Abstracts tagged "Randomized Trial"

Abstract Number: 1769 • ACR Convergence 2025
Classification of Relapses of Eosinophilic Granulomatosis with Polyangiitis After Two-Years of Treatment with Anti-Interleukin-5/Receptor Therapy
Christian Pagnoux¹, Arnaud Bourdin², Bernhard Hellmich³, Nader Khalidi⁴, David Jackson⁵, David Jayne⁶, Parameswaran Nair⁷, Ulrich Specks⁸, Benjamin Terrier⁹, Lena Börjesson Sjö¹⁰, Priya Jain¹¹, Aadarsh Lal¹², Sofia Necander¹³, Claire Walton¹⁴, Michael Wechsler¹⁵ and Peter Merkel¹⁶, ¹Mount Sinai Hospital, University Health Network, Toronto, and Canadian Vasculitis Research Network (CanVasc), Toronto, ON, Canada, ²Department of Respiratory Diseases, Montpellier University Hospitals, Arnaud de Villeneuve Hospital, Montpellier, France, ³Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ⁴Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, Canada, ⁵Guy’s Severe Asthma Centre, Guy's and St Thomas’ NHS Trust, London, and School of Immunology and Microbial Sciences, King's College London, London, United Kingdom, ⁶University of Cambridge, Cambridge, United Kingdom, ⁷Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, ON, Canada, ⁸Mayo Clinic, Rochester, MN, ⁹Cochin Hospital, Paris, France, ¹⁰Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gothenburg, Sweden, ¹¹BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ¹²Respiratory & Immunology, AstraZeneca, Bengaluru, Karnataka, India, ¹³Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁴Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹⁵Department of Medicine, National Jewish Health, Denver, ¹⁶University of Pennsylvania, Philadelphia, PA
Background/Purpose: Results from the ongoing open-label extension (OLE) of the MANDARA trial (NCT04157348) have demonstrated the efficacy of two years of anti-interleukin-5/receptor (anti-IL-5/R) therapies in…
Abstract Number: 1176 • ACR Convergence 2025
VISIBLE Post-Inflammatory Pigmentation Journeys: Exploring the Impact of Pigmentation
Tarek Dawamne¹, Olivia Choi, MD, PhD, FAAD², Alison Tran³, Jacob Beer⁴, Katelyn Rowland², Theodore Alkousakis², Oyediran Adelakun², Elizabeth Skobelev², Sancharitha Ramji², Tony Ma⁵, Daphne Chan² and Jenna Lester⁶, ¹Texas A&M School of Engineering Medicine, Houston, TX, USA, Houston, TX, ²Johnson & Johnson, Horsham, PA, USA, Horsham, PA, ³Lake Granbury Medical Center, Department of Dermatology, Dallas, TX, USA, Dallas, TX, ⁴Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, Miami, FL, USA, Miami, FL, ⁵Johnson & Johnson, Spring House, PA, USA, Spring House, PA, ⁶University of California, San Francisco, CA, USA, San Francisco, CA
Background/Purpose: Post-inflammatory pigment alteration (PIPA) following resolution of psoriasis plaques is an important, neglected problem that disproportionately impacts people of color.1-3 VISIBLE, an ongoing Phase…
Abstract Number: 0567 • ACR Convergence 2025
Sonelokimab in Biologic-Experienced Patients With Active Psoriatic Arthritis: Results From a Phase 2 Trial (ARGO) and Study Design of a Phase 3 Trial (IZAR-2) in Patients With Inadequate Response or Intolerance to Biologic TNFi, Including a Risankizumab Reference Arm
