Abstracts tagged "Randomized Trial"

Abstract Number: 2238 • ACR Convergence 2023
Longitudinal Effect of Guselkumab on Biomarkers of Inflammation and Cardiovascular Risk in Bionaive Patients with Active Psoriatic Arthritis and High Systemic Inflammatory Burden: Post-hoc Analysis of a Phase 3, Randomized, Double-blind, Placebo-Controlled Study
Arthur Kavanaugh¹, Enrique Soriano², Jan Dutz³, Carlo Selmi⁴, Emmanouil Rampakakis⁵, Natalie shiff⁶, Francois Nantel⁷, Frederic Lavie⁸ and Laura Coates⁹, ¹Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ²Rheumatology Section, Internal Medicine Services, Hospital Italiano de Buenos Aires, and University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ³Department of Dermatology and Skin Science, Vancouver General Hospital, Vancouver, BC, Canada, ⁴Rheumatology and Clinical Immunology, Humanitas Research Hospital / Internal Medicine, Humanitas University, Rozzano, Italy, ⁵McGill University, Department of Pediatrics / JSS Medical Research, Scientific Affairs, Montreal, QC, Canada, ⁶Immunology, Janssen Scientific Affairs, LLC / Adjunct, Community Health and Epidemiology, University of Saskatchewan, Horsham, PA, ⁷Nantel Medsci Consult, Consultant, Montreal, QC, Canada, ⁸The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France, ⁹University of Oxford, Oxford, United Kingdom
Background/Purpose: Psoriatic arthritis (PsA) has been associated with an increased risk of cardiovascular (CV) disease, likely due to accelerated atherosclerosis secondary to chronic inflammation.1 As…
Abstract Number: 0519 • ACR Convergence 2023
Long-Term Safety and Efficacy of Bimekizumab in Patients with Active Ankylosing Spondylitis: 5-Year Results from a Phase 2b Study and Its Open-Label Extension
Atul Deodhar¹, Victoria Navarro-Compán², Denis Poddubnyy³, Lianne Gensler⁴, Sofia Ramiro⁵, Tetsuya Tomita⁶, Helena Marzo-Ortega⁷, Carmen Fleurinck⁸, Thomas Vaux⁹, Ute Massow¹⁰, Désirée van der Heijde⁵ and Xenofon Baraliakos¹¹, ¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ²Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ³Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁵Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁶Graduate School of Health Science, Morinomiya University of Medical Science, Osaka, Japan, ⁷NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁸UCB Pharma, Oosterzele, Belgium, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰UCB Pharma, Monheim am Rhein, Germany, ¹¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody, selectively inhibits IL-17F in addition to IL17A. BKZ has demonstrated clinical efficacy and safety up to 3 years…
Abstract Number: 1343 • ACR Convergence 2023
Cardiovascular (CV) and Malignancy Events in the Filgotinib Rheumatoid Arthritis (RA) Clinical Development Program up to 8.3 Years
Xavier Mariette¹, Sven Borchmann², Sandrine Aspeslagh³, Jaime Calvo- Alén⁴, Richard Moriggl⁵, Zoltan Szekanecz⁶, Francesco De Leonardis⁷, Nadia Verbruggen⁸, Paul Van Hoek⁹, Marc Schmalzing¹⁰, Andreas Stallmach¹¹, Christina Charles-Schoeman¹², Vijay Rajendran¹³, Christine Rudolph⁹, Chris Watson¹⁴, Yoshiya Tanaka¹⁵ and Ernest Choy¹⁶, ¹Université Paris-Saclay, Le Kremlin-Bicêtre, France, ²Department of Internal Medicine, University of Cologne, Cologne, Germany, ³Department of Medical Oncology, UZ Brussel, Brussels, Belgium, ⁴Rheumatology, Bioaraba Research Unit, Hospital Universitario Araba, Vitoria, Spain, ⁵Institute of Animal Breeding and Genetics, University of Veterinary Medicine, Vienna, Austria, ⁶Division of Rheumatology, University of Debrecen, Debrecen, Hungary, ⁷Medical Affairs, Galapagos GmbH, Basel, Switzerland, ⁸Biostatistics, Galapagos NV, Mechelen, Belgium, ⁹Medical Safety, Galapagos NV, Mechelen, Belgium, ¹⁰University Hospital, Rheumatology/Clinical Immunology, Department of Internal Medicine II, Würzburg, Germany, ¹¹Department of Internal Medicine, Jena University Hospital, Jena, Germany, ¹²UCLA Medical Center, Santa Monica, CA, ¹³Clinical Research, Galapagos NV, Mechelen, Belgium, ¹⁴Medical Affairs, Galapagos Biotech Ltd., Cambridge, United Kingdom, ¹⁵University of Occupational and Environmental Health, Kitakyushu, Japan, ¹⁶Section of Rheumatology, Cardiff University, Cardiff, United Kingdom
