Abstracts tagged "Randomized Trial"

Abstract Number: 0656 • ACR Convergence 2025
Low-dose belimumab reduced disease flares in patients with systemic lupus erythematosus at low disease activity: a multicenter, randomized, double-blind, placebo-controlled trial
Fangfang Sun¹, Huijing Wang¹, Danting Zhang¹, Nan Shen¹, Sheng Chen¹, Tiing Li¹, Weiguo Wan², Shengming Dai³ and Shuang Ye⁴, ¹Renji Hospital, Shanghai, China (People's Republic), ²Huashan Hospital, Shanghai, China (People's Republic), ³Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China (People's Republic), ⁴Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Shanghai, Shanghai, China (People's Republic)
Background/Purpose: B-lymphocyte stimulator was involved in the pathogenesis of SLE. The humanized monoclonal antibody belimumab with 10mg/kg was effective for active patients. The efficacy of…
Abstract Number: 0801 • ACR Convergence 2025
Achieving Sustained Lupus Low Disease Activity State and Remission With Ianalumab (VAY736) in Patients with Systemic Lupus Erythematosus: A post hoc Analysis From a Phase II Study
Eric Morand¹, Corine Gaillez², Stephen Oliver³, Swati Ghanshani⁴, Marilia Pozzobon⁵, Weibin Bao⁶ and Ed Vital⁷, ¹Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, ²Novartis Pharma AG, Basel, Switzerland, Croissy Sur Seine, France, ³Novartis Pharma AG, Basel, Switzerland, ⁴Novartis Healthcare Private Limited, Hyderabad, India, Hyderabad, India, ⁵Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland, ⁶Novartis Pharmaceuticals Corporation, Hanover, NJ, ⁷University of Leeds, Leeds, England, United Kingdom
Background/Purpose: Ianalumab, a fully human monoclonal antibody against the B cell–activating factor receptor (BAFF-R), has a dual mechanism of action of B cell depletion through…
Abstract Number: 2356 • ACR Convergence 2025
Clinical Efficacy in Male and Female Patients With Active Psoriatic Arthritis Treated With Deucravacitinib: A Pooled Analysis of Pivotal Phase 3 Studies
Lihi Eder¹, Philip J. Mease², Joseph F Merola³, Alexis Ogdie⁴, Atul Deodhar⁵, Laura Coates⁶, Stefan Varga⁷, Navya Kalapala⁷, Ying-Ming Jou⁸, Eleni Vritzali⁹ and Laure Gossec¹⁰, ¹University of Toronto, Toronto, ON, Canada, ²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ³Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ⁵Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁶Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Princeton, ⁹Bristol Myers Squibb, Boudry, Switzerland, ¹⁰Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France
Background/Purpose: PsA affects male and female patients equally; however, variations in clinical manifestations and treatment responses between sexes have been reported. Deucravacitinib is an oral,…
Abstract Number: 1531 • ACR Convergence 2025
Achieving Remission and Low Disease Activity with Belimumab Versus Placebo in Patients with SLE Excluding the Glucocorticoid Component from Target Definitions: A Post Hoc Analysis of Five Phase 3 Trials
Ioannis Parodis¹, Julius Lindblom², Roger A. Levy³, Alexander Tsoi¹, Margherita Zen⁴, Dionysis Nikolopoulos⁵, Munther Khamashta⁶, Ryan Tomlinson⁷, Anca Askanase⁸, Ronald van Vollenhoven⁹ and Mandana Nikpour¹⁰, ¹Karolinska Institutet and Karolinska University Hospital, Department of Medicine Solna, Division of Rheumatology, Stockholm, Sweden, ²Karolinska Institutet, Stockholm, Sweden, ³GSK, Specialty Care, Global Medical Affairs, Collegeville, PA, ⁴University of Padua, Department of Medicine, Division of Rheumatology, Padua, Italy, ⁵Karolinska Institutet and Karolinska University Hospital, Division of Rheumatology, Department of Medicine Solna, Stockholm, Sweden, ⁶GSK, Medical Affairs, Dubai, United Arab Emirates, ⁷GSK, Development – R&D, Collegeville, PA, ⁸Columbia University Medical Center, New York, NY, ⁹Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Department of Rheumatology, Amsterdam, Netherlands, ¹⁰University of Sydney School of Public Health and Department of Rheumatology, Royal Prince Alfred Hospital, Sydney, Victoria, Australia
Background/Purpose: An integrated post hoc analysis of five Phase 3 trials in adults with SLE showed greater benefit of belimumab (BEL) than placebo (PBO), plus…
Abstract Number: 0654 • ACR Convergence 2025
Obinutuzumab Shows Promise in Lupus Nephritis Regardless of Baseline Serological Markers: An Exploratory Post Hoc Analysis of a Phase II Trial
Ed Vital¹, Benni Vargas², Julie Rae², Tracey Wang³, Jason Hackney², Cary Looney⁴, William Pendergraft², Liz Lightstone⁵, Brad Rovin⁶, Richard Furie⁷ and Harini Raghu², ¹University of Leeds, Leeds, England, United Kingdom, ²Genentech, Inc., South San Francisco, CA, ³Hoffmann-La Roche Ltd, Missssauga, ON, Canada, ⁴F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁵Department of Immunology and Inflammation, Faculty of Medicine, Imperial College London, London, England, United Kingdom, ⁶The Ohio State University, Columbus, OH, ⁷Division of Rheumatology, Northwell Health, Great Neck, NY
Background/Purpose: Lupus nephritis (LN) is characterized by kidney inflammation. B cells play a central role in LN pathogenesis and type I interferon (IFN-I) pathway activation…
Abstract Number: 0776 • ACR Convergence 2025
Efficacy and Safety of Upadacitinib in Giant Cell Arteritis: 2-Year Results From the Re-Randomized, Double-Blind SELECT-GCA Phase 3 Trial
Wolfgang Schmidt¹, Arathi Setty², Christian Dejaco³, Andrea Rubbert-Roth⁴, Maria Cid⁵, Tomonori Ishii⁶, Avani D. Joshi², Nathaniel Zerad², Aditi Kadakia⁷, Shaofei Zhao², Weihan Zhao², Ivan Lagunes², Charles Phillips⁸, Daniel Blockmans⁹ and Peter Merkel¹⁰, ¹Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology Berlin-Buch; Waldfriede Hospital, Rheumatology, Berlin, Germany, ²AbbVie Inc, North Chicago, IL, ³Medical University of Graz, Department of Rheumatology, Graz, Austria; Department of Rheumatology, Hospital of Brunico (SABES-ASDAA), Brunico, Italy, ⁴Division of Rheumatology and Immunology, Cantonal Hospital St Gallen, St Gallen, Switzerland, ⁵Department of Autoimmune Diseases (member of European Reference Network RITA), Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, ⁶Division of Hematology and Rheumatology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, ⁷AbbVie Inc, Woburn, MA, ⁸AbbVie Inc, Princeton, NJ, ⁹Department of General Internal Medicine, University Hospitals Leuven; Department of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium, ¹⁰University of Pennsylvania, Philadelphia, PA

Background/Purpose: In the SELECT-GCA phase 3 trial, treatment of patients with GCA with upadacitinib 15 mg (UPA15) demonstrated superior rates of disease remission, fewer disease…
Abstract Number: 2357 • ACR Convergence 2025
Impact of Sonelokimab, a Novel IL-17A- and IL-17F-Inhibiting Nanobody, in Active Psoriatic Arthritis: Key Subgroup Analyses in the Randomized, Double-Blind, Placebo-Controlled Phase 2 ARGO Trial
Lihi Eder¹, Iain McInnes², Christopher Ritchlin³, Alexis Ogdie⁴, Arthur Kavanaugh⁵, Laura Coates⁶, Georg Schett⁷, Alan Kivitz⁸, Nuala Brennan⁹, Alex Godwood⁹, Matthew R. Thomas⁹, Eva Cullen⁹, Kristian Reich¹⁰, Joseph F Merola¹¹ and Philip J. Mease¹², ¹University of Toronto, Toronto, ON, Canada, ²University of Glasgow, Glasgow, United Kingdom, ³University of Rochester Medical Center, Canandaigua, NY, ⁴University of Pennsylvania, Philadelphia, PA, ⁵University of California, San Diego, School of Medicine, San Diego, CA, ⁶Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁷Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, ⁸Altoona Center for Clinical Research, Duncansville, PA, ⁹MoonLake Immunotherapeutics AG, Zug, Switzerland, ¹⁰MoonLake Immunotherapeutics AG and Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, Zug, Switzerland, ¹¹Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ¹²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA
Background/Purpose: PsA is a chronic inflammatory disease affecting heterogeneous tissues, with unmet need for therapies with robust efficacy across disease domains. Sonelokimab (SLK) is a…
Abstract Number: 1521 • ACR Convergence 2025
Kidney-Related Outcomes With Obinutuzumab in Patients With Active Lupus Nephritis: A Pre-Specified Exploratory Analysis of the Clinical Trial Data
Brad Rovin¹, William Pendergraft², Liz Lightstone³, Eric Daugas⁴, Richard Furie⁵, Theodore Omachi², Imran Hassan⁶, Elsa Martins⁷, Thomas Schindler⁷, Jay Garg², Luis Quintana⁸, Piotr Leszczyński⁹ and Ana Malvar¹⁰, ¹The Ohio State University, Columbus, OH, ²Genentech, Inc., South San Francisco, CA, ³Department of Immunology and Inflammation, Faculty of Medicine, Imperial College London, London, England, United Kingdom, ⁴Department of Nephrology, Hospital Bichat - Claude-Bernard, Paris, France, ⁵Division of Rheumatology, Northwell Health, Great Neck, NY, ⁶Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁷F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁸Department of Nephrology, Hospital Clinic, Barcelona, Spain, ⁹Department of Internal Medicine and Metabolic Diseases, Poznan University of Medical Sciences, Poznan, Poland, ¹⁰Organización Médica de Investigación, Buenos Aires, Argentina
Background/Purpose: Lupus nephritis (LN) is the most common, severe, organ-threatening manifestation of systemic lupus erythematosus (SLE). The randomized, double-blind, placebo-controlled, Phase III REGENCY trial (NCT04221477)…
Abstract Number: 0650 • ACR Convergence 2025
Obinutuzumab Demonstrates Steroid-Sparing Effects and Consistent Benefit In Patients with Lupus Nephritis When Using Multiple Primary Endpoint Definitions: A Secondary Analysis of Phase III Trial Results
Brad Rovin¹, Jay Garg², Richard Furie³, Rachel Jones⁴, Amit Saxena⁵, Pasquale Esposito⁶, Elsa Martins⁷, Claire Petry⁷, Nicolas Frey⁷, Bongin Yoo², Imran Hassan⁸, Thomas Schindler⁷, Theodore Omachi⁹, William Pendergraft², Mittermayer Santiago¹⁰, Gustavo Aroca Martínez¹¹ and Ana Malvar¹², ¹The Ohio State University, Columbus, OH, ²Genentech, Inc., South San Francisco, CA, ³Division of Rheumatology, Northwell Health, Great Neck, NY, ⁴Renal Medicine, Cambridge University Hospitals, Cambridge, England, United Kingdom, ⁵Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, ⁶Clinica Nefrologica, Dialisi, Trapianto, Department of Internal Medicine, University of Genoa and IRCCS Ospedale Policlinico San Martino, Genova, Italy, ⁷F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁸Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁹Genentech, Inc., South San Francisco, ¹⁰Bahiana School of Medicine and Public Health and UFBA, Federal University of Bahia, and Clínica SER da Bahia, Salvador, Bahia, Brazil, ¹¹Universidad Simón Bolívar, Barranquilla, Colombia y Clínica de la Costa, Barranquilla, Colombia, ¹²Organización Médica de Investigación, Buenos Aires, Argentina
Background/Purpose: The Phase III REGENCY study (NCT04221477) demonstrated superiority of obinutuzumab (OBI) over placebo (PBO) in achieving complete renal response (CRR) at Week 76 when…
Abstract Number: 0498 • ACR Convergence 2025
Pharmacokinetic Similarity of DRL_AB, a Proposed Biosimilar Abatacept (Orencia®): Results from a Randomized, Single Dose, Double-Blind, Parallel Arm, Comparative Pharmacokinetic Study in Healthy Subjects by the Intravenous Route.
