Abstracts tagged "Randomized Trial"

Abstract Number: LB06 • ACR Convergence 2025
AgAIN Study: First Head-to-Head Trial of Secukinumab vs. Ustekinumab in TNFα Inhibitor-Experienced Psoriatic Arthritis Patients Reveals Better Efficacy Across Multiple Domains
Frank Behrens¹, Patrizia Sternad², Klaus Krueger³, Christine App⁴, Stephanie Lefevre⁴ and Christiane Schiedel⁴, ¹Department of Rheumatology, Frankfurt University Hospital, Frankfurt, Germany, ²Medizinisches Versorgungszentrum für Rheumatologie Dr. M. Welcker GmbH, Planegg, Germany, ³Rheumatologisches Praxiszentrum, München, Germany, ⁴Novartis Pharma GmbH, Nürnberg, Germany
Background/Purpose: Psoriatic arthritis (PsA) patients with prior failure or intolerance to TNFα inhibitors (TNFi) represent a clinically challenging population with limited therapeutic options. The AgAIN…
Abstract Number: LB10 • ACR Convergence 2025
Four-Year Safety and Efficacy of Deucravacitinib in Systemic Lupus Erythematosus: Results From a Phase 2 Program
Eric F. Morand¹, Cristina Arriens², Marilyn Pike³, Joan Merrill⁴, Victoria Werth⁵, Zahi Touma⁶, Razvan C. Ionitescu⁷, Masato Okada⁸, Ilias Kouris⁹, Yogita Kolekar¹⁰, Junyu Nie¹⁰, Venkat Renukuntla¹⁰, Thomas Wegman¹⁰ and Ronald van Vollenhoven¹¹, ¹Sub-Faculty of Clinical and Molecular Medicine, Monash University, Melbourne, Victoria, Australia, Melbourne, Victoria, Australia, ²Oklahoma Medical Research Foundation, Oklahoma City, ³Rheumatology, MedPharm Consulting, Inc, Bethesda, ⁴Department of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, ⁵University of Pennsylvania, Merion Station, Pennsylvania, ⁶University of Toronto, Toronto, Ontario, Canada, ⁷Medart Cliniq, Department of Rheumatology, Râmnicu Vâlcea, Romania, ⁸St. Luke's International Hospital, Tokyo, Japan, ⁹Eli Lilly and Company Global, Basingstoke, United Kingdom, ¹⁰Bristol Myers Squibb, Princeton, ¹¹Amsterdam UMC, Amsterdam, Netherlands
Background/Purpose: There is a substantial unmet need for effective, well-tolerated therapies for patients with SLE. Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor…
Abstract Number: LB19 • ACR Convergence 2025
Rosnilimab, a Selective and Potent Depleter of Pathogenic T Cells, Demonstrates Efficacy, Safety, and Translational Proof of Mechanism in a Rheumatoid Arthritis Phase 2B Trial
Jonathan Graf¹, Amy Archer², Sergiy Kovalenko³, Katarzyna Kolossa⁴, John Serpa⁵, Tamta Kobakhidze⁶, Daniela Cepoi⁷, Andrea Everding⁸, Costantino Pitzalis⁹, Catherine Aversa², Martin Dahl², May Hafez², Paul Lizzul², Priya Raina², Bruce Randazzo², Yangsu Ren², Khalil Saikali², Cailin Sibley¹⁰, Gerd Burmester¹¹, Jacques-eric GOTTENBERG¹², Iain McInnes¹³, Eduardo Mysler¹⁴, Lee Simon¹⁵, Josef Smolen¹⁶, Jeffrey Sparks¹⁷, Ronald van Vollenhoven¹⁸, Michael Weinblatt¹⁹ and Paul Emery²⁰, ¹UCSF, San Francisco, California, ²AnaptysBio Inc, San Diego, California, ³Arensia Exploratory Medicine, Kyiv, Ukraine, ⁴MICS Centrum Medyczne, Bydgoszcz, Poland, ⁵Allied Biomedical Research Institute, Miami, Florida, ⁶Research Institute of Clinical Medicine Todua Clinic, Tbilisa, Georgia, ⁷Nicolae Testemitanu State University of Medicine & Pharmacy, Chisinau, Moldova, ⁸MVZ Rheumatologie & Autoimmunmedzin Hamburg GmbH, Hamburg, Germany, ⁹QMUL, Bromley Kent, United Kingdom, ¹⁰AnaptysBio Inc, San Diego, ¹¹Charité - Universitétsmedizin Berlin, Berlin, Germany, ¹²Hautepierre Hospital, STRASBOURG, France, ¹³University of Glasgow, Glasgow, United Kingdom, ¹⁴OMI, Buenos Aires, Argentina, ¹⁵SDG LLC, West Newton, Massachusetts, ¹⁶Medical University of Vienna, Vienna, Austria, ¹⁷Brigham and Women's Hospital, Boston, Massachusetts, ¹⁸Amsterdam UMC, Amsterdam, Netherlands, ¹⁹Brigham and Women's Hospital/ Harvard Medical School, Waban, Massachusetts, ²⁰University of Leeds, Leeds, United Kingdom