Atul Deodhar¹, Laure Gossec², Philip J. Mease³, Xenofon Baraliakos⁴, Lihi Eder⁵, Alan Kivitz⁶, Helena Marzo-Ortega⁷, Frank Behrens⁸, Ana-Maria Orbai⁹, Georg Schett¹⁰, Arthur Kavanaugh¹¹, Dennis McGonagle¹², Christopher Ritchlin¹³, Nuala Brennan¹⁴, Ben Porter-Brown¹⁴, Eva Cullen¹⁴, Matthew R. Thomas¹⁴, Marius Albulescu¹⁴, Alex Godwood¹⁴, Kristian Reich¹⁵ and Laura Coates¹⁶, ¹Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵University of Toronto, Toronto, ON, Canada, ⁶Altoona Center for Clinical Research, Duncansville, PA, ⁷NIHR Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, United Kingdom, ⁸Rheumatology, Immunology - Inflammation Medicine, University Hospital Goethe-University & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany, ⁹Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ¹⁰Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, ¹¹University of California, San Diego, School of Medicine, San Diego, CA, ¹²Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, United Kingdom, ¹³University of Rochester Medical Center, Canandaigua, NY, ¹⁴MoonLake Immunotherapeutics AG, Zug, Switzerland, ¹⁵MoonLake Immunotherapeutics AG and Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, Zug, Switzerland, ¹⁶Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Sonelokimab (SLK), a novel Nanobody that binds to both IL-17A and IL-17F with similarly high affinity, is designed to target difficult-to-reach sites of inflammation.…
Abstract Number: 0260 • ACR Convergence 2025
Development of a Consensus Definition of VEXAS Flare for Use in Clinical Research
Lachelle D. Weeks¹, Danielle Hammond², Sinisa Savic³, Mael Heiblig⁴, Onima Chowdhury⁵, Arsène Mekinian⁶, Carmelo Gurnari⁷, Radhakrishanan Ramchandren⁸, Sophie georgin-Lavialle⁹, Marcela ferrada¹⁰, Sarah A. Buckley¹¹, Bryan G. harder¹¹, Sandra Goble¹¹, David Beck¹² and Matthew Koster¹³, ¹Dana Farber Cancer Institute, Boston, MA, ²The University of Texas MD Anderson Cancer Center, Houston, TX, ³University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ⁴Lyon-Sud Hospital, Hospices Civils de Lyon, Paris and Université Claude Bernard, Lyon, France, ⁵Oxford University Hospitals’ NHS Foundation Trust and Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom, ⁶Department of Internal Medicine, Inflammation-Immunopathology-Biotherapy Department (DMU i³), Saint-Antoine University Hospital, ⁷⁵⁰¹² Paris, France, Paris, France, ⁷Department of Biomedicine and Prevention, University of Rome Tor Vergata and Translational Hematology and Oncology Research Department, Taussig Cancer Center, Cleveland Clinic, Clevland, OH, Rome, Italy, ⁸University of Pittsburgh Medical Center, Pittsburgh, PA, ⁹Sorbonne university, Tenon hospital, DMU³ID, CEREMAIA, ERN RITA, Paris, France, ¹⁰University of Maryland, Bethesda, MD, ¹¹Sobi Inc., Waltham, MA, ¹²Center for Human Genetics and Genomics, NYU Grossman School of Medicine. Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine. Department of Biochemistry and Molecular Pharmacology, NYU Grossman School of Medicine, New York, NY, USA, New York, NY, ¹³Mayo Clinic, Rochester, MN
Background/Purpose: VEXAS syndrome is a recently identified, severe systemic hemato-inflammatory disease with a complex and heterogeneous clinical presentation. The disease is associated with significant morbidity…
Abstract Number: L16 • ACR Convergence 2024
Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial
Megan Clowse¹, David Isenberg², Joan Merrill³, Thomas Dörner⁴, Michelle Petri⁵, Edward Vital⁶, Eric Morand⁷, Teri Jimenez⁸, Stephen Brookes⁹, Janine Gaiha-Rohrbach¹⁰, Christophe Martin¹¹, Annette Nelde¹² and Christian Stach¹³, ¹Division of Rheumatology and Immunology, Duke University, Durham, NC, ²Department of Ageing, Rheumatology and Regenerative Medicine, Division of Medicine, University College London, London, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany, ⁵Johns Hopkins University School of Medicine, Baltimore, MD, ⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁷Centre for Inflammatory Diseases, Monash University, Melbourne, Australia, ⁸UCB, Raleigh, NC, ⁹Biogen, Maidenhead, United Kingdom, ¹⁰Biogen, Cambridge, MA, ¹¹UCB, Slough, United Kingdom, ¹²Biogen, Baar, Switzerland, ¹³UCB, Monheim am Rhein, Germany
Background/Purpose: Dapirolizumab pegol (DZP) is a novel, polyethylene glycol (PEG)-conjugated antigen-binding (Fab') fragment, lacking an Fc domain, that inhibits CD40L signaling. By binding to CD40L,…
Abstract Number: L08 • ACR Convergence 2024
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging and Parallel-group Study to Evaluate the Safety and Efficacy of XG005 in Subjects with Painful Osteoarthritis of the Knee
Limin Ren¹, Wenjie Zheng², Zhenpeng Guan³, Yang Zhang⁴, Zeyu Huang⁵, Tong Li⁶, Yuwei Peng⁷, Qiuli Wu⁸, Wei Gou⁹, Wei Zhao¹⁰, Pengyan Qiao¹¹, Xiaoli Pan¹² and Guang-Liang Jiang¹³, ¹Peking University, People’s Hospital, Rheumatology and Immunology Department, Beijing, China, ²Yantai Yuhuangding Hospital of Qingdao University, Department of Orthopedics, Yantai, China, ³Peking University, Shougang Hospital, Department of Orthopedics, Beijing, China, ⁴Division of Orthopaedic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China, ⁵West China Hospital of Sichuan University, Department of Orthopedics, Chengdu, China, ⁶Xiangya Hospital of Central South University, Rheumatology and Immunology Department, Changsha, China, ⁷PingXiang People’s Hospital, Rheumatology and Immunology Department, Pingxiang, China, ⁸Tianjin Medical University General Hospital, Department of Orthopedics, Tianjin, China, ⁹Hebei Petrochina Central Hospital, Rheumatology and Immunology Department, Langfang, China, ¹⁰Central Hospital Affiliated to Shenyang Medical College, Department of Orthopedics, Shenyang, China, ¹¹Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital, Rheumatology and Immunology Department, Taiyuan, China, ¹²Affiliated Hospital of Zunyi Medical University, Rheumatology and Immunology Department, Zunyi, China, ¹³Xgene Pharmaceutical, Lexington, MA
Background/Purpose: Osteoarthritis (OA) affects 595 million people globally; cases are projected to increase 49-95% for various joints by 2050 as populations age (GBD 2023). OA…
Abstract Number: L14 • ACR Convergence 2024
A Withdrawal Study of Colchicine in Behçet Syndrome
Basak Sirin¹, Sinem Nihal Esatoglu², Hasan Yazıcı³ and Gulen Hatemi⁴, ¹Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Istanbul, Turkey, ²Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul,Türkiye/Istanbul University- Cerrahpaşa, Behcet's Disease Research Center, Istanbul, Turkey, ³Academic Hospital, Istanbul, Turkey, ⁴Istanbul University- Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Istanbul,Türkiye/Istanbul University- Cerrahpaşa, Behcet's Disease Research Center, Istanbul,Türkiye, Istanbul, Turkey
Background/Purpose: Previous randomized controlled studies reported conflicting results regarding the effectiveness of colchicine on oral ulcers in Behçet syndrome (BS). A randomized drug discontinuation design…
Abstract Number: L15 • ACR Convergence 2024
LEVI-04, a Novel neurotrophin-3 Inhibitor, Substantially Improves Pain and Function Without Deleterious Effects on Joint Structure in People with Knee Osteoarthritis: A Randomized Controlled Phase II Trial
Philip Conaghan¹, Ali Guermazi², Nathaniel Katz³, Asger Bihlet⁴, Dror Rom⁵, Michael Perkins⁶, Bernadette Hughes⁶, Claire Herholdt⁶, Iwona Bombelka⁶ and Simon Westbrook⁶, ¹University of Leeds, Leeds, United Kingdom, ²Boston University, West Roxbury, MA, ³Rin Sof Innovation, Ltd, Boston, MA, ⁴NBCD A/S, Soeborg, Denmark, ⁵Prosoft Clinical, Chesterbrook, ⁶Levicept Ltd, Ramsgate, United Kingdom
Background/Purpose: There is an urgent need for new therapies to treat OA. Excess neurotrophins (NT) are implicated in OA and other painful conditions. Previous OA…
Abstract Number: 0401 • ACR Convergence 2024
Biologic Abatement and Capturing Kids Outcomes and Flare Frequency in Juvenile Spondyloarthritis: Baseline Characteristics and Enrollment
Cora Sears¹, Cassandra Muir¹, Timothy Brandon¹, Polly Ferguson², Colleen Correll³, Margalit Rosenkranz⁴, Kevin Baszis⁵, Tzielan Lee⁶, Edward Oberle⁷, Matthew Stoll⁸, Kathryn Cook⁹, Eyal Muscal¹⁰, Hemalatha Srinivasalu¹¹, Daniel Lovell¹², Sampath Prahalad¹³, Michal Cidon¹⁴, Evan Mulvihill¹⁵, Marisa Klein-Gitelman¹⁶, Daniel Kingsbury¹⁷, Jennifer Cooper¹⁸, Natalie Rosenwasser¹⁹, Erin Treemarcki²⁰, Joyce Chang²¹, Stacey Tarvin²², Heather Walters²³, Michael Shishov²⁴, Lisa Buckley²⁵, Mary Toth²⁶, Ashley Cooper²⁷, Rui Xiao²⁸, Emily Neu²⁹, Melanie Kohlheim³⁰, Jenny Leal³¹, Kweli Archie³², English Holland³³, Miles Holland³⁴, Aamena Hameed³⁵, Asad Khan³⁶, Lynn Murphy³⁷, Sean Murphy³⁸, Justin Neu²⁹, Rachel Richmond³⁹, Dylan Suplee⁴⁰, Theresa Suplee⁴¹, Dawn Wiley⁴² and Pamela Weiss⁴³, ¹Children's Hospital of Philadelphia, Philadelphia, PA, ²University of Iowa Carver College of Medicine, Iowa City, IA, ³University of Minnesota, Minneapolis, MN, ⁴UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, ⁵Washington Univ in St. Louis School of Medicine, St Louis, MO, ⁶Stanford University School of Medicine, Palo Alto, CA, ⁷Nationwide Children's Hospital, Columbus, OH, ⁸University of Alabama at Birmingham, Birmingham, AL, ⁹Akron Children's Hospital, Akron, OH, ¹⁰Baylor College of Medicine, Houston, TX, ¹¹Children's National Hospital, Washington, DC, ¹²Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ¹³Emory + Children's Pediatric Institute, Atlanta, GA, ¹⁴Children's Hospital of Los Angeles, Los Angeles, CA, ¹⁵Nemours/A.I.duPont Hospital for Children, Wilmington, DE, ¹⁶Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, ¹⁷Legacy Health, Portland, OR, ¹⁸University of Colorado/Children's Hospital Colorado, Aurora, CO, ¹⁹Seattle Children's Hospital, Seattle, WA, ²⁰University of Utah, Salt Lake City, UT, ²¹Boston Children's Hospital, Boston, MA, ²²Indiana University School of Medicine, Indianapolis, IN, ²³Northwell Health, New Hyde Park, NY, ²⁴Phoenix Children's Hospital, Phoenix, AZ, ²⁵Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN, ²⁶Nemours Foundation, Orlando, FL, ²⁷Children's Mercy Kansas City, Kansas City, MO, ²⁸University of Pennsylvania, Philadelphia, PA, ²⁹Parent Partner, Sidney, OH, ³⁰Parent Partner, Granville, OH, ³¹Parent Partner, Columbus, OH, ³²Parent Partner, Philadelphia, PA, ³³Parent Partner, Williamsburg, VA, ³⁴Patient Partner, Williamsburg, VA, ³⁵Parent Partner, Franklin Park, NJ, ³⁶Patient Partner, Franklin Park, NJ, ³⁷Parent Partner, Haddon Heights, NJ, ³⁸Patient Partner, Haddon Heights, NJ, ³⁹Parent Partner, Albuquerque, NM, ⁴⁰Patient Partner, Maple Shade, NJ, ⁴¹Parent Partner, Maple Shade, NJ, ⁴²Parent Partner, Downingtown, PA, ⁴³Children's Hospital of Philadelphia, Philadelphia, PA
