Abstracts tagged "Response Criteria"

Abstract Number: 2486 • ACR Convergence 2023
Should SLE Patients Entering Clinical Trials Be Required to Have at Least One BILAG a And/or Two BILAG B Scores?
Ewa Olech¹ and Joan Merrill², ¹IQVIA, Rheumatology Consultants, PLLC, Las Vegas, NV, ²Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: High placebo response rates have challenged interpretation of clinical trial results in SLE and may have contributed to failure of some effective treatments. One…
Abstract Number: 2551 • ACR Convergence 2023
Remission and Low Disease Activity (LDA) in Patients with SLE Treated with Belimumab (BEL): Results from a Large Integrated Analysis
Ioannis Parodis¹, Julius Lindblom¹, Roger A. Levy², Margherita Zen³, Nursen Cetrez¹, Alvaro Gomez⁴, Shereen Oon⁵, Christine Henning⁶, Munther Khamashta⁷, Holly A. Quasny⁸, Deven Chauhan⁹, Anca Askanase¹⁰, Ronald van Vollenhoven¹¹ and Mandana Nikpour¹², ¹Karolinska Institutet, Stockholm, Sweden, ²GlaxoSmithKline, Global Medical Affairs, Collegeville, PA, ³University of Padua, Division of Rheumatology, Department of Medicine, Padua, Italy, ⁴Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, ⁵University of Melbourne at St Vincent’s Hospital, Departments of Rheumatology and Medicine, Fitzroy, Australia, ⁶GlaxoSmithKline, US Medical Affairs, Durham, NC, ⁷GSK Gulf, Medical Affairs Department, Dubai, United Arab Emirates, ⁸GlaxoSmithKline, Research & Development, Durham, NC, ⁹GlaxoSmithKline, Value Evidence and Outcomes, Brentford, United Kingdom, ¹⁰Columbia University Medical Center, New York, NY, ¹¹Amsterdam Rheumatology and Immunology Center and Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands, ¹²The University of Melbourne at St. Vincent’s Hospital Melbourne, Departments of Medicine and Rheumatology, Melbourne, Australia
Background/Purpose: A key treatment goal in SLE management is the attainment of remission or LDA,1 for which various definitions exist, including “Definitions of Remission in…
Abstract Number: 0459 • ACR Convergence 2023
Upadacitinib Monotherapy versus Methotrexate in Patients with Rheumatoid Arthritis: Efficacy and Safety Through 5 Years in the SELECT-EARLY Randomized Controlled Trial
Ronald van Vollenhoven¹, Vibeke Strand², Tsutomu Takeuchi³, Nilmo Chávez⁴, Pablo Mannucci Walter⁵, Attul Singhal⁶, Jerzy Swierkot⁷, Nasser Khan⁸, Xianwei Bu⁹, Yihan Li⁹, Sara Penn⁹, Heidi Camp⁹ and Jacob Aelion¹⁰, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Stanford University, Portola Valley, CA, ³Keio University School of Medicine and Saitama Medical University, Tokyo, Japan, ⁴Instituto Guatemalteco de Seguridad Social, Guatemala, Guatemala, ⁵Aprillus Asistencia e Investigación, Buenos Aires, Argentina, ⁶Southwest Rheumatology Research Group, Dallas, TX, ⁷Department of Rheumatology and Internal Medicine, Wrocław Medical Hospital, Wrocław, Poland, ⁸Pharmacovigilance and Patient Safety, AbbVie, Inc., North Chicago, IL, ⁹AbbVie, Inc., North Chicago, IL, ¹⁰West Tennessee Research Institute, Jackson, TN
Background/Purpose: To evaluate the efficacy and safety of upadacitinib (UPA) monotherapy vs MTX monotherapy over 5 yrs among MTX-naïve patients with moderately to severely active…
Abstract Number: 0507 • ACR Convergence 2023
The Use of PSAID-12 in Remote Monitoring Correlates with In-person Clinical Examination Findings in Psoratic Arthritis
Antoni Chan and NiSoe Nwe, Royal Berkshire NHS Foundation Trust, Reading, United Kingdom
Background/Purpose: Patient-reported outcome measures (PROMs) are important tools for evaluating disease activity, functional status, and quality of life in patients with psoriatic arthritis (PsA). The…
Abstract Number: 0520 • ACR Convergence 2023
How Do Early Disease Activity and Early Clinical Response Associate with Long-Term Outcomes with Ixekizumab in Radiographic Axial Spondyloarthritis?
