King's College London,, London, United Kingdom, ⁸Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, ⁹Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gaithersburg, MD, ¹¹Translational Science & Experimental Medicine, Early Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ¹²BioPharmaceutials Medical, AstraZeneca, Cambridge, United Kingdom, ¹³University of Pennsylvania, Philadelphia, PA
Background/Purpose: Eosinophilic inflammation is a key pathophysiological mechanism of eosinophilic granulomatosis with polyangiitis (EGPA). Oral glucocorticoids (OGCs) and immunosuppressants remain the basis for the standard…
Abstract Number: L10 • ACR Convergence 2023
Dazodalibep, a CD40L Antagonist, in a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Subjects with Sjögren’s Disease Having Unacceptable Symptomatic Burden but Limited Extraglandular Organ Involvement
E. William St. Clair¹, Liangwei Wang², Ilias Alevizos², William A. Rees², Alan N. Baer³, Wan-Fai Ng⁴, Ghaith Noaiseh⁵ and Chiara Baldini⁶, ¹Department of Medicine, Duke University Medical Center, Durham, NC, USA, Durham, NC, ²Horizon Therapeutics plc, Rockville, MD, ³Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA, Baltimore, MD, ⁴Translational and Clinical Research Institute, Newcastle University, Newcastle, United Kingdom, ⁵Division of Allergy, Clinical Immunology and Rheumatology, Department of Medicine, University of Kansas, Kansas City, KS, USA, Kansas CIty, KS, ⁶Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy
Background/Purpose: Dazodalibep (DAZ) is a non-antibody fusion protein that acts as a CD40L antagonist and blocks costimulatory signals between immune cells, including T cells, B…
Abstract Number: L15 • ACR Convergence 2023
AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography
Robert Keenan¹, James Cheng-Chung WEI², Sarah Morris³, Pamella Mundell³, Wen Wei³, Ke Shi³, Zancong Shen³, Vijay Hingorani⁴, Shunqi Yan³, Bahram Kiani⁵ and Litain Yeh³, ¹Arthrosi Therapeutics, Inc., Chapel Hill, NC, ²Chung Shan Medical University, Taichung, Taiwan (Republic of China), ³Arthrosi Therapeutics, Inc., San Diego, CA, ⁴Vanguard Healthsciences, Inc., San Diego, CA, ⁵Wake Forest University School of Medicine, Winston-Salem, NC
Background/Purpose: AR882 is a novel and selective URAT1 inhibitor currently in clinical stage development for the treatment of gout and tophaceous gout and has demonstrated…
Abstract Number: L12 • ACR Convergence 2023
Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis
Alan Kivitz¹, Elena Tomaselli Muensterman², Arthur Kavanaugh³, Désirée van der Heijde⁴, Piotr A. Klimiuk⁵, Guillermo Valenzuela⁶, Eva Dokoupilova⁷, Gabrielle Poirier⁸, Bhaskar Srivastava⁸, Sue Dasen⁸, Xinyan Zhang⁸, Mona Trivedi², Haoling Holly Weng⁹, Ting Hong¹⁰, Peter Pothula¹⁰ and Xenofon Baraliakos¹¹, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Takeda Development Center Americas, Inc., Cambridge, MA, ³Division of Rheumatology, Allergy & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ⁵Department of Rheumatology and Internal Diseases, Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Białystok, Poland, ⁶Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁷Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University and MEDICAL PLUS, s.r.o., Brno and Uherské Hradiště, Czech Republic, ⁸Nimbus Discovery, Inc., Boston, MA, ⁹HW MedAdvice LLC, San Diego, CA, ¹⁰Takeda Development Center Americas, Inc., Boston, MA, ¹¹Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany
Background/Purpose: TYK2 mediates signaling by key cytokines involved in the pathogenesis of immune-mediated inflammatory diseases such as psoriatic arthritis (PsA) and psoriasis (PsO). TAK-279 is…
Abstract Number: L16 • ACR Convergence 2023
Withdrawal of Immunosuppressant and Low-dose Steroids in IgG4-RD Patients with Stable Disease (WInS IgG4-RD): An Investigator-initiated, Multi-center, Open-label, Randomized Controlled Trial