Background/Purpose: Inactive disease is the goal for youth with spondyloarthritis (SpA). Many patients are interested in stopping medications after inactive disease is achieved. The risk…
Abstract Number: 1421 • ACR Convergence 2024
Differential Impact of B-cell Targeted Monotherapy and Combination Regimen on the Peripheral Blood Transcriptome of Adults with Active Sjögren Disease
Coziana Ciurtin¹, Lucia Martin-Gutierrez¹, John Casement², Kyle Thompson³, Fai Ng⁴, Andre van Maurik⁵ and Elizabeth Jury¹, ¹University College London, London, United Kingdom, ²Newcastle University, Newcastle, United Kingdom, ³Newcastle University, Newcastle, England, United Kingdom, ⁴Newcastle University, Newcastle upon Tyne, England, United Kingdom, ⁵Precision Medicine, GlaxoSmithKline, Stevenage, United Kingdom
Background/Purpose: Sjögren disease (SD) is characterised by B-cell hyperactivity associated with increased levels of B-lymphocyte stimulator (BlyS), but there are no effective biologic treatments for…
Abstract Number: 1596 • ACR Convergence 2024
Efficacy of Eosinophil-Targeting Therapies According to Disease Severity in Patients with Eosinophilic Granulomatosis with Polyangiitis
Bernhard Hellmich¹, Peter Merkel², David Jayne³, Benjamin Terrier⁴, Florence Roufosse⁵, Parameswaran Nair⁶, Nader Khalidi⁶, David J. Jackson⁷, Shunsuke Furuta⁸, Lena Börjesson Sjö⁹, Sofia Necander⁹, Anat Shavit¹⁰, Claire Walton¹¹ and Michael Wechsler¹², ¹Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ²University of Pennsylvania, Philadelphia, PA, ³University of Cambridge, Cambridge, United Kingdom, ⁴Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, ⁵Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, ⁶McMaster University and St Joseph’s Healthcare, Hamilton, ON, Canada, ⁷Guy’s Severe Asthma Centre, Guy’s and St Thomas’ NHS Trust; School of Immunology and Microbial Sciences, King’s College London, London, United Kingdom, ⁸Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan, ⁹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ¹¹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹²National Jewish Health, Denver, CO
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by asthma, eosinophilia, and small-to-medium size vessel vasculitis, with individual manifestations widely ranging…
Abstract Number: 2056 • ACR Convergence 2024
Deucravacitinib Treatment Did Not Impact Immune Response to SARS-CoV-2 Vaccines and Infection in Patients with Plaque Psoriasis: Results from the Phase 3 POETYK Long-Term Extension Trial
Kevin Winthrop¹, Joseph Merola², Akimichi Morita³, Diamant Thaçi⁴, Jianzhong Zhang⁵, Aditi Basu Ba⁶, Ian M. Catlett⁷, John Schwarz⁶ and Yi Luo⁶, ¹School of Medicine, Oregon Health and Science University, Portland, OR, ²UT Southwestern Medical Center, Newton, MA, ³Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ⁴Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ⁵Department of Dermatology, Peking University People’s Hospital, Beijing, China, ⁶Bristol Myers Squibb, Princeton, ⁷Bristol Myers Squibb, Princeton, NJ
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
