Abstracts tagged "Biologicals"

Abstract Number: 0014 • ACR Convergence 2025
NKX019, an allogeneic off-the-shelf CD19 targeting CAR-NK cell therapy, induces deep CD19+ B cell depletion in hematological malignancy and models of autoimmune disease
Mira Tohmé, Meriam Vejiga, Wendy Yu, Emily Kang, Katharine Yu, Jessica Sood, Ivan Chan, Kyle Hansen, David Shook and Phung Gip, Nkarta, South San Francisco, CA
Background/Purpose: Autologous CAR T-cell therapies have remarkable clinical activity in autoimmune disease (AD) via B-cell targeting, with many patients achieving durable, drug-free remission. However, safety…
Abstract Number: 2593 • ACR Convergence 2025
Single Switch from Reference Denosumab to TVB-009 in Women with Postmenopausal Osteoporosis: Analysis of the Phase 3, Randomized, Double-Blind, Multinational, Multicenter Study
Karel Pavelka¹, Frank Schneider², Deepak S³, Bracha Timan⁴, Hadas Barkay⁴ and Anton Buchner², ¹Institute of Rheumatology and Department of Rheumatology, ¹st Faculty of Medicine, Charles University, Prague, Czech Republic, Prague, Czech Republic, ²Teva GmbH, Ulm, Germany, ³Teva Pharma India Private Limited, Bangalore, India, ⁴Teva Pharmaceutical Industries Ltd., Netanya, Israel
Background/Purpose: TVB-009 is being developed as a proposed biosimilar candidate to the reference denosumab. Biosimilarity of TVB-009 to US-licensed denosumab (US-denosumab) and EU-approved denosumab was…
Abstract Number: 2447 • ACR Convergence 2025
Longitudinal Disease Activity Trajectories in Patients with Systemic Lupus Erythematosus Treated with Belimumab
Fumin Qi¹, Yin Zhao², Wei Bian¹, Jian Hao¹, Na zhang¹ and Wei Wei¹, ¹Tianjin Medical University General Hospital, Tianjin, China (People's Republic), ²Affiliated Hospital of Yunnan University, Yunnan, China (People's Republic)
Background/Purpose: To investigate the longitudinal disease activity trajectories in patients with systemic lupus erythematosus (SLE) treated with belimumab.Methods: A prospective cohort of SLE treated with…
Abstract Number: 2280 • ACR Convergence 2025
Changes of B Cell Subsets During Treatment with Abatacept in Patients with Rheumatoid Arthritis
Athanasios Mavropoulos¹, Christos Liaskos², Ioannis Alexiou³, Christina Katsiari⁴, Dimitrios Bogdanos⁵ and Lazaros Sakkas⁶, ¹University of Thessaly, Volos, Greece, ²University of Thessaly, Faculty of Medicine, Larisa, Greece, ³University General Hospital of larissa, Larissa, Greece, ⁴University General Hospital of Larisa, University of Thessaly Faculty of Medicine, Larisa, Greece, ⁵Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece, ⁶Department of Rheumatology, University of Thessaly, Larissa, Greece
Background/Purpose: Abatacept, an efficacious therapy for rheumatoid arthritis (RA), inhibits the interaction between CD28 on T cells and CD80/CD86 on antigen-presenting cells (APCs). The aim…
Abstract Number: 1878 • ACR Convergence 2025
Customized Therapy for SLE: How Disease Severity Influences the Use of Corticosteroids and Biologics in Patients with SLE in the Lupus Federated Data Network (LupusNet) and a US Claims Database
