Abstracts tagged "clinical trial"

Abstract Number: 0596 • ACR Convergence 2023
Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in a Phase 2 Trial in Systemic Lupus Erythematosus (SLE): Achievement of Sustained SRI(4), BICLA and Dual Responses over 48 Weeks
Richard Furie¹, Cristina Arriens², Kenneth Kalunian³, Marilyn Pike⁴, Ronald van Vollenhoven⁵, Coburn Hobar⁶, Ayanbola Elegbe⁶, Samantha Pomponi⁶, Subhashis Banerjee⁶, Shalabh Singhal⁶, Thomas Wegman⁷ and Eric Morand⁸, ¹Northwell Health, Manhasset, NY, ²Oklahoma Medical Research Foundation and University of Oklahoma Health Sciences Center, Department of Arthritis & Clinical Immunology, Oklahoma City, OK, ³University of California San Diego, La Jolla, CA, ⁴MedPharm consulting, Inc., Raleigh, NC, ⁵Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁶Bristol Myers Squibb, Princeton, NJ, ⁷Bristol Myers Squibb, Beaver Falls, PA, ⁸Monash University, Centre for Inflammatory Diseases, Melbourne, Australia
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor approved in multiple countries for the treatment of adults with plaque psoriasis. In…
Abstract Number: 0839 • ACR Convergence 2023
Efficacy and Safety of Nipocalimab in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA): The Multicenter, Randomized, Double-blinded, Placebo-controlled Phase 2a IRIS-RA Study
Peter C. Taylor¹, Georg Schett², Fowzia Ibrahim³, Bei Zhou⁴, Jocelyn H. Leu⁵, Sophia G. Liva⁵, Qingmin Wang⁵, Ricardo Rojo Cella⁵, Chetan S. Karyekar⁵ and Kaiyin Fei⁵, ¹Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ²Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany, ³Janssen Research & Development, LLC, High Wycombe, United Kingdom, ⁴Janssen Research & Development, LLC, Chesterbrook, PA, ⁵Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: RA is a chronic inflammatory disease associated with autoantibodies. Despite the use of targeted therapies, up to half of patients fail to achieve remission…
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: 0360 • ACR Convergence 2023
Increasing the Etanercept Dose in Juvenile Idiopathic Arthritis Patients: Does It Help Reaching the Treatment Target? A Post-hoc Analysis of the Best4Kids Randomised Clinical Trial
Bastiaan van Dijk¹, Sytske Anne Bergstra¹, Merlijn van den Berg², Dieneke Schonenberg-Meinema², Lisette van Suijlekom-Smit², Marion van Rossum³, Yvonne Koopman⁴, Rebecca Ten Cate¹, CF Allaart¹, Danielle Brinkman¹ and Petra Hissink Muller¹, ¹Leiden University Medical Center, Leiden, Netherlands, ²Emma Children's Hospital, Amsterdam University Medical Centers, Amsterdam, Netherlands, ³Amsterdam Rheumatology and Immunology Center | Reade, Amstelveen, Netherlands, ⁴HagaZiekenhuis Juliana Children's Hospital, The Hague, Netherlands
Background/Purpose: The relation between etanercept dose and clinical outcomes of juvenile idiopathic arthritis (JIA) is unclear. Most studies only evaluated doses up to 0.8 mg/kg/week…
Abstract Number: 0598 • ACR Convergence 2023
Litifilimab Modulates Type I IFN Biomarkers in Patients with SLE or CLE in the Phase 2 LILAC Study
Richard Furie¹, Victoria Werth², Eric Milliman³, Kyle Ferber³, Fergal Casey³, Roland Brown³, Denitza Raitcheva³, Jad Zoghbi³, Danielle Graham³, George Kong³, Youmna Lahoud³, Nathalie Franchimont⁴ and Catherine Barbey⁵, ¹Northwell Health, Manhasset, NY, ²University of Pennsylvania and Corporal Michael J. Crescenz VAMC, Philadelphia, PA, ³Biogen, Cambridge, MA, ⁴Former employee of Biogen, Cambridge, MA, ⁵Biogen, Baar, Switzerland
Background/Purpose: Litifilimab is a humanized IgG1 mAb targeting BDCA2, a receptor expressed on plasmacytoid dendritic cells (pDCs), that negatively regulates the production of Type I…
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: 010 • 2023 Pediatric Rheumatology Symposium
Remotely Delivered Psychological Intervention May Be Beneficial to Youth with Childhood-Onset Lupus: A Preliminary Investigation
Natoshia Cunningham¹, Michelle Adler², Ashley Danguecan³, Mallet Reid², Samantha Ely⁴, Mathew Reeves², Lawrence Ng³, Paris Moaf³, Sarah Mossad³, Tala El Tal³, Luana Flores Pereira³, Deborah Levy³, Linda Hiraki³, Jennifer Stinson³, Sarah Ahola Kohut³, Khalid Abulaban⁵, Elizabeth Kessler⁵, Stacy Allen⁵, Tamar Rubinstein⁶, Evin Rothschild⁶, Natalie Rosenwasser⁷, Kabita Nanda⁷, Susan Canny⁷, Emily Smitherman⁸, Livie Huie⁸, James Birmingham⁹, Allison Thompson¹⁰, Janel Thompson¹⁰, Miranda Moyer¹⁰, Emily Nguyen¹⁰, Angela Chapson¹⁰ and Andrea Knight³, ¹Michigan State University, Grand Rapids, MI, ²Michigan State University, East Lansing, ³The Hospital for Sick Children, Toronto, ON, Canada, ⁴Wayne State University, Michigan State University, Detroit, MI, ⁵Helen DeVos Children's Hospital, Grand Rapids, MI, ⁶Children's Hospital at Montefiore, New York, NY, ⁷Seattle Children's Hospital, Seattle, WA, ⁸University of Alabama at Birmingham, Birmingham, AL, ⁹Metro Health, Cleveland, ¹⁰Patient Co-Investigative Team
Background/Purpose: Childhood-onset systemic lupus erythematosus (cSLE) is associated with fatigue, pain, and depressive symptoms that adversely impact health-related quality of life. The Treatment and Education…
Abstract Number: 126 • 2023 Pediatric Rheumatology Symposium
Facilitating Peer-to-Peer Conversations Around Key Clinical Trial Recruitment Barriers in the Limit-JIA Trial Using Low-Fidelity Video Capture
Melanie Kohlheim¹, Eveline Wu², Laura Schanberg³, Vincent Del Gaizo¹, Catherine Lavallee⁴, Marc Natter⁵, Katie Clem⁶, Brian Shakley⁶ and Kevin Urban⁷, ¹CARRA, Washington, DC, ²UNC Chapel Hill, Chapel Hill, NC, ³Duke University Medical Center, Durham, NC, ⁴Virginia Tech Carilion School of Medicine, ROANOKE, VA, ⁵Boston Children's Hospital, Boston, MA, ⁶LIFT 1428, Llc, Ooltewah, TN, ⁷Business Coaching for Creatives, New York, NY
Background/Purpose: The LIMIT-JIA trial aims to study if early abatacept treatment can prevent disease extension in children with recent-onset, uncomplicated, and oligoarticular or limited JIA.…
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…

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