Abstracts tagged "Biologicals"

Abstract Number: L11 • ACR Convergence 2023
Risk of Cardiovascular Events According to Biological Agent Exposure in Patients with Ankylosing Spondylitis: A Korean Population-based Study
Oh Chan Kwon, Hye Sun Lee, Juyeon Yang, Yong-Beom Park and Min-Chan Park, Yonsei University College of Medicine, Seoul, South Korea
Background/Purpose: Patients with ankylosing spondylitis (AS) have a higher risk of cardiovascular events than controls. Although biological disease-modifying anti-rheumatic drugs (bDMARDs) are efficacious in treating…
Abstract Number: 0346 • ACR Convergence 2023
Use, Safety and Persistence of Biosimilars in Adult Patients Diagnosed with Juvenile Idiopathic Arthritis: Results from the Spanish Registry of Adverse Events of Targeted Therapies in Rheumatic Diseases (BIOBADASER)
Juan José Bethencourt¹, Lucia Otero-Valera², JAVIER MANERO³, Eva Perez-Pampin⁴, Yanira Pérez Vera⁵, SARA MANRIQUE⁶, Maria Sagrario Bustabad Reyes⁷, Mercedes Freire González⁸, Dolores Ruiz-Montesinos⁹, Lourdes Mateo Soria¹⁰, Raquel Martín Domenech¹¹, Manuel Moreno Ramos¹², Fernando Alonso² and Isabel Castrejon¹³, ¹Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain, ²Spanish Society of Rheumatology, Madrid, Spain, ³Department of Rheumatology, Hospital Universitario Miguel Servet, Zaragoza, Spain, ⁴Rheumatology Department Complejo Hospitalario Universitario Santiago, Santiago de compostela, Spain, ⁵Hospital Universitario Dr Negrín, Las Palmas de Gran Canaria, Spain, ⁶Division of Rheumatology, Hospital Regional Universitario Carlos Haya, Malaga, Spain, ⁷Hospital Universitario de Canarias, La Laguna, Spain, ⁸Rheumatology department, Complexo Hospitalario Universitario A Coruña (CHUAC). Instituto de Investigación Biomédica A Coruña (INIBIC), A Coruña, Spain, ⁹Hospital Universitario Virgen Macarena, Sevilla, Spain, ¹⁰HOSPITAL GERMANS TRIAS I PUJOL, Badalona, Spain, ¹¹Hopsital General de Elda, Alicante, Spain, ¹²Hospital Clínico Universitario Virgen dela Arrixaca, Murcia, Spain, ¹³Hospital General Universitario Gregorio Marañón, Madrid, Spain
Background/Purpose: Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease of childhood. The emergence of new biologic agents has led to changes in…
Abstract Number: 0445 • ACR Convergence 2023
Comparison of the Efficacy, Safety and Immunogenicity of a Proposed Biosimilar MSB11456 with Tocilizumab Reference Product in Moderate-to-severe Rheumatoid Arthritis: Results of a Randomized Double-blind Study
Anna Zubrzycka-Sienkiewicz¹, Maria Misterska-Skora², Małgorzata Socik Pojawa³, Kamilla Klama⁴, Martin Ullmann⁵, Corinne Petit-Frere⁵, Andras Illes⁵, Peter Baker⁵, Joëlle Monnet⁵ and Jan Brzezicki⁶, ¹Reumatika - Centrum Reumatologil, Warsaw, Poland, ²Centrum Medyczne Oporów, Wrocław, Poland, ³MICS Centrum Medyczne Warszawa, Warsaw, Poland, ⁴Solumed Centrum Medyczne, Poznań, Poland, ⁵Fresenius Kabi SwissBiosimilars, Eysins, Switzerland, ⁶Centrum Kliniczno Badawcze, Elbląg, Poland
Background/Purpose: Tocilizumab is an anti‑interleukin‑6 receptor monoclonal antibody indicated for treating rheumatoid arthritis (RA) and other inflammatory diseases. MSB11456 is a proposed biosimilar to US‑licensed…
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: 0784 • ACR Convergence 2023
Kidney-Related Outcomes and Steroid-Sparing Effects in Patients with Active Lupus Nephritis Treated with Obinutuzumab: A Post Hoc Analysis of a Phase 2 Trial