Sofia Ramiro¹, Cedric Lukas², Louis Bessette³, Pendleton Wickersham⁴, Soyi Liu-Leage⁵, Tommaso Panni⁵, Rebecca Bolce⁵, Boris Janos⁵, Michael Nissen⁶ and James Cheng-Chung Wei⁷, ¹Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ²CHU Montpellier, Montpellier, France, ³Centre de l'Ostéoporose et de Rhumatologie de Québec, Quebec City, QC, Canada, ⁴Arthritis Associates PA, San Antonio, TX, ⁵Eli Lilly and Company, Indianapolis, IN, ⁶Geneva University Hospitals, Geneva, Switzerland, ⁷Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan
Background/Purpose: The ASAS-EULAR recommendations for the management of axial spondyloarthritis (axSpA) advise that a patient be assessed for biological disease-modifying anti-rheumatic drug (bDMARD) treatment response…
Abstract Number: 0746 • ACR Convergence 2023
The Association Between Sonographic Imaging Phenotype and Response to Treatment in Patients with Psoriatic Arthritis
Jessica Gutierrez Manjarrez¹, Sydney Thib², Richard J. Cook³ and Lihi Eder⁴, ¹Women’s College Research Institute / Department of Medicine, University of Toronto, Toronto, ON, Canada, ²Women’s College Research Institute, Toronto, ON, Canada, ³Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON, Canada, ⁴Women’s College Research Institute, Division of Rheumatology, University of Toronto, Toronto, ON, Canada
Background/Purpose: Ultrasound (US) may improve characterization of psoriatic arthritis (PsA) phenotypes and help predict disease outcomes. We aimed to assess whether US phenotypes are associated…
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: 0974 • ACR Convergence 2023
Validation of Boolean 2.0 Criteria for Assessing Remission and Predicting Quality of Life in Korean Patients with Rheumatoid Arthritis Undergoing Targeted Therapy
Soo-Kyung Cho¹, Yeo-Jin Song¹, Jungyong Han², Hye Won Kim³, Eunwoo Nam³ and Yoon-Kyoung Sung¹, ¹Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ³Hanyang University Institute for Rheumatology Research, Seoul, South Korea
Background/Purpose: The management of rheumatoid arthritis (RA) focuses on achieving remission as a treatment goal. The updated ACR/EULAR remission definition (Boolean criteria 2.0) has raised…
Abstract Number: 1079 • ACR Convergence 2022
Intravenous Immunoglobulin in Antineutrophil Cytoplasmic Antibody-associated Vasculitis: Study of 28 Cases from a Single Univeristary Hospital
Fabricio Benavides Villanueva¹, Cristina Corrales¹, Vanesa Calvo Río², Javier Loricera³, Nuria Aviles⁴, Juan M Blanco Madrigal⁵, Santos Castañeda⁶, Miguel Angel Gonzalez Gay⁷ and Ricardo Blanco³, ¹Hospital Universitario Marqués de Valdecilla, Santander, Spain, ²Valdecilla Hospital, Santander, Spain, ³Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ⁴Hospital Universitario Perpetuo Socorro, Albacete, Spain, ⁵Basurto University Hospital, Bilbao, Spain, ⁶Division of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Spain, ⁷Hospital Universitario Marques de Valdecilla, Lugo, Spain
Background/Purpose: Anti neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) includes granulomatosis with polyangiitis (GPA), eosinophilic granulomatosis with polyangiitis (EGPA) or microscopic polyarteritis (MPA). Standard treatment is…
Abstract Number: 1147 • ACR Convergence 2022
Transcriptomic Changes Induced by Tocilizumab in Ex-Vivo PBMCs from Patients with GCA in Remission. Predictors of Response
Marco A Alba¹, Roser Alba¹, Georgina Espigol Frigolé², Javier Marco Hernández², Sergio Prieto², Marc Corbera-Bellalta³ and Maria C Cid³, ¹IDIBAPS, Barcelona, Spain, ²Hospital Clínic de Barcelona, Barcelona, Spain, ³Hospital Clinic, University of Barcelona, Barcelona, Spain
Background/Purpose: Glucocorticoids (GCs) are only effective therapy able to induce disease remission, but most patients relapse when GC are tapered and suffer from GC-related toxicity.…
Abstract Number: 1362 • ACR Convergence 2022
Validation of the 2016 ACR/EULAR Myositis Response Criteria in Juvenile Dermatomyositis (JDM) Clinical Trials and Consensus Profiles
Hanna Kim¹, Didem Saygin², Christian Douglas³, john mcgrath³, Jesse Wilkerson³, angela Pistorio⁴, Ann Reed⁵, Chester Oddis⁶, Frederick Miller⁷, Jiří Vencovský⁸, Nicola Ruperto⁹, Rohit Aggarwal¹⁰ and Lisa G Rider⁷, ¹Division of Rheumatology, Department of Medicine, George Washington University School of Medicine and Health Sciences; Juvenile Myositis Therapeutic and Translation Studies Unit, PTRB, NIAMS, NIH, Bethesda, MD, ²University of Chicago, Chicago, IL, ³Social and Scientific Systems, Inc., Durham, NC, ⁴IRCCS Istituto Giannina Gaslini, Genoa, Italy, ⁵Duke University School of Medicine, Durham, NC, ⁶University of Pittsburgh, Pittsburgh, PA, ⁷Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, Bethesda, MD, ⁸Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ⁹IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy, ¹⁰Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Juvenile dermatomyositis (JDM) ACR-EULAR myositis response criteria (MRC) were developed based on absolute % changes in 6 core set measures (CSM) differentially weighted to…
Abstract Number: 1370 • ACR Convergence 2022
Abatacept in the Treatment of Refractory Juvenile Dermatomyositis
Gulnara Mamyrova¹, William Nguyen², Hassan Awal¹, Derek Jones¹, Alison Ehrlich³, Kathleen Brindle⁴, Shahriar Haji-Momenian⁴, Robert Sheets⁵, Adeline Y. Chin⁶, Shajia Lu⁷, Massimo Gadina⁷, Hanna Kim⁸, Olcay Y. Jones⁹, Lisa G Rider¹⁰ and Rodolfo V Curiel¹, ¹Division of Rheumatology, Department of Medicine, George Washington University School of Medicine and Health Sciences, Washington, DC, ²Division of Rheumatology, Department of Medicine, George Washington University, School of Medicine and Health Sciences, Washington, DC, ³Department of Dermatology, George Washington University School of Medicine and Health Sciences, Washington, DC, ⁴Department of Radiology, George Washington University School of Medicine and Health Sciences, Washington, DC, ⁵Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, University of California San Diego, Rady Children's Hospital, San Diego, CA, ⁶Juvenile Myositis Therapeutic and Translation Studies Unit, PTRB, NIAMS, NIH, Bethesda, MD, ⁷Translational Immunology Section, NIAMS, NIH, Bethesda, MD, ⁸Division of Rheumatology, Department of Medicine, George Washington University School of Medicine and Health Sciences; Juvenile Myositis Therapeutic and Translation Studies Unit, PTRB, NIAMS, NIH, Bethesda, MD, ⁹Division of Rheumatology, Department of Medicine, George Washington University School of Medicine and Health Sciences; Pediatric Rheumatology, Walter Reed National Military Medical Center, Bethesda, MD, ¹⁰Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, Bethesda, MD
Background/Purpose: This open-label 24-week study was conducted to evaluate the safety and efficacy of abatacept in patients with refractory juvenile dermatomyositis (JDM).Methods: Ten patients of…
