Abstracts tagged "clinical trial"

Abstract Number: 0895 • ACR Convergence 2025
Impact of Glucocorticoid Tapering in Giant Cell Arteritis: Analysis From the SELECT-GCA Trial
FRANK BUTTGEREIT¹, Kevin Winthrop², Leonard Calabrese³, Ivan Lagunes⁴, Aditi Kadakia⁵, Ana Romero⁶, Shaofei Zhao⁴, Weihan Zhao⁴, Arathi Setty⁴ and Jeffrey Curtis⁷, ¹Charité University Medicine Berlin, Berlin, Berlin, Germany, ²Oregon Health & Science University, Portland, OR, ³Cleveland Clinic, Cleveland, OH, ⁴Abbvie Inc, North Chicago, IL, ⁵AbbVie Inc, Woburn, MA, ⁶AbbVie, Barcelona, Spain, ⁷University of Alabama at Birmingham, Birmingham
Background/Purpose: This study assessed the occurrence of adverse events of serious infections, herpes zoster, and opportunistic infection during concomitant treatment with GCs and after GC…
Abstract Number: 0574 • ACR Convergence 2025
Bimekizumab 3-Year Efficacy In Patients With Psoriasis And Risk Factors For Progression To Psoriatic Arthritis Or Screening Positive For Psoriatic Arthritis: Long-Term Results From Five Phase 3/3b Trials
Richard G. Langley¹, Joseph F Merola², Diamant Thaçi³, Emi Nishida⁴, Bruce Strober⁵, Richard B. Warren⁶, José M. López Pinto⁷, Christina Crater⁸, Sarah Kavanagh⁸ and Paolo Gisondi⁹, ¹Dalhousie University, Halifax, NS, Canada, ²Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ³Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ⁴Nagoya City West Medical Center, Nagoya, Japan, ⁵Department of Dermatology, Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell, CT, ⁶Dermatology Centre, Northern Care Alliance, NHS Foundation Trust & Division of Musculoskeletal and Dermatological Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom, ⁷UCB, Madrid, Spain, ⁸UCB, Morrisville, NC, ⁹Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy
Background/Purpose: Psoriatic arthritis (PsA) affects up to one-third of patients with psoriasis;1 early identification and intervention for patients with psoriasis and risk factors (RFs) for…
Abstract Number: 0779 • ACR Convergence 2025
Interim Results of a Randomized Placebo Controlled Study of IL-1 Inhibitor Goflikicept in Patients With Familial Mediterranean Fever
Olga Uhanova¹, serdal Ugurlu², Mikhail Kostik³, Tamara Sarkisyan⁴, Anna Yeghiazaryan⁴, Lidiya Lysenko⁵, Vilen Rameev⁵, Omer Karadag⁶, Valentina Vardanyan⁷, Veli Yazisiz⁸, Tatiana Sotnikova⁹, Vyacheslav Podsvirov¹, Alina Egorova¹⁰, Daria Bukhanova¹⁰, Sergey Grishin¹⁰, Tolga Tuncel¹¹, Mikhail Samsonov¹⁰ and Ahmet Gul¹², ¹Terafarm LLC, Stavropol, Russia, ²Istanbul University-Cerrahpasa, Department of Internal Medicine, Division of Rheumatology, Istanbul, Turkey, ³Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russia, ⁴Center of Medical Genetics and Primary Health Care LTD, Yerevan, Armenia, ⁵Sechenov’s ¹st State Moscow Medical University, Moscow, Russia, ⁶Division of Rheumatology, Department of Internal Medicine, Hacettepe University School of Medicine, Ankara, Turkey, ⁷Ecosense Diagnostic Center, Yerevan, Armenia, ⁸Akdeniz University, Faculty of Medicine, Antalya, Turkey, ⁹State Budgetary Institution of Healthcare of Moscow Multispeciality Hospital named after S.P. Botkin of the Moscow City and Sechenov University, Moscow, Russia, ¹⁰R-Pharm JSC, Moscow, Russia, ¹¹TRpharm, Istanbul, Turkey, ¹²Istanbul University, Istanbul Faculty of Medicine, Division of Rheumatology, Istanbul, Istanbul, Turkey
Background/Purpose: Goflikicept (GFC; RPH-104) is a novel fusion protein inhibiting interleukin-1 (IL-1). This study aimed to investigate its efficacy and safety in IL-1β-driven monogenic autoinflammatory…
