Abstracts tagged "clinical trial"

Abstract Number: 0840 • ACR Convergence 2023
Head-to-Head Comparison of TLL-018 and Tofacitinib in Patients with Active Rheumatoid Arthritis: Final Results from a Phase IIa Study
Xiaofeng Zeng¹, chanyuan wu², Jiankang Hu³, SHENGYUN LIU⁴, Zhenyu Jiang⁵, Jingyang Li⁶, Xiaoxia Wang⁷, Ju Liu⁸, Chaofan Yuan⁹, Guang Yang¹⁰ and Chris Liang¹⁰, ¹Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ²Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ³Pingxiang People’s Hospital, PingXiang, China, ⁴The First Affiliated Hospital Of Zhengzhou University, Zhengzhou, China, ⁵The First Hospital of Jilin University, Changchun, China, ⁶Zhuzhou Central Hospital, Zhuzhou, China, ⁷Second Hospital of Shanxi Medical University, Taiyuan, China, ⁸Jiujiang No. 1 People’s Hospital, JiuJiang, China, ⁹Hangzhou Highlightll Pharmaceutical Co., Ltd, Beijing, China, ¹⁰Hangzhou Highlightll Pharmaceutical Co., Ltd, HangZhou, China
Background/Purpose: None of the currently approved treatments for rheumatoid arthritis (RA) can achieve ACR50 in >50% of the patients, and 5 – 20% of the…
Abstract Number: 1343 • ACR Convergence 2023
Cardiovascular (CV) and Malignancy Events in the Filgotinib Rheumatoid Arthritis (RA) Clinical Development Program up to 8.3 Years
Xavier Mariette¹, Sven Borchmann², Sandrine Aspeslagh³, Jaime Calvo- Alén⁴, Richard Moriggl⁵, Zoltan Szekanecz⁶, Francesco De Leonardis⁷, Nadia Verbruggen⁸, Paul Van Hoek⁹, Marc Schmalzing¹⁰, Andreas Stallmach¹¹, Christina Charles-Schoeman¹², Vijay Rajendran¹³, Christine Rudolph⁹, Chris Watson¹⁴, Yoshiya Tanaka¹⁵ and Ernest Choy¹⁶, ¹Université Paris-Saclay, Le Kremlin-Bicêtre, France, ²Department of Internal Medicine, University of Cologne, Cologne, Germany, ³Department of Medical Oncology, UZ Brussel, Brussels, Belgium, ⁴Rheumatology, Bioaraba Research Unit, Hospital Universitario Araba, Vitoria, Spain, ⁵Institute of Animal Breeding and Genetics, University of Veterinary Medicine, Vienna, Austria, ⁶Division of Rheumatology, University of Debrecen, Debrecen, Hungary, ⁷Medical Affairs, Galapagos GmbH, Basel, Switzerland, ⁸Biostatistics, Galapagos NV, Mechelen, Belgium, ⁹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹⁰University Hospital, Rheumatology/Clinical Immunology, Department of Internal Medicine II, Würzburg, Germany, ¹¹Department of Internal Medicine, Jena University Hospital, Jena, Germany, ¹²UCLA Medical Center, Santa Monica, CA, ¹³Clinical Research, Galapagos NV, Mechelen, Belgium, ¹⁴Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁵University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁶Section of Rheumatology, Cardiff University, Cardiff, United Kingdom
Background/Purpose: Filgotinib (FIL) is a Janus kinase (JAK) 1 preferential inhibitor for the treatment of RA. Data from the ORAL Surveillance post-marketing study (NCT02092467) suggest…
Abstract Number: 1503 • ACR Convergence 2023
Disease Course and Complement as Predictors of Response to Standard of Care Plus Placebo in Patients with SLE: A Post Hoc Analysis of Dapirolizumab Pegol and Epratuzumab Clinical Trial Data
Christian Stach¹, Caroline Gordon², Vanessa Taieb³, George Stojan⁴ and Joan Merrill⁵, ¹UCB Pharma, Monheim am Rheim, Germany, ²Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom, ³UCB Pharma, Colombes, France, ⁴UCB, Baltimore, MD, ⁵Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: High placebo responses pose challenges to systemic lupus erythematosus (SLE) clinical trials.1This analysis aims to identify predictors of standard of care plus placebo (SOC+PBO)…