Ashley Orillion¹, Federico Zazzetti², Anna Sheahan³, Clair Blacketer¹, Michel van Speybroeck⁴, Sarah Gasman¹, Reyhan Sonmez⁵, Erika Noss¹, Manuel Ugarte-Gil⁶, Rocío Gamboa-Cárdenas⁷, Víctor Pimentel-Quiroz⁸, Kaleb Michaud⁹, Patti Katz¹⁰, Rangi Kandane-Rathnayake¹¹, Eric Morand¹², Worawit Louthrenoo¹³, Alberta Hoi¹⁴, Yi-Hsing Chen¹⁵, Jiacai Cho¹⁶, Laniyati Hamijoyo¹⁷, Shue Fen Luo¹⁸, Sandra Navarra¹⁹, Mandana Nikpour²⁰, José María Pego-Reigosa²¹, Iñigo Rúa-Figueroa²², Zulema Plaza²³, María Galindo-Izquierdo²⁴, Julia Martínez Barrio²⁵, Jaime Calvo²⁶, Antonio Fernández-Nebro²⁷, Raúl Menor Almagro²⁸, EVA GLORIA TOMERO MURIEL²⁹, Javier Narváez³⁰ and Chetan S. Karyekar³¹, ¹Johnson & Johnson, Spring House, PA, USA, Spring House, PA, ²Johnson & Johnson, Horsham, PA, USA, Ambler, PA, ³Johnson & Johnson, Horsham, PA, USA, Horhsam, PA, ⁴Johnson & Johnson, Beerse, Belgium, Beerse, Belgium, ⁵Capgemini Consulting, Zurich, Switzerland, Zurich, Switzerland, ⁶Grupo Peruano de Estudio de Enfermedades Autoinmunes Sistémicas, Universidad Científica del Sur, Lima, Peru; Hospital Guillermo Almenara Irigoyen, EsSalud, Lima, Peru, Lima, Peru, ⁷Universidad Científica del Sur, Lima, Peru, ⁸Grupo Peruano de Estudio de Enfermedades Autoinmunes Sistémicas, Universidad Científica del Sur, Lima, Perú; Rheumatology Department, Hospital Guillermo Almenara Irigoyen, EsSalud, Lima, Perú, Lima, Peru, ⁹University of Nebraska Medical Center, Omaha, NE, ¹⁰UCSF, San Rafael, CA, ¹¹Center for Inflammatory Diseases, Monash University, Clayton, Victoria, Australia, ¹²Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, ¹³Chiang Mai University Hospital, Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai, Thailand, Chiang Mai, Thailand, ¹⁴Centre for Inflammatory Diseases, Monash University and Department of Rheumatology, Monash Health, Clayton, Victoria, Australia, ¹⁵Taichung Veterans General Hospital, Division of Allergy, Immunology and Rheumatology, Taichung, Taiwan, Taichung, Taiwan (Republic of China), ¹⁶National University Hospital, Rheumatology Division, Department of Medicine, Singapore, Singapore, Singapore, Singapore, ¹⁷Padjadjaran University/Hasan Sadikin General Hospital, Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Bandung, Indonesia, Badung, Indonesia, ¹⁸Chang Gung Memorial Hospital, Chang Gung University, Department of Rheumatology, Allergy and Immunology, Taipei, Taiwan, Taoyuan, Taiwan (Republic of China), ¹⁹University of Santo Tomas, Manila, Philippines, ²⁰University of Sydney, School of Public Health, Faculty of Medicine and Health, Sydney, New South Wales, Australia; St Vincent’s Hospital Melbourne, Department of Rheumatology, Fitzroy, Victoria, Australia, Melbourne, Victoria, Australia, ²¹Department of Rheumatology, University Hospital of Vigo, Vigo, Spain; IRIDIS Group (Investigation in Rheumatology and Immune-Diseases), Galicia Sur Health Research Institute, Vigo, Spain, ²²Hospital de Gran Canaria Doctor Negrin, Las Palmas GC, Spain, ²³Research Unit, Spanish Society of Rheumatology, Madrid, Spain, Madrid, Spain, ²⁴Department of Rheumatology, Hospital Universitario ¹² de Octubre, Madrid, Spain, Madrid, Madrid, Spain, ²⁵Department of Rheumatology, Hospital Gregorio Marañón, Madrid, Spain, Madrid, Madrid, Spain, ²⁶Department of Rheumatology, Hospital Universitario Araba, School of Medicne, Universidad del País Vasco, BIOARABA Health Research Institute, Vitoria, Spain, Vitoria, Pais Vasco, Spain, ²⁷Hospital Regional Universitario de Malaga, Malaga, Spain, Malaga, Spain, ²⁸Department of Rheumatology, Hospital de Jerez, Spain, Puerto De Santa María, Spain, ²⁹Hospital Universitario de la Princesa, Madrid, Spain, ³⁰Hospital Universitario de Bellvitge, Barcelona, Spain, ³¹Johnson & Johnson, Spring House, PA, USA, Spring House