Background/Purpose: Over 50% of RA patients require multiple b/tsDMARD classes due to inadequate or lost response. Rosnilimab, an investigational monoclonal antibody that selectively targets and…
Abstract Number: LB20 • ACR Convergence 2025
Efficacy and Safety of Deucravacitinib up to Week 52: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study in Patients With Active Psoriatic Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs
Désirée van der Heijde¹, Philip Mease², Carle Paul³, Frank Behrens⁴, Laure Gossec⁵, Yuko Kaneko⁶, Lihi Eder⁷, Laura Coates⁸, Andrew Pink⁹, Weiguo Wan¹⁰, Enrique Soriano¹¹, Piotr Leszczyński¹², Jose Scher¹³, Atul Deodhar¹⁴, Chahin Pachai¹⁵, Janice Li¹⁶, Xue Fan¹⁶, Sahar Rabbat¹⁶, Caroline Sardinas¹⁷, Michael Plewinski¹⁸, John Vaile¹⁹ and Joseph Merola²⁰, ¹Leiden University Medical Center, Meerssen, Netherlands, ²Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington, ³Department of Dermatology, INSERM Infinity, Toulouse University, Toulouse, France, ⁴Goethe-University & Fraunhofer ITMP, Frankfurt, Germany, ⁵Sorbonne Université, AP-HP & EULAR, Paris, France, ⁶Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ⁷University of Toronto, Toronto, Ontario, Canada, ⁸University of Oxford, Oxford, United Kingdom, ⁹St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, United Kingdom, ¹⁰Huashan Hospital, Fudan University, Shanghai, China (People's Republic), ¹¹Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ¹²Department of Internal Medicine and Metabolic Disorders, Poznań University of Medical Sciences, Poznań, Poland, ¹³New York University School of Medicine, New York, New York, ¹⁴Oregon Health & Science University, Portland, Oregon, ¹⁵Bristol Myers Squibb, Princeton, New Jersey, ¹⁶Bristol Myers Squibb, Princeton, ¹⁷Bristol Myers Squibb, garwood, New Jersey, ¹⁸Bristol Myers Squibb, Green Brook Township, New Jersey, ¹⁹Bristol Myers Squibb, Warren, New Jersey, ²⁰UT Southwestern Medical Center, Dallas, Texas
Background/Purpose: Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor being investigated in active PsA in the global, randomized, double-blind, placebo (PBO)-controlled, phase 3…
Abstract Number: 2082 • ACR Convergence 2025
Pharmacokinetic Profile of MM-II Following a Single Intra-Articular Injection in Patients with Knee Osteoarthritis in a Phase 2b Randomized, Controlled, Dose-Ranging Trial
Thomas Schnitzer¹, Xavier Chevalier², Helene Rovsing³, Edith Lau⁴, Sidsel Boll⁵, Ballari Brahmachari⁶, Richard Chou⁷, Tarini Joshi⁸, Roni Wechsler⁹, Sveta Weiner¹⁰, Mudgal Kothekar¹¹, Asger Bihlet¹² and Philip Conaghan¹³, ¹Northwestern University Feinberg School of Medicine, Chicago, IL, ²Henri Mondor Hospital, University Paris XII UPEC, Créteil, France, ³Sanos Clinic, Gandrup, Denmark, ⁴Hong Kong Center for Clinical Research, Hong Kong, Hong Kong, ⁵Sanos Clinic, Vejle, Denmark, ⁶Sun Pharmaceuticals Industries Ltd., mumbai, Maharashtra, India, ⁷Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁸Sun Pharmaceutical Industries Limited, Mumbai, India, ⁹Moebius Medical, Tel Aviv, Israel, ¹⁰Sun Pharma Advanced Research Company Limited, Princeton, NJ, ¹¹Sun Pharma Advanced Research Company Limited, Andheri (E), Princeton, NJ, ¹²NBCD A/S, Herlev, Denmark, ¹³University of Leeds, Leeds, United Kingdom
Background/Purpose: MM-II is a first-in-class investigational treatment for knee OA pain that consists of a one-time IA injection of empty liposomes comprised of phospholipids dipalmitoylphosphatidylcholine…
Abstract Number: 1443 • ACR Convergence 2025
Long-Term Safety and Efficacy of Upadacitinib in Patients With Psoriatic Arthritis: 5-Year Results From the Phase 3 SELECT-PsA 1 Study
Iain McInnes¹, Koji Kato², Marina Magrey³, Joseph Merola⁴, mitsumasa kishimoto⁵, Derek Haaland⁶, Ivan Lagunes⁷, Laura Coates⁸, Yanxi Liu⁹, Erin Mancl¹⁰, Bhumik Parikh¹¹ and Charles Phillips¹², ¹University of Glasgow, Glasgow, United Kingdom, ²Abbvie. Inc, North Chicago, IL, ³Case Western Reserve University School of Medicine/University Hospitals Cleveland, Richfield, OH, ⁴UT Southwestern Medical Center, Dallas, TX, ⁵Kyorin University School of Medicine, Tokyo, Japan, ⁶The Waterside Clinic, Oro Medonte, ON, Canada, ⁷Abbvie Inc, North Chicago, IL, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁹Abbvie Inc, Florham Park, NJ, ¹⁰AbbVie, Chicago, IL, ¹¹AbbVie, Hillsborough Township, NJ, ¹²AbbVie Inc, Princeton, NJ
Background/Purpose: We evaluated safety and efficacy of upadacitinib (UPA) versus adalimumab (ADA) at week 260 (5-years) from the long-term extension of SELECT-PsA 1.Methods: Randomized patients…
Abstract Number: 0589 • ACR Convergence 2025
Comparing Efficacy of Upadacitinib in Male and Female Patients with axSpA: Results from the SELECT-AXIS 1 and 2 Trials
Sofia Ramiro¹, Anna Molto², Elena Nikiphorou³, Marcelo Pinheiro⁴, Jamie Urbanik⁵, Tianming Gao⁶, Shirley Chen⁷, Jayne Stigler⁸, Jessica A. Walsh⁹ and Lihi Eder¹⁰, ¹Leiden University Medical Center, Bunde, Netherlands, ²Assistance Publique Hôpitauxde Paris, Paris, France, ³King's College London, London, United Kingdom, ⁴UNIFESP/ EPM, São Paulo, São Paulo, Brazil, ⁵AbbVie, Grayslake, IL, ⁶AbbVie, North Chicago, IL, ⁷AbbVie, Somerset, NJ, ⁸AbbVie, Round Lake, IL, ⁹Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT, ¹⁰University of Toronto, Toronto, ON, Canada
Background/Purpose: Evidence suggests that the treatment effectiveness of TNFis and IL-17is is higher in male (M) vs female (F) patients (pts) with axSpA.1,2 Data comparing…
Abstract Number: 0338 • ACR Convergence 2025
Fractures and Changes in Bone Mineral Density During Two Years of Low Dose Glucocorticoid Treatment for Rheumatoid Arthritis: A Systematic Literature Review and Individual Participant Data Meta-Analysis
Andriko Palmowski¹, Tobias Haugegaard², Ingiäld Hafstörm³, Henning Bliddal⁴, Judith Oldenkott⁵, Siegfried Wassenberg⁶, Ernest Choy⁷, John Kirwan⁸, Robin Christensen⁹, Maarten Boers¹⁰ and FRANK BUTTGEREIT¹¹, ¹Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ²The Parker Institute, Kopenhagen, Denmark, ³Karolinska Institutet, Stockholm, Sweden, ⁴The Parker Institute, Frederiksberg, Denmark, ⁵Charité, Berlin, Germany, ⁶Rheumazentrum Ratingen, Ratingen, Germany, ⁷Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, ⁸University of Bristol, Bristol, United Kingdom, ⁹Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen, Hovedstaden, Denmark, ¹⁰Amsterdam UMC, Vrije Universiteit, Amersfoort, Netherlands, ¹¹Charité University Medicine Berlin, Berlin, Berlin, Germany
Background/Purpose: It is unclear to what extent low dose glucocorticoids (GCs) impact bone health in patients with rheumatoid arthritis (RA). RA leads to bone loss…
Abstract Number: 2006 • ACR Convergence 2025
Storytelling and Navigation to Improve Gout Follow-up: A Multicenter, Randomized Controlled Trial
Lesley Jackson¹, Rahima Begum², Gary Cutter², Hyon K. Choi³, Brett Faine⁴, Nora G. Singer⁵, Natalie McCormick⁶, hamid shokoohi⁷, Blair Parry⁷, Oliva Nelson⁷, James Booth¹, Zachary Armor¹, John Osborne¹, Kenneth Saag⁸ and Maria I. ("Maio") Danila⁹, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Alabama at Birmingham, Birmingham, ³MASSACHUSETTS GENERAL HOSPITAL, Lexington, MA, ⁴University of Iowa, Iowa City, IA, ⁵The MetroHealth System at Case Western Reserve University School of Medicine, Cleveland, OH, ⁶Massachusetts General Hospital, Boston, ⁷Massachusetts General Hospital, Boston, MA, ⁸The University of Alabama at Birmingham, Birmingham, AL, ⁹University of Alabama at Birmingham (UAB), Birmingham VA Medical Center, Birmingham, AL
Background/Purpose: Patients with gout are frequently treated in the emergency department (ED) for flares but may not receive consistent outpatient care. Approaches to mitigate this…
Abstract Number: 1353 • ACR Convergence 2025
Phase 3 Study of the Efficacy, Safety and Immunogenicity of the Proposed Tocilizumab Biosimilar RGB-19, Intravenously Administered to Participants With Active Rheumatoid Arthritis: 52-Week Data
Gerd Burmester¹, Hiroaki Matsuno², Ernest Choy³, Masato Okada⁴, Roshan Dias⁵, Károly Horvát-Karajz⁵, Gordana Dancer⁵, Yusuke Karibe⁶, Suguru Masuda⁶, Joachim Kiefer⁵ and Paul Emery⁷, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²Matsuno Clinic for Rheumatic Disease, Toyama, and Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, ³Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, ⁴Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, ⁵Gedeon Richter Plc, Budapest, Hungary, ⁶Mochida Pharmaceutical Co., Ltd, Tokyo, Japan, ⁷University of Leeds, Leeds, England, United Kingdom
Background/Purpose: RGB-19 is a proposed biosimilar to tocilizumab, a monoclonal antibody that competitively inhibits the binding of interleukin-6 (IL-6) to its receptor. Results of a…
Abstract Number: 0576 • ACR Convergence 2025
Factors impacting progression from oligoarticular to polyarticular PsA: Data from the FOREMOST study
Laura Coates¹, Philip J. Mease², Joseph Merola³, Lourdes Perez Chada⁴, Dafna D. Gladman⁵, Alen Zabotti⁶, Ulrich Mrowietz⁷, mitsumasa kishimoto⁸, Cynthia Deignan⁹, Siddharth Chaudhari¹⁰, Lichen Teng¹¹ and Laure Gossec¹², ¹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ³UT Southwestern Medical Center, Dallas, TX, ⁴Harvard Medical School, Wayland, MA, ⁵Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Division of Rheumatology, Toronto, ON, Canada, ⁶Division of Rheumatology, Department of Medicine (DMED), Academic Hospital "Santa Maria della Misericordia", ASUFC, University of Udine, Udine, Italy, Udine, Italy, ⁷Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany, ⁸Kyorin University School of Medicine, Tokyo, Japan, ⁹Amgen, Inc., Agoura Hills, CA, ¹⁰Amgen Inc., Thousand Oaks, CA, ¹¹Amgen Inc., Thousand Oaks, ¹²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France
Background/Purpose: FOREMOST (NCT03747939)1 offers novel insights on early oligoarticular (oligo, ≤4 active joints) PsA. Our aim was to analyse progression to polyarticular (poly; >4 active…
Abstract Number: 0335 • ACR Convergence 2025
Discontinuation and Non-Publication of Osteoarthritis Clinical Studies: A Cross-Sectional Analysis of 10,686,413 Patients
Mohamed Abdelsalam¹, Hadeer Hafez², Maryam Lasheen³, Bassant Elaraby Elsayed Badwy⁴, Omar Sameh Nabil El Sedafy¹, Abdelrahman M Hafez⁵, Omnia Samy El-Sayed⁴, Menat Alla Ayman Ali Mahdy⁴, Ali Tarek Hassanin³, Mohamed Reda Awad⁶ and Mohammed Safwat Kamal Hamza⁷, ¹Misr University For Science and Technology, ⁶ october, Al Jizah, Egypt, ²⁶th October University, ⁶ october, Al Jizah, Egypt, ³Misr University For Science and Technology, Helwan, Al Qahirah, Egypt, ⁴Misr University For Science and Technology, Nasr City, Al Qahirah, Egypt, ⁵Faculty of medecine, Damietta university, Mansoura, Ad Daqahliyah, Egypt, ⁶Al Azhar University, Cairo, Egypt, Giza, Al Jizah, Egypt, ⁷Faculty of Medicine, Misr University for Science and Technology, ⁶ october, Al Jizah, Egypt
Background/Purpose: Osteoarthritis (OA) is rising at an alarming rate, affecting millions worldwide and threatening mobility, independence, and quality of life. High-quality evidence is essential to…
Abstract Number: 1999 • ACR Convergence 2025
Characterization of Infusion Reactions Within 1 Hour of Treatment With Nanoencapsulated Sirolimus Plus Pegadricase: Pooled Results From the Phase 3 DISSOLVE I and DISSOLVE II Trials
Herbert Baraf¹, Andrew J. Sulich², Guillermo J. Valenzuela³, Rehan Azeem⁴, Ben Peace⁵, Bhavisha Desai⁶ and Puja Khanna⁷, ¹The Center for Rheumatology and Bone Research, Rheumatology, Wheaton, Maryland, USA; Division of Rheumatology, The George Washington University, Washington, DC, ²Shores Rheumatology, St. Clair Shores, MI, ³Iris Rheumatology, Plantation, FL, ⁴Global MACD, Sobi Inc., Waltham, MA, ⁵Statistical Science, Sobi, Stockholm, Sweden, ⁶Sobi, Glastonbury, CT, ⁷Division of Rheumatology, University of Michigan, Ann Arbor, MI
Background/Purpose: Uricase-based therapies may profoundly lower serum uric acid (sUA) in patients (pts) with uncontrolled gout (UG) but often lead to anti-drug antibody (ADA) formation,…
Abstract Number: 1232 • ACR Convergence 2025
Does Social Support Reduce Bodily Pain among African American Women with SLE?: Findings from a Randomized Controlled Trial
Jerik Leung¹, Tomika Caldwell², Paul Nietert³, Clara Dismuke⁴, Hetlena Johnson⁵, Edith Williams⁶ and Everette Keller³, ¹Emory University, Rollins School of Public Health, Atlanta, GA, ²Medical University of Souty Carolina, Charleston, ³Medical University of South Carolina, Charleston, SC, ⁴VA Palo Alto Health Care System, Menlo Park, ⁵Lupus Community Advocate/Researcher, Columbia, SC, ⁶University of Rochester Medical Center, Rochester, NY
Background/Purpose: Peer mentoring has been shown to be an effective intervention for chronic conditions with evidence to suggest that it might improve health related bodily…
Abstract Number: 0573 • ACR Convergence 2025
Effects of Sonelokimab, an IL-17A- and IL-17F-Inhibiting Nanobody, on Patient-Reported Symptoms and Quality of Life in Psoriatic Arthritis: Results From the Randomized, Double-Blind, Placebo-Controlled Phase 2 ARGO Trial
Joseph F Merola¹, Alexis Ogdie², Alice B. Gottlieb³, Fabian Proft⁴, Nuala Brennan⁵, Alex Godwood⁵, Matthew R. Thomas⁵, Eva Cullen⁵, Kristian Reich⁶, Laura Coates⁷ and Laure Gossec⁸, ¹Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ²University of Pennsylvania, Philadelphia, PA, ³Department of Dermatology, UT Southwestern Medical Center, Dallas, TX, ⁴Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ⁵MoonLake Immunotherapeutics AG, Zug, Switzerland, ⁶MoonLake 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, ⁷Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁸Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France
Background/Purpose: Sonelokimab (SLK) is a novel IL-17A- and IL-17F-inhibiting Nanobody designed to target difficult-to-reach sites of inflammation due to its small size and albumin-binding domain.…

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