Naveen Reddy¹, Narendra Maharaj¹, Pramod Kumar Reddy¹, Mansi Dhananjaya Jakhade¹, Maria Velinova² and Vendel Kemény³, ¹Biologics, Dr. Reddy’s Laboratories Ltd., Hyderabad, India, Hyderabad, India, ²ICON – Early Development Services Van Swietenlaan ⁶ ⁹⁷²⁸ NZ, Groningen, Netherlands, Groningen, Netherlands, ³ICON Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely Rottenbiller utca ¹³ ¹⁰⁷⁷, Budapest, Hungary, Budapest, Hungary
Background/Purpose: Dr. Reddy’s-abatacept (DRL_AB) is being developed as a biosimilar to the reference product (RP) (RP-US licensed Orencia®) and the reference medicinal product (RMP) (RMP-EU…
Abstract Number: 2353 • ACR Convergence 2025
Efficacy of Vunakizumab in Reducing Pain in Ankylosing Spondylitis: A Post-Hoc Analysis of a Phase 2/3 Clinical Trial
Jian Xu, Yifan Yang, Shuang Liu, Ru Bai, Shu Li, Guofang Zhang, Xiangyu Wang, Xinyu Xu, Mai Zheng and Daying Feng, The First Affiliated Hospital of Kunming Medical University, Kunming, China (People's Republic)
Background/Purpose: Ankylosing spondylitis (AS) is a chronic inflammatory disease that primarily affects the spine and sacroiliac joints, resulting in significant pain, stiffness, and functional impairment.…
Abstract Number: 1465 • ACR Convergence 2025
Sustainability of Clinical Response Through 2 Years Among Upadacitinib-Treated Patients With Axial Spondyloarthritis: Data From the SELECT-AXIS 1 and SELECT-AXIS 2 Trials
Victoria Navarro-Compan¹, Philip J. Mease², Lianne S. Gensler³, Martin Rudwaleit⁴, Yael Klionsky⁵, Jayne Stigler⁶, Erin Mancl⁷, Shirley Chen⁸, Jamie Urbanik⁹ and Xenofon Baraliakos¹⁰, ¹Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ³Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁴Bielefeld University, Medical School and University Medical Centre OWL, Klinikum Bielefeld, Department of Rheumatology, Bielefeld, Germany, ⁵Division of Rheumatology, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC, ⁶AbbVie, Round Lake, IL, ⁷AbbVie, Chicago, IL, ⁸AbbVie, Somerset, NJ, ⁹AbbVie, Grayslake, IL, ¹⁰Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Treatment with the oral JAK inhibitor upadacitinib (UPA) has shown efficacy and safety in patients with active axial spondyloarthritis (axSpA), including both radiographic (r-axSpA,…
Abstract Number: 0645 • ACR Convergence 2025
Achievement of Low Disease Activity and Remission in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial
Eric Morand¹, Lucy Carter², Maria Dall'Era³, Michelle Petri⁴, Ed Vital⁵, Teri Jimenez⁶, Janine Gaiha-Rohrbach⁷, Bernard Lauwerys⁸, Annette Nelde⁹, Christian Stach¹⁰ and Ronald van Vollenhoven¹¹, ¹Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Division of Rheumatology, University of California, San Francisco, CA, ⁴Johns Hopkins University School of Medicine, Timonium, MD, ⁵University of Leeds, Leeds, England, United Kingdom, ⁶UCB, Raleigh, NC, ⁷Biogen, Cambridge, MA, ⁸Systemic and Inflammatory Rheumatic Diseases Section, Institute of Experimental and Clinical Research (IREC), UCLouvain, Brussels, Belgium, ⁹Biogen, Baar, Switzerland, ¹⁰UCB, Monheim am Rhein, Germany, ¹¹Department of Rheumatology, Amsterdam University Medical Centre, Amsterdam, Netherlands
Background/Purpose: Dapirolizumab pegol (DZP) is a novel CD40L inhibitor with broad modulatory effects on SLE immunopathology;1,2 it consists of a polyethylene glycol (PEG)-conjugated antigen-binding fragment…
Abstract Number: 0477 • ACR Convergence 2025
At the patient level, ultrasound evaluation during the follow up of rheumatoid arthritis does not modify radiographic evolution: a prospective, multicenter, randomized, pragmatic clinical trial (BCD study)
Alexandre GARMENDIA¹, Valerie Devauchelle², Grégoire CORMIER³, LE GOFF Benoit⁴, Aleth Perdriger⁵, Saloua Mammou⁶, Emannuel Hoppe⁷, Emmanuelle Dernis⁸, Jose Le Noach⁹, Carine Salliot¹⁰, florent garrigues¹, Raphael Auffret¹, Ichem Mohtarif¹¹, Mateusz Chodorowsky¹¹, Thierry MARHADOUR¹², Divi Cornec¹³, Dewi Guellec¹, Emmanuelle Courtois Communier¹, Alain SARAUX¹⁴ and sandrine jousse¹², ¹CHU de BREST, Brest, Bretagne, France, ²UBO, Brest, France, ³Centre Hospitalier département de Vendée, La Roche Sur Yon, France, ⁴CHU Nantes, Nantes, France, ⁵Rennes University, Rennes, France, ⁶CHU TOURS, TOURS, France, ⁷CHU ANGERS, Angers, France, ⁸Rheumatology Department, Le Mans Central Hospital, Le Mans, France, LE MANS, France, ⁹Centre Hospitalier de Lorient, Lorient, France, ¹⁰CHR orleans, Orleans, France, ¹¹CHU de Brest, Brest, France, ¹²LBAI, UMR¹²²⁷, University of Brest, CHU Brest, Brest, France, Brest, France, ¹³Departement of Rhumatology, CHU Brest, Université de Brest, INSERM UMR¹²²⁷: LBAI, Brest, France, Brest, France, ¹⁴CHU Brest, Brest, France
Background/Purpose: Previous studies, including TASER and ARTIC (1,2), failed to demonstrate a significant benefit of ultrasound (US) compared to clinical evaluation in achieving clinical remission…
Abstract Number: 2339 • ACR Convergence 2025
Joint Groups Involved in Early Oligoarticular Psoriatic Arthritis and the Impact of Apremilast Treatment: Data From FOREMOST
Alen Zabotti¹, Joseph F Merola², Ulrich Mrowietz³, Philip J. Mease⁴, Laure Gossec⁵, mitsumasa kishimoto⁶, Michele Brunori⁷, Lichen Teng⁸, Dafna D. Gladman⁹ and Laura Coates¹⁰, ¹Division of Rheumatology, Department of Medicine (DMED), Academic Hospital "Santa Maria della Misericordia", ASUFC, University of Udine, Udine, Italy, Udine, Italy, ²Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ³Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany, ⁴Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁵Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France, ⁶Kyorin University School of Medicine, Tokyo, Japan, ⁷Amgen Inc, Zurich, Switzerland, ⁸Amgen Inc., Thousand Oaks, ⁹Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Division of Rheumatology, Toronto, ON, Canada, ¹⁰Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Data on disease progression and joint involvement patterns in early oligoarticular (oligo) PsA are sparse. In the FOREMOST study (NCT03747939), apremilast (APR) decreased the…

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