Abstracts tagged "clinical trial"

Abstract Number: 2055 • ACR Convergence 2022
SRI-4 and BICLA: How Well Do They Agree Across Trials of Active Systemic Lupus Erythematosus?
Alfredo Aguirre¹, Mimi Kim², Kosalaram Goteti³, Ying Li³, Amy Kao⁴, Nathalie Franchimont⁵, George Kong⁵, Catherine Barbey⁶, Qing Zuraw⁷, Robert Gordon⁷, David Manner⁸, Maria Silk⁹, Teodora Staeva¹⁰, Hoang Nguyen¹¹, Richard Furie¹², Matthew Linnik¹³ and Maria Dall'Era¹⁴, ¹University of California, San Francisco, San Francisco, CA, ²Albert Einstein College of Medicine, Larchmont, NY, ³EMD Serono, Boston, MA, ⁴EMD Serono, Billerica, MA, ⁵Biogen, Cambridge, MA, ⁶Biogen, Baar, Switzerland, ⁷Janssen Research and Development, LLC, Spring House, PA, ⁸Eli Lilly and Company, Indianapolis, IN, ⁹Eli Lilly, Carmel, IN, ¹⁰Lupus Research Alliance, New York, NY, ¹¹Lupus Research Alliance, Houston, TX, ¹²Northwell Health, Great Neck, NY, ¹³Eli Lilly and Company, San Diego, CA, ¹⁴University of California, Division of Rheumatology, San Francisco, CA
Background/Purpose: The Systemic Lupus Erythematosus Responder Index 4 (SRI-4) and the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) are currently the most…
Abstract Number: 2212 • ACR Convergence 2022
Long-term Efficacy and Safety of Subcutaneous Tocilizumab in Patients with Polyarticular or Systemic Juvenile Idiopathic Arthritis – an Extension Study of 2 Phase 1b Clinical Trials
Hermine Brunner¹, Athimalaipet Ramanan², Gerd Horneff³, Kirsten Minden⁴, Inmaculada Calvo Penades⁵, Mauro Zucchetto⁶, Laura Brockwell⁷, Oliver Gordon⁷ and Fabrizio De Benedetti⁸, ¹Division of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Department of Pediatrics, Cincinnati, OH, ²Bristol Royal Hospital for Children, Bristol, United Kingdom, ³Pediatrics, Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin, Germany, ⁴Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Pediatric Rheumatology Unit, Hospital Universitario y Politécnico La Fe, València, Spain, ⁶Parexel International, Milano, Italy, ⁷Roche Products Ltd, Welwyn Garden City, United Kingdom, ⁸Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesu', Rome, Italy
Background/Purpose: Dosing regimens for subcutaneous tocilizumab (SC-TCZ) in patients with polyarticular-course or systemic juvenile idiopathic arthritis (pJIA or sJIA) were determined for SC-TCZ in 2…
Abstract Number: 0140 • ACR Convergence 2022
Continued Treatment with Nintedanib in Patients with Progressive Fibrosing Autoimmune Disease-Related Interstitial Lung Diseases (ILDs): Data from INBUILD-ON
Eric Matteson¹, Danielle Antin-Ozerkis², Francesco Bonella³, Nazia Chaudhuri⁴, Vincent Cottin⁵, Heiko Müller⁶, Carl Coeck⁷, Klaus Rohr⁸ and Wim Wuyts⁹, ¹Mayo Clinic College of Medicine and Science, Rochester, MN, USA, Rochester, MN, ²Section of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine, New Haven, CT, ³Center for Interstitial and Rare Lung Diseases, Pneumology Department, Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany, ⁴North West Interstitial Lung Disease Unit, Manchester University Foundation Trust, Wythenshawe, Manchester, United Kingdom, ⁵Coordinating Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, University of Lyon, INRAE, Lyon, France, ⁶Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, Biberach, Germany, ⁷Boehringer Ingelheim SComm, Brussels, Brussels, Belgium, ⁸Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, ⁹Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium, Leuven, Belgium
Background/Purpose: In the INBUILD trial in patients with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis, nintedanib reduced the rate of decline in forced vital…
Abstract Number: 0355 • ACR Convergence 2022
Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study
Amit Saxena¹, Dawn Caster², Salem Almaani³, Amber Rosales⁴ and Henry Leher⁵, ¹NYU School of Medicine, New York, NY, ²University of Louisville, Louisville, KY, ³The Ohio State University Medical Center, Columbus, OH, ⁴Aurinia Pharmaceuticals Inc., Rockville, MD, ⁵Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: Persistent proteinuria increases the risk of comorbidities in lupus nephritis, and rapid reductions in protein have shown to be predictive of improved long-term renal…
Abstract Number: 0519 • ACR Convergence 2022