Brad Rovin¹, Jorge Ross Terres², Sophia Giang³, Thomas Schindler⁴, Armando Turchetta⁵, Jay Garg², Richard Furie⁶, William F. Pendergraft III² and Ana Malvar⁷, ¹Ohio State University, Columbus, OH, ²Genentech, Inc., South San Francisco, CA, ³Genentech, Inc., San Francisco, CA, ⁴F. Hoffmann-La Roche Ltd, Basle, Switzerland, ⁵F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁶Northwell Health, Manhasset, NY, ⁷Hospital Fernandez, Buenos Aires, Argentina
Background/Purpose: Preservation of long-term kidney function and sustained reduction of glucocorticoid use are major therapeutic goals in lupus nephritis (LN). In the randomized, double-blind, placebo-controlled,…
Abstract Number: 1107 • ACR Convergence 2023
Predictors of Pegloticase Urate-lowering Response in the Presence and Absence of Methotrexate Co-therapy
James Mossell¹, Mai Duong², Katie Obermeyer², Lissa Padnick-Silver², Brian LaMoreaux² and Sanjay Chabra³, ¹Arthritis and Osteoporosis Center of South Georgia, Tifton, GA, ²Horizon Therapeutics, Deerfield, IL, ³Texas Arthritis Center, El Paso, TX
Background/Purpose: Pegloticase can lower serum urate (SU) in patients with uncontrolled gout who are refractory to/intolerant of oral urate-lowering therapies. However, antidrug antibodies (ADAs) can…
Abstract Number: 1330 • ACR Convergence 2023
Certolizumab-pegol, Abatacept, Tocilizumab or Active Conventional Therapy in Early Rheumatoid Arthritis: 48 Week Patient-reported Outcomes of the NORD-STAR Trial
John Lampa¹, Dan Nordstrom², Ronald van Vollenhoven³, Merete Hetland⁴, Espen A Haavardsholm⁵, Mikkel Østergaard⁶, Anna Rudin⁷, Marte Schrumpf Heiberg⁵, Michael Nurmohamed³, Bjorn Gudbjornsson⁸, Kristina Lend⁹, Kim Hørslev-Petersen¹⁰, Tuulikki Sokka-Isler¹¹, Gerdur Maria Grondal¹², Simon Krabbe¹³, Joakim Lindqvist¹⁴, Anna-Karin Hultgård Ekwall¹⁵, Daniel Glinatsi¹⁶, Meliha Kapetanovic¹⁷, Cidem Gentline¹⁴, Anna-Birgitte Aga¹⁸, Heikki Relas², Tove Lorenzen¹⁹, Giovanni Cagnotto²⁰, Johan Back²¹, Oliver Hendricks²², Bas Dijkshoorn²³, Kajsa Öberg²⁴, Maud-Kristine Aga Ljoså²⁵, Eli Brodin²⁶, Hanne Merete Lindegaard²⁷, Annika Söderbergh²⁸, Milad Rizk²⁹, Alf Kastbom³⁰, Per Larsson³¹, Line Uhrenholt³², Søren Just³³, David J Stevens³⁴, Trine B Laurberg³⁵, Gunnstein Bakland³⁶, Inge Olsen³⁷, Joseph Sexton¹⁸ and Till Uhlig¹⁸, ¹Stockholm County, Hãsselby, Sweden, ²Helsinki University Hospital, Helsinki, Finland, ³Amsterdam University Medical Centers, Amsterdam, Netherlands, ⁴Copenhagen Center for Arthritis Research, Rigshospitalet, Copenhagen, Denmark, ⁵Diakonhjemmet Hospital, Oslo, Norway, ⁶Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet; University of Copenhagen, Copenhagen, Denmark, ⁷Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, ⁸Centre for Rheumatology Research, University Hospital, Reykjavik, Iceland, ⁹Amsterdam UMC, Karolinska Institute, Stockholm, Sweden, ¹⁰University of Southern Denmark, Odense, Denmark, ¹¹Jyvaskyla Central Hospital, Jyväskylä, Finland, ¹²Department for Rheumatology, Landspitali University Hospital, Reykjavik, Iceland, ¹³Herlev-Gentofte University Hospital, Herlev, Denmark, ¹⁴Karolinska University Hospital, Stockholm, Sweden, ¹⁵Department of Rheumatology and Inflammation research, Sahlgrenska Academy, University of Gothenburg, Kullavik, Sweden, ¹⁶Copenhagen Center for Arthritis Research, Rigshospitalet, Copenhagen, Sweden, ¹⁷Lund University and Skåne University Hospital, Lund, Sweden, ¹⁸Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway, ¹⁹Silkeborg University Hospital, Silkeborg, Denmark, ²⁰Skåne