Abstract Number: 0403 • ACR Convergence 2025
IL-6 as a Predictor of Response to Olokizumab in Polyarticular-Course Juvenile Idiopathic Arthritis: Results of the Phase 2 Clinical Trial
Ekaterina Alexeeva¹, Tatiana Dvoryakovskaya¹, Elena Zholobova², Elizaveta Krekhova³, Valeria Matkava⁴, Rinat Raupov⁵, Daria Bukhanova⁶, Alina Egorova⁶, Sergey Grishin⁶, Mikhail Samsonov⁶, Mikhail Kostik⁷ and Irina Nikishina⁴, ¹National Medical Research Center for Children’s Health Federal State Autonomous Institution of the Russian Federation Ministry of Health and I.M. Sechenov First Moscow State Medical University (Sechenovskiy University), Moscow, Russia, ²I.M.Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia, ³National Medical Research Center for Children’s Health Federal State Autonomous Institution of the Russian Federation Ministry of Health, Moscow, Russia, ⁴V.A.Nasonova Research Institute of Rheumatology, Moscow, Russia, ⁵H.Turner National Medical Research Center for Childrens Orthopaedics and Trauma Surgery, Saint-Petersburg, Russia, ⁶R-Pharm JSC, Moscow, Russia, ⁷Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russia
Background/Purpose: Olokizumab (OKZ) is a direct interleukin-6 (IL-6) inhibitor. IL-6 is an attractive target for the treatment of pJIA. The aim of the study was…
Abstract Number: 2663 • ACR Convergence 2025
PAXIS: A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Phase 2 Study (Part 1) Followed by an Open-Label Period (Part 2) to Assess the Efficacy and Safety of Pacritinib in Patients with VEXAS Syndrome
David Beck¹, Mael Heiblig², Sinisa Savic³, Marcela ferrada⁴, Arsène Mekinian⁵, Onima Chowdhury⁶, Danielle Hammond⁷, Lachelle D. Weeks⁸, Carmelo Gurnari⁹, Yohei Kirino¹⁰, Sophie georgin-Lavialle¹¹, Sarah A. Buckley¹², Bryan G. harder¹², Sandra Goble¹² and Matthew Koster¹³, ¹Center 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, ²Lyon-Sud Hospital, Hospices Civils de Lyon, Paris and Université Claude Bernard, Lyon, France, ³University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ⁴University of Maryland, Bethesda, MD, ⁵Department of Internal Medicine, Inflammation-Immunopathology-Biotherapy Department (DMU i³), Saint-Antoine University Hospital, ⁷⁵⁰¹² Paris, France, Paris, France, ⁶Oxford University Hospitals’ NHS Foundation Trust and Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom, ⁷The University of Texas MD Anderson Cancer Center, Houston, TX, ⁸Dana Farber Cancer Institute, Boston, MA, ⁹Department 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, ¹⁰Yokohama City University Graduate School of Medicine, Yokohama, Japan, ¹¹Sorbonne university, Tenon hospital, DMU³ID, CEREMAIA, ERN RITA, Paris, France, ¹²Sobi Inc., Waltham, MA, ¹³Mayo Clinic, Rochester, MN
Background/Purpose: VEXAS syndrome (Vacuoles, E1 ubiquitin-activating enzyme, X-linked, Autoinflammatory, Somatic) is a systemic disorder characterized by an overlap of hematologic and inflammatory features. Treatment poses…
Abstract Number: 2440 • ACR Convergence 2025
Effect of Cenerimod on Four Main Clinical Items of SLEDAI-2K Score in SLE Patients in a Phase 2b Study
Anca Askanase¹, Bruno Flamion², Ouali Berkani² and Cecile Dubois², ¹Columbia University Medical Center, New York, NY, ²Viatris Innovation, Allschwil, Switzerland
Background/Purpose: Cenerimod is a selective S1P1 receptor modulator that has the potential to reduce the abnormal immune response seen in Systemic lupus erythematosus (SLE) thereby…
Abstract Number: 2288 • ACR Convergence 2025
Efficacy of Ivarmacitinib in Patients with Moderate-to-severe Rheumatoid Arthritis Stratified by Baseline Characteristics: A Post-hoc Study of a Phase III Clinical Trial
Yuan Xue, Bo Wei, Xiaojing Huang and Rui Ding, Zhongshan Hospital Xiamen University, Xiamen, China (People's Republic)
Background/Purpose: Ivarmacitinib (SHR0302), a selective Janus kinase 1 inhibitor, has demonstrated efficacy in patients with moderate-to-severe rheumatoid arthritis (RA). This post-hoc study aimed to evaluate…
Abstract Number: 2012 • ACR Convergence 2025
A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ABP-671 in Subjects with Hyperuricemia or Gout in China
ullrich schwertschlag¹, yan yang², Jingfei li³, Roy Wu⁴, adam jin² and William Shi⁵, ¹Atom Therapeutics, PALO ALTO, CA, ²Atom Therapeutics, Suzhou, China (People's Republic), ³Atom Therapeutics, Suzhou, Jiangsu, China (People's Republic), ⁴Atom Bioscience, San Francisco, CA, ⁵Atom Therapeutics, Newark, CA
Background/Purpose: ABP-671 is a novel, selective and potent URAT1 inhibitor in development for the treatment of elevated serum uric acid (sUA) levels and gout.Methods: Subjects…
Abstract Number: 1545 • ACR Convergence 2025
Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: Interim Analysis of a Phase 3 Randomized Placebo-controlled Study
Susan Manzi¹, Ian Bruce², Eric Morand³, Richard Furie⁴, Yoshiya Tanaka⁵, Patricia Puzio⁶, Emon Khan⁷, Jenny Wissmar⁸, Michael Song⁹ and Catharina Lindholm¹⁰, ¹Lupus Center of Excellence, Autoimmunity Institute, Allegheny Health Network, Pittsburgh, PA, ²Centre for Public Health, Faculty of Medicine, Health and Life Sciences, Queen's University, Belfast, Manchester, United Kingdom, ³Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, ⁴Division of Rheumatology, Northwell Health, Great Neck, NY, ⁵University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, ⁶BioPharmaceuticals R&D, AstraZeneca US, Gaithersburg, MD, ⁷BioPharmaceuticals R&D, Late Respiratory and Immunology, AstraZeneca, Academy House, Cambridge, United Kingdom, ⁸BioPharmaceuticals R&D, Late-Stage Development, Respiratory & Immunology, AstraZeneca, Gothenburg, Sweden, ⁹BioPharmaceuticals R&D, Late Clinical Development Immunology, AstraZeneca, Boston, MA, ¹⁰BioPharmaceuticals R&D, Late Clinical Development Immunology, AstraZeneca, Gothenburg, Sweden
Background/Purpose: Intravenous (IV) anifrolumab (300 mg, every 4 weeks [Q4W]) is an approved biologic add-on therapy for moderate to severe SLE;1 a subcutaneous (SC) formulation…
Abstract Number: 1441 • ACR Convergence 2025
Efficacy and Safety of Vunakizumab in Patients with Active Ankylosing Spondylitis by Cigarette Smoking Status: A Post Hoc Analysis of a Randomized, Double-blind, Phase 2/3 Study
Hongbin Li¹ and Huilin Li², ¹Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Nei Mongol, China (People's Republic), ²Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China (People's Republic)
Background/Purpose: Vunakizumab, a humanized anti-interleukin-17A monoclonal antibody, has shown significant efficacy and favorable safety in patients with active ankylosing spondylitis (AS), leading to its approval…
Abstract Number: 0720 • ACR Convergence 2025
Current State of Racial, Ethnic, Sex, and Geographical Diversity in ANCA-associated vasculitis and Giant Cell Arteritis Trials
