Abstracts tagged "Biologicals"

Abstract Number: 0360 • ACR Convergence 2020
Does Smoking Affect Secukinumab Treatment Outcomes and Safety in Patients with Psoriatic Arthritis? – Real World Data from German Observational Study
Elke Riechers¹, Uta Kiltz², Jan Brandt-Jürgens³, Peter Kästner⁴, Daniel Peterlik⁵ and Hans-Peter Tony⁶, ¹Hannover Medical School, Hannover, Germany, ²Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, ³Rheumatologische Schwerpunktpraxis Berlin, Berlin, Germany, ⁴Ambulantes Rheumazentrum, Erfurt, Germany, ⁵Novartis Pharma GmbH, Nürnberg, Germany, ⁶Rheumatology/Clinical Immunology, Department of Internal Medicine II, Würzburg, Germany
Background/Purpose: Several studies have shown an negative association between smoking status and psoriatic arthritis (PsA) clinical outcomes1,2. The German non-interventional study AQUILA provides real-world data…
Abstract Number: 0567 • ACR Convergence 2020
Rheumatologist’s Perception of the Efficacy, Safety and Willingness to Prescribe Infliximab and Use Alternate Drug Supply Programs to Lower Cost of Rheumatoid Arthritis Care
Cesar Galan¹, Alan Puric², Guy Cozzi², Michele Hamburger³, Elisea Avalos-Reyes⁴ and Kjel Johnson¹, ¹CVS Health, Lincoln, RI, ²CVS Health, Northbrook, IL, ³Frances Hamburger Institute, Hauppauge, NY, ⁴CVS Health, Irving, TX
Background/Purpose: There is interest in employing biosimilar therapies for patients with rheumatoid arthritis (RA), which have been shown comparable to originator biologics in safety and…
Abstract Number: 0800 • ACR Convergence 2020
A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis
Jonathan Kay¹, Janusz Jaworski², Rafal Wojciechowski³, Piotr Wiland⁴, Anna Dudek⁵, Marek Krogulec⁶, Slawomir Jeka⁷, Agnieszka Zielinska⁸, Jakub Trefler⁹, Katarzyna Bartnicka-Maslowska¹⁰, Magdalena Krajewska-Wlodarczyk¹¹, Piotr Klimiuk¹², Daniel Furst*¹³, SangJoon Lee¹⁴, YunJu Bae¹⁴, GoEun Yang¹⁴, JaeKyoung Yoo¹⁴, HyunJin Lee¹⁴ and Edward C Keystone¹⁵, ¹University of Massachusetts Medical School, Worcester, MA, ²Reumatika-Centrum Reumatologii, Warsaw, Poland, ³University Hospital No 2, Bydgoszcz, Poland, ⁴Medical Univeristy, Wroclaw, Poland, ⁵Centrum Medyczne AMED, Warsaw, Poland, ⁶Rheumatology Clinic NZOZ Lecznica MAK-MED, Nadarzyn, Poland, ⁷2nd Univ Hospital, CM UMK, Bydgoszcz, Poland, ⁸Medycyna Kliniczna Marzena Waszczak-Jeka, Warsaw, Poland, ⁹Reuma Centrum, Warsaw, Poland, ¹⁰Centrum Medyczne AMED oddzial w Łodzi, Łódź, Poland, ¹¹University of Warmia and Mazury, Olsztyn, Poland, ¹²Medical University of Białystok and Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk, Białystok, Poland, ¹³Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA, Los Angeles, CA, ¹⁴Celltrion, Inc., Incheon, Republic of Korea, ¹⁵Mount Sinai Hospital, Toronto, ON, Canada
Background/Purpose: CT-P17 (100 mg/mL) is the first proposed biosimilar of the high concentration and citrate-free formulation of reference adalimumab. The purpose of this study was…
Abstract Number: 0854 • ACR Convergence 2020
Mortality and Adverse Events of Special Interest in Adult Patients with Systemic Lupus Erythematosus Receiving Intravenous Belimumab: A Post Hoc Descriptive Summary of Serious Psychiatric Events
Saira Sheikh¹, Ricardo Acayaba de Toledo², Laura Geraldino-Pardilla³, Julia Harris⁴, Regina Kurrasch⁵, Andrew Liu⁴, Kathleen Maksimowicz-McKinnon⁶, Holly Quasny⁷, David Roth⁵, Lilian Soto⁸ and Rajesh Punwaney⁵, ¹University of North Carolina Thurston Arthritis Research Center, Chapel Hill, ²Faculdade de Medicina de São José do Rio Preto, São Paulo, Brazil, ³Division of Rheumatology, Columbia University Vagelos College of Physicians and Surgeons, New York, ⁴GlaxoSmithKline, Uxbridge, United Kingdom, ⁵GlaxoSmithKline, Collegeville, ⁶Henry Ford Hospital, Detroit, ⁷GlaxoSmithKline, Research Triangle Park, ⁸Facultad de Medicina, Clinical Hospital of Universidad de Chile, Santiago, Chile
