Abstracts tagged "clinical trial"

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: 0567 • ACR Convergence 2025
Sonelokimab in Biologic-Experienced Patients With Active Psoriatic Arthritis: Results From a Phase 2 Trial (ARGO) and Study Design of a Phase 3 Trial (IZAR-2) in Patients With Inadequate Response or Intolerance to Biologic TNFi, Including a Risankizumab Reference Arm
Atul Deodhar¹, Laure Gossec², Philip J. Mease³, Xenofon Baraliakos⁴, Lihi Eder⁵, Alan Kivitz⁶, Helena Marzo-Ortega⁷, Frank Behrens⁸, Ana-Maria Orbai⁹, Georg Schett¹⁰, Arthur Kavanaugh¹¹, Dennis McGonagle¹², Christopher Ritchlin¹³, Nuala Brennan¹⁴, Ben Porter-Brown¹⁴, Eva Cullen¹⁴, Matthew R. Thomas¹⁴, Marius Albulescu¹⁴, Alex Godwood¹⁴, Kristian Reich¹⁵ and Laura Coates¹⁶, ¹Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵University of Toronto, Toronto, ON, Canada, ⁶Altoona Center for Clinical Research, Duncansville, PA, ⁷NIHR Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, United Kingdom, ⁸Rheumatology, Immunology - Inflammation Medicine, University Hospital Goethe-University & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany, ⁹Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ¹⁰Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, ¹¹University of California, San Diego, School of Medicine, San Diego, CA, ¹²Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, United Kingdom, ¹³University of Rochester Medical Center, Canandaigua, NY, ¹⁴MoonLake Immunotherapeutics AG, Zug, Switzerland, ¹⁵MoonLake 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, ¹⁶Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Sonelokimab (SLK), a novel Nanobody that binds to both IL-17A and IL-17F with similarly high affinity, is designed to target difficult-to-reach sites of inflammation.…
Abstract Number: 0694 • ACR Convergence 2025
Treatment of Sjögren’s disease by blocking FcRn: clinical and translational data from RHO, a phase 2 randomized, placebo controlled, double-blind, proof-of-concept study with efgartigimod
isabelle peene¹, Gwenny Verstappen², Joke Deprez³, Frans Kroese², Suzanne Arends², Andrew Kelly⁴, Lana Vandersarren⁵, Edward Bowen⁶, Julie Jacobs⁷, Paul Meyvisch⁸, Dirk Elewaut⁹ and Hendrika Bootsma¹⁰, ¹University Hospital Ghent, Ghent, Belgium, ²University Medical Center Groningen, Groningen, Netherlands, ³Ghent University, Ghent, Belgium, ⁴Argenx, Philadelphia, PA, ⁵Argenx, Boston, MA, ⁶IQVIA, Stevenage, United Kingdom, ⁷argenx, Ravels, Belgium, ⁸argenx, Ghent, Belgium, ⁹VIB Center for Inflammation Research, and Ghent University Hospital, Department of Rheumatology, Ghent, Belgium, ¹⁰UMCG, Groningen, Netherlands
Background/Purpose: Background/Purpose Sjögren’s disease (SjD) is a chronic, systemic autoimmune disease characterized by lymphocytic infiltration and progressive, immune-mediated dysfunction of the exocrine glands. Immunoglobulin (Ig)…
Abstract Number: 1438 • ACR Convergence 2025
Similar Efficacy of Bimekizumab in Two Clinical Endotypes of Axial Spondyloarthritis: 2-Year Results from Two Phase 3 Studies and Their Open-Label Extension
Félicie Costantino¹, Ann-Sophie De Craemer², Filip Van den Bosch², Maxime Breban³, Vanessa Taieb⁴, Diana Voiniciuc⁵, Natasha de Peyrecave⁶, Dirk Elewaut⁷ and Maria-Antonietta D'Agostino⁸, ¹Department of Rheumatology, Ambroise Paré Hospital, AP-HP, Paris, France and Infection & Inflammation, UMR ¹¹⁷³, Inserm, UVSQ/Université Paris Saclay, Montigny-Le-Bretonneux, France, ²Department of Internal Medicine and Pediatrics, Ghent University and VIB Center for Inflammation Research, Ghent, Belgium, ³CHU Ambroise-Paré, Boulogne-Billancourt, France, ⁴UCB, Colombes, France, ⁵UCB, Slough, United Kingdom, ⁶UCB, Brussels, Belgium, ⁷VIB Center for Inflammation Research, and Ghent University Hospital, Department of Rheumatology, Ghent, Belgium, ⁸Department of Rheumatology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
