Abstracts tagged "clinical trial"

Abstract Number: 0453 • ACR Convergence 2021
Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated Results from 2 Phase 3, Randomized, Double-blind Clinical Trials for CsDMARD-IR and Bio-IR Patients
Andrew Ostor¹, Kim Papp², Mireia Moreno³, Cathy Spargo⁴, Lisa Barcomb⁵, Ahmed M. Soliman⁵, Wenjing Lu⁶, Ann Eldred⁵ and Lars Erik Kristensen⁷, ¹Monash University, Cabrini Hospital, and Emertius Research, Melbourne, Australia, ²K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, ³Rheumatology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí, Universitat Autònoma de Barcelona, Barcelona, Spain, ⁴Vincent Pallotti Hospital, Johannesburg, South Africa, ⁵Abbvie Inc., North Chicago, IL, ⁶AbbVie Inc., North Chicago, ⁷The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Frederiksberg, Denmark
Background/Purpose: Risankizumab (RZB) is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. RZB is being investigated…
Abstract Number: 1169 • ACR Convergence 2021
Patient Preferences for Outcome Measures for a Pragmatic Knee Osteoarthritis (OA) Clinical Trial: Results of a Cross-Sectional Patient Survey That Included Racial/Ethnic Minorities
Jasvinder Singh, University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Many effective treatments are available for knee osteoarthritis (OA), however comparative effectiveness research (CER) of various treatments to each other is limited. One of…
Abstract Number: 1341 • ACR Convergence 2021
Ixekizumab Shows a Pattern of Pain Improvement in Patients with and Without Measurable Inflammation in Psoriatic Arthritis
Kurt de Vlam¹, Gaia Gallo², Philip Mease³, Proton Rahman⁴, Venkatesh Krishnan², David Sandoval², Chen Yen Lin², Danting Zhu², Rebecca Bolce² and Philip Conaghan⁵, ¹University Hospitals Leuven, Leuven, Belgium, ²Eli Lilly and Company, Indianapolis, IN, ³Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁴Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ⁵Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom
Background/Purpose: The efficacy of ixekizumab (IXE) and adalimumab (ADA) in patients with psoriatic arthritis (PsA) has been previously reported using ACR 50 and Psoriasis Area…
Abstract Number: 1688 • ACR Convergence 2021
Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 9.3 Years: An Updated Integrated Safety Analysis
Peter C Taylor¹, Tsutomu Takeuchi², Gerd Burmester³, Patrick DUREZ⁴, Josef Smolen⁵, Walter Deberdt⁶, Jinglin Zhong⁷, Jorge Ross Terres⁶, Natalia Bello⁶ and Kevin Winthrop⁸, ¹University of Oxford, Oxford, United Kingdom, ²Div. Rheumatology, Keio University, Tokyo, Japan, ³Charité University Medicine Berlin, Berlin, Germany, ⁴Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Brussels, Belgium, ⁵Medical University of Vienna, Vienna, Austria, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷IQVIA, Morrisville, NC, ⁸Oregon Health & Science University, Portland, OR
Background/Purpose: Baricitinib (bari) is an oral selective Janus kinase (JAK)1/JAK 2 inhibitor approved for the treatment of adult patients with moderately to severely active rheumatoid…
Abstract Number: 1747 • ACR Convergence 2021
BIIB059 Demonstrates Improvement in Joint Manifestations in Participants with Systemic Lupus Erythematosus in Part a of a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study
Ronald van Vollenhoven¹, Richard Furie², Kenneth Kalunian³, Maria Dall'Era⁴, Victoria Werth⁵, Xiaobi Huang⁶, Hua Carroll⁶, Cristina Musselli⁶, Catherine Barbey⁷ and Nathalie Franchimont⁶, ¹Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³UC San Diego, La Jolla, CA, ⁴University of California San Francisco, Corte Madera, CA, ⁵Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁶Biogen, Cambridge, MA, ⁷Biogen, Baar, Switzerland
Background/Purpose: Joint involvement, a frequent manifestation of SLE, can be assessed using global lupus disease activity indices (SLEDAI-2K, BILAG-2004) and/or by assessing joint tenderness and…
Abstract Number: 1806 • ACR Convergence 2021
Designing a Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Guselkumab (TREMFYA®/sup>) Dosing Interval in Psoriatic Arthritis Patients with Inadequate Response to Tumor Necrosis Factor Inhibition
Alexis Ogdie-Beatty¹, Joseph Merola², Philip Mease³, Christopher Ritchlin⁴, Jose Scher⁵, Daphne Chan⁶, Soumya Chakravarty⁷, Wayne Langholff⁸, Olivia Choi⁹, Yevgeniy Krol⁹, Katelyn Rowland⁹ and Alice Gottlieb¹⁰, ¹University of Pennsylvania, Philadelphia, PA, ²Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ³Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ⁴Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, ⁵New York University School of Medicine, New York, NY, ⁶Janssen Scientific Affairs, LLC, Spring House, PA, ⁷Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Scientific Affairs, LLC, Horsham, PA, ¹⁰Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic therapy for patients (pts) with PsA, though a sizeable proportion of pts…
Abstract Number: 0455 • ACR Convergence 2021
Abatacept Reverses Subclinical Arthritis in Patients with High-risk to Develop Rheumatoid Arthritis -results from the Randomized, Placebo-controlled ARIAA Study in RA-at Risk Patients
Juergen Rech¹, Mikkel Ostergaard², Koray Tascilar³, Melanie Hagen⁴, Larissa Valor Mendez⁴, Arnd Kleyer⁴, Gerhard Kroenke⁴, David Simon⁵, Verena Schoenau⁴, Axel Hueber⁶, Stefan Kleinert⁷, Xenofon Baraliakos⁸, Martin Fleck⁹, Andrea Rubbert-Roth¹⁰, Frank Behrens¹¹, David Kofler¹², Martin Feuchtenberger¹³, Michael Zaenker¹⁴, Reinhard Voll¹⁵, Cornelia Glaser¹⁶, Eugen Feist¹⁷, Gerd Burmester¹⁸, Kirsten Karberg¹⁹, Johannes Strunk²⁰, Juan D Cañete²¹, Esperanza Naredo²², Maria Filkova²³, Ladislav Senolt²⁴ and Georg Schett²⁵, ¹Friedrich-Alexander University (FAU) Erlangen-Nuernberg and Universitaetsklinikum Erlangen, Department of Internal Medicine 3 - Rheumatology and Immunology, Germany, Erlangen, Germany, ²Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Glostrup, Denmark, ³Friedrich Alexander University of Erlangen Nuremberg, Universitaetsklinikum Erlangen Department of Medicine-3 Rheumatology and Immunology, Erlangen, Germany, ⁴Friedrich-Alexander University (FAU) Erlangen-Nuernberg and Universitaetsklinikum Erlangen, Medical Department 3, Rheumatology & Immunology, Erlangen, Germany, ⁵Department of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nrnberg, Erlangen, Germany, ⁶sozialstiftung-bamberg.de, Bamberg, Germany, ⁷Praxisgemeinschaft Rheumatologie - Nephrologie (PGRN), Erlangen, Germany, ⁸Rheumazentrum Ruhrgebiet, Herne, Germany, ⁹Asklepios Klinikum Bad Abbach Klinik und Poliklinik für Rheumatologie/ Klin. Immunologie, Bad Abbach, Germany, ¹⁰Kantonspital St Gallen, St.Gallen, Switzerland, ¹¹Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Frankfurt/Main, Germany, ¹²Division of Rheumatology and Clinical Immunology, Department I of Internal Medicine; University Hospital Cologne, Cologne, Germany, ¹³MED | BAYERN OST GmbH Fachbereich Rheumatologie, Burghausen, Germany, ¹⁴Immanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau, Germany, ¹⁵Department of Rheumatology and Clinical Immunology, University Medical Center, Faculty of Medicine, Albert-Ludwigs-University of Freiburg, Freiburg, Germany, ¹⁶Universitätsklinikum Freiburg Klinik für Rheumatologie und Klinische Immunologie, Freiburg, Germany, ¹⁷Helios Department of Rheumatology, Vogelsang-Gommern, Germany, ¹⁸Charité University Medicine Berlin, Berlin, Germany, ¹⁹Praxis für Rheumatologie und Innere Medizin, Berlin, Germany, ²⁰Krankenhaus Porz am Rhein GmbH Rheumaklinik, Köln (Porz), Germany, ²¹Rheumatology Department, Hospital Clinic, Barcelona, Spain, ²²Department of Rheumatology and Joint and Bone Research Unit, Hospital Fundación Jiménez Díaz and Autónoma University, Madrid, Spain, ²³Institute of Rheumatology and Connective Tissue Research Laboratory, Department of Rheumatology of First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic, ²⁴Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, ²⁵Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany
Background/Purpose: Rheumatoid arthritis (RA) has a preclinical phase that is characterized by the presence of antibodies against citrullinated proteins (ACPA), subclinical arthritis and pain. ACPA…
Abstract Number: 1225 • ACR Convergence 2021
Baseline Extracellular Matrix Biomarkers Predict Abatacept Treatment Response in MTX-Naive, ACPA+ Patients with Early RA
Paul Emery¹, Yoshiya Tanaka², Vivian Bykerk³, Clifton Bingham⁴, Tom WJ Huizinga⁵, Gustavo Citera⁶, Chun Wu⁷, Sarah Hu⁷, Peter Schafer⁷, Jinqi Liu⁷, Sean Connolly⁷, Robert Wong⁸ and Roy Fleischmann⁹, ¹Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, United Kingdom, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Division of Rheumatology, Hospital for Special Surgery, New York City, NY, ⁴Johns Hopkins University, Baltimore, MD, ⁵Leiden University Medical Center, Leiden, Netherlands, ⁶Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Basking Ridge, NJ, ⁹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Predictive biomarkers reflecting RA processes and treatment (tmt) efficacy are urgently needed to inform medical options. Markers of bone remodeling and extracellular matrix (ECM)…
Abstract Number: 1345 • ACR Convergence 2021
Long-Term Safety and Effectiveness of Upadacitinib in Patients with Psoriatic Arthritis: Results at 56 Weeks from the SELECT-PsA 1 Study
Iain McInnes¹, Koji Kato², Marina Magrey³, Joseph Merola⁴, Mitsumasa Kishimoto⁵, Cesar Pacheco Tena⁶, Derek Haaland⁷, Liang Chen⁸, Yuanyuan Duan⁹, Patrick Zueger¹⁰, Jianzhong Liu¹¹, Ralph Lippe¹², Aileen Pangan¹¹ and Frank Behrens¹³, ¹University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, ²AbbVie Inc, Shinagawa- Ku, Japan, ³Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, USA, Richfield, OH, ⁴Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ⁵Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Yokohama, Japan, ⁶Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico, ⁷McMaster University, Hamilton, Ontario and The Waterside Clinic, Oro Medonte, ON, Canada, ⁸AbbVie Inc., North Chicago, ⁹AbbVie Inc, North Chicago, ¹⁰AbbVie Inc., Mettawa, IL, ¹¹AbbVie Inc., North Chicago, IL, ¹²AbbVie Deutschland GmbH & Co. KG, Berlin, Germany, ¹³Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Frankfurt/Main, Germany
Background/Purpose: In the SELECT-PsA 1 study, through 24 weeks (wks), once daily upadacitinib 15 mg (UPA15) and 30 mg (UPA30) showed improvements in musculoskeletal symptoms,…
Abstract Number: 1691 • ACR Convergence 2021
Long-Term Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis
Gerd Burmester¹, Stanley Cohen², Kevin Winthrop³, Peter Nash⁴, Andrea Rubbert-Roth⁵, Atul Deodhar³, Ori Elkayam⁶, Eduardo Mysler⁷, Yoshiya Tanaka⁸, Jianzhong Liu⁹, Ana Paula Lacerda⁹, Bosny Pierre-Louis⁹, Tim Shaw¹⁰ and Philip Mease¹¹, ¹Charité University Medicine Berlin, Berlin, Germany, ²Metroplex Clinical Research Center, Dallas, TX, ³Oregon Health & Science University, Portland, OR, ⁴Griffith University, Brisbane, Australia, ⁵Kantonspital St Gallen, St.Gallen, Switzerland, ⁶Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, ⁷Organización Medica de Investigación, Rheumatology, Buenos Aires, Argentina, ⁸University of Occupational and Environmental Health, Kitakyushu, Japan, ⁹AbbVie Inc., North Chicago, IL, ¹⁰AbbVie Inc., North Chicago, ¹¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA
Background/Purpose: The efficacy and safety of the oral Janus kinase inhibitor, upadacitinib (UPA), has been evaluated for several rheumatic diseases. The objective of this analysis…
Abstract Number: 1748 • ACR Convergence 2021
The Peroxisome Proliferator-Activated Receptor-γ (PPAR) Agonist Pioglitazone Improves Vascular and Metabolic Dysfunction in Patients with Systemic Lupus Erythematosus (SLE)
Sarfaraz Hasni¹, Yenealem Temesgen-Oyelakin², Michael Davis³, Sarthak Gupta⁴, Elaine Poncio⁵, Mohammad Naqi¹, Xinghao Wang⁶, Christopher Oliveira⁷, Dillon Claybaugh¹, Amit Dey¹, Shajia Lu¹, Philip Carlucci⁸, Zerai Manna¹, Yinghui Shi¹, Isabel Ochoa⁵, Donald Thomas⁹, Theo Heller¹⁰, Massimo Gadina¹¹, Jun Chu⁴, Monica Purmalek¹, Xiaobai Li¹², Martin Playford¹³, Nehal Mehta¹³ and Mariana Kaplan¹, ¹National Institutes of Health, Bethesda, MD, ²National Institutes of Health (NIH), Bethesda, MD, ³NIAMS, Bethesda, MD, ⁴National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD, ⁵NIH/NIAMS, Bethesda, MD, ⁶NIAMS/NIH, Bethesda, MD, ⁷National Institutes of Health (NIH), Vienna, VA, ⁸New York University School of Medicine, New York, NY, ⁹Arthritis and Pain Associates of Prince George's County, Silver Spring, MD, ¹⁰NIDDK/National Institutes of Health, Bethesda, MD, ¹¹National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD, ¹²Clinical Center, National Institutes of Health, Bethesda, MD, ¹³NHLBI/National Institutes of Health, Bethesda, MD