Background/Purpose: Intravenous (IV) belimumab (BEL) is approved in patients ≥5 years of age with active systemic lupus erythematosus (SLE). Results of the BASE study (the…
Abstract Number: 0935 • ACR Convergence 2020
Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Trial of BIIB059, an Anti-Blood Dendritic Cell Antigen 2 Antibody, in SLE
Richard Furie¹, Ronald van Vollenhoven², Kenneth Kalunian³, Sandra Navarra⁴, Juanita Romero-Díaz⁵, Victoria Werth⁶, Xiaobi Huang⁷, Hua Carroll⁸, Adam Meyers⁷, Cristina Musselli⁷, Catherine Barbey⁹ and Nathalie Franchimont⁷, ¹Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ²Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ³University of California San Diego, La Jolla, CA, ⁴University of Santo Tomas, Manila, Philippines, ⁵Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, ⁶University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ⁷Biogen, Cambridge, MA, ⁸Biogen, Cambridge, ⁹Biogen, Baar, Switzerland
Background/Purpose: Type I interferons (IFN-I), inflammatory mediators principally produced by plasmacytoid dendritic cells (pDCs), components of the innate immune system, have been implicated in the…
Abstract Number: 1339 • ACR Convergence 2020
COVID-19 in Patients with Inflammatory Arthritis: A Prospective Study on the Effects of Comorbidities and DMARDs on Clinical Outcomes
Rebecca Haberman¹, Rochelle Castillo¹, Alan Chen², Di Yan¹, Deborah Ramirez², Vaish Sekar², Robert Lesser², Gary Solomon², Andrea Neimann², Rebecca Blank¹, Peter Izmirly³, Dan Webster⁴, Alexis Ogdie⁵, Andrea Troxel², Samrachana Adhikari² and Jose Scher¹, ¹NYU School of Medicine, New York City, ²NYU Langone Health, New York City, ³New York University, New York, NY, ⁴Sage Bionetworks, Seattle, ⁵Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: The COVID-19 pandemic has quickly emerged as the most challenging global health crisis in a generation. Affecting initially China, New York City (NYC) quickly…
Abstract Number: 1441 • ACR Convergence 2020
Effects of Belimumab on Renal Outcomes, Overall SLE Control and Biomarkers: Findings from a Phase 3, Randomized, Placebo-controlled 104-week Study in Patients with Active Lupus Nephritis
Richard Furie¹, Brad Rovin², Frédéric Houssiau³, Gabriel Contreras⁴, Ana Malvar⁵, Amit Saxena⁶, Xueqing Yu⁷, Y K Onno Teng⁸, Pieter van Paassen⁹, Ellen M Ginzler¹⁰, Diane Kamen¹¹, Mary Oldham¹², Damon Bass¹³, Andre van Maurik¹⁴, Mary Beth Welch¹³, Yulia Green¹⁵, Beulah Ji¹⁵, Christi Kleoudis¹⁶ and David Roth¹⁷, ¹Northwell Health, Great Neck, NY, ²The Ohio State University, Columbus, ³Cliniques Universitaires Saint-Luc, Brussels, Belgium, ⁴University of Miami Miller School of Medicine, Miami, ⁵Organizacion Medica de Investigacion, Buenos Aires, Argentina, ⁶NYU School of Medicine, New York, ⁷Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China (People's Republic), ⁸Leiden University Medical Center, Leiden, Netherlands, ⁹Maastricht University, Academisch Ziekenhuis Maastricht, Maastricht, Netherlands, ¹⁰SUNY Downstate Health Sciences University, Brooklyn, ¹¹Medical University of South Carolina, Charleston, SC, ¹²GlaxoSmithKline, Stevenage, United Kingdom, ¹³GlaxoSmithKline, Research Triangle Park, ¹⁴GlaxoSmithKline, Stevenage, ¹⁵GlaxoSmithKline, Uxbridge, ¹⁶Parexel (*At the time of study), Durham, ¹⁷GlaxoSmithKline, Collegeville
Background/Purpose: Belimumab (BEL) has demonstrated efficacy in systemic lupus erythematosus (SLE) in 4 positive pivotal trials. This study assessed the efficacy and safety of intravenous…
Abstract Number: 1831 • ACR Convergence 2020
Biomarkers Linked to Anti-IFN-I and Ustekinumab Suggest Distinct Mechanism of Action in Systemic Lupus Erythematosus
Thomas Dörner¹, George Tsokos², Kenneth Kalunian³, Ronald van Vollenhoven⁴, Ashley Orillion⁵, Matteo Cesaroni⁵, Jacqueline Benson⁶, Marc Chevrier⁷, Shawn Rose⁸, Stanley Marciniak⁵, Zhenling Yao⁵, Bhaskar Srivastava⁵, Jessica Schreiter⁵, Frédéric Baribaud⁵, Tatiana Ort⁵, Jarrat Jordan⁵ and Loqmane Seridi⁵, ¹DRFZ and Charité University Hospitals, Berlin, Germany, ²Division of Rheumatology & Clinical Immunology/Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, ³University of California San Diego, La Jolla, CA, ⁴Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ⁵Janssen Research & Development, LLC, Spring House, PA, ⁶Janssen Research & Development, LLC, South San Francisco, CA, ⁷Janssen Research & Development, LLC, Collegeville, PA, ⁸Janssen Research & Development, LLC, Princeton Junction, NJ
Background/Purpose: Clinical and biological heterogeneity pose a significant hurdle in SLE, making biomarkers that define patient subsets crucial for developing tailored therapies. Interventional SLE trials…
Abstract Number: 0100 • ACR Convergence 2020
Concordance Between the QuantiFERON-TB Gold In-Tube and Tuberculin Test for the Diagnosis of Latent Tuberculosis Infection in Patients with Rheumatic Diseases
Cristobal Pavez Perales¹, Ana Quiles Rocher², Elena Grau Garcia³, Marta De la Rubia Navarro¹, Samuel Leal Rodriguez⁴, Roxana Gonzalez Mazario¹, Jorge Juan Fragio Gil¹, Cristina Alcañiz Escandell³, Jose Ivorra Cortes¹, Inmaculada Chalmeta Verdejo¹, Luis Gonzalez Puig⁵, Isabel Martinez Cordellat¹, Rosa Negueroles Albuixech¹, Jose Eloy Oller Rodriguez¹, Francisco Miguel Ortiz Sanjuan⁴, Elvira Vicens Bernabeu⁴, Carmen Najera Herranz¹, Ines Canovas Olmos¹ and Jose Andres Roman Ivorra¹, ¹Rheumatology Department. HUP La Fe, Valencia, Spain, ²Medical School, UCV, Valencia, Valencia, Spain, ³Rheumatology Department. HUP La Fe, Valencia, Comunidad Valenciana, Spain, ⁴Rheumatology Department, HUP La Fe, Valencia, Spain, ⁵Rheumatology Department. HUP La Fe, Torrente ( Valencia), Spain
Background/Purpose: Patients with rheumatic diseases (RD) are at higher risk of latent tuberculosis infection (LTBI) reactivation. To detect and treat it before starting treatment, especially with biological therapies, decrease the reactivation risk. Diagnosis is carried…
Abstract Number: 0235 • ACR Convergence 2020
Safety and Biological Activity of Rozibafusp Alfa in Subjects with Rheumatoid Arthritis: Final Results of a Phase 1b Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study
Lubna Abuqayyas¹, Laurence Cheng¹, Kyong Park¹, Marcia Teixeira dos Santos¹, Barbara Sullivan¹, Hui Wang¹, Yanchen Zhou¹, Vishala Chindalore², Stanley Cohen³, Alan Kivitz⁴, Maximilian Posch⁵ and Jane Parnes¹, ¹Amgen Inc., Thousand Oaks, CA, ²Pinnacle Research Group, Anniston, AL, ³Metroplex Clinical Research Center, Dallas, TX, ⁴Altoona Center for Clinical Research/Altoona Arthritis and Osteoporosis Center, Duncansville, PA, ⁵Charité Research Organisation, Berlin, Germany
Background/Purpose: B-cell activating factor (BAFF) and inducible costimulator ligand (ICOSL) are implicated in autoimmune disease pathogenesis, and clinical findings support their utility as drug targets…
Abstract Number: 0364 • ACR Convergence 2020
Subcutaneous Secukinumab 150 Mg Provides Sustained Relief in Total and Nocturnal Back Pain, Morning Stiffness, Fatigue, and Low Disease Activity in Patients with Active Ankylosing Spondylitis: End-of-study (5-year) Data from the MEASURE 2 Trial
Helena Marzo-Ortega¹, Corinne Miceli-Richard², Sonja Gill³, Marina Magrey⁴, Paula Machado⁵, Abhijit Shete⁶, Jianyuan Wang⁶, Susanne Rohrer⁶ and Atul Deodhar⁷, ¹The University of Leeds, Leeds Institute for Rheumatic and Musculoskeletal Medicine, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK, Leeds, United Kingdom, ²Paris Descartes University, Department of Rheumatology - Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France, ³412 – 3075 Hospital Gate, Oakville, Canada, ⁴Case Western Reserve University School of Medicine, Cleveland, OH, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁶Novartis Pharma AG, Basel, Switzerland, ⁷Oregon Health & Science University, Portland, OR
Background/Purpose: Patients (pts) with ankylosing spondylitis (AS) report pain (70–80%), stiffness (20–40%), and fatigue (50–60%) as the most troubling symptoms. Early diagnosis and sustained improvement…
Abstract Number: 0573 • ACR Convergence 2020
Effects of Successive Switches of Two Different Biosimilars of Etanercept on Outcomes in Inflammatory Rheumatic Diseases in Daily Practice
Uta Kiltz¹, Styliani Tsiami², Xenofon Baraliakos¹ and Juergen Braun¹, ¹Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: A single switch from an originator to a biosimilar product has been shown to be safe and effective in the treatment of rheumatic musculoskeletal…
Abstract Number: 0804 • ACR Convergence 2020
Factors That Influence Biological Survival in Rheumatoid Arthritis: Results of a Real-world Cohort from the Netherlands
Elise van Mulligen¹, Saad Ahmed¹, Angelique Weel², Mieke Hazes³, Annette van der Helm - van Mil⁴ and Pascal de Jong¹, ¹Erasmus MC, Rotterdam, Netherlands, ²Erasmus School of Health Policy & Management, Maasstad hospital, Erasmus MC, Rotterdam, Netherlands, ³Erasmus Medical Center, Rotterdam, Netherlands, ⁴Leiden University Medical Center, Erasmus Medical Center, Leiden, Netherlands
Background/Purpose: Data on biological survival, stratified for discontinuation reasons, and predictors that influence survival time have not been explored extensively. Therefore, we aim to explore…
Abstract Number: 0860 • ACR Convergence 2020
PREVAIL 1: A Multiple Ascending Dose Study in Normal Healthy Volunteers of PRV-3279, a Novel Bispecific DART Molecule Targeting CD32B and CD79B on B Cells, with Potential for Treatment of SLE
Paul Dunford¹, Gail Comer¹, Ralph Raymond¹, Donald Jung¹, Paul Moore², Francisco Leon¹ and Joan Merrill³, ¹Provention Bio, Oldwick, NJ, ²MacroGenics, Rockville, MD, ³Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: B-cell targeted therapeutics have proven efficacious in the treatment of autoimmune disorders. A desired improvement in efficacy and safety necessitate the development of alternate,…
Abstract Number: 0986 • ACR Convergence 2020
BIIB059, a Humanized Monoclonal Antibody Targeting Blood Dendritic Cell Antigen 2 on Plasmacytoid Dendritic Cells, Shows Dose-Related Efficacy in a Phase 2 Study in Participants with Active Cutaneous Lupus Erythematosus
Victoria Werth¹, Richard Furie², Juanita Romero-Díaz³, Sandra Navarra⁴, Kenneth Kalunian⁵, Ronald van Vollenhoven⁶, Filippa Nyberg⁷, Benjamin Kaffenberger⁸, Saira Sheikh⁹, Goran Radunovic¹⁰, Xiaobi Huang¹¹, Hua Carroll¹², Francois Gaudreault¹², Adam Meyers¹¹, Catherine Barbey¹³, Cristina Musselli¹¹ and Nathalie Franchimont¹¹, ¹University of Pennsylvania and the Michael J. Crescenz VA Medical Center, Philadelphia, PA, ²Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico, ⁴University of Santo Tomas, Manila, Philippines, ⁵University of California San Diego, La Jolla, CA, ⁶Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, ⁷Karolinska University Hospital, Stockholm, Sweden, ⁸Ohio State University, Columbus, OH, ⁹Division of Rheumatology, Allergy and Immunology, University of North Carolina, Chapel Hill, NC, ¹⁰Institute of Rheumatology, University of Belgrade, Belgrade, Serbia, ¹¹Biogen, Cambridge, MA, ¹²Biogen, Cambridge, ¹³Biogen, Baar, Switzerland
Background/Purpose: No approved targeted therapies have been developed for cutaneous lupus erythematosus (CLE), a disfiguring autoimmune disease that severely impairs quality of life.1 BIIB059 is…

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