Abstracts tagged "BLyS"

Abstract Number: L18 • 2019 ACR/ARP Annual Meeting
A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study
Di Wu¹, Jing Li ², Dong Xu ², Wenxiang Wang ³, Lin Li ⁴, Jianmin Fang ³ and Fengchun Zhang ⁵, ¹Peking Union Medical College Hospital, Beijing, Beijing, China (People's Republic), ²Department of Rheumatology and Clinical Immunology Peking Union Medical College Hospital, Beijing, China (People's Republic), ³RemeGen, Ltd., Yantai, China (People's Republic), ⁴RemeGen, Ltd., Beijing, China (People's Republic), ⁵Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China (People's Republic)
Background/Purpose: Telitacicept, also named RC18, is a novel recombinant fusion protein constructed with the extracellular domain of the human transmembrane activator and calcium modulator and…
Abstract Number: 2572 • 2019 ACR/ARP Annual Meeting
Efficacy Analysis of Patients with Systemic Lupus Erythematosus Treated with Belimumab or Placebo Plus Standard Therapy in Phase 3 Trials by Baseline Levels of BLyS mRNA and Type 1 Interferon Inducible Gene Signature Status
Angela R Jones-Leone¹, Shaun Flint ², Roger Abramino Levy ³, David Roth ⁴, Robert Henderson ², Christel Wilkinson ², Beulah Ji ⁵ and Damon L Bass ³, ¹GlaxoSmithKline, Upper Providence, ²GlaxoSmithKline, Stevenage, United Kingdom, ³GlaxoSmithKline, Collegeville, PA, ⁴GSK, Collegeville, PA, ⁵GSK, Uxbridge, Middlesex, United Kingdom
Background/Purpose: Belimumab (BEL) is a B-lymphocyte stimulator (BLyS) inhibitor approved as an add-on to standard of care (SoC) for patients with autoantibody-positive SLE with active…
Abstract Number: 1 • 2018 ACR/ARHP Annual Meeting
Profiling of B-Cell Related Factors and Its Decoy Receptors in Rheumatoid Arthritis: Potential Clues for Patient Stratification
Javier Rodríguez-Carrio^1,2, Mercedes Alperi-López³, Patricia López¹, Francisco Javier Ballina-García⁴ and Ana Suárez¹, ¹Area of Immunology, Department of Functional Biology, University of Oviedo, Oviedo, Spain, ²Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Spain, ³Department of Rheumatology, Hospital Universitario Central de Asturias, Asturias, Spain, ⁴Department of Rheumatology, Hospital Universitario Central de Asturias, Oviedo, Spain
Background/Purpose: B-cell over-activation plays a key role in the pathogenesis of rheumatoid arthritis (RA), thus being recognized as a therapeutic target. However, the activation of…
Abstract Number: 2642 • 2018 ACR/ARHP Annual Meeting
Atacicept Dose Rationale for a Phase 3 Study in Patients with High Disease Activity and Auto-Antibody Positive SLE
Jinshan Shen¹, Orestis Papasouliotis², Eileen Samy¹, Philipp Haselmayer³, Peter Chang⁴, Victor Ona¹ and Amy H. Kao¹, ¹EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ²Merck Institute for Pharmacometrics, an affiliate of Merck KGaA, Darmstadt, Germany, Lausanne, Switzerland, ³Merck KGaA, Darmstadt, Germany, ⁴EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), BIllerica, MA
Background/Purpose: Atacicept targets the B-cell-stimulators BLyS and APRIL, and is in development for the treatment of patients (pts) with SLE. Here, we integrated non-clinical and…
Abstract Number: 2678 • 2018 ACR/ARHP Annual Meeting
Integrated Safety Profile of Atacicept from All Clinical Studies to Date
Caroline Gordon^1,2, Roberto Bassi³, Peter Chang⁴, Amy H. Kao³, David Jayne⁵, David Wofsy⁶, Victor Ona³ and Patricia Fleuranceau-Morel³, ¹Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom, ²University of Birmingham, Birmingham, United Kingdom, ³EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ⁴EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), BIllerica, MA, ⁵Department of Medicine, University of Cambridge, Cambridge, United Kingdom, ⁶Rheumatology, University of California, San Francisco, San Francisco, CA
Background/Purpose: We conducted an integrated analysis of pooled safety data from all 17 atacicept clinical studies to date, across multiple indications, to further define atacicept’s…
Abstract Number: 889 • 2017 ACR/ARHP Annual Meeting
Attainment of Low Disease Activity By Patients with Systemic Lupus Erythematosus Starting with High Disease Activity in a 24-Week, Randomized, Placebo-Controlled, Phase IIb Study of Atacicept (ADDRESS II)
Eric F Morand¹, Joan T. Merrill², Amy H. Kao³, Cristina Vazquez-Mateo³, Stephen Wax⁴, Peter Chang⁴, Kishore Pudota³ and David A. Isenberg⁵, ¹Monash University, Melbourne, Australia, ²Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ³EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ⁴EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), BIllerica, MA, ⁵Centre for Rheumatology, Division of Medicine, University College London, London, United Kingdom
Background/Purpose: Low disease activity (LDA) in lupus patients is increasingly a goal of treatment. For instance, Lupus Low Disease Activity State (LLDAS) attainment is associated…
Abstract Number: 2585 • 2017 ACR/ARHP Annual Meeting
Safety Profile in SLE Patients Treated with Atacicept in a Phase IIb Study (ADDRESS II) and Its Extension Study
Joan T. Merrill¹, Daniel J. Wallace², Cristina Vazquez-Mateo³, Amy H. Kao³, Patricia Fleuranceau-Morel³, Peter Chang⁴ and David A. Isenberg⁵, ¹Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, ²Cedars-Sinai Medical Center, UCLA, Los Angeles, CA, ³EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ⁴EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), BIllerica, MA, ⁵Centre for Rheumatology Research, University College London, London, England
Background/Purpose: Atacicept targets the B-cell stimulating factors, BLyS and APRIL, and has demonstrated a clinical response in SLE patients (pts) with high disease activity (HDA;…
Abstract Number: 742 • 2016 ACR/ARHP Annual Meeting
A Pivotal Phase III, Randomized, Placebo-Controlled Study of Belimumab in Patients with Systemic Lupus Erythematosus Located in China, Japan, and South Korea
Fengchun Zhang¹, Sang-Cheol Bae², Damon Bass³, Myron Chu³, Sally Egginton⁴, David Gordon³, David Roth³, Yoshiya Tanaka⁵ and Jie Zheng⁶, ¹Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, ²Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, The Republic of, ³GSK, Philadelphia, PA, ⁴GSK, Stevenage, United Kingdom, ⁵University of Occupational and Environmental Health, Kitakyushu, Japan, ⁶Ruijin Hospital affiliated to Shanghai Jiao Tong University, Shanghai, China
Background/Purpose: SLE is an autoimmune disease associated with elevated levels of B Lymphocyte Stimulator (BLyS). This study assessed the efficacy and safety of belimumab (BLyS-specific…
Abstract Number: 745 • 2016 ACR/ARHP Annual Meeting
Clinical and Laboratory Correlates of Response in a Phase 3 Clinical Trial of Belimumab or Placebo Administered Subcutaneously Plus Standard Care to Patients with Systemic Lupus Erythematosus (SLE)
Ronald F. van Vollenhoven¹, William Stohl², Richard Furie³, Norma Lynn Fox⁴, James Groark⁵, Damon Bass⁵, Milena Kurtinecz⁵, Bonnie Pobiner⁶, William Eastman⁶, Tania Gonzalez-Rivera⁵ and David Gordon⁵, ¹Department of Clinical Immunology & Rheumatology, Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, ²Division of Rheumatology, University of Southern California Keck School of Medicine, Los Angeles, CA, ³Division of Rheumatology, Northwell Health, Great Neck, NY, ⁴GSK, Potomac, MD, ⁵GSK, Philadelphia, PA, ⁶GSK, Research Triangle Park, NC
Background/Purpose: The SRI (SLE responder index) is a composite measure established as a primary endpoint in SLE clinical trials. However, it has been questioned whether…
Abstract Number: 756 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetics and Exposure-Response Relationship of Belimumab Administered Subcutaneously to SLE Patients
Herbert Struemper¹, Mita Thapar², David Gordon³ and David Roth³, ¹Quantitative Clinical Development, PAREXEL, Durham, NC, ²ICON, Marlow, United Kingdom, ³GSK, Philadelphia, PA
Background/Purpose: Monthly (q4w) intravenously (IV) administered belimumab 10 mg/kg is approved for the treatment of adults with active, autoantibody-positive SLE receiving standard therapy. The present…
Abstract Number: 626 • 2015 ACR/ARHP Annual Meeting
Efficacy of Belimumab and Targeting of Rheumatoid Factor Positive B-Cells in Sjögren’s Syndrome: Follow-up of the Open-Label Phase II Study
Luca Quartuccio¹, Sara Salvin², Laura Corazza¹, Saviana Gandolfo², Martina Fabris³ and Salvatore De Vita⁴, ¹S. Maria della Misericordia, University of Udine, Italy, Udine, Italy, ²Rheumatology Clinic, University of Udine, Udine, Italy, ³Clinic of Rheumatology, University of Udine, Udine, Italy, