Abstracts tagged "Outcome measures"

Abstract Number: 0814 • ACR Convergence 2021
Patient Characteristics, Efficacy, and Treatment Patterns of Tofacitinib Monotherapy in Patients with RA: Contextualization of Randomized Controlled Trial Results with Real-world Data
Janet Pope¹, Axel Finckh², Lucia Silva-Fernández³, Peter Mandl⁴, Haiyun Fan⁵, Jose L Rivas⁶, Monica Valderrama⁶ and María Montoro⁶, ¹University of Western Ontario, London, ON, Canada, ²University Hospital of Geneva, Geneve - Vesenaz, Switzerland, ³Hospital Universitari Son Espases, Palma de Mallorca, Spain, ⁴Division of Rheumatology, Medical University of Vienna, Vienna, Austria, ⁵Pfizer Inc, Collegeville, PA, ⁶Pfizer SLU, Madrid, Spain
Background/Purpose: Randomized controlled trials (RCTs) have long been considered the gold standard for clinical research, but can be complemented with real-world data (RWD) to further…
Abstract Number: 1259 • ACR Convergence 2021
Association of SLE Responder Index (SRI) Attainment and Long-term Clinical Outcomes
Kathryn Connelly¹, Rangi Kandane-Rathnayake¹, Alberta Hoi², Worawit Louthrenoo³, Laniyati Hamijoyo⁴, Jiacai Cho⁵, Aisha Lateef⁶, Shue-Fen Luo⁷, Yeong-Jian Wu⁸, C.S. Lau⁹, YI-HSING CHEN¹⁰, Sandra Navarra¹¹, Leonid Zamora¹¹, Zhanguo Li¹², Yuan An¹², Sargunan Sockalingam¹³, Yanjie Hao¹⁴, Zhuoli Zhang¹⁴, Madelynn Chan¹⁵, Yasuhiro Katsumata¹⁶, Masayoshi Harigai¹⁶, Shereen Oon¹⁷, Sang-Cheol Bae¹⁸, Sean O’Neill¹⁹, Kathryn Gibson¹⁹, Jun Kikuchi²⁰, B.M.D.B. Basnayake²¹, Tsutomu Takeuchi²², Kristine (Pek Ling) Ng²³, Fiona Goldblatt²⁴, Annie Law²⁵, Nicola Tugnet²⁶, Yoshiya Tanaka²⁷, Sunil Kumar²⁸, Michael Tee²⁹, Jin Yu Tan³⁰, Chetan Karyekar³¹, Mandana Nikpour³², Vera Golder¹ and Eric Morand³³, ¹Monash University, Clayton, Australia, ²Department of Rheumatology, Monash Health & Department of Medicine, School of Clinical Sciences, Monash University, Melbourne, Australia, ³Maharaj Nakorn Chiangmai, Chiang Mai, Thailand, ⁴University of Padjadjaran, Bandung, Indonesia, ⁵National University Health System (NUHS), Singapore, Singapore, ⁶National University Hospital, Singapore, Singapore, ⁷Chang Gung Memorial Hospital, Taipei, Taiwan, ⁸Chang Gung Memorial Hospital, Taoyuan County, Taiwan, ⁹University of Hong Kong, Hong Kong, Hong Kong, ¹⁰Taichung Veterans General Hospital, Taichung, Taiwan (Republic of China), ¹¹University of Santo Tomas Hospital, Manila, Philippines, ¹²People's Hospital, Peking University Health Science Center, Beijing, China (People's Republic), ¹³University of Malaya, Kuala Lumpur, Malaysia, ¹⁴Peking University First Hospital, Beijing, China (People's Republic), ¹⁵Tan Tock Seng Hospital, Singapore, Singapore, ¹⁶Tokyo Women's Medical University School of Medicine, Tokyo, Japan, ¹⁷Melbourne Health, Parkville, Australia, ¹⁸Hanyang University Medical Center, Seoul, Republic of Korea, ¹⁹Liverpool Hospital, Sydney, Australia, ²⁰Keio University School of Medicine, Tokyo, Japan, ²¹Teaching (General) Hospital, Kandy, Sri Lanka, ²²Div. Rheumatology, Keio University, Tokyo, Japan, ²³North Shore Hospital, Auckland, New Zealand, ²⁴Flinders Medical Centre, Adelaide, Australia, ²⁵Singhealth, Singapore, Singapore, ²⁶Auckland District Health Board, Auckland, New Zealand, ²⁷University of Occupational and Environmental Health, Kitakyushu, Japan, ²⁸Counties Manukau Health, Auckland, New Zealand, ²⁹University of the Philippines, Quezon City, Philippines, ³⁰Janssen Asia Pacific, Singapore, Singapore, ³¹Janssen R&D, Spring House, PA, ³²University of Melbourne at St Vincent's Hospital, Melbourne, Australia, ³³School of Clinical Sciences at Monash Health, Monash University Faculty of Medicine, Nursing and Health Sciences, Monash Medical Centre Clayton, Melbourne, Australia