Background/Purpose: Filgotinib (FIL) is a Janus kinase (JAK) 1 preferential inhibitor for the treatment of RA. Data from the ORAL Surveillance post-marketing study (NCT02092467) suggest…
Abstract Number: 1827 • ACR Convergence 2023
Revolutionizing Fibromyalgia Treatment: Exploring the Efficacy of a New FDA Cleared Photoceutical Device
Timothy Demchak¹, Ernesto Leal-Junior², Neide Ribeiro², Heliodora Casalechi², Douglas Johnson³ and Shaiane Tomazoni⁴, ¹Indiana State University, Terre Haute, IN, ²Nove de Julho University, São Paulo, Brazil, ³Multi Radiance Medical, Solon, OH, ⁴University of Bergen, Bergen, Norway
Background/Purpose: Fibromyalgia syndrome effects 2-8% of the general population and is characterized by specific tender points. FM annual economic impact $12-$14 billion.Current treatments are only…
Abstract Number: 2320 • ACR Convergence 2023
Predicting Remission and Low Disease Activity Attainment in Patients with Systemic Lupus Erythematosus
Raffaele Da Mutten¹, Nursen Cetrez², Julius Lindblom², Shereen Oon³, Dionysis Nikolopoulos¹, Mandana Nikpour⁴ and Ioannis Parodis², ¹Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, ²Karolinska Institutet, Stockholm, Sweden, ³St Vincent's Hospital, Fitzroy, Australia, ⁴The University of Melbourne at St. Vincent’s Hospital Melbourne, Departments of Medicine and Rheumatology, Melbourne, Australia
Background/Purpose: Response to therapy in SLE varies significantly and presents a considerable challenge in terms of predictability. Development of predictive models with ability to accurately…
Abstract Number: 0530 • ACR Convergence 2023
Impact of Upadacitinib on Wearable Device-Measured Physical Activity in Patients with Ankylosing Spondylitis from the SELECT-AXIS 2 Trial
Jeffrey Curtis¹, Rebecca Grainger², Dan Webster³, Jie Shen⁴, Ana Biljan⁵, Anna Shmagel⁴, Peter Wung⁴ and Philip J. Mease⁶, ¹University of Alabama at Birmingham, Birmingham, AL, ²University of Otago, Wellington, New Zealand, ³AbbVie, Inc., Libertyville, IL, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Buffalo Grove, IL, ⁶Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA
Background/Purpose: Physical activity is associated with reduced pain, improved mobility and physical function in people with ankylosing spondylitis (AS) and plays a crucial role in…
Abstract Number: 1397 • ACR Convergence 2023
Sustainability of Clinical Response at Week 52 to Upadacitinib Among Patients with Axial SpA: Data from the SELECT-AXIS 1 and SELECT-AXIS 2 Trials
Victoria Navarro-Compán¹, Lianne Gensler², Martin Rudwaleit³, Fabiana Ganz⁴, Shirley Chen⁴, Jayne Stigler⁴, Anna Schmagel⁴ and Xenofon Baraliakos⁵, ¹Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ²University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ³University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, ⁴AbbVie, Inc., North Chicago, IL, ⁵Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany
Background/Purpose: Upadacitinib 15 mg (UPA), an oral Janus kinase inhibitor, has shown efficacy and tolerability through 14 weeks in patients (pts) with active radiographic axial…
Abstract Number: 1898 • ACR Convergence 2023
Patient After Visit Instructions at a University Rheumatology Outpatient Clinic: Do They Make a Difference?