Abstract Number: 1414 • ACR Convergence 2022
2022 Revision of the ACR/EULAR Remission Criteria for Rheumatoid Arthritis
Paul Studenic¹, Daniel Aletaha², Maarten de Wit³, Tanja Stamm⁴, Farideh Alasti⁵, Diane Lacaille⁶, Josef Smolen¹ and David Felson⁷, ¹Medical University of Vienna, Vienna, Austria, ²Medical University Vienna, Wien, Austria, ³Patient research partner, Amsterdam, Netherlands, ⁴Medical University of Vienna, CeMSIIS - Center for Medical Statistics, Informatics, and Intelligent Systems, Section for Outcomes Research, Wien, Austria, ⁵Medical University of Vienna, Department of Internal Medicine 3, Division of Rheumatology, Vienna, Austria, ⁶Arthritis Research Canada, University of British Columbia, Vancouver, BC, Canada, ⁷Boston University, Boston, MA
Background/Purpose: More than 10 years ago ACR and EULAR endorsed provisional criteria to define remission in RA, both Boolean and index-based. However, the agreement between…
Abstract Number: 1628 • ACR Convergence 2022
The Sjogren Tool for Assessing Response (STAR): Assessment of Response Rates Overall, According to Baseline Activity and by Domain: Reanalysis of 9 Clinical Trials in Primary Sjogren Syndrome
Raphaèle Seror¹, Gabriel Baron², Divi CORNEC³, Elodie Perrodeau², Marine Camus⁴, Professor Simon Bowman⁵, Michele Bombardieri⁶, Hendrika Bootsma⁷, Suzanne Arends⁷, jacques-eric gottenberg⁸, Benjamin A. Fisher⁹, Wolfgang Hueber¹⁰, Joel Van Roon¹¹, Valerie Devauchelle¹², Liseth de Wolff¹³, Peter Gergely¹⁴, Xavier Mariette¹⁵ and Raphaël Porcher¹⁶, ¹University Hospital Paris-Saclay, Le Kremlin Bicêtre, France, ²AP-HP Hôtel Dieu Hospital, Université Paris Descartes, Paris, France, ³CHRU Brest, Brest, France, ⁴Department of Rheumatology, Université Paris-Saclay, APHP Hôpital Bicêtre, Le Kremlin Bicêtre, France, ⁵University Hospitals Birmingham, Birmingham, United Kingdom, ⁶Experimental Medicine and Rheumatology, William Harvey Research Institute, Queen Mary University, London, United Kingdom, ⁷University Medical Center Groningen, Groningen, Netherlands, ⁸Strasbourg University Hospital, Strasbourg, France, ⁹University of Birmingham, Birmingham, United Kingdom, ¹⁰Novartis Pharmaceuticals, Basel, Switzerland, ¹¹Rheumatology & Clinical Immunology, University of Utrecht, Utrecht, Netherlands, ¹²Université de Bretagne Occidentale, Brest, France, ¹³UMCG, Zwolle, Netherlands, ¹⁴Novartis Pharma, Basel, Switzerland, ¹⁵Paris-Saclay University, Rueil Malmaison, Ile-de-France, France, ¹⁶Université Paris Cité, Hôtel-Dieu, Paris, France
Background/Purpose: The ESSDAI and ESSPRI, used alone, are not able to capture all features of primary Sjögren's syndrome (pSS). The NECESSITY consortium developed the Sjögren's…
Abstract Number: 1974 • ACR Convergence 2022
Which ACR Response Definition Should Be Used for Disease Activity Claims in Approval Studies of Rheumatoid Arthritis? A Systematic Evaluation
Andreas Kerschbaumer¹, Victoria Konzett², Josef Smolen¹ and Daniel Aletaha³, ¹Medical University of Vienna, Vienna, Austria, ²Division of Rheumatology / Department of Medicine III / Medical University of Vienna, Vienna, Austria, ³Medical University Vienna, Wien, Austria
Background/Purpose: The American College of Rheumatology (ACR) response definition was developed in 1995 by Felson et al. as a composite outcome and has been the…

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