Myeloablation Followed by Hematopoietic Stem Cell Transplantation Leads to Long-term Normalization of Systemic Sclerosis Molecular Signatures
Nancy Wareing¹, Xuan Wang², Lynette Keyes-Elstein³, Ellen Goldmuntz⁴, Marka Lyons⁵, Peter McSweeney⁶, Daniel Furst⁷, Richard Nash⁶, Leslie Crofford⁸, Beverly Welch⁹, Ashley Pinckney¹⁰, Maureen Mayes¹¹, Keith Sullivan¹² and Shervin Assassi¹³, ¹UTHealth Houston McGovern Medical School, Houston, TX, ²Baylor Institute for Immunology Research, Dallas, TX, ³Rho, Chapel Hill, NC, ⁴NIAID/ NIH, Washington, DC, ⁵University of Texas McGovern Medical School at Houston, Houston, TX, ⁶Colorado Blood Cancer Institute, Denver, CO, ⁷University of California Los Angeles, Los Angeles, CA, ⁸Vanderbilt University Medical Center, Nashville, TN, ⁹NIAID/NIH, Bethesda, MD, ¹⁰Rho, St. Louis Park, MN, ¹¹Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, ¹²Duke University, Durham, NC, ¹³McGovern Medical School, University of Texas, Houston, TX
Background/Purpose: In the randomized Scleroderma: Cyclophosphamide Or Transplantation (SCOT trial), normalization of systemic sclerosis (SSc) peripheral blood gene expression signatures at the 26-month visit was…
Abstract Number: 0987 • ACR Convergence 2022
A Randomized Placebo-Controlled Phase 1 Study in Healthy Adult Volunteers of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALPN-303, a Potent Dual BAFF/APRIL Antagonist for the Treatment of Systemic Lupus Erythematosus and Other Autoantibody-Associated Diseases
Stacey Dillon¹, Pille Harrison², Jason Lickliter³, Kristi Manjarrez¹, Alina Smith¹, Mary Lessig¹, Lori Blanchfield¹, Russell Sanderson¹, Allison Chunyk¹, Tiffany Blair¹, Amanda Enstrom¹, Martin Wolfson¹, Mark Rixon¹, Hany Zayed⁴, Rupert Davies¹ and Stanford Peng¹, ¹Alpine Immune Sciences, Seattle, WA, ²Alpine Immune Sciences, Taunton, United Kingdom, ³Nucleus Network, Melbourne, Australia, ⁴Alpine Immune Sciences, San Francisco, CA
Background/Purpose: B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) are tumor necrosis factor (TNF) superfamily members that bind TACI (transmembrane activator and CAML…
Abstract Number: 1427 • ACR Convergence 2022
Impact of Upadacitinib versus Abatacept on Individual Disease Outcomes in Patients with Rheumatoid Arthritis and Inadequate Responses to Biologic DMARDs
Ronald van Vollenhoven¹, Andrea Rubbert-Roth², Stephen Hall³, Ricardo Xavier⁴, Anna K Shmagel⁵, Yanna Song⁵, Samuel Anyanwu⁵ and Vibeke Strand⁶, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Division of Rheumatology, Cantonal Clinic St Gallen, St.Gallen, Switzerland, ³Emeritus Research and Monash University, Melbourne, Australia, ⁴Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil, ⁵AbbVie, Inc., North Chicago, IL, ⁶Stanford University School of Medicine, Stanford, CA
Background/Purpose: The phase 3 SELECT-CHOICE trial of patients with rheumatoid arthritis (RA) and prior inadequate response to biologic DMARD(s) (bDMARD-IR) demonstrated superiority of the JAK…
Abstract Number: 1614 • ACR Convergence 2022
Females with Non-Radiographic but Not with Radiographic Axial Spondyloarthritis Are Less Likely to Achieve Inactive Disease State Than Males: Results from a Multicountry Prospective Observational Study
Denis Poddubnyy¹, Joachim Sieper², Servet Akar³, Santiago Muñoz-Fernández⁴, Hildrun Haibel², Torsten Diekhoff⁵, Mikhail Protopopov⁶, Elisabeth Altmaier⁷, Fabiana Ganz⁸ and Robert Inman⁹, ¹Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Charité - Universitätsmedizin, Berlin, Berlin, Germany, ³Izmir Katip Celebi University School of Medicine, Izmir, Turkey, ⁴Servicio de Reumatología, Hospital Universitario Infanta Sofía, Universidad Europea, Madrid, Spain, ⁵Department of Radiology, Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁶Charité Universitätsmedizin Berlin, Berlin, Germany, ⁷GKM Gesellschaft für Therapieforschung mbH, Munich, Germany, ⁸AbbVie, Inc., Luzern, Switzerland, ⁹University Health Network, Toronto, ON, Canada
Background/Purpose: Emerging evidence suggests that men and women experience axial spondyloarthritis (axSpA) differently. Some studies suggested that the probability of treatment response was lower in…
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: 2108 • ACR Convergence 2022
Changes in Serum Cytokines by Week 24 Correlate with Long-Term Efficacy of Guselkumab Through Two Years in Bio-Naïve Adults with PsA
Stefan Siebert¹, Georg Schett², Siba P. Raychaudhuri³, Monica Guma⁴, Warner Chen⁵, Sheng Gao⁵, Soumya Chakravarty⁶, May Shawi⁷ and Proton Rahman⁸, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, Scotland, United Kingdom, ²Universitätsklinikum Erlangen, Erlangen, Germany, ³Rheumatology, Allergy, and Clinical Immunology, University of California Davis, School of Medicine, Sacramento, CA, ⁴Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California San Diego, La Jolla, CA, ⁵Janssen Research and Development, LLC, Spring House, PA, ⁶Janssen Scientific Affairs, LLC; Drexel University College of Medicine, Villanova, PA, ⁷Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, ⁸Memorial University, St. John's, NL, Canada
Background/Purpose: The IL-23p19 inhibitor guselkumab has shown robust efficacy vs placebo (PBO) in the phase 3 DISCOVER-1 and DISCOVER-2 studies of adults with active PsA,1,2…
Abstract Number: 2235 • ACR Convergence 2022
Clinical Impact of a Digital Behavioral Therapy for Fibromyalgia Management in a Decentralized Trial
Yifei Dai¹, Michael Rosenbluth², Michael Gendreau³, Nicolette Vega⁴, Zunera Ghalib⁴, Allison Kraus⁴ and Brian Keefe⁵, ¹Swing Therapeutics, Gainesville, FL, ²Swing Therapeutics, San Francisco, CA, ³GENDREAU CONSULTING, LLC, Poway, CA, ⁴Swing Therapeutics, San Francisco, ⁵Swing Therapeutics, New York, NY
Background/Purpose: Cognitive behavioral therapy (CBT) has demonstrated level 1A evidence for management of fibromyalgia (FM). Acceptance and Commitment Therapy (ACT), a form of CBT, has…
Abstract Number: 0159 • ACR Convergence 2022
B Cell Phenotype in Adult Patients with Idiopathic Inflammatory Myositis (IIM) Before and After Belimumab
Tam Quach¹, Anne Davidson² and Galina Marder³, ¹Feinstein Institute for Medical Research, Manhasset, NY, ²Feinstein Institutes for Medical Research, Manhasset, NY, ³Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY
Background/Purpose: Recent observations suggest the importance of the BAFF pathway in the pathogenesis of Idiopathic Inflammatory Myositis (IIM). Elevated serum levels of circulating BAFF in…
Abstract Number: 0356 • ACR Convergence 2022
Early Reductions in Proteinuria with Voclosporin Treatment Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials
Anca Askanase¹, Lucy Hodge², Vanessa Birardi³ and Henry Leher³, ¹Columbia University Medical Center, New York, NY, ²Aurinia Pharmaceuticals, Seattle, WA, ³Aurinia Pharmaceuticals Inc, Rockville, MD
Background/Purpose: Voclosporin, a novel calcineurin inhibitor, is approved for the treatment of adults with lupus nephritis in combination with background immunotherapy and was successfully tested…
Abstract Number: 0520 • ACR Convergence 2022
Combination Therapy of Mycophenolate Mofetil and Pirfenidone vs. Mycophenolate Alone: Results from the Scleroderma Lung Study III
Dinesh Khanna¹, Cathie Spino², Elana Bernstein³, Jonathan Goldin⁴, Donald Tashkin⁴, Michael roth⁴ and On Behalf of SLS III Investigators², ¹Division of Rheumatology, Department of Internal Medicine, Scleroderma Program, University of Michigan, Ann Arbor, MI, ²University of Michigan, Ann Arbor, MI, ³Columbia University, New York, NY, ⁴University of California Los Angeles, Los Angeles, CA
Background/Purpose: Scleroderma Lung Study (SLS) II established mycophenolate mofetil (MMF) as an active therapy for scleroderma-related interstitial lung disease (SSc-ILD) and the need to consider…
Abstract Number: 0989 • ACR Convergence 2022
Regulatory T Cell Defects in SLE and Therapy with a Novel IL-2 Mutein: Phase 1 Clinical Results with Efavaleukin Alfa
Nandita Sarkar¹, Xuguang Hu¹, Nadia Tchao¹, Richard Furie², Alan Kivitz³, Stanley B Cohen⁴ and Kevin Gorski⁵, ¹Amgen Inc., South San Francisco, CA, ²Northwell Health, Great Neck, NY, ³Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ⁴Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ⁵Amgen, Inc., Thousand Oaks, CA
Background/Purpose: Regulatory T cells (Treg) are critical for maintaining self-tolerance and preventing autoimmunity, and IL-2 is essential for their development, survival and suppressive function. Defects…

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