Background/Purpose: The management of SLE varies worldwide. Current SLE treatment goals focus on preventing flares, controlling disease activity, and preventing organ damage accrual. LupusNet is…
Abstract Number: 1536 • ACR Convergence 2025
Evaluating Systemic Lupus Erythematosus Remission Among Patients Initiating Belimumab in a Real-World Setting in the USA
Aarat M Patel¹, Renee L. Gennarelli², Temitope Bello², Ali Bonakdar² and Karen Worley³, ¹GSK, US Medical Affairs, Durham, NC, ²Cencora, Real-World Evidence, Conshohocken, PA, ³GSK, Global Real-World Evidence & Health Outcomes Research, Collegeville, PA
Background/Purpose: The Definition Of Remission In SLE (DORIS) criteria were developed to provide alignment on defining remission in patients with SLE.1,2 Belimumab (BEL) treatment increases…
Abstract Number: 1436 • ACR Convergence 2025
Angiogenesis Markers in Difficult to Treat Psoriatic Arthritis Patients
Devy Zisman¹, Amir Haddad², Dunia Araide³, Noa Hayat², Tal Gazitt⁴, Joy Feld⁵, Michal Aizenberg Peleg¹, Muhanad Abu-Elhija¹, Ameen Batheesh¹, Abdulla Watad⁶, Alina Simanovich¹, Nili Stein¹, Kateryna Milman² and Michal Amit Rahat¹, ¹Carmel Medical Center, Haifa, Israel, ²Carmel Medical Centre, Haifa, Israel, ³The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, HaZafon, Israel, ⁴Carmel Hospital, Haifa, Israel, ⁵Carmel and Zvulun Medical Centre, Haifa, Israel, ⁶Tel Hashomer Medical Center, Ramat Gan, Israel
Background/Purpose: Difficult to treat (D2T) psoriatic arthritis (PsA) presents a state of active inflammatory disease manifestations despite therapy with at least two biologic disease modifying…
Abstract Number: 1277 • ACR Convergence 2025
Combination Therapy with Rituximab and Cyclophosphamide for Treating Pediatric Patients with Severe Manifestations of Rheumatic Disease
Eileen Rife¹, Daniel Reiff², John Bridges³, Emily Smitherman¹, randy Cron¹, Matthew Stoll¹, Melissa Mannion¹, Peter Weiser⁴ and Livie Timmerman⁵, ¹University of Alabama at Birmingham, birmingham, AL, ²Boys Town Hospital, Omaha, ³University of Alabama at Birmingham/Children's of Alabama, Birmingham, AL, ⁴University of Alabama at Birmingham, Birmingham, ⁵University of Alabama at Birmingham, Gardendale, AL
Background/Purpose: Current practice guidelines recommend either rituximab (RTX) or cyclophosphamide (CYC) for treatment of organ-threatening manifestations of systemic vasculitis or connective tissue disease (e.g., diffuse…
Abstract Number: 1053 • ACR Convergence 2025
Trends in Cost and Utilization of Biologic Medications for Rheumatologic Conditions: A Medicare Claims Study (2013–2022)
Taylor Koenig, Cleveland Clinic, Rocky River, OH
Background/Purpose: Biologic therapies have transformed rheumatologic disease management over the past two decades. As utilization of these high-cost medications increases and additional biologic and biosimilar…