Linyi Peng¹, Yuxue nie¹, Jiaxin Zhou¹, Lijun Wu², Fang Wang³, Xiaomei Chen⁴, Jieqiong Li¹, Yu Peng¹, Hui Lu¹, Lidan Zhao¹, Mengtao Li¹, Yan Zhao¹, Xiaofeng Zeng⁵, Yunyun Fei¹ and Wen Zhang¹, ¹Peking Union Medical College Hospital，Department of Rheumatology and Clinical Immunology, National Clinical Research Center for Dermatologic and Immunologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Beijing, China, ²Xinjiang Uygur Autonomous Region People's Hospital, XinJiang, China, ³Beijing Hospital, Beijing, China, ⁴Xinjiang Uygur Autonomous Region People's Hospital, Wulumuqi, China, ⁵Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China
Background/Purpose: IgG4-related disease (IgG4-RD) is a fibroinflammatory disease. Remission induction treatment with glucocorticoid (GC) is usually effective, but its tendency of relapse makes the strategy…
Abstract Number: 0595 • ACR Convergence 2023
Renal Involvement in Patients with Systemic Lupus Erythematosus Treated with Anifrolumab Compared with Placebo over a 4-Year Period
Richard A. Furie¹, Kenneth Kalunian², Eric Morand³, Ian Bruce⁴, Susan Manzi⁵, Gelareh Atefi⁶, Gary Bryant⁶, Micki Hultquist⁷, Raj Tummala⁷, Gabriel Abreu⁸, Catharina Lindholm⁸ and Hussein Al-Mossawi⁹, ¹Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ²University of California San Diego, La Jolla, CA, ³Monash University, Centre for Inflammatory Diseases, Melbourne, Australia, ⁴University of Manchester, Manchester, United Kingdom, ⁵Lupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, PA, ⁶BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, ⁷BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁸BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁹BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: In patients with SLE, nephritis is present in 50%–60% during the first 10 years of disease.1 Renal involvement is associated with poor clinical outcomes…
Abstract Number: 1431 • ACR Convergence 2023
Izokibep, a Unique IL-17A Inhibitor, Improves Patient-Reported Outcomes in Patients with Active Psoriatic Arthritis up to Week 46 – Phase 2 RCT Results
Peter C. Taylor¹, Kurt de Vlam², Philip J. Mease³, Paul M. Peloso⁴, Dieter Wetzel⁵, Apinya Lertratanakul⁶, Nikolai Brun⁷, Brian Wiens⁸, Jan Brandt-Juergens⁹, Edit Drescher¹⁰, Eva Dokoupilova¹¹, Anna Rowińska-Osuch¹², Nadia Abdel-Kader Martin¹³ and Frank Behrens¹⁴, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²University Hospitals Leuven, Leuven, Belgium, ³Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁴ACELYRIN, INC., Naples, FL, ⁵toclinco GmbH, Freiburg im Breisgau, Germany, ⁶ACELYRIN, Chicago, IL, ⁷Affibody AB, Solna, Sweden, ⁸ACELYRIN, Inc., Half Moon Bay, CA, ⁹rheumatologische Schwerpunktpraxis, Berlin, Germany, ¹⁰Csolnoky Ferenc Hospital / Vital Medical Center Private Clinci, Veszprém, Hungary, ¹¹Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology; MEDICAL PLUS sro, Brno, Czech Republic, ¹²ETG Warszawa, Warsaw, Poland, ¹³Hospital Quironsalud Infanta Luisa, Sevilla, Spain, ¹⁴Goethe University, Division of Rheumatology, University Hospital and Fraunhofer Institute for Translational Medicine & Pharmacology, Frankfurt, Germany
Background/Purpose: Izokibep is a novel small protein IL-17A inhibitor, unique for its high IL-17A binding affinity, a small size at 18.6 kD and albumin binding…
Abstract Number: 1988 • ACR Convergence 2023
Extended-Release versus Immediate-Release Triamcinolone Acetonide for Osteoarthritis of the Knee with Comorbid Diabetes Type 2 Diabetes Mellitus: A Post Hoc Analysis
Andrew Spitzer¹, Helena Rodbard², Sheikh Usman Iqbal³, Masato Nakazawa³, Mary DiGiorgi³ and Roy Winston³, ¹Cedars-Sinai Medical Center, Los Angeles, CA, ²Endocrine and Metabolic Consultants, Rockville, MD, ³Pacira BioSciences, Inc., Tampa, FL
Background/Purpose: Intraarticular (IA) corticosteroids are generally considered safe and effective to treat osteoarthritis of the knee (OAK) but may cause hyperglycemia that may last for…
Abstract Number: 2543 • ACR Convergence 2023
Clinical and Radiographic Results of Tapering and Withdrawing CsDMARDs versus Stable Treatment in Patients with Rheumatoid Arthritis in Remission: 3-year Results from a Randomized Controlled Trial
Kaja Eriksrud Kjørholt¹, Nina Paulshus Sundlisæter¹, Anna-Birgitte Aga¹, Joseph Sexton¹, Inge Olsen², Hallvard Fremstad³, Cristina Spada⁴, Tor Magne Madland⁵, Christian A Høili⁶, Gunnstein Bakland⁷, Åse Lexberg⁸, Inger Johanne Widding Hansen⁹, Inger Myrnes Hansen¹⁰, Hilde Haukland¹¹, Maud-Kristine Aga Ljoså¹², Ellen Moholt¹, Till Uhlig¹, Tore Kvien¹, Daniel Solomon¹³, Désirée van der Heijde¹⁴, Espen Haavardsholm¹ and Siri Lillegraven¹, ¹Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ²Oslo University Hospital, Oslo, Norway, ³Møre og Romsdal Hospital Trust, Ålesund, Norway, ⁴Lillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway, ⁵Haukeland University Hospital, Bergen, Norway, ⁶Østfold Hospital Trust, Moss, Norway, ⁷University Hospital of North Norway, Tromsø, Norway, ⁸Drammen Hospital, Vestre Viken HF, Drammen, Norway, ⁹Sørlandet Hospital HF, Kristiansand, Norway, ¹⁰Helgeland Hospital Trust Mo i Rana, Mo i Rana, Norway, ¹¹Martina Hansens Hospital, Bærum, Norway, ¹²Ålesund Hospital, Ålesund, Norway, ¹³Brigham and Women's Hospital, Newton, MA, ¹⁴Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Tapering of disease-modifying antirheumatic drugs (DMARDs) to achieve drug-free remission is a potential goal for the growing group of patients with rheumatoid arthritis (RA)…
Abstract Number: 0597 • ACR Convergence 2023
Efficacy of Anifrolumab in Systemic Lupus Erythematosus by Overall and Organ-Specific SLEDAI-2K Improvements: Results from the Randomized, Placebo-Controlled Phase 3 Long-Term Extension Study
Richard A. Furie¹, Kenneth Kalunian², Eric Morand³, Ian Bruce⁴, Susan Manzi⁵, Yoshiya Tanaka⁶, Kevin Withrop⁷, Ihor Hupka⁸, Micki Hultquist⁹, Raj Tummala⁹, Gabriel Abreu¹⁰, Catharina Lindholm¹⁰ and Hussein Al-Mossawi¹¹, ¹Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ²University of California San Diego, La Jolla, CA, ³Monash University, Centre for Inflammatory Diseases, Melbourne, Australia, ⁴University of Manchester, Manchester, United Kingdom, ⁵Lupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, PA, ⁶University of Occupational and Environmental Health, Kitakyushu, Japan, ⁷Oregon Health & Science University, Schools of Medicine and Public Health,, Portland, OR, ⁸BioPharmaceuticals R&D, AstraZeneca, Warsaw, Poland, ⁹BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ¹⁰BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹¹BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: SLE is a systemic autoimmune disease requiring long-term treatment. In this placebo-controlled phase 3 TULIP long-term extension (LTE) study,1 the impact of anifrolumab in…
Abstract Number: 1432 • ACR Convergence 2023
Experiences and Perspectives of Patients with Psoriatic Arthritis Participating in a Randomized Controlled Trial of Dietary Interventions
Lihi Eder¹, Sanjana Tarannum², Kathleen Bush³, Sarah Cohen⁴, Charlene Compher⁴, Helen Emanoilidis², Sarah Gillespie³, Dafna Gladman⁵, Vinod Chandran⁶, Jose Scher⁷ and Alexis R Ogdie⁴, ¹Women’s College Research Institute, Division of Rheumatology, University of Toronto, Toronto, ON, Canada, ²Women's College Hospital, Toronto, ON, Canada, ³Division of Rheumatology, University of Pennsylvania School of Medicine, Philadelphia, PA, ⁴University of Pennsylvania, Philadelphia, PA, ⁵Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada, ⁶Schroeder Arthritis Institute, Krembil Research Institute, University Health Network and Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, ON, Canada, ⁷New York University School of Medicine, New York, NY
