Abstracts tagged "Biologicals"

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…
Abstract Number: 1342 • ACR Convergence 2020
Efficacy Outcomes Following Etanercept Withdrawal by Sustained Remission Status in Patients with Nr-axSpA: Results from RE-EMBARK
Filip Van den Bosch¹, Peter Nash², James Cheng-Chung Wei³, Francisco Blanco⁴, Vassilis Tsekouras⁵, Chuanbo Zang⁶, Daniela Graham⁷, Edmund Arthur⁸, Pamela Selema⁶, Bonnie Vlahos⁶ and Atul Deodhar⁹, ¹Ghent University Hospital, Ghent, Belgium, ²School of Medicine Griffith University, Brisbane, Queensland, Australia, ³Chung Shan Medical University Hospital, Taichung, Taiwan (Republic of China), ⁴INIBIC-Complejo Hospitalario Universitario A Coruña, A Coruna, Spain, ⁵Pfizer, Nicosia, Cyprus, ⁶Pfizer, Collegeville, PA, ⁷Pfizer, Groton, PA, ⁸Pfizer, Peapack, NJ, ⁹Oregon Health & Science University, Portland, OR
Background/Purpose: Etanercept (ETN) is effective and well tolerated in patients with non-radiographic axial spondyloarthritis (nr-axSpA). However, there is limited information on the effects of withdrawing…
Abstract Number: 1465 • ACR Convergence 2020
The Impact of the Combined Vaccination Scheme Against Streptococcus Pneumoniae on the Incidence of Related Infections in Patients with Rheumatoid Arthritis Treated with Biologic or Targeted Synthetic DMARD: Data from BIOBADASER 3.0
Sebastian Rodriguez-Garcia¹, Carlos Sanchez-Piedra², Raul Castellanos-Moreira³, Dolores Ruiz-Montesinos⁴, Victoria Hernandez⁵, Manuel Pombo-Suarez⁶, Fernando Sanchez-Alonso², Loreto Carmona⁷ and JJ Gómez-Reino⁸, ¹La Princesa University Hospital, Madrid, Spain, ²Biobadaser, Research Unit, Sociedad Española de Reumatología, Madrid, Spain, ³Hospital Clinic of Barcelona, Barcelona, Spain, ⁴Hospital Virgen Macarena, Sevilla, Spain, ⁵Hospital Clínic Barcelona, Barcelona, Spain, ⁶Hospital Clínico de Santiago, Santiago de Compostela, Spain, ⁷Instituto de Salud Musculoesquelética, Madrid, Spain, ⁸IDIS-CHUS - Rheumatology Group, Santiago de Compostela, Spain
Background/Purpose: Respiratory infections are among the leading causes of hospitalization in rheumatoid arthritis (RA) and Streptococcus Pneumoniae (SP) is one of the most frequent pathogens…
Abstract Number: 1840 • ACR Convergence 2020
A Novel Biomarker Identifies Systemic Lupus Erythematous (SLE) Patients Who Benefit from Obexelimab (XmAb®5871) Treatment
Ying Ding¹, Debra Zack¹, Bart Burington¹, Allen Yang¹, Joan Merrill², Judith James³, John Desjarlais¹, Raphael Clynes¹ and Joel Guthridge⁴, ¹Xencor Inc, Monrovia, CA, ²New York University, New York, ³Oklahoma Medical Research Foundation, Oklahoma City, ⁴Oklahoma Medical Research Foundation, Oklahoma City, OK
Background/Purpose: We previously reported Phase 2 SLE trial results for obexelimab, a CD19-targeted FcγRIIb engager that suppresses B-cell activation [1]. The primary endpoint, which measured…
Abstract Number: 0124 • ACR Convergence 2020
Appropriate Timing of Denosumab Dosing and Subsequent Therapy After Discontinuation: An Academic Medical Center Experience
Hugo Raposo¹, Daniel Lindstrom¹ and Jonathan Cheah², ¹University of Massachusetts Medical School, Worcester, MA, ²University of Massachusetts Medical School, Shrewsbury, MA
Background/Purpose: Denosumab, a monoclonal antibody that binds to the receptor activator of nuclear factor kappa-B ligand (RANKL) is a popular choice for osteoporosis therapy. However,…
Abstract Number: 0236 • ACR Convergence 2020
Safety and Usability of Infliximab Administration by Auto-injector (AI) and Pre-filled Syringe (PFS) in Patients with Active Rheumatoid Arthritis (RA): Patient-reported Experience from a Multicenter, Randomized Controlled Pivotal Trial
Rene Westhovens¹, DaeHyun Yoo², Piotr Wiland³, Marek Zawadzki⁴, Delina Ivanova⁵, Alfredo Berrocal Kasay⁶, Elias Chalouhi⁷, Eva Balázs⁸, SangJoon Lee⁹, SungHyun Kim⁹, JeeHye Suh⁹, NooRi Han⁹ and HoJae Lee⁹, ¹University Hospitals Leuven, Belgium, Leuven, Belgium, ²Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, ³Medical Univeristy, Wroclaw, Poland, ⁴Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, ⁵Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, ⁶ABK Reuma SRL, LIMA, Peru, ⁷Clinica Internacional Sede Lima, Lima, Peru, ⁸Dr. Bugyi István Hospital, Szentes, Hungary, ⁹Celltrion, Inc., Incheon, Republic of Korea
Background/Purpose: The subcutaneous (SC) formulation of CT-P13 received marketing authorization for RA from the EMA by demonstrating non-inferiority compared to CT-P13 intravenous for efficacy in…
Abstract Number: 0365 • ACR Convergence 2020
Experience with Apremilast in Treatment of Psoriatic Arthritis in US Clinical Practice; Assessments from Trio Health and the American Rheumatology Network (ARN)
Colin Edgerton¹, Andrew Frick², Simon Helfgott³, Kent Kwas Huston⁴, Jasvinder Singh⁵ and Nehad Soloman⁶, ¹Articularis Healthcare, Summerville, SC, ²Trio Health, Louisville, CO, ³BWH- HMS, Boston, MA, ⁴Kansas City Physician Partners, Kansas City, MO, ⁵University of Alabama at Birmingham, Birmingham, AL, ⁶Arizona Arthritis & Rheumatology Associates, P.C., Peoria, AZ
Background/Purpose: Apremilast is the one targeted immune modulating (TIM) treatment for psoriatic arthritis (PsA) that may be combined with csDMARDs, biologic therapies, or used as…

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