Abstract Number: 0573 • ACR Convergence 2025
Effects of Sonelokimab, an IL-17A- and IL-17F-Inhibiting Nanobody, on Patient-Reported Symptoms and Quality of Life in Psoriatic Arthritis: Results From the Randomized, Double-Blind, Placebo-Controlled Phase 2 ARGO Trial
Joseph F Merola¹, Alexis Ogdie², Alice B. Gottlieb³, Fabian Proft⁴, Nuala Brennan⁵, Alex Godwood⁵, Matthew R. Thomas⁵, Eva Cullen⁵, Kristian Reich⁶, Laura Coates⁷ and Laure Gossec⁸, ¹Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ²University of Pennsylvania, Philadelphia, PA, ³Department of Dermatology, UT Southwestern Medical Center, Dallas, TX, ⁴Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ⁵MoonLake Immunotherapeutics AG, Zug, Switzerland, ⁶MoonLake 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, ⁷Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁸Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France
Background/Purpose: Sonelokimab (SLK) is a novel IL-17A- and IL-17F-inhibiting Nanobody designed to target difficult-to-reach sites of inflammation due to its small size and albumin-binding domain.…
Abstract Number: 0779 • ACR Convergence 2025
Interim Results of a Randomized Placebo Controlled Study of IL-1 Inhibitor Goflikicept in Patients With Familial Mediterranean Fever
Olga Uhanova¹, serdal Ugurlu², Mikhail Kostik³, Tamara Sarkisyan⁴, Anna Yeghiazaryan⁴, Lidiya Lysenko⁵, Vilen Rameev⁵, Omer Karadag⁶, Valentina Vardanyan⁷, Veli Yazisiz⁸, Tatiana Sotnikova⁹, Vyacheslav Podsvirov¹, Alina Egorova¹⁰, Daria Bukhanova¹⁰, Sergey Grishin¹⁰, Tolga Tuncel¹¹, Mikhail Samsonov¹⁰ and Ahmet Gul¹², ¹Terafarm LLC, Stavropol, Russia, ²Istanbul University-Cerrahpasa, Department of Internal Medicine, Division of Rheumatology, Istanbul, Turkey, ³Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russia, ⁴Center of Medical Genetics and Primary Health Care LTD, Yerevan, Armenia, ⁵Sechenov’s ¹st State Moscow Medical University, Moscow, Russia, ⁶Division of Rheumatology, Department of Internal Medicine, Hacettepe University School of Medicine, Ankara, Turkey, ⁷Ecosense Diagnostic Center, Yerevan, Armenia, ⁸Akdeniz University, Faculty of Medicine, Antalya, Turkey, ⁹State Budgetary Institution of Healthcare of Moscow Multispeciality Hospital named after S.P. Botkin of the Moscow City and Sechenov University, Moscow, Russia, ¹⁰R-Pharm JSC, Moscow, Russia, ¹¹TRpharm, Istanbul, Turkey, ¹²Istanbul University, Istanbul Faculty of Medicine, Division of Rheumatology, Istanbul, Istanbul, Turkey
Background/Purpose: Goflikicept (GFC; RPH-104) is a novel fusion protein inhibiting interleukin-1 (IL-1). This study aimed to investigate its efficacy and safety in IL-1β-driven monogenic autoinflammatory…
Abstract Number: 0474 • ACR Convergence 2025
Real-World Experience of Janus Kinase Inhibitors; Retention and Factors Associated with Discontinuation