Abstract Number: 1946 • ACR Convergence 2023
Zetomipzomib Demonstrates Favorable Long-term Safety and Tolerability Profile Without Signs of Immunosuppression: Results from the PRESIDIO Study and Its Open-label Extension Study in Patients with Dermatomyositis and Polymyositis
Rohit Aggarwal¹, Namita Goyal², Diana Lam³, Allen Ng³, Richard Leff⁴, Kathryn Ray³, Eunmi Park³ and Noreen Henig³, ¹University of Pittsburgh, Pittsburgh, PA, ²UCI Health, Orange, CA, ³Kezar Life Sciences, South San Francisco, CA, ⁴Kezar Life Sciences, Chadds Ford, PA
Background/Purpose: Polymyositis (PM) and dermatomyositis (DM) are chronic autoimmune diseases characterized by muscle inflammation and weakness. In a collagen-induced myositis mouse model, immunoproteasome inhibition has…
Abstract Number: 2233 • ACR Convergence 2023
Neutrophil Levels Associate with Early Improvement in Spinal Pain and Week 24 Multi-Domain Disease Control During Guselkumab Treatment in Active Psoriatic Arthritis: Post Hoc Pooled Analyses of Two Phase 3 Randomized Controlled Trials
Thomas Macleod¹, Xenofon Baraliakos², Emmanouil Rampakakis³, Warner Chen⁴, Antonius Pieter J Van Den Heuvel⁴, Loqmane Seridi⁴, May Shawi⁵, Frederic Lavie⁶, Joseph F. Merola⁷, Proton Rahman⁸ and Dennis McGonagle⁹, ¹University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁴Translational Sciences, Janssen Research & Development, LLC, Spring House, PA, ⁵Immunology, Janssen Research & Development, LLC, Titusville, NJ, ⁶The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁷Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ⁸Craig Dobbin Research Institute, Memorial University, St. John's, NL, Canada, ⁹Leeds Biomedical Research Centre, University of Leeds, Leeds, United Kingdom
Background/Purpose: Neutrophils have potential pathogenic roles in chronic inflammatory diseases (e.g., neutrophilic cutaneous microabscesses in psoriasis, and neutrophils in the synovial fluid/tissue in PsA and…
Abstract Number: 2345 • ACR Convergence 2023
Paired Kidney Biopsies from the AURORA 2 Study of Voclosporin in Active Lupus Nephritis
Samir Parikh¹, Salem Almaani², Arnon Arazi³, Huijuan Song¹, Pearlly Yan¹, Estela Puchulu-Campanella¹, Clint Abner⁴, Ernie Yap⁴, Krista Piper⁴, Robert B. Huizinga⁵ and Henry Leher⁴, ¹Ohio State University, Columbus, OH, ²Ohio State University Medical Center, Columbus, OH, ³Broad Institute of MIT and Harvard, Melrose, MA, ⁴Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada, ⁵Reformation Consulting Services, North Saanich, BC, Canada
Background/Purpose: Voclosporin is approved for the treatment of adults with active lupus nephritis. Addition of voclosporin to mycophenolate mofetil (MMF) and low-dose glucocorticoids in the…
Abstract Number: 0372 • ACR Convergence 2023
Efficacy and Safety of Secukinumab in Juvenile Idiopathic Arthritis: Interim Results from the Extension of the JUNIPERA Trial
Hermine Brunner¹, Ivan Foeldvari², Ekaterina Alexeeva³, Nuray Aktay Ayaz⁴, Grant Schulert⁵, Seza Ozen⁶, Artem Popov⁷, Athimalaipet V Ramanan⁸, Christiaan Scott⁹, Betul Sozeri¹⁰, Elena Zholobova¹¹, Sudhanshu Chakraborty¹², Xuan Zhu¹³, Ruvie Martin¹³, Sarah Whelan¹⁴, Sharonjeet Kaur¹⁵, Luminita Pricop¹³, Daniel J Lovell¹⁶, Alberto Martini¹⁷ and Nicolino Ruperto¹⁸, ¹Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH, ²Hamburger Zentrum fuer Kinder und Jugendrheumatologie, Rheumatology, Hamburg, Germany, ³National Scientific and Practical Center of Children's Health, Rheumatology, Moscow, Russia, ⁴Department of Pediatric Rheumatology, Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey, ⁵Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁶Hacettepe University Medical Faculty, Ankara, Turkey, ⁷Ural State Medical University Ekaterinburg, Sverdlovsk, Russia, ⁸Bristol Royal Hospital for Children & Translational Health Sciences, University of Bristol, Bristol, United Kingdom, ⁹Department of Paediatric Rheumatology, Red Cross War Memorial Children’s Hospital, University of Cape Town, Cape Town, South Africa, ¹⁰Division of Pediatric Rheumatology, University of Health Sciences, Ümraniye Training and Research Hospital, Istanbul, Turkey, ¹¹First Moscow State Medical University, n.a. I.M.Sechenov, Moscow, Russia, ¹²IQVIA, Durrham, NC, ¹³Novartis Pharmaceuticals Corporation, East Hanover, NJ, ¹⁴Novartis Ireland Ltd, Dublin, Ireland, ¹⁵Novartis Pharma AG, Basel, Switzerland, ¹⁶UC Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OH, ¹⁷Università di Genova, Genova, Italy, ¹⁸IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, Genova, Italy
Background/Purpose: Secukinumab has demonstrated efficacy and safety in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) categories of juvenile idiopathic arthritis (JIA) for…
Abstract Number: 0600 • ACR Convergence 2023
Identification of Subsets of SLE Patients Responsive to Baricitinib by Transcriptomic Analysis at Baseline
Prathyusha Bachali¹, Amrie Grammer² and Peter Lipsky², ¹AMPEL BioSolutions, Redmond, WA, ²AMPEL BioSolutions, Charlottesville, VA
Background/Purpose: Baricitinib is an inhibitor of Jak1 approved for treatment of rheumatoid arthritis, atopic dermatitis, alopecia areata and Covid-19. A phase 2 trial showed success…
Abstract Number: 1104 • ACR Convergence 2023
Dotinurad, a Potent and Selective Uricosuric Agent, Exhibited Promising Pharmacokinetics and Pharmacodynamic Profiles to Significantly Reduce Serum Urate Levels Following Once Daily Dosing in Healthy U.S. Subjects in a Phase 1 Clinical Trial
Scott Baumgartner, Raymond Zheng, Mark Harnett and Jay Kranzler, Urica Therapeutics Inc., New York, NY
Background/Purpose: Dotinurad is a potent and selective URAT1 inhibitor that has been approved as a once-daily drug for the treatment of hyperuricemia with or without…
Abstract Number: 1379 • ACR Convergence 2023
Population Pharmacokinetic/Pharmacodynamic Modeling of Dazodalibep, a CD40L Antagonist, in Healthy Volunteers and Patients with Rheumatoid Arthritis and Sjogren’s Syndrome
Kenneth Der¹, Ryan Crass², Brendan Smith³, Wonkyung Byon⁴, Yan Xin⁵ and Jiayin Huang⁶, ¹Horizon Therapeutics, Danville, CA, ²Apellis Pharmaceuticals, Michigan, ³A2-Ai, Michigan, ⁴Amador Bioscience, Michigan, ⁵Horizon Therapeutics, South San Francisco, CA, ⁶Horizon Therapeutics, Chicago, IL
Background/Purpose: Sjögren's (SjS) is a chronic, systemic autoimmune disease caused by aberrant activation and infiltration of lymphocytes. Dazodalibep (DAZ), a novel non-antibody biologic antagonist of…
Abstract Number: 1505 • ACR Convergence 2023
Long-term Safety and Efficacy of Voclosporin in Black Patients with Lupus Nephritis: Results from the AURORA 1 and AURORA 2 Studies
Gabriel Contreras¹, Matt Baker², Lucy Hodge² and Ernie Yap², ¹University of Miami Health System, Miami, FL, ²Aurinia Pharmaceuticals Inc., Edmonton, AB, Canada