Background/Purpose: Dietary Interventions in psoriatic arthritis (DIPSA) is a randomized controlled trial (RCT) assessing the efficacy of dietary modifications in patients with psoriatic arthritis (PsA).…
Abstract Number: 1997 • ACR Convergence 2023
A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis
Richard Eastell¹, Bente Langdahl², Yoon-Sok Chung³, Rafal Plebanski⁴, Edward Czerwinski⁵, Eva Dokoupilova⁶, Jerzy Supronik⁷, Jan Rosa⁸, Anna Rowińska-Osuch⁹, Ki-Hyun Baek¹⁰, Audrone Urboniene¹¹, Sohui Ahn¹², Younghee Rho¹² and Jisuk Ban¹², ¹University of Sheffield, Sheffield, United Kingdom, ²Aarhus University Hospital, Aarhus, Denmark, ³Ajou University Hospital, Suwon, South Korea, ⁴Klinika Zdrowej Kosci, Łódź, Poland, ⁵Futuremeds, Krakowskie Centrum Medyczne sp z oo, Krakow, Poland, ⁶Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology; MEDICAL PLUS sro, Brno, Czech Republic, ⁷OsteoMedic sc A Racewicz J Supronik, Bialystok, Poland, ⁸Affidea Praha, s.r.o.; Faculty of Medicine in Hradec Kralove, Charles University, Prague; Hradec Kralove, Czech Republic, ⁹ETG Warszawa, Warszawa, Poland, ¹⁰Yeouido ST. Mary's Hospital, Seoul, South Korea, ¹¹JSC Saules seimos medicinos centras, Kaunas, Lithuania, ¹²Samsung Bioepis, Incheon, South Korea
Background/Purpose: SB16 is a human monoclonal antibody to the receptor activator of nuclear factor κΒ ligand that has been developed as a proposed biosimilar to…
Abstract Number: 0623 • ACR Convergence 2023
Nailfold Capillaroscopy in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Treated with Nintedanib
Vanessa Smith¹, Christopher Denton², Ariane Herrick³, Carina Ittrich⁴, Margarida Alves⁵ and Maurizio Cutolo⁶, ¹Ghent University Hospital, Gent, Belgium, ²University College London, London, United Kingdom, ³University of Manchester, Salford, United Kingdom, ⁴Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany, Biberach an der Riss, Germany, ⁵Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, ⁶Laboratory of Experimental Rheumatology, Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino Polyclinic, Genova, Italy
Background/Purpose: Microvascular damage is part of the pathogenesis of systemic sclerosis and is associated with internal organ involvement. Nintedanib is a tyrosine kinase inhibitor approved…
Abstract Number: 1515 • ACR Convergence 2023
Performance of the Revised CRISS in a Phase 3 Trial of Early Systemic Sclerosis
Dinesh Khanna¹, Christopher Denton², Masataka Kuwana³, Daniel Furst⁴, Suiyuan Huang¹, Barbara White⁵ and Robert Spiera⁶, ¹University of Michigan, Ann Arbor, MI, ²University College London, London, United Kingdom, ³Nippon Medical School Graduate School of Medicine, Tokyo, Japan, ⁴University of California Los Angeles, Los Angeles, CA, ⁵SFJ Pharmaceuticals, Towson, MD, ⁶Hosptial for Special Surgery, New York, NY
Background/Purpose: Revised CRISS has been proposed an approvable outcome measure in early diffuse cutaneous SSc (dcSSc)1. The index is undergoing the FDA review as part…
Abstract Number: 2113 • ACR Convergence 2023
Impact of Sociodemographic Factors on Efficacy and Safety of Tofacitinib in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of Phase 2/3/3b/4 Studies
Grace Wright¹, Eduardo Mysler², Kevin Roberts³, Lindsay Sweet⁴ and Ahmed Shelbaya⁵, ¹Grace C Wright MD PC, New York, NY, ²Organizacion Medica de Investigacion, Buenos Aires, Argentina, ³Pfizer Inc., Cambridge, MA, ⁴Pfizer Inc., Collegeville, PA, ⁵Pfizer Inc., New York, NY
Background/Purpose: Sociodemographic factors can impact treatment response and safety outcomes in patients (pts) with RA. Here, we explore the impact of sociodemographic index (SDI) on…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM CT on October 25. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].