Background/Purpose: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease mainly affecting the sacroiliac joints and spine.1 Peripheral manifestations are common, contributing to disease burden.2 Two…
Abstract Number: 1538 • ACR Convergence 2025
Safety, Pharmacodynamics, and Efficacy of a Novel Plasmacytoid Dendritic Cells Targeting Antibody in Healthy Adults and Patients with SLE or Cutaneous Lupus Erythematosus with Active Skin Lesions: A First-In-Human Study of KK4277
Minoru Hasegawa¹, Jun Kinoshita², Shigeki Otsubo³, Kana Yamada³ and Ehsanollah Esfandiari⁴, ¹Division of Medicine, University of Fukui, Yoshida-gun, Fukui, Japan, ²Kyowa Kirin Co., Ltd., Chiyoda-ku, Tokyo, Japan, ³Kyowa Kirin Co., Ltd., Tokyo, Japan, ⁴Kyowa kirin International plc, London, United Kingdom
Background/Purpose: Plasmacytoid dendritic cells (pDCs) are known to be the main source of type 1 interferon (IFN), which is the cause of various autoimmune diseases.…
Abstract Number: 1998 • ACR Convergence 2025
Reduction in Tophi Observed in Patients with Uncontrolled Gout Treated with NASP: Results from Phase 3 DISSOLVE Studies
Herbert Baraf¹, Puja Khanna², Frédéric Lioté³, Rehan Azeem⁴, Wesley DeHaan⁵, Ben Peace⁶, Hugues Santin-Janin⁷, Bhavisha Desai⁸ and Alan Kivitz⁹, ¹The Center for Rheumatology and Bone Research, Rheumatology, Wheaton, Maryland, USA; Division of Rheumatology, The George Washington University, Washington, DC, ²Division of Rheumatology, University of Michigan, Ann Arbor, MI, ³Université Paris Cité-Inserm UMR¹¹³² & Rheumatology Department, GH Paris Saint Joseph & Institut Arthur Vernes, Paris, France, ⁴Global MACD, Sobi Inc., Waltham, MA, ⁵Sobi, Inc, Waltham, MA, ⁶Statistical Science, Sobi, Stockholm, Sweden, ⁷Sobi, BASEL, Switzerland, ⁸Sobi, Glastonbury, CT, ⁹Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: Patients (pts) with uncontrolled gout (UG) and tophi experience joint pain, impaired function and poor quality of life (Schlesinger et al. Semin Arthritis Rheum…
Abstract Number: 2281 • ACR Convergence 2025
Effectiveness of Upadacitinib in Patients with Rheumatoid Arthritis in Canadian Real-World Practice: Final Results from the CLOSE-UP Post-Marketing Observational Study
Louis Bessette¹, Andrew Chow², Raman Rai³, Hugues Allard-Chamard⁴, Pauline Boulos⁵, Guylaine Roy⁶ and Dalinda Liazoghli⁶, ¹Centre de l'Ostéoporose et de Rhumatologie de Québec, Quebec, QC, Canada, ²Credit Valley Rheumatology, Mississauga, McMaster University, Hamilton, University of Toronto, Toronto, ON, Canada, ³Drs. Rai & Sekhon Medicine Professional Corporation, Brampton, ON, Canada, ⁴Université de Sherbrooke, Sherbrooke, Canada, ⁵McMaster University, Hamilton, ON, Canada, ⁶AbbVie Corporation, Saint-Laurent, QC, Canada
Background/Purpose: Upadacitinib (UPA) is an oral, selective Janus kinase (JAK)-inhibitor proven effective and well-tolerated in patients with rheumatoid arthritis (RA) in 6 randomized clinical trials.…
Abstract Number: 2393 • ACR Convergence 2025
Improving Clinical Outcomes In SLE Arthritis Trials: Post-Hoc Analysis Of A Prospective Intervention Study
Samuel Wood¹, Khaled Mahmoud², Md Yuzaiful Md Yusof², Philip Conaghan², Elizabeth Hensor² and Ed Vital³, ¹University of Leeds, Leeds Institute for Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ²University of Leeds, Leeds, United Kingdom, ³University of Leeds, Leeds, England, United Kingdom