Manuel Carpio Tumba¹, Aida Mohamadi², Diana Louden³, Victor Pimentel-Quiroz⁴, Michael Putman⁵, Didem Saygin⁶, Raisa Lomanto Silva⁷ and Sebastian E Sattui⁸, ¹University of Pittsburgh, Pittsburgh, PA, ²Tehran University of Medical Sciences, Tehran, Iran, ³University of Washington, Seattle, WA, ⁴Universidad Científica del Sur, San Isidro, Peru, ⁵The Medical College of Wisconsin, Milwaukee, WI, ⁶Rush University Medical Center, Chicago, IL, ⁷Massachusetts General Hospital, Boston, MA, ⁸Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Randomized controlled trials (RCTs) generate unbiased efficacy estimates and are required for regulatory approval. Understanding the degree to which they include racial, ethnic, sex,…
Abstract Number: 0572 • ACR Convergence 2025
Real-World Treat-to-Target Strategy in Psoriatic Arthritis: 48-week Results from the MONITOR-PsA Cohort
Jean-Guillaume Letarouilly¹, Elnaz Saeedi², Raphaël Hurtubise³, Lija James⁴, Nicola Gullick⁵, Deepak Jadon⁶, William Tillett⁷, Yvonne Sinomati⁴, Laura Tucker⁴, Nadia Mian⁸, Sophia Massa³ and Laura Coates⁹, ¹Université de Lille, CHU Lille, Service de rhumatologie, Lille, France, LILLE, Nord-Pas-de-Calais, France, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Oxford, ³Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Oxford, United Kingdom, ⁴Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK, Oxford, United Kingdom, ⁵Rheumatology Department, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK, Coventry, United Kingdom, ⁶Department of Medicine, University of Cambridge, Cambridge, UK, Cambridge, United Kingdom, ⁷Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ⁸BM BS, MMedSc,, Oxford, United Kingdom, ⁹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: A treat-to-target (T2T) strategy in psoriatic arthritis (PsA) is supported by International PsA recommendations but not widely practiced in clinic. The aim of the…
Abstract Number: 0777 • ACR Convergence 2025
Development of a Disease Activity Index for the Assessment of VEXAS Syndrome (VEXAS-DAI)
Kevin Byram¹, Herman Mann², Danielle Hammond³, Sinisa Savic⁴, Yohei Kirino⁵, Carmelo Gurnari⁶, Mael Heiblig⁷, Thibault Comont⁸, Arsène Mekinian⁹, Mrinal Patnaik¹⁰, Lachelle D. Weeks¹¹, Gary Ho¹², Onima Chowdhury¹³, Adam Al-Hakim¹⁴, Scott Goldberg¹⁵, Marcela ferrada¹⁶, Sophie georgin-Lavialle¹⁷, Peter Grayson¹⁸, Emma Groarke¹⁹, Bhavisha Patel²⁰, Megan Sullivan²¹, Sarah A. Buckley²², Bryan G. harder²², Sandra Goble²², Matthew Koster¹⁰ and David Beck²³, ¹Vanderbilt University Medical Center, Nashville, TN, ²Institute of Rheumatology, Praha ², Czech Republic, ³The University of Texas MD Anderson Cancer Center, Houston, TX, ⁴University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ⁵Yokohama City University Graduate School of Medicine, Yokohama, Japan, ⁶Department 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, ⁷Lyon-Sud Hospital, Hospices Civils de Lyon, Paris and Université Claude Bernard, Lyon, France, ⁸Centre Hospitalier Universitaire Toulouse Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France, ⁹Department of Internal Medicine, Inflammation-Immunopathology-Biotherapy Department (DMU i³), Saint-Antoine University Hospital, ⁷⁵⁰¹² Paris, France, Paris, France, ¹⁰Mayo Clinic, Rochester, MN, ¹¹Dana Farber Cancer Institute, Boston, MA, ¹²New York University Grossman School of Medicine, VA New York Harbor Health Care System, Brooklyn, NY, ¹³Oxford University Hospitals’ NHS Foundation Trust and Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom, ¹⁴University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine,, Leeds, United Kingdom, ¹⁵New York University Grossman School of Medicine, Brooklyn, NY, ¹⁶University of Maryland, Bethesda, MD, ¹⁷Sorbonne university, Tenon hospital, DMU³ID, CEREMAIA, ERN RITA, Paris, France, ¹⁸National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Chevy Chase, MD, ¹⁹National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, ²⁰National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Beltsville, MD, ²¹Mayo Clinic Arizona, Scottsdale, AZ, ²²Sobi Inc., Waltham, MA, ²³Center 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