University Hospital, Lund, Sweden, ²¹Uppsala University Hospital, Uppsala, Sweden, ²²Danish Hospital for Rheumatic Diseases, Sønderborg, Denmark, ²³Amsterdam Rheumatology and Immunology Center, Location Reade, Amsterdam, Netherlands, ²⁴Falu Hospital, Falun, Sweden, ²⁵Ålesund Hospital, Ålesund, Norway, ²⁶Haukeland University Hospital, Bergen, Norway, ²⁷Odense Hospital, Odense, Denmark, ²⁸Örebro University Hospital, Örebro, Sweden, ²⁹Västmanlands Hospital Västerås, Västerås, Sweden, ³⁰Linköping University, Linköping, Sweden, ³¹Academic Specialist Center, Stockholm, Sweden, ³²Aalborg University Hospital, Aalborg, Denmark, ³³Section of Rheumatology, Department of Medicine, Odense University Hospital – Svendborg Hospital, Odense, Denmark, ³⁴St. Olavs Hospital, Trondheim, Norway, ³⁵Aarhus University Hospital, Aarhus, Denmark, ³⁶University Hospital of North Norway, Tromsø, Norway, ³⁷Oslo University Hospital, Oslo, Norway
Background/Purpose: The optimal first-line treatment of patients with early rheumatoid arthritis (eRA) is not established. Methods: In this investigator-initiated, randomized, open-label study (NCT01491815), patients with…
Abstract Number: 1499 • ACR Convergence 2023
Year-5 Follow-up of Belimumab Safety (mortality and Malignancies) in Patients with Systemic Lupus Erythematosus (SLE) Who Completed a Phase 4, 52-week, Randomized, Double-blind Placebo-controlled Safety Study
Saira Sheikh¹, James Cheng-Chung Wei², Dana Tegzova³, William Stohl⁴, Ricardo Acayaba de Toledo⁵, Tamara Mucenic⁶, Mauricio R. Abello Banfi⁷, Kathleen Maksimowicz-McKinnon⁸, Carlos Abud-Mendoza⁹, Sandra Navarra¹⁰, Mercedes García¹¹, IGNACIO GARCÍA-DE LA TORRE¹², Sofia Fernandes¹³, Julia HN Harris¹⁴, Abhishek Roy¹⁵, Jose Miyar Olaiz¹⁶, Paul WIlde¹⁷ and David A. Roth¹⁸, ¹University of North Carolina at Chapel Hill, Chapel Hill, NC, ²Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, ³Institute of Rheumatology, Prague, Czech Republic, ⁴University of Southern California Keck School of Medicine, Division of Rheumatology, Los Angeles, CA, ⁵Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto, Service of Rheumatology of the Internal Medicine Department, São José do Rio Preto, Brazil, ⁶Hospital Moinhos de Vento, Porto Alegre, Brazil, ⁷Centro Integral de Reumatología del Caribe, Barranquilla, Colombia, ⁸Medical University of South Carolina, Charleston, SC, ⁹Hospital Central “Dr Ignacio Morones Prieto”, Unidad Regional de Reumatología y Osteoporosis, Hospital Central; Facultad de Medicina de la Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico, ¹⁰University of Santo Tomas Hospital, Joint and Bone Center, Manila, Philippines, ¹¹Hospital Interzonal General de Agudos José de San Martín, La Plata, Argentina, ¹²Universidad de Guadalajara/Hospital General de Occidente, Guadalajara, Mexico, ¹³GlaxoSmithKline, Stevenage, United Kingdom, ¹⁴GlaxoSmithKline, Immunology Biostatistics, Brentford, United Kingdom, ¹⁵GlaxoSmithKline, Bangalore, India, ¹⁶GlaxoSmithKline, Safety Evaluation and Risk Management, Brentford, United Kingdom, ¹⁷GlaxoSmithKline, Clinical Development, Brentford, United Kingdom, ¹⁸GlaxoSmithKline, Collegeville, PA
Background/Purpose: Belimumab (BEL) is an approved treatment for active SLE and LN, in addition to standard therapy (ST). Despite BEL clinical studies demonstrating a favorable…
Abstract Number: 1815 • ACR Convergence 2023