Background/Purpose: Black patients with lupus nephritis (LN) are reported to have more severe disease, are often refractory to treatment, and have worse long-term outcomes. Voclosporin…
Abstract Number: 1972 • ACR Convergence 2023
Evaluation of Myositis Autoantibodies as Predictors of Response to IVIG: Post-hoc Analysis of a Large Randomized, Double-Blind, Placebo-Controlled Phase III Trial
Christina Charles-Schoeman¹, Joachim Schessl², Rohit Aggarwal³ and and the ProDERM investigators⁴, ¹UCLA Medical Center, Santa Monica, CA, ²Friedrich-Baur-Institute, Ludwig-Maximilians University of Munich, Munich, Germany, ³University of Pittsburgh, Pittsburgh, PA, ⁴Institutions in Europe and North America, Vienna, Austria
Background/Purpose: Dermatomyositis (DM) is an immune-mediated inflammatory myopathy (IIM). Two subsets ofautoantibodies have been identified in patients with IIM: Myositis-specific antibodies (MSA) and myositis-associated antibodies…
Abstract Number: 2239 • ACR Convergence 2023
Achievement of Disease Control in PsA Patients Treated with Upadacitinib at Week 152: Post Hoc Analysis of the Long-term Extensions of Two Phase 3 Trials
Arthur Kavanaugh¹, Kristi Mizelle², Oliver FitzGerald³, Enrique Soriano⁴, Peter Nash⁵, Sandra Ciecinski⁶, Limei Zhou⁶, Arathi Setty⁶ and Laure Gossec⁷, ¹Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ²Tidewater Physicians Multispecialty Group, Newport News, VA, ³Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland, ⁴Rheumatology Section, Internal Medicine Services, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁵School of Medicine, Griffith University, Brisbane, Australia, ⁶AbbVie, Inc., North Chicago, IL, ⁷Sorbonne Université and Pitié Salpêtrière Hospital, Paris, France
Background/Purpose: A main goal of therapy for patients (pts) with PsA is to achieve and maintain the lowest possible level of disease activity across domains.1…
Abstract Number: 2486 • ACR Convergence 2023
Should SLE Patients Entering Clinical Trials Be Required to Have at Least One BILAG a And/or Two BILAG B Scores?
Ewa Olech¹ and Joan Merrill², ¹IQVIA, Rheumatology Consultants, PLLC, Las Vegas, NV, ²Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: High placebo response rates have challenged interpretation of clinical trial results in SLE and may have contributed to failure of some effective treatments. One…
Abstract Number: 0429 • ACR Convergence 2023
Direct and Indirect Effects of Upadacitinib or Adalimumab on Pain in Rheumatoid Arthritis: Results from a Randomized Phase 3 Study
Peter C. Taylor¹, David Walsh², Tsutomu Takeuchi³, Bruno Fautrel⁴, Janet Pope⁵, Andrew Garrison⁶, Yanna Song⁶, Sara K. Penn⁶, Ralph Lippe⁷, Diane Caballero⁸ and Arthur Kavanaugh⁹, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²University of Nottingham, Nottingham, United Kingdom, ³Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ⁴Sorbonne Université APHP, Paris, France, ⁵University of Western Ontario, London, ON, Canada, ⁶AbbVie, Inc., North Chicago, IL, ⁷AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁸AbbVie, Inc., Chicago, IL, ⁹University of California San Diego, School of Medicine, Riverside, CA
Background/Purpose: Rapid and sustained pain control is an important goal for patients (pts) with rheumatoid arthritis (RA). Control of inflammation in RA does not always…

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