Background/Purpose: The SLE Responder Index (SRI) is a composite responder definition employed as a clinical trial endpoint in SLE. Despite its widespread adoption, recent discrepant…
Abstract Number: 1863 • ACR Convergence 2021
Consistent Efficacy with Apremilast in Men and Women to Treat Oral Ulcers Associated with Behçet’s Syndrome: Results from Phase 3 Researching Oral Apremilast Safety and Efficacy in Behçet’s Disease (RELIEF) Study
Gülen Hatemi¹, Alfred Mahr², Mitsuhiro Takeno³, Doyoung Kim⁴, Melike Melikoğlu⁵, Sue Cheng⁶, Sven Richter⁶, Shauna Jardon⁷, Maria Paris⁶, Mindy Chen⁶ and Yusuf Yazici⁸, ¹Istanbul University‒Cerrahpaşa, Cerrahpaşa Medical School and Behçet’s Disease Research Center, İstanbul, Turkey, ²Kantonsspital St. Gallen, St.Gallen, Switzerland, ³Musashi Kosugi Hospital, Kawasaki, Japan, ⁴Yonsei University College of Medicine and Severance Hospital, Seoul, Republic of Korea, ⁵Istanbul University‒Cerrahpaşa, İstanbul, Turkey, ⁶Amgen Inc., Thousand Oaks, CA, ⁷Amgen Inc., Gilbert, AZ, ⁸New York University School of Medicine, New York, NY
Background/Purpose: Painful, recurring oral ulcers (OU) associated with Behçet’s syndrome negatively affect quality of life (QoL). Differences across sexes were reported in the frequency of…
Abstract Number: 0336 • ACR Convergence 2021
The Incremental Clinical Utility of a Multianalyte Assay Panel with Cell-Bound Complement Activation Products versus a Traditional ANA Testing Strategy for the Diagnosis and Treatment of SLE
Tyler O'Malley¹, Fenglong Xie², yujie Su², cassie Clinton², Debra J. Zack¹, Jeffrey Curtis³ and John Wegener¹, ¹Exagen Inc., Vista, CA, ²University of Alabama at Birmingham, Birmingham, AL, ³Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: The comparative clinical utility of various diagnostic tests to aid the differential diagnosis of SLE is unclear. We compare the outcomes of testing with…
Abstract Number: 0690 • ACR Convergence 2021
Impact of Achieving 2016 ACR/EULAR Response Criteria on Patient Centered Outcome Measures in Myositis
Didem Saygin¹, Siamak Moghadam-Kia², Chester Oddis², Dana Ascherman², Nicole Neiman², Diane Koontz² and Rohit Aggarwal², ¹University of Chicago, Chicago, IL, ²University of Pittsburgh, Pittsburgh, PA
Background/Purpose: The 2016 ACR/EULAR Myositis Response Criteria represent a composite measure that is increasingly being used as a primary end point in myositis clinical trials.…
Abstract Number: 0845 • ACR Convergence 2021
A Non-Interventional Prospective Observational Study of Treatment with Etanercept Biosimilar (SB4) in Rheumatoid Arthritis in Real Life Clinical Practice; Interim Analysis of the ‘BENEFICIAL’ Study
Panagiotis Athanassiou¹, Andreas Bounas², Dimitrios Boumpas³, Prodromos Sidiropoulos⁴, Christina Tsalapaki⁵, Alexandros Garyfallos⁶, Eleftheria Grika⁷, Paraskevi Voulgari⁸, Angeliki Kekki⁹, Zafeirios Anagnostopoulos⁹, Georgios Karachalios⁹ and Nikos Antonakopoulos⁹, ¹Department of Rheumatology, St. Paul’s Hospital of Thessaloniki, Thessaloniki, Greece, ²General Clinic of Patras “Olympion”, Rheumatology, Patras, Greece, ³“Attikon” University Hospital, Rheumatology and Clinical Immunology Unit ,4th University Pathology Clinic, Athens, Greece, ⁴Department of Rheumatology, Clinical Immunology and Allergy, University of Crete, Heraklion, Greece, ⁵General Hospital of Athens “Hippokratio", Department of Medicine, National and Kapodistrian University of Athens, Athens, Greece, Athens, Greece, ⁶General Hospital of Thessaloniki “Ippokratio" , Τhessaloniki, Greece, Thessaloniki, Greece, ⁷Rheumatology Clinic, General Hospital “Evangelismos”, Athens, Greece, ⁸Rheumatology Clinic, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece, ⁹Genesis Pharma SA, Athens, Greece, Athens, Greece