The Association of Body Mass Index with SARS-CoV-2 Infection (COVID-19) in Patients with Inflammatory Arthritis on Biologic Disease Modifying Anti-Rheumatic Drugs: Results from the Singapore National Biologics Register
Preeti Dhanasekaran¹, Margaret Ma², Manjari Lahiri², Li Wearn Koh³, Stanley Angkodjojo⁴, Andrew Yu Keat Khor⁵, James Jiaqi Liu⁶, Stephanie Wong⁷ and Siaw Ing Yeo⁶, ¹National University of Singapore, Singapore, Singapore, ²National University Hospital, Singapore, Singapore, ³Tan Tock Seng Hospital, Braddell Heights, Singapore, ⁴Sengkang General Hospital / Singhealth, Singapore, Singapore, ⁵Changi General Hospital, Singapore, Singapore, ⁶Singapore General Hospital, Singapore, Singapore, ⁷Tan Tock Seng Hospital, Singapore, Singapore
Background/Purpose: To determine the association of body mass index (BMI) with incident COVID-19 infection in patients with inflammatory arthritis (IA) using biologic disease-modifying anti-rheumatic drugs…
Abstract Number: 2164 • ACR Convergence 2023
Real-world Persistence of Initial Targeted Therapy Strategy in Monotherapy versus Combination Therapy in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
Carlos Sánchez-Piedra¹, Lorena Expósito², PALOMA VELA³, Manuel José Moreno Ramos⁴, Cristina Campos⁵, Cristina Bohorquez⁶, Jerusalem Calvo⁷, Zulema Plaza⁸, Marta Domínguez⁹ and Jose Federico Diaz-Gonzalez¹⁰, ¹Health Technology Assessment Agency (AETS), Instituto de Salud Carlos III, Madrid, Spain, ²Rheumatology Unit, Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain, ³Rheumatology, Hospital General Universitario Alicante, Alicante, Spain, ⁴Rheumatology Department Hospital Virgen de la Arrixaca, El Palmar Murcia, Spain, ⁵Rheumatology Unit, Hospital General Universitario de Valencia, Valencia, Spain, ⁶Rheumatology Unit, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain, ⁷Reina Sofia University Hospital, Córdoba, Spain, ⁸Universidad Autónoma de Madrid, Madrid, Spain, ⁹Sociedad Española de Reumatología, Madrid, Spain, ¹⁰Hospital Universitario de Canarias, La Laguna, Spain
Background/Purpose: Clinical practice guidelines, based on information from clinical trials, provide different recommendations for the use of combination therapies for the treatment of rheumatoid arthritis…
Abstract Number: 2245 • ACR Convergence 2023
Drug Survival of Risankizumab vs Other Biologics After 13 Months of Treatment Among Patients with PsA in the Multicountry Postmarketing Observational VALUE Study
Lars Erik¹, Kim A Papp², Andrew Östör³, Vassilis Stakias⁴, Tshepiso Madihlaba⁴, Ralph Lippe⁵, Ran Liu⁴ and Diamant Thaçi⁶, ¹Bispebjerg-Frederiksberg Hospital, Vedbæk, Denmark, ²Alliance Clinical Research and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada, ³Monash University & Emeritus Research; Australian National University, Melbourne, Australia, ⁴AbbVie, Inc., North Chicago, IL, ⁵AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, ⁶Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany
Background/Purpose: Risankizumab (RZB) is an optimized IL-23 inhibitor (IL-23i) currently approved for the treatment of plaque psoriasis (PsO), PsA, and Crohn's disease. In a post…
Abstract Number: 2482 • ACR Convergence 2023
Preinflammatory Mesenchymal (PRIME) Cell Signature Genes Enrichment Predicts Treatment Response and Joint Prognosis in Rheumatoid Arthritis