Background/Purpose: Musculoskeletal (MSK) manifestations of SLE are the most frequently assessed domain in clinical trials. Optimal MSK assessment is contested; candidates include the binary or…
Abstract Number: 2624 • ACR Convergence 2025
Results of Large Multi-Site Pragmatic Clinical Trial Comparing Corticosteroids or Blinded Lidocaine-only Injections in Treating Osteoarthritis of the Knee
Joshua Baker¹, Katherine Wysham², Mercedes Quinones³, Bryant England⁴, Kaitian Jin¹, Marianna Olave⁵, Sarah Wetzel⁶, Rachel Gillcrist⁷, Criswell Lavery¹, Natalie Keller⁸, Kimberly Hayes⁹, Bridget Kramer⁴, Hannah Brubeck¹⁰, Bibiana Ateh¹¹, Daniel K. White¹², Alexis Ogdie¹³, Rui Xiao¹, Tuhina Neogi¹⁴ and Carla Scanzello¹, ¹University of Pennsylvania, Philadelphia, PA, ²VA PUGET SOUND/UNIVERSITY OF WASHINGTON, Seattle, WA, ³Washington DC VA Medical Center, Bethesda, MD, ⁴University of Nebraska Medical Center, Omaha, NE, ⁵Brown University, Philadelphia, PA, ⁶Drexel University, Pittsburgh, PA, ⁷Dartmouth College, Lebanon, NH, ⁸University of Oklahoma, Philadelphia, PA, ⁹Teachers College, Columbia University, Philadelphia, PA, ¹⁰VA Puget Sound Health Care System, Seattle, WA, ¹¹Washington VA Medical Center, Washington, District of Columbia, ¹²University of Delaware, Newark, DE, ¹³Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Wilmington, DE, ¹⁴Boston University School of Medicine, Boston, MA
Background/Purpose: Intra-articular corticosteroids are widely used for routine management of chronic pain from knee osteoarthritis (KOA), though estimates of their benefit vary widely. We aimed…
Abstract Number: 0401 • ACR Convergence 2025
Longitudinal Effectiveness of Abatacept in JIA: Results From an Ongoing JIA Registry
Daniel Lovell¹, Nicolino Ruperto², Jennifer Huggins³, Ekaterina Alexeeva⁴, Colleen Correll⁵, John Bohnsack⁶, Stacey Tarvin⁷, Gabriele Simonini⁸, Thomas Griffin⁹, Andrew Zeft¹⁰, Gerd Horneff¹¹, Pierre Quartier¹², Iionka Orban¹³, Heather Walters¹⁴, Valda Stanevica¹⁵, Julisa Patel¹⁶, Adam M Huber¹⁷, Margalit Rosenkranz¹⁸, Daniel Kingsbury¹⁹, Rosie Scuccimarri²⁰, Gabriel Vega Cornejo²¹, Joost Swart²², Robert Carroll²³, Hermine Brunner¹, Tina Sherrard²⁴, Chiara Pallotti²⁵, Clara Malattia²⁶ and Alberto Martini²⁶, ¹Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Università degli Studi Milano-Bicocca, Milan, Italy, ³Cincinnati Children's Medical Center, Cincinnati, OH, ⁴National Medical Research Center for Children’s Health Federal State Autonomous Institution of the Russian Federation Ministry of Health and I.M. Sechenov First Moscow State Medical University (Sechenovskiy University), Moscow, Russia, ⁵University of Minnesota, Minneapolis, MN, ⁶University of Utah, Salt Lake City, UT, ⁷Riley Hospital for Children at Indiana University, Indianapolis, IN, ⁸Rheumatology Unit, ERN-ReCONNET center, Meyer Children's Hospital IRCCS, Firenze, Firenze, Italy, ⁹Atrium Health Levine Children’s Hospital, Charlotte, NC, ¹⁰Cleveland Clinic, Cleveland, OH, ¹¹Asklepios Klinik, Hamburg, Germany, ¹²Hôpital Necker-Enfants Malades, Paris, France, ¹³Department of Rheumatology and Clinical Immunology of Semmelweis University, Budapest, Hungary, ¹⁴Northwell, New Hyde Park, NY, ¹⁵Riga Stradiņš University, Riga, Latvia, ¹⁶Children’s Hospital of Georgia, Augusta University, Augusta, GA, ¹⁷IWK Grace Health Centre, Halifax, NS, Canada, ¹⁸University of Pittsburgh, Pittsburgh, PA, ¹⁹Randall Children’s Hospital at Legacy Emanuel, Portland, OR, ²⁰McGill University Health Centre, Montreal, QC, Canada, ²¹Clinica de reumatología Guadalajara, Guadalajara, Jalisco, Mexico, ²²Wilhelmina Children's Hospital / UMC Utrecht, Utrecht, Utrecht, Netherlands, ²³Bristol Myers Squibb, London, United Kingdom, ²⁴Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ²⁵Istituto G. Gaslini, Servizio di Sperimentazioni Cliniche Pediatriche, Genova, Italy, ²⁶Istituto G. Gaslini Pediatria II Reumatologia and University of Genova, Genova, Italy