Background/Purpose: SB4 is an etanercept biosimilar that obtained EU regulatory approval in 2016, and became available in Greece in 2018. Due to lack of published…
Abstract Number: 1261 • ACR Convergence 2021
The Impact of Remission and Low Disease Activity Attainment on Health-related Quality of Life in Two Phase III Clinical Trials of Belimumab in Systemic Lupus Erythematosus
Sharzad Emamikia¹, Shereen Oon², Alvaro Gomez¹, Julius Lindblom¹, Alexander Borg¹, Yvonne Enman¹, Eric Morand³, David Grannas⁴, Ronald van Vollenhoven⁵, Mandana Nikpour⁶ and Ioannis Parodis⁷, ¹Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden, ²Department of Rheumatology, St Vincent's Hospital, Fitzroy, Australia, ³School of Clinical Sciences at Monash Health, Monash University Faculty of Medicine, Nursing and Health Sciences, Monash Medical Centre Clayton, Melbourne, Australia, ⁴Divison of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden, ⁵Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, ⁶University of Melbourne at St Vincent's Hospital, Melbourne, Australia, ⁷Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden and Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
Background/Purpose: Health-related quality of life (HRQoL) is considered one of the most important outcomes in clinical trials of systemic lupus erythematosus (SLE), along with reduction…
Abstract Number: 1879 • ACR Convergence 2021
Delayed Diagnosis of IgG4 Related Disease Is Associated with Worse Outcome: A Retrospective, Real-life Observational Study
Elisheva Pokroy-Shapira¹, Iftach Sagy², Katya Meridor³ and Yair Molad⁴, ¹Institute of Rheumatology, Rabin Medical Center, Beilinson Hospital, and Tel Aviv University, Petach Tikva, Israel, ²Clinical Research Center, Soroka University Medical Center, Beer Sheva and Ben Gurion University of the Negev, DVIRA, Israel, ³Tel Aviv Sourasky Medical Center, Kfar Saba, Israel, ⁴Rabin Medical Center, Beilinson Hospital, and Tel Aviv University, Petah-Tikva, Israel
Background/Purpose: The purpose of this study was to characterize clinical and pathological features as well as disease outcome of an Israeli incident cohort of patients…
Abstract Number: 0341 • ACR Convergence 2021
Addition of Narrative Text Abstraction to ICD-Based Abstraction Significantly Improves Identification of Lupus Nephritis in Real-World Data
Meghan Tierney and Chris Rowe, PicnicHealth, San Francisco, CA
Background/Purpose: Lupus nephritis (LN) is often underrecognized and difficult to identify retrospectively, presenting challenges for clinicians and researchers hoping to explore this condition using real-world…
Abstract Number: 0717 • ACR Convergence 2021
Association of Fatigue with Disease Activity in Myositis
Tissa Bijoy George¹, Anjana Chandrasekhara Pillai², Siamak Moghadam-Kia³, Nicole Neiman⁴, Dana Ascherman³, Chester Oddis³, Dianxu Ren⁴ and Rohit Aggarwal³, ¹UPMC McKeesport, Monroeville, PA, ²UPMC, Pittsburgh, PA, ³University of Pittsburgh, Pittsburgh, PA, ⁴University of Pittsburgh Medical Center, Pittsburgh, PA
Background/Purpose: The Idiopathic inflammatory myopathies are a heterogeneous group of rare systemic autoimmune diseases with muscle as the primary target. Fatigue is one of the…
Abstract Number: 0850 • ACR Convergence 2021
Regression Methods for Modeling Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Scores for Early Stage Knee Osteoarthritis
Benjamin Sweigart and Michael LaValley, Boston University School of Public Health, Boston, MA
Background/Purpose: The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score [range 0-20] is a common outcome measure for clinical trials and observational studies…
Abstract Number: 1268 • ACR Convergence 2021
Predicting Adverse Pregnancy Outcomes in Women with Systemic Lupus Erythematosus: A Comparison of Machine Learning Methods
Melissa Fazzari¹, Marta Guerra², Jane Salmon² and Mimi Kim³, ¹Albert Einstein College of Medicine, Bronx, NY, ²Hospital for Special Surgery, New York, NY, ³Albert Einstein College of Medicine, Larchmont, NY
Background/Purpose: Nearly 20% of pregnancies in patients with Systemic lupus erythematosus (SLE) result in an adverse pregnancy outcome (APO); early identification of women with SLE…
Abstract Number: 1893 • ACR Convergence 2021
“From Where I Stand”: Using Multiple Anchors Yields Different Benchmarks for Meaningful Improvement and Worsening in the Rheumatoid Arthritis Flare Questionnaire (RA-FQ)
Susan Bartlett¹, Vivian Bykerk², Orit Schieir³, Marie-France Valois¹, Louis Bessette⁴, Gilles Boire⁵, Glen Hazlewood⁶, Carol Hitchon⁷, Edward Keystone⁸, Janet Pope⁹, Diane Tin¹⁰, Carter Thorne¹¹, Clifton Bingham¹² and CATCH Investigators¹³, ¹McGill University, Montréal, QC, Canada, ²Hospital for Special Surgery, New York, NY, ³Canadian Early Arthritis Cohort Study, Montréal, QC, Canada, ⁴Centre de l'Ostoporose et de Rhumatologie de Qubec, Québec City, QC, Canada, ⁵Universite de Sherbrooke, Sherbrooke, QC, Canada, ⁶University of Calgary, Calgary, AB, Canada, ⁷University of Manitoba, Winnipeg, MB, Canada, ⁸Keystone Consulting Enterprises Inc., Toronto, ON, Canada, ⁹University of Western Ontario, London, ON, Canada, ¹⁰The Arthritis Program Research Group, Newmarket, ON, Canada, ¹¹Southlake Regional Health Centre, Newmarket, ON, Canada, ¹²Johns Hopkins University, Baltimore, MD, ¹³Canadian Early Arthritis Cohort Investigators, Toronto, ON, Canada
Background/Purpose: The RA-FQ is a patient-reported measure of current disease activity in RA that can be used to identify disease flares. The RA-FQ queries pain,…
Abstract Number: L01 • ACR Convergence 2020
Outcomes of COVID-19 Infection in Patients with Rheumatic Diseases in a Multicenter Healthcare System: A Comparative Cohort Study
Naomi Serling-Boyd¹, Kristin D'Silva¹, Tiffany Hsu², Xiaoqing Fu³, Rachel Wallwork⁴, April Jorge¹, Yuqing Zhang¹, Ellen Gravallese⁵, Hyon K. Choi⁶, Jeffrey Sparks⁷ and Zachary Wallace⁸, ¹Massachusetts General Hospital, Boston, MA, ²Brigham and Women's Hospital, Jamaica Plain, MA, ³Mass General Hospital, Boston, MA, ⁴Johns Hopkins Hospital, Baltimore, MA, ⁵Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ⁶MASSACHUSETTS GENERAL HOSPITAL, Lexington, MA, ⁷Brigham and Women's Hospital, Boston, MA, ⁸Massachusetts General Hospital, Newton, MA
Background/Purpose: The risk of poor outcomes from COVID-19 among rheumatic disease patients compared to the general population remains poorly understood. Filling this knowledge gap is…
Abstract Number: 0167 • ACR Convergence 2020
Rheumatoid Arthritis Patient Phenotypes from a Digital Health Coaching Engagement Program
Jonathan Patterson¹, Kirby Magid², Dhiren Patel³ and Matt Allison³, ¹Pack Health, Birmingham, AL, ²University of North Carolina at Charlotte, Charlotte, ³Pack Health, Birmingham
Background/Purpose: The goal of this study was to examine whether cluster analysis could be used to identify homogeneous subgroups of engagement in RA patients enrolled…

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