Abstracts tagged "Outcome measures"

Abstract Number: 0658 • ACR Convergence 2021
ACCORD: A Novel Rheumatology Transition Clinic Structure for Adolescent and Young Adult Patients with Childhood Onset Rheumatic Disease
Rebecca Overbury¹, Kelly Huynh², Tracy Frech¹, John Bohnsack¹ and Aimee Hersh¹, ¹University of Utah, Salt Lake City, UT, ²Intermountain Health Care, Salt Lake City, UT
Background/Purpose: The transition of health care from Pediatric to Adult providers for adolescents and young adults with childhood onset rheumatic disease continues to be associated…
Abstract Number: 0792 • ACR Convergence 2021
Remission Rates of Patients with Rheumatoid Arthritis in a Tertiary Care
Nils Gildemeister¹, Imke Redeker², Bjoern Buehring¹, Ioana Andreica¹, David Kiefer³, Xenofon Baraliakos¹, Juergen Braun¹ and Uta Kiltz¹, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, ²German Rheumatism Research Centre (DRFZ), Berlin, Germany, ³Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Essen, Germany
Background/Purpose: The main goal of treatment for patients (pts.) with rheumatoid arthritis (RA) is to achieve remission, in order to both, preserve physical function and…
Abstract Number: 1258 • ACR Convergence 2021
Measurement of Specific Organ Domains in Lupus Randomised Controlled Trials
Kathryn Connelly¹, Jeevan Vettivel², Vera Golder², Rangi Kandane-Rathnayake² and Eric Morand³, ¹Monash University, Camberwell, Australia, ²Monash University, Clayton, Australia, ³Monash University, Melbourne, Australia
Background/Purpose: Randomised controlled trials (RCTs) in SLE typically adopt composite responder definitions as primary efficacy endpoints, however outcomes within individual organ domains are also important…
Abstract Number: 1809 • ACR Convergence 2021
Efficacy of Tofacitinib on Enthesitis in Patients with Active Psoriatic Arthritis
Philip Mease¹, Ana-Maria Orbai², Oliver FitzGerald³, Mohamed Bedaiwi⁴, Dona L Fleishaker⁵, Rajiv Mundayat⁶, Pamela Young⁷ and Philip S Helliwell⁸, ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, ²Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ³Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland, ⁴Division of Rheumatology, College of Medicine, King Saud University Medical City, Riyadh, Saudi Arabia, ⁵Pfizer Inc, Groton, CT, ⁶Pfizer Inc, New York, NY, ⁷Pfizer Inc, Collegeville, PA, ⁸Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom
Background/Purpose: Enthesitis (inflammation where the tendon, ligament, or joint capsule insert into the bone) has been associated with higher disease activity and reduced quality of…
Abstract Number: 0320 • ACR Convergence 2021
Performance of the Clinical Trials ESSDAI (ClinTrialsESSDAI), an Adjusted ESSDAI Score, in Two Randomised Clinical Trials in Patients with Primary Sjögren’s Syndrome
Liseth de Wolff¹, Suzanne Arends², Elena Pontarini³, Michele Bombardieri³, Simon J Bowman⁴ and Hendrika Bootsma², ¹University Medical Centre Groningen, Groningen, Netherlands, ²University Medical Center Groningen, Groningen, Netherlands, ³Queen Mary University of London, William Harvey Research Institute, London, United Kingdom, ⁴Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
Background/Purpose: Recent randomised controlled trials (RCTs) in primary Sjögren’s syndrome (pSS) failed to show clinical efficacy.1-3 Several RCTs used the EULAR Sjögren’s Syndrome Disease Activity…
Abstract Number: 0674 • ACR Convergence 2021
A Behavioral Intervention to Improve Gout Outcomes in African Americans with Gout: A 12-month Multicenter, Randomized Controlled Trial
Jasvinder Singh¹, Kenneth Saag¹, Joshua Baker², Amy Joseph³, Seth Eisen⁴ and Terence Shaneyfelt¹, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Pennsylvania, Philadelphia, PA, ³Washington University / St. Louis VA, St Louis, MO, ⁴Washington University School of Medicine, St Louis, MO
Background/Purpose: Gout outcomes and severity are worst in African Americans compared to Caucasians with gout. Racial Disparities in gout are well-described. Few or no data…
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…

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