Abstracts tagged "Biologicals"

Abstract Number: L05 • ACR Convergence 2024
Prolonged Plasma Urate-Lowering After a Single Intravenous Administration of PRX-115, a Novel PEGylated Uricase, in Participants with Elevated Urate Levels
Christian Schwabe¹, Orit Cohen Barak², Alexandra Cole³, Hadar Reuveni², Liron Shelev², Liora Blinder-Haddad² and Nicola Dalbeth⁴, ¹NZCR, Auckland, New Zealand, ²Protalix Ltd, Karmiel, Israel, ³NZCR, Christchurch, New Zealand, ⁴University of Auckland, Auckland, New Zealand
Background/Purpose: PEGylated uricases have already demonstrated therapeutic modality in the treatment of refractory gout patients. PRX-115 is a recombinant homotetrameric uricase enzyme, produced from Candida…
Abstract Number: L13 • ACR Convergence 2024
Anifrolumab Long-Term Treatment Is More Effective Against Organ Damage Than Standard of Care Alone: Results from an External Control Arm Study on Organ Damage in Phase 3 Clinical Trials and the University of Toronto Lupus Clinic Cohort
Zahi Touma¹, Ian Bruce², Richard A. Furie³, Eric Morand⁴, Raj Tummala⁵, Shelly Chandran⁶, Gabriel Abreu⁷, Jacob Knagenhjelm⁷, Kellyn Arnold⁸, Hopin Lee⁸, Eleanor Ralphs⁸, Danuta Kielar⁹, Aleksander Bedenkov⁹ and Miina Waratani⁹, ¹Schroeder Arthritis Institute, University Health Network, Toronto, ON, Canada, ²Queen's University Belfast, Belfast, United Kingdom, ³Northwell Health, Manhasset, NY, ⁴Centre for Inflammatory Diseases, Monash University, Melbourne, Australia, ⁵BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, ⁶Astrazeneca, Mississauga, ON, Canada, ⁷BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ⁸IQVIA, London, United Kingdom, ⁹Biopharmaceuticals Medicine, AstraZeneca, Cambridge, United Kingdom
Background/Purpose: In SLE, persistent disease activity, disease flares and long-term glucocorticoid (GC) use all contribute to organ damage accrual. The effects of novel therapies on…
Abstract Number: L19 • ACR Convergence 2024
Efficacy and Safety of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s Disease: Results from a Phase 3 Study and a Pooled Analysis of Two Prospective Trials
Alexei Grom¹, Uwe Ullman², Adnan Mahmood³, Josefin Blomkvist³, Brian Jamieson⁴ and Fabrizio De Benedetti⁵, ¹Cincinnati Children’s Hospital, Division of Rheumatology, Cincinnati, OH, ²Sobi, Basel, Switzerland, ³Sobi, Stockholm, Sweden, ⁴Sobi, Inc., Morrisville, NC, ⁵Bambino Gesu Children's Hospital, Rome, Italy
Background/Purpose: MAS is a life-threatening complication of Still’s disease, characterized by interferon-gamma (IFNg)-driven macrophage activation and systemic hyperinflammation. Emapalumab, an anti-IFNg antibody, binds free and…
Abstract Number: 0237 • ACR Convergence 2024
Tofacitinib: A Retrospective Study on Safety and Adverse Effects
Vrushal Kale¹, Sandeep yadav², Canchi Balakrishnan³, Rohini Samant⁴, Bishakha Swain⁴, Shaurav Khanna⁵, Aashish Agrawal⁵ and Aditi Patankar⁴, ¹P D Hinduja national Hospital and medical Research centre, Mumbai, Maharashtra, India, ²Pd Hinduja hospital, Thane, Maharashtra, India, ³P D Hinduja Hospital and Medical Research Centre, Mahim, Mumbai, Mahin, Maharashtra, India, ⁴P D Hinduja Hospital and Medical Research Centre, Mumbai, mumbai, Maharashtra, India, ⁵P D Hinduja Hospital and Medical Research Centre, Mahim, Mumbai, Mumbai, Maharashtra, India
Background/Purpose: Tofacitinib, an oral Janus kinase inhibitor, is widely used in India to treat rheumatoid arthritis (RA) and other autoimmune diseases. Although its efficacy is…
Abstract Number: 0468 • ACR Convergence 2024
Plasma Calprotectin Assessed in Multiple Biological Treatment Strategies for Early Rheumatoid Arthritis over 48 Weeks
David Stevens¹, Lene Sundbakk², Amirhossein Kazemi², Marte Heiberg³, Tuulikki Sokka-Isler⁴, Bjorn Gudbjornsson⁵, Kristina Lend⁶, Anna Rudin⁷, Michael Nurmohamed⁸, Jon Lampa⁹, Merete Hetland¹⁰, Mikkel Ostergaard¹¹, Ronald Van Vollenhoven¹², Tillmann Uhlig², Espen Haavardsholm² and Hilde Hammer³, ¹St. Olavs hospital, Trondheim, Norway, ²Diakonhjemmet Hospital, Oslo, Norway, ³Diakonhjemmet Hospital, Oslo, Oslo, Norway, ⁴University of Eastern Finland, Faculty of Health Sciences, Jyvaskyla, Finland, ⁵Landspitali University Hospital and University of Iceland, Reykjavik, Iceland, ⁶Amsterdam UMC, Karolinska Institute, Stockholm, Sweden, ⁷Institute of Medicine, University of Gothenburg, Gothenburg, Sweden, ⁸Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁹Karolinska University Hospital, Hässelby, Sweden, ¹⁰Rigshospitalet Glostrup and University of Copenhagen, Glostrup, Denmark, ¹¹Department of Clinical Medicine, University of Copenhagen and Center for Rheumatology, Copenhagen Center for Arthritis Research, Glostrup, Denmark, ¹²Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands
Background/Purpose: Plasma calprotectin is a sensitive biomarker of inflammation in patients with rheumatoid arthritis (RA) and reflects activation of granulocytes and macrophages. Calprotectin has not…
Abstract Number: 0561 • ACR Convergence 2024
Axial Spondyloarthritis Patients with Comorbid Fibromyalgia Feel Worse, Work Less and More Often Try Multiple Biological DMARDs − Results from a Population-Based Cohort
Annie Brink¹, Elisabeth Mogard², Elisabet Lindqvist², Jonas Sagard², Johan Karlsson Wallman¹ and Tor Olofsson², ¹Lund University, Department of Clinical Sciences Lund, Section of Rheumatology and Skåne University Hospital, Lund, Sweden, Lund, Skane Lan, Sweden, ²Lund University, Department of Clinical Sciences Lund, Section of Rheumatology and Skåne University Hospital, Lund, Sweden, Lund, Sweden
Background/Purpose: A growing arsenal of biologic/targeted synthetic DMARDs often makes inflammation control an attainable target in axial spondyloarthritis (axSpA). Yet, many patients keep suffering from…
Abstract Number: 0745 • ACR Convergence 2024
Tocilizumab in Monotherapy vs. Combined in Aortitis Associated with Giant Cell Arteritis. Multicenter Open-label Study of 196 Patients
Adrián Martín-Gutiérrez¹, Javier Loricera², Carmen Secada Gómez³, Javier Narvaez-García⁴, Olga Maíz Alonso⁵, Iñigo Hernández-Rodríguez⁶, Susana Romero Yuste⁷, Eugenio De Miguel⁸, Eva Galindez-Agirregoikoa⁹, ivan Ferraz-Amaro¹⁰, Julio Sánchez-Martín¹¹, Patricia Moya Albarado¹², Cristina Campos Fernández¹³, Fernando Lopez-Gutierrez¹⁴, Santos Castañeda¹⁵ and Ricardo Blanco-Alonso¹⁶, and the Tocilizumab in Giant Cell Arteritis Spanish Collaborative Group, ¹Hospital Universitario Marques de Valdecilla, IDIVAL, Renedo de Piélagos, Cantabria, Spain, ²Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ³Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ⁴Hospital Universitario de Bellvitge, Barcelona, Spain, ⁵3Hospital Universitario de Donosti, San Sebastian, Spain, San Sebastian, Pais Vasco, Spain, ⁶Complejo Hospitalario Universitario de Vigo, Vigo, Spain, ⁷Department of Rheumatology, University Hospital Complex of Pontevedra, Pontevedra, Spain, ⁸Hospital Universitario La Paz, Madrid, Spain, ⁹BASURTO UNIVERSITY HOSPITAL, BILBAO, Spain, ¹⁰Rheumatology, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Canarias, Spain, ¹¹Hospital Universitario 12 de Octubre, Madrid, Spain, ¹²Hospital de San Pau, Barcelona, Spain, ¹³Escuela de Doctorado, Universidad Católica de Valencia San Vicente Mártir, Valencia, Spain, ¹⁴Rheumatology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Cantabria, Spain, ¹⁵Hospital Universitario de la Princesa, Madrid, Spain, ¹⁶Division of Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Immunopathology group, Santander, Spain
Background/Purpose: Aortitis related to Giant Cell Arteritis (GCA-aortitis) is a frequent and potential severe complication. Tocilizumab (TCZ) was approved in GCA, but the efficacy in…
Abstract Number: 1035 • ACR Convergence 2024
Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors
Elisabet Castañeda Estévez¹, Cristina Vergara Dangond¹, Martina Steiner¹, Maria Beatriz Paredes Romero¹, Ana Esteban Vázquez¹, Tatiana Cobo Ibañez¹, Laura Trives Folguera¹, Maria Liz Romero Bogado¹, Isabel De La Cámara Fernandez¹, Patricia Richi Alberti¹, Ana Valeria Acosta Alfaro², Iria De La Osa Subtil³ and Santiago Muñoz Fernández⁴, ¹Department of Rheumatology. Hospital Universitario Infanta Sofía., Madrid, Spain, ²Hospital Universitario Infanta Sofía., Madrid, Spain, ³Department of Medicine, Faculty of Biomedical and Health Sciences, European University of Madrid., Madrid, Spain, ⁴Hospital Universitario Infanta Sofía. Universidad Europea de Madrid, Madrid, Spain
Background/Purpose: Recently, the European Medicines Agency (EMA) published a health alert that extended to all JAK inhibitors (JAKi) due to a possible class effect, recommending…
Abstract Number: 1387 • ACR Convergence 2024
Olokizumab Effect on Chronic Pain in Rheumatoid Arthritis: Results of the Observational Study
Andrey Karateev¹, Sofia Kuzkina², Galym Togizbayev³, Elena Polishuk¹, Ekaterina Filatova¹, Vera Amirdzhanova¹, Victoria Khlaboshchina¹, Natalia Lapkina⁴, Andrey Baranov⁴ and Alexander Lila⁵, ¹V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia, ²R-Pharm, Moscow, Russia, ³Kazakh National Medical University named after Asfendiyarov S, Almaty, Kazakhstan, ⁴Yaroslavl State Medical University, Yaroslavl, Russia, ⁵Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian Federation, Moscow, Russia
Background/Purpose: To evaluate efficacy and safety of olokizumab (interleukin-6 inhibitor) in RA patients with special attention to chronic pain and a signs of central sensitization.Methods:…
Abstract Number: 1495 • ACR Convergence 2024
Real-World Reduction in Disease Flares and Oral Corticosteroid Use with Anifrolumab Therapy in Systemic Lupus Erythematosus: A Claims-Based Study
Mawuena Binka¹, Rana Muhammad Qasim Khan², Joseph Tkacz³, Donna McMorrow³, Laurence Gozalo³ and Gail Kerr⁴, ¹BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, ²BioPharmaceuticals Medical, AstraZeneca, Wilmington, ³Inovalon, Bowie, MD, ⁴Veterans Affairs Medical Center, Georgetown and Howard University Hospitals, Washington, DC
Background/Purpose: Systemic lupus erythematosus (SLE) is a complex, chronic autoimmune disease characterized by frequent episodes of disease activity (flares) of varying severity.1 SLE flares are…
Abstract Number: 1864 • ACR Convergence 2024
S-4321, a Novel Dual-cell Bidirectional PD-1:FcγRIIb Selective Agonist Antibody for the Treatment of Autoimmune Disease
Julia Manasson¹, Marisella Panduro², Michael Cianci², Minasri Borah², Stephanie Grebinoski², Joshua Vitlip², Stephen Lutz², Ishan Sharma², Elliott Wittenberg², Allison Colthart², Samuel Perry², Maria Cecilia Ramello², Chelsea R. Parker Harp², Jyothsna Visweswaraiah², Ryan Peckner², Alex Pellerin², Heather Vital³, John Sundy⁴, Nathan Higginson-Scott², Kevin L. Otipoby² and Daniela Cipolletta², ¹Seismic Therapeutic, New York, NY, ²Seismic Therapeutic, Watertown, MA, ³Seismic Therapeutic, Lexington, MA, ⁴Seismic Therapeutic, Chapel Hill, NC
Background/Purpose: The dysregulation of immune checkpoint receptors on T cells and antigen presenting cells (APCs) drives autoimmunity while receptor agonism is expected to restore immune…
Abstract Number: 2144 • ACR Convergence 2024
Impact of Immunogenicity on Clinical Outcomes in Postmenopausal Women with Osteoporosis: Results from a Randomized Controlled Phase 3 Study to Compare CT-P41 (Proposed Denosumab Biosimilar) and Reference Denosumab
Jean-Yves Reginster¹, Stuart L. Silverman², Edward Czerwinski³, Przemyslaw Borowy⁴, Tomasz Budlewski⁵, Joanna Kwiatek⁶, Svitlana Postol⁷, Airi Põder⁸, Jerzy Supronik⁹, SungHyun Kim¹⁰, JeeHye Suh¹⁰, GoEun Yang¹⁰, NooRi Han¹⁰, NaHyun Kim¹⁰ and SeoHee Bae¹⁰, ¹Biochemistry Dept, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia, CLARENS, Switzerland, ²OMC clinical research center and Cedars Sinai Medical Center, Beverly Hills, CA, ³Krakowskie Centrum Medyczne, Kraków, Poland, ⁴Krakowskie Centrum Medyczne, Krakow, Poland, ⁵Department of Rheumatology, Medical University of Lodz, Lodz, Poland, ⁶Centrum Medyczne Poznan - PRATIA, Skorzewo, Poland, ⁷Medical Center of Medbud - Clinic LLC, Kyiv, Ukraine, ⁸Clinical Research Centre Ltd, Tartu, Estonia, ⁹Osteo-Medic s.c., Białystok, Poland, ¹⁰Celltrion, Inc., Incheon, Republic of Korea

Background/Purpose: CT-P41 has been developed as a proposed biosimilar of the reference denosumab (DEN), a fully human monoclonal antibody that binds the cytokine receptor activator…
Abstract Number: 2364 • ACR Convergence 2024
Reporting Mental Health and Associated Disorders from Trials of Bimekizumab in Patients with Active Axial Spondyloarthritis and Psoriatic Arthritis
Marina Magrey¹, Denis Poddubnyy², Mark Lebwohl³, Rajan Bajracharya⁴, Dirk de Cuyper⁵, Alexander Marten⁶, Luke Peterson⁷, Jeffrey L. Stark⁸ and Joseph F. Merola⁹, ¹Case Western Reserve University School of Medicine/University Hospitals, Richfield, OH, ²Charite-Universitatsmedizin Berlin, Berlin, Germany, ³Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ⁴UCB Pharma, Slough, United Kingdom, ⁵UCB Pharma, Brussels, Belgium, ⁶UCB Pharma, Monheim am Rhein, Germany, ⁷UCB Pharma, Morrisville, NC, ⁸UCB Pharma, Smyrna, GA, ⁹UT Southwestern Medical Center, Dallas, TX
Background/Purpose: Anxiety and depression are highly prevalent in patients (pts) with axial spondyloarthritis (axSpA)/PsA.1,2 We report mental health data in pts with axSpA/PsA from trials…
Abstract Number: 2609 • ACR Convergence 2024
Drivers of Infliximab Biosimilar Uptake: A Comparative Analysis of New Biosimilar Initiations versus Switching in a National Rheumatology Registry
Eric Roberts¹, Nick Bansback², Chien-Wen Tseng³, Steve Shiboski⁴, Jing Li⁵, Gabriela Schmajuk⁶ and Jinoos Yazdany⁷, ¹University of California, San Francisco, SF, CA, ²University of British Columbia, Vancouver, BC, Canada, ³University of Hawai'i John A. Burns School of Medicine, Honolulu, ⁴University of California, San Francisco, San Francisco, ⁵University of California, San Francisco, San Francisco, CA, ⁶UCSF / SFVA, San Francisco, CA, ⁷UCSF, San Francisco, CA
Background/Purpose: Biosimilars hold promise for reducing pharmaceutical expenditures, however uptake has lagged. We analyzed the variability in new biosimilar starts and switching from bio-originator infliximab…
Abstract Number: 0243 • ACR Convergence 2024
Humoral Response to SARS-CoV-2 Vaccination and Breakthrough COVID-19 Disease in Patients with Immune-mediated Inflammatory Diseases Receiving Biological Treatment
Eve-Kai Raussi, Maigi Eisen, Küllike Palk and Marge Kütt, North Estonia Medical Centre Foundation, Tallinn, Estonia
Background/Purpose: Immune response in patients with immune-mediated inflammatory diseases (IMID) is compromised. As SARS-CoV-2 vaccine trials excluded patients on immunosuppressive therapy, data about vaccination efficacy…

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