Background/Purpose: VEXAS syndrome is a recently described severe disease characterized by a complex overlap of inflammatory and hematologic features. Due to the severity and refractory…
Abstract Number: 0401 • ACR Convergence 2025
Longitudinal Effectiveness of Abatacept in JIA: Results From an Ongoing JIA Registry
Daniel Lovell¹, Nicolino Ruperto², Jennifer Huggins³, Ekaterina Alexeeva⁴, Colleen Correll⁵, John Bohnsack⁶, Stacey Tarvin⁷, Gabriele Simonini⁸, Thomas Griffin⁹, Andrew Zeft¹⁰, Gerd Horneff¹¹, Pierre Quartier¹², Iionka Orban¹³, Heather Walters¹⁴, Valda Stanevica¹⁵, Julisa Patel¹⁶, Adam M Huber¹⁷, Margalit Rosenkranz¹⁸, Daniel Kingsbury¹⁹, Rosie Scuccimarri²⁰, Gabriel Vega Cornejo²¹, Joost Swart²², Robert Carroll²³, Hermine Brunner¹, Tina Sherrard²⁴, Chiara Pallotti²⁵, Clara Malattia²⁶ and Alberto Martini²⁶, ¹Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Università degli Studi Milano-Bicocca, Milan, Italy, ³Cincinnati Children's Medical Center, Cincinnati, OH, ⁴National Medical Research Center for Children’s Health Federal State Autonomous Institution of the Russian Federation Ministry of Health and I.M. Sechenov First Moscow State Medical University (Sechenovskiy University), Moscow, Russia, ⁵University of Minnesota, Minneapolis, MN, ⁶University of Utah, Salt Lake City, UT, ⁷Riley Hospital for Children at Indiana University, Indianapolis, IN, ⁸Rheumatology Unit, ERN-ReCONNET center, Meyer Children's Hospital IRCCS, Firenze, Firenze, Italy, ⁹Atrium Health Levine Children’s Hospital, Charlotte, NC, ¹⁰Cleveland Clinic, Cleveland, OH, ¹¹Asklepios Klinik, Hamburg, Germany, ¹²Hôpital Necker-Enfants Malades, Paris, France, ¹³Department of Rheumatology and Clinical Immunology of Semmelweis University, Budapest, Hungary, ¹⁴Northwell, New Hyde Park, NY, ¹⁵Riga Stradiņš University, Riga, Latvia, ¹⁶Children’s Hospital of Georgia, Augusta University, Augusta, GA, ¹⁷IWK Grace Health Centre, Halifax, NS, Canada, ¹⁸University of Pittsburgh, Pittsburgh, PA, ¹⁹Randall Children’s Hospital at Legacy Emanuel, Portland, OR, ²⁰McGill University Health Centre, Montreal, QC, Canada, ²¹Clinica de reumatología Guadalajara, Guadalajara, Jalisco, Mexico, ²²Wilhelmina Children's Hospital / UMC Utrecht, Utrecht, Utrecht, Netherlands, ²³Bristol Myers Squibb, London, United Kingdom, ²⁴Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ²⁵Istituto G. Gaslini, Servizio di Sperimentazioni Cliniche Pediatriche, Genova, Italy, ²⁶Istituto G. Gaslini Pediatria II Reumatologia and University of Genova, Genova, Italy
Background/Purpose: Abatacept is a selective T-cell co-stimulation modulator approved for use in JIA. Efficacy and safety of abatacept in patients (pts) with JIA have been…
Abstract Number: 2626 • ACR Convergence 2025
Lorecivivint Delayed Time to Pain and Function Worsening Compared to Placebo: Evaluation of Knee OA Symptom Progression Outcomes in a Phase 3 Trial (OA-07)
Yusuf Yazici¹ and Christopher Swearingen², ¹NYU Grossman School of Medicine, La Jolla, CA, ²Biosplice Therapeutics, Inc, San Diego, CA
Background/Purpose: Increased pain and decreased function are hallmarks of knee OA progression. Lorecivivint (LOR), an intra-articular CLK/DYRK inhibitor thought to modulate inflammatory and Wnt pathways,…

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