Background/Purpose: Premature cardiovascular events in SLE are associated with significant mortality and morbidity with no effective treatments described to date. Both immune dysregulation characteristics of…
Abstract Number: 1807 • ACR Convergence 2021
Relationships Between Fatigue and Hemoglobin/C-Reactive Protein Levels and Associations Between Fatigue and Clinical Response in Patients with Active Psoriatic Arthritis: Results from Two Randomized Controlled Trials of Guselkumab (TREMFYA®)
Proton Rahman¹, Philip Mease², Atul Deodhar³, Laure Gossec⁴, Arthur Kavanaugh⁵, Soumya Chakravarty⁶, Alexa Kollmeier⁷, Yan Liu⁸, Xiwu Lin⁸, May Shawi⁹ and Chenglong Han⁸, ¹Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, ²Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ³Oregon Health & Science University, Portland, OR, ⁴Sorbonne Université; APHP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France, ⁵University of California San Diego, La Jolla, CA, ⁶Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, ⁷Janssen Research & Development, LLC, La Jolla, CA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada
Background/Purpose: Fatigue is a key patient (pt)-reported symptom of psoriatic arthritis (PsA).1,2 Utilizing data from the Phase 3 DISCOVER-1 (D1) and -2 (D2) studies, these…
Abstract Number: 0477 • ACR Convergence 2021
TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Trial
Gregory Sullivan¹, Mary Kelley², Annabelle Iserson¹, Perry Peters², Ashild Peters², Candace Flint¹, Judy Gendreau³, Herb Harris¹, Ben Vaughn⁴ and Seth Lederman⁵, ¹Tonix Pharmaceuticals, Inc., Chatham, NJ, ²Tonix Pharmaceuticals, Inc., San Diego, CA, ³Gendreau Consulting, LLC, Poway, CA, ⁴Rho, Inc., Cary, NC, ⁵Tonix Pharmaceuticals, Inc., South Dartmouth, MA
Background/Purpose: Fibromyalgia (FM) is characterized by chronic widespread pain, fatigue, and nonrestorative sleep, a symptom constellation suggestive of a pathological disturbance in central pain processing…
Abstract Number: 1230 • ACR Convergence 2021
Impact of Serologic Status on Clinical Responses to Upadacitinib or Abatacept in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Biologic DMARDs: Sub-Group Analysis from the Phase 3 SELECT-CHOICE Study
Andrea Rubbert-Roth¹, Jeffrey Sparks², Arnaud Constantin³, Ricardo Xavier⁴, Yanna Song⁵, Jessica Suboticki⁵ and Roy Fleischmann⁶, ¹Kantonspital St Gallen, St.Gallen, Switzerland, ²Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, ³Toulouse University Hospital, Toulouse Cedex 9, France, ⁴Departamento de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, ⁵AbbVie Inc., North Chicago, IL, ⁶University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: In patients with RA who had a prior inadequate response or intolerance to biologic DMARDs, the oral Janus kinase inhibitor, upadacitinib (UPA), demonstrated superiority…
Abstract Number: 1350 • ACR Convergence 2021
Sustained Improvement in Physical Function, Disease Impact and Health-Related Quality of Life in Patients with Psoriatic Arthritis Treated with Bimekizumab: 3-Year Results from a Phase 2b Open-Label Extension Study
Laure Gossec¹, Akihiko Asahina², Alice Gottlieb³, Laura Coates⁴, Barbara Ink⁵, Deepak Assudani⁶, Jason Coarse⁷, Scarlett Hellot⁸, Jason Eells⁶ and Philip Mease⁹, ¹Sorbonne Université and Hôpital Pitié-Salpêtrière, Paris, France, ²Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ³Icahn School of Medicine at Mount Sinai, New York, NY, ⁴Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom, ⁵UCB Celltech, Slough, UK, Slough, United Kingdom, ⁶UCB Pharma, Slough, United Kingdom, ⁷UCB Pharma, Raleigh, NC, ⁸UCB Pharma, Colombes, France, ⁹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17F and IL-17A, and has demonstrated clinical improvements in joint and skin…

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