Abstract Number: 2363 • ACR Convergence 2024
“How Quickly Will I Feel Better with This New Drug?” – Rapidity of Treatment Response in Patients with Axial Spondyloarthritis Treated with Bimekizumab: Analysis from Two Phase 3 Studies
Atul Deodhar¹, Elena Nikiphorou², Abhijeet Danve³, Stephen Hall⁴, Vanessa Taieb⁵, Diana Voiniciuc⁶, Marina Magrey⁷ and Xenofon Baraliakos⁸, ¹Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ²King's College London, London, United Kingdom, ³Section of Rheumatology, Department of Medicine, Yale School of Medicine, New Haven, CT, ⁴Cabrini Medical Centre, Monash University, and Emeritus Research, Melbourne, Victoria, Australia, ⁵UCB Pharma, Colombes, France, ⁶UCB Pharma, Slough, United Kingdom, ⁷Case Western Reserve University School of Medicine/University Hospitals, Richfield, OH, ⁸Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Two phase 3 studies were conducted where treatment…
Abstract Number: 0502 • ACR Convergence 2024
Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study
Gerd Burmester¹, Jakub Trefler², Artur Racewicz³, Janusz Jaworski⁴, Agnieszka Zielińska⁵, Marek Krogulec⁶, Sławomir Jeka⁷, Rafał Wojciechowski⁸, Katarzyna Kolossa⁹, Anna Dudek¹⁰, Magdalena Krajewska-Włodarczyk¹¹, Paweł Hrycaj¹², Piotr Adrian Klimiuk¹³, SungHyun Kim¹⁴, JeeHye Suh¹⁴, GoEun Yang¹⁴, Yunah Kim¹⁴, YooBin Jung¹⁴, JiWoo Hong¹⁴ and Josef Smolen¹⁵, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²REUMA RESEARCH, Wrocław, Poland, ³Zdrowie Osteo-Medic, Warszawa, Poland, ⁴Reumatika-Centrum Reumatologii, Warszawa, Poland, ⁵MICS Centrum Medyczne Warszawa, Warszawa, Poland, ⁶NZOZ Lecznica MAK - MED, Nadarzyn, Poland, ⁷MICS Centrum Medyczne, Polska, Poland, ⁸Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, PL, Bydgoszcz, Poland, ⁹MICS Centrum Medyczne Bydgoszcz, Bydgoszcz, Poland, ¹⁰Centrum Medyczne Amed, Warszawa, Poland, ¹¹University of Warmia and Mazury, Clinic of Rheumatology, Olsztyn, Poland, ¹²Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł, Poznań, Poland, ¹³Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Department of Rheumatology and Internal Diseases, Białystok, Poland, ¹⁴Celltrion, Inc., Incheon, Republic of Korea, ¹⁵Medical University of Vienna, Vienna, Austria
Background/Purpose: The therapeutic equivalence of CT-P47 (a proposed biosimilar to reference tocilizumab [ref-tocilizumab]) was demonstrated in patients with moderate to severe RA through disease activity…
Abstract Number: 1427 • ACR Convergence 2024
Observed and Simulated Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Fully Human FcRn Blocking Monoclonal Antibody, in Adults with Sjögren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study
Sophia G. Liva¹, fudan Zheng¹, Jocelyn H. Leu², Kathy Sivils³, Keying Ma¹, He Li⁴, Steven Leonardo⁵, Kim Lo¹, Jada Idokogi¹, Kim Campbell¹ and Jonathan J. Hubbard¹, ¹Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ²Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, PA, ³Johnson & Johnson Innovative Medicine, Edmond, OK, ⁴Janssen Research & Development, LLC, Therapeutics Discovery, Spring House, PA, ⁵Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA
Background/Purpose: Sjögren’s disease (SjD) is a chronic, progressive autoimmune disease characterized by aberrant B lymphocyte activity, elevated IgG production, and the presence of IgG autoantibodies…

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