Background/Purpose: Abatacept is a selective T-cell co-stimulation modulator approved for use in JIA. Efficacy and safety of abatacept in patients (pts) with JIA have been…
Abstract Number: 0777 • ACR Convergence 2025
Development of a Disease Activity Index for the Assessment of VEXAS Syndrome (VEXAS-DAI)
Kevin Byram¹, Herman Mann², Danielle Hammond³, Sinisa Savic⁴, Yohei Kirino⁵, Carmelo Gurnari⁶, Mael Heiblig⁷, Thibault Comont⁸, Arsène Mekinian⁹, Mrinal Patnaik¹⁰, Lachelle D. Weeks¹¹, Gary Ho¹², Onima Chowdhury¹³, Adam Al-Hakim¹⁴, Scott Goldberg¹⁵, Marcela ferrada¹⁶, Sophie georgin-Lavialle¹⁷, Peter Grayson¹⁸, Emma Groarke¹⁹, Bhavisha Patel²⁰, Megan Sullivan²¹, Sarah A. Buckley²², Bryan G. harder²², Sandra Goble²², Matthew Koster¹⁰ and David Beck²³, ¹Vanderbilt University Medical Center, Nashville, TN, ²Institute of Rheumatology, Praha ², Czech Republic, ³The University of Texas MD Anderson Cancer Center, Houston, TX, ⁴University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ⁵Yokohama City University Graduate School of Medicine, Yokohama, Japan, ⁶Department of Biomedicine and Prevention, University of Rome Tor Vergata and Translational Hematology and Oncology Research Department, Taussig Cancer Center, Cleveland Clinic, Clevland, OH, Rome, Italy, ⁷Lyon-Sud Hospital, Hospices Civils de Lyon, Paris and Université Claude Bernard, Lyon, France, ⁸Centre Hospitalier Universitaire Toulouse Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France, ⁹Department of Internal Medicine, Inflammation-Immunopathology-Biotherapy Department (DMU i³), Saint-Antoine University Hospital, ⁷⁵⁰¹² Paris, France, Paris, France, ¹⁰Mayo Clinic, Rochester, MN, ¹¹Dana Farber Cancer Institute, Boston, MA, ¹²New York University Grossman School of Medicine, VA New York Harbor Health Care System, Brooklyn, NY, ¹³Oxford University Hospitals’ NHS Foundation Trust and Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, United Kingdom, ¹⁴University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine,, Leeds, United Kingdom, ¹⁵New York University Grossman School of Medicine, Brooklyn, NY, ¹⁶University of Maryland, Bethesda, MD, ¹⁷Sorbonne university, Tenon hospital, DMU³ID, CEREMAIA, ERN RITA, Paris, France, ¹⁸National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Chevy Chase, MD, ¹⁹National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, ²⁰National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Beltsville, MD, ²¹Mayo Clinic Arizona, Scottsdale, AZ, ²²Sobi Inc., Waltham, MA, ²³Center for Human Genetics and Genomics, NYU Grossman School of Medicine. Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine. Department of Biochemistry and Molecular Pharmacology, NYU Grossman School of Medicine, New York, NY, USA, New York, NY
Background/Purpose: VEXAS syndrome is a recently described severe disease characterized by a complex overlap of inflammatory and hematologic features. Due to the severity and refractory…
Abstract Number: 0572 • ACR Convergence 2025
Real-World Treat-to-Target Strategy in Psoriatic Arthritis: 48-week Results from the MONITOR-PsA Cohort