Takayuki Fujii¹, Dana Orange², Caryn Hale², Koichi Murata¹, Hideo Onizawa¹, Akira Onishi¹, Masao Tanaka³, Akio Morinobu⁴ and Shuichi Matsuda⁵, ¹Department of Advanced Medicine for Rheumatic Diseases, Graduate School of Medicine, Kyoto University, Kyoto, Japan, ²Rockefeller University, New York, NY, ³Graduate School of Medicine, Kyoto University, Kyoto, Japan, ⁴Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan, ⁵Department of Orthopaedic Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan
Background/Purpose: This study aimed to determine predictors of treatment response and radiographic progression following the initiation of biological disease-modifying antirheumatic medications (bDMARDs) in patients with…
Abstract Number: 0354 • ACR Convergence 2023
Open-label Phase 3 Study of Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis: Pharmacokinetics, Effectiveness, Safety, and Immunogenicity over 252 Weeks
Nicolino Ruperto¹, Daniel J Lovell², Sarah Ringold³, Xie L. Xu⁴, Jocelyn H. Leu³, Edwin Lam³, Yuhua Wang³, Alberto Martini⁵ and Hermine Brunner⁶, ¹IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, Genova, Italy, ²UC Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, OH, ³Janssen Research & Development, LLC, Spring House, PA, ⁴Janssen Research & Development, LLC, San Diego, CA, ⁵Universita degli Studi di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Genova, Italy, ⁶Cincinnati Children's Hospital Medical Center, Division of Rheumatology, Cincinnati, OH
Background/Purpose: The phase 3, Intravenous Golimumab in Pediatric Participants with Active Polyarticular-Course JIA Despite MTX (GO-VIVA) study demonstrated that golimumab (GLM) 80 mg/m2 at Week…
Abstract Number: 0447 • ACR Convergence 2023
Glucocorticoid Use in Rheumatoid Arthritis Patients Initiating Biological or Targeted Synthetic Disease Modifying Anti-rheumatic Drugs (b/tsDMARDs) in Real Life: Data from BIOBADASER
Lucia Otero-Valera¹, Jose María Alvaro-Gracias², Jerusalem Calvo³, Cristina Campos⁴, Alicia Garcia Dorta⁵, Fernando Sánchez-Alonso⁶ and Isabel Castrejon⁷, ¹Spanish Society of Rheumatology, Madrid, Spain, ²Hospital General Universitario Gregorio Marañon, Madrid, Spain, ³Reina Sofia University Hospital, Córdoba, Spain, ⁴Rheumatology Unit, Hospital General Universitario de Valencia, Valencia, Spain, ⁵Rheumatology Unit, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain, ⁶Fundación Española de Reumatología, Madrid, Spain, ⁷Hospital Universitario Gregorio Marañón, Madrid, Spain
Background/Purpose: Glucocorticoids are frequently used as bridging therapy for rheumatoid arthritis (RA) patients starting conventional synthetic DMARDs. Both EULAR and ACR guidelines (1,2), recommend to…
Abstract Number: 0587 • ACR Convergence 2023
Impact of up to 24 Months Intravenous (IV) Belimumab (BEL) Treatment on Steroid Use and Disease Activity in Patients with SLE in Clinical Practice: Additional Post Hoc Pooled Analysis of Multicountry OBSErve Cohort Data
Daniel Moldaver¹, Seth Anderson², Marguerite Bracher³, Roger A. Levy⁴, Holly A. Quasny⁵, Robert Wood⁶, Rosie Wild⁶, Alexandra Cusmano⁶ and Elke Rottier⁶, ¹GlaxoSmithKline, Value Evidence and Outcomes, Ontario, Canada, ²GlaxoSmithKline, Value Evidence and Outcomes, Collegeville, PA, ³GlaxoSmithKline, Value Evidence and Outcomes, Stevenage, United Kingdom, ⁴GlaxoSmithKline, Global Medical Affairs, Collegeville, PA, ⁵GlaxoSmithKline, Research & Development, Durham, NC, ⁶Adelphi Real World, Real-World Evidence, Cheshire, United Kingdom
Background/Purpose: The clinical effectiveness of 6-month IV BEL use in SLE has previously been described in a post hoc pooled analysis from six OBSErve cohort…

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