Dijo Joseph, Rong Hu, Robert Min, Meenakshi Jolly and Sobia Hassan, Rush University Medical Center, Chicago, IL
Background/Purpose: As low health literacy (HL) has been linked to poor health outcomes in rheumatic diseases, it is important to optimize organizational HL. One way…
Abstract Number: 2334 • ACR Convergence 2023
Remission Attainment in Patients with Systemic Lupus Erythematosus Treated with Anifrolumab Compared with Placebo over a 4-Year Period
Ronald van Vollenhoven¹, Eric Morand², Richard A. Furie³, Kenneth Kalunian⁴, Raj Tummala⁵, Gabriel Abreu⁶, Hussein Al-Mossawi⁷ and Catharina Lindholm⁶, ¹Amsterdam University Medical Centers, Amsterdam, Netherlands, ²Monash University, Centre for Inflammatory Diseases, Melbourne, Australia, ³Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ⁴University of California San Diego, La Jolla, CA, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁶BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁷BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: In patients with SLE, remission is an established therapeutic goal associated with reduced damage accrual and flares, and improved health-related quality of life.1 Here,…
Abstract Number: 0582 • ACR Convergence 2023
Evaluation of Anifrolumab Treatment Responses by the Short Form 36 Health Survey Version 2 in SLE: A Post Hoc Analysis of the Placebo-Controlled Phase 3 Long-Term Extension Trial
Vibeke Strand¹, Kenneth Kalunian², Barnabas Desta³, Caroline Seo⁴, Gabriel Abreu⁵, Raj Tummala³, Catharina Lindholm⁵ and Hussein Al-Mossawi⁶, ¹Stanford University, Palo Alto, CA, ²University of California San Diego, La Jolla, CA, ³BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁴BioPharmaceuticals Medical Evidence, AstraZeneca, Gaithersburg, MD, ⁵BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁶BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: SLE is a chronic disease that progressively reduces patients’ health-related quality of life.1 In a post hoc analysis of the TULIP trials, patients with…
Abstract Number: 1423 • ACR Convergence 2023
Impact of Upadacitinib on Enthesitis and Dactylitis by Location in Patients with Psoriatic Arthritis and an Inadequate Response to Biologic DMARDs from the SELECT-PsA 2 Trial
Laura Coates¹, Catherine Bakewell², Majed Khraishi³, Shirley Chen⁴, Tianming Gao⁴, Arathi Setty⁴, Heather Jones⁵, Sandra Ciecinski⁴ and Eduardo Mysler⁶, ¹University of Oxford, Oxford, United Kingdom, ²Intermountain Healthcare Medical Group, Salt Lake City, UT, ³Memorial University of Newfoundland, St. John's, NL, Canada, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie, Inc., Mettawa, IL, ⁶Organización Medica de Investigación, Buenos Aires, Argentina
Background/Purpose: Enthesitis and dactylitis are associated with reduced quality of life and greater impairment in daily activities. In the SELECT-PsA 2 phase 3 trial, the…
Abstract Number: 1982 • ACR Convergence 2023
Effect of Denosumab on Knee Pain and Bone Marrow Lesions in Symptomatic Knee Osteoarthritis
Terence O'Neill¹, Matthew Parkes¹, Michael Bowes², Richard Hodgson¹ and David Felson³, ¹University of Manchester, Manchester, United Kingdom, ²Imorphics, Manchester, United Kingdom, ³Boston University, Boston, MA
Background/Purpose: There are currently no licensed therapies which reduce progression of knee OA. Current therapies focus on reducing pain, have limited effect, and some have…
Abstract Number: 2487 • ACR Convergence 2023
Phase 2 Safety and Efficacy of Subcutaneous (s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over 28 Weeks in Patients with Systemic Lupus Erythematosus (SLE) of Moderate-to-Severe Activity
Nan Shen¹, Stanislav Ignatenko², Alexander Gordienko³, Josefina Cortés Hernández⁴, Nancy Agmon-Levin⁵, Pongthorn Narongroeknawin⁶, Katarzyna Romanowska -Prochnicka⁷, Hana Ciferska⁸, Masanari Kodera⁹, James Cheng-Chung Wei¹⁰, Piotr Leszczynski¹¹, Joung-Liang Lan¹², Eduardo Mysler¹³, Rafal Wojciechowski¹⁴, Tunde Tarr¹⁵, Elena Vishneva¹⁶, Yi-Hsing Chen¹⁷, Yuko Kaneko¹⁸, Stephanie Finzel¹⁹, Alberta Hoi²⁰, Ajchara Koolvisoot²¹, Shin-Seok Lee²², Lie Dai²³, Hiroshi Kaneko²⁴, Bernadette Rojkovich²⁵, Lingyun Sun²⁶, Eugeny Zotkin²⁷, Jean-Francois Viallard²⁸, Masao Katayama²⁹, Berta Paula Magallares-Lopez³⁰, Tirtha Sengupta³¹, Carol Sips³² and Stephen J Oliver³², ¹Shanghai Institute of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University (SJTUSM), Shanghai, China, ²Charité Research Organisation GmbH, Berlin, Germany, ³SM Kirov Military Medical Academy, St. Petersburg, Russia, ⁴Lupus Unit, Rheumatology Department, Vall d’Hebron Hospitals, Barcelona, Spain, ⁵Yabludowicz Center for Autoimmune Disease, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel, ⁶Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand, ⁷Department of Systemic Connective Tissue Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland, ⁸Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ⁹Department of Dermatology, Japan Community Healthcare Organization Chukyo Hospital, Nagoya, Japan, ¹⁰Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, ¹¹Department of Internal Medicine, Poznan University of Medicine Sciences, Poznan, PL, Poznań, Poland, ¹²China Medical University Hospital, Taichung, Taiwan, ¹³Organizacion Medica de Investigacion, Buenos Aires, Argentina, ¹⁴Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, Poland, ¹⁵Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, ¹⁶LLC Family Clinic, Yekaterinburg, RU, Yekaterinburg, Russia, ¹⁷Taichung Veterans General Hospital, Taichung, Taiwan, ¹⁸Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ¹⁹Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, University of Freiburg, Freiburg, Germany, ²⁰Monash University, Department of Medicine, Sub-faculty of Clinical and Molecular Medicine, Melbourne, Australia, ²¹Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, ²²Chonnam National University Medical School & Hospital, Gwangju, South Korea, ²³Department of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China, ²⁴Division of Rheumatic Disease, National Center for Global Health and Medicine, Tokyo, Japan, ²⁵Department of Rheumatology and Physiotherapy, Polyclinic of the Hospitaller Brothers of St. John of God, Semmelweis University, Budapest, Hungary, ²⁶Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China, ²⁷VA Nasonova Research Institute of Rheumatology, Moscow, Russia, ²⁸CHU de Bordeaux, Hôpital Haut-Lévêque, Pessac, France, ²⁹National Hospital Organization, Nagoya Medical Center, Nagoya, JP, Nagoya, Japan, ³⁰Department of Rheumatology, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain, ³¹Novartis Pharma India, Hyderabad, Hyderabad, India, ³²Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Ianalumab is a novel defucosylated human IgG1 mAb targeting the receptor for B cell Activating Factor belonging to the TNF Family (BAFF-R) providing potent…
Abstract Number: 0589 • ACR Convergence 2023
A Comparative Evaluation of IgA2 Anti-dsDNA Antibodies and Clinical Outcome in Two Clinical Trials of Belimumab After Rituximab in SLE
Muhammad RA Shipa¹, Daniel McCluskey¹, Laura Cooney² and Michael Ehrenstein¹, ¹University College London, London, United Kingdom, ²Immune Tolerance Network, Seattle, WA
Background/Purpose: We have shown that serum IgA2 anti-dsDNA antibody levels is a biomarker of response to belimumab after rituximab in SLE (BEAT-lupus trial) (1). We…
Abstract Number: 1426 • ACR Convergence 2023
Distinct Treatment Response Trajectories in Patients with Psoriatic Arthritis Receiving Tofacitinib
Dafna Gladman¹, William R Tillett², David Gruben³, Laura Coates⁴, Stefanie Hahne⁵ and Mikhail Volkov⁶, ¹Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Department of Medicine, University of Toronto, Toronto, ON, Canada, ²Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ³Pfizer Inc., Groton, CT, ⁴University of Oxford, Oxford, United Kingdom, ⁵Pfizer Pharma GmbH, Berlin, Germany, ⁶Pfizer BV, Capelle aan den IJssel, Netherlands
Background/Purpose: PsA is a heterogeneous disease, and identifying clinical phenotypes may assist clinical decision making. Patients (pts) treated with advanced therapies demonstrate varying treatment responses.…

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