Joseph Nathan¹, Bayram Farisogullari², Nicholas Jones³, Mohammad Ayoub³, James Brown³, Sarah Levy³, James Brader⁴, Ayse Ersoy⁴, Blossom Israni⁴, Mark Lloyd⁴, Afzal Latheef⁵, Diane Hill⁵, Amybel Taylor⁶, Darshani Arachchige⁶, Hlaing Chitsu⁶, Helen Linklater⁶, Kunal Lather⁷, Luke Gompels⁷, Eman Elfar⁸, Ritu Malaiya⁸, Pedro Machado⁹ and Patrick Kiely¹⁰, ¹St George's Hospital, London, United Kingdom, ²University College London, London, ³Croydon Health Services NHS Trust, Croydon, England, United Kingdom, ⁴Frimley Health NHS Foundation Trust, Frimley, England, United Kingdom, ⁵St George's University Hospitals NHS Foundation Trust, London, England, United Kingdom, ⁶Surrey and Sussex Healthcare NHS Trust, Redhill, England, United Kingdom, ⁷Somerset NHS Foundation Trust, Taunton, England, United Kingdom, ⁸Epsom and St Helier University Hospitals NHS Trust, Carshalton, England, United Kingdom, ⁹Department of Rheumatology, University College London, and Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, Centre for Rheumatology & Department of Neuromuscular Diseases, University College London, London, United Kingdom, ¹⁰St George's University Hospitals NHS Foundation Trust, London, United Kingdom
Background/Purpose: The use of Janus Kinase inhibitors (JAKi) to treat RA and PsA in a real-world setting has not been well described. Our aim was…
Abstract Number: 0011 • ACR Convergence 2025
KT502, a novel CD19-directed TCE (T-cell engager), leads to rapid and deep B-cell depletion with low cytokine release
Min Bao, John Wang, Jay Zhao and Weihao Xu, Kali Therapeutics, San Mateo, CA
Background/Purpose: Chimeric antigen receptor T-cell (CAR-T) therapies targeting CD19 have shown unprecedented effects in treatment-resistant autoimmune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis…
Abstract Number: 2594 • ACR Convergence 2025
Comparing Immunogenicity Between TVB-009 and Reference Denosumab in Healthy Adults and Participants with Postmenopausal Osteoporosis
Karel Pavelka¹, Frank Schneider², Deepak S³, Bracha Timan⁴, Hadas Barkay⁴ and Anton Buchner², ¹Institute of Rheumatology and Department of Rheumatology, ¹st Faculty of Medicine, Charles University, Prague, Czech Republic, Prague, Czech Republic, ²Teva GmbH, Ulm, Germany, ³Teva Pharma India Private Limited, Bangalore, India, ⁴Teva Pharmaceutical Industries Ltd., Netanya, Israel
Background/Purpose: TVB-009 is being developed as a proposed biosimilar candidate to the reference denosumab. Denosumab is a human IgG2 monoclonal antibody that binds to the…
Abstract Number: 2374 • ACR Convergence 2025
Bimekizumab Efficacy And Safety Through 5 Years In Patients With Moderate To Severe Plaque Psoriasis In The US And Canada
Andrew Blauvelt¹, Saakshi Khattri², Phoebe Rich³, Ronald Vender⁴, Kenneth B. Gordon⁵, Balint Szilagyi⁶, Heather Herr⁷, Bertram Knapp⁶, Delphine Deherder⁸, Sarah Kavanagh⁹ and Kim Papp¹⁰, ¹Blauvelt Consulting, LLC, Portland, OR, ²The Mount Sinai Hospital, New York, NY, ³Oregon Dermatology and Research Center, Portland, OR, ⁴Dermatrials Research Inc., Hamilton, ON, Canada, ⁵Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, ⁶UCB, Monheim am Rhein, Germany, ⁷UCB, Smyrna, GA, ⁸UCB, Braine-l'Alleud, Belgium, ⁹UCB, Morrisville, NC, ¹⁰Probity Medical Research and Alliance Clinical Trials, Waterloo, and Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada
Background/Purpose: Given the chronic nature of psoriasis, and the loss of response observed with biologic therapies over time, it is crucial to establish the long-term…

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