Jean-Guillaume Letarouilly¹, Elnaz Saeedi², Raphaël Hurtubise³, Lija James⁴, Nicola Gullick⁵, Deepak Jadon⁶, William Tillett⁷, Yvonne Sinomati⁴, Laura Tucker⁴, Nadia Mian⁸, Sophia Massa³ and Laura Coates⁹, ¹Université de Lille, CHU Lille, Service de rhumatologie, Lille, France, LILLE, Nord-Pas-de-Calais, France, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Oxford, ³Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Oxford, United Kingdom, ⁴Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK, Oxford, United Kingdom, ⁵Rheumatology Department, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK, Coventry, United Kingdom, ⁶Department of Medicine, University of Cambridge, Cambridge, UK, Cambridge, United Kingdom, ⁷Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ⁸BM BS, MMedSc,, Oxford, United Kingdom, ⁹Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: A treat-to-target (T2T) strategy in psoriatic arthritis (PsA) is supported by International PsA recommendations but not widely practiced in clinic. The aim of the…
Abstract Number: 0720 • ACR Convergence 2025
Current State of Racial, Ethnic, Sex, and Geographical Diversity in ANCA-associated vasculitis and Giant Cell Arteritis Trials
Manuel Carpio Tumba¹, Aida Mohamadi², Diana Louden³, Victor Pimentel-Quiroz⁴, Michael Putman⁵, Didem Saygin⁶, Raisa Lomanto Silva⁷ and Sebastian E Sattui⁸, ¹University of Pittsburgh, Pittsburgh, PA, ²Tehran University of Medical Sciences, Tehran, Iran, ³University of Washington, Seattle, WA, ⁴Universidad Científica del Sur, San Isidro, Peru, ⁵The Medical College of Wisconsin, Milwaukee, WI, ⁶Rush University Medical Center, Chicago, IL, ⁷Massachusetts General Hospital, Boston, MA, ⁸Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Randomized controlled trials (RCTs) generate unbiased efficacy estimates and are required for regulatory approval. Understanding the degree to which they include racial, ethnic, sex,…
Abstract Number: 1441 • ACR Convergence 2025
Efficacy and Safety of Vunakizumab in Patients with Active Ankylosing Spondylitis by Cigarette Smoking Status: A Post Hoc Analysis of a Randomized, Double-blind, Phase 2/3 Study
Hongbin Li¹ and Huilin Li², ¹Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Nei Mongol, China (People's Republic), ²Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China (People's Republic)
Background/Purpose: Vunakizumab, a humanized anti-interleukin-17A monoclonal antibody, has shown significant efficacy and favorable safety in patients with active ankylosing spondylitis (AS), leading to its approval…
Abstract Number: 1542 • ACR Convergence 2025
Alternative Definitions of Moderate Flares That Simulate Clinical Practice in Systemic Lupus Erythematosus: Post Hoc Exploration of Moderate Flares in Patients Treated with Dapirolizumab Pegol in a 48-Week Phase 3 Trial
Richard Furie¹, George Bertsias², Lucy Carter³, Eric Morand⁴, Marta Mosca⁵, Marilyn Pike⁶, Vanessa Taieb⁷, Annette Nelde⁸, Ed Vital⁹ and Christian Stach¹⁰, ¹Division of Rheumatology, Northwell Health, Great Neck, NY, ²Rheumatology and Clinical Immunology, University Hospital of Heraklion and University of Crete Medical School and Foundation for Research and Technology-Hellas (FORTH), Infections and Immunity, Institute of Molecular Biology and Biotechnology, Heraklion, Greece, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁴Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, ⁵University of Pisa, Pisa, Pisa, Italy, ⁶Rheumatology, MedPharm Consulting, Inc., Bethesda, MD, ⁷UCB, Colombes, France, ⁸Biogen, Baar, Switzerland, ⁹University of Leeds, Leeds, England, United Kingdom, ¹⁰UCB, Monheim am Rhein, Germany
Background/Purpose: Despite the evolution of various flare definitions and their inclusion in SLE clinical trials, moderate flares tend to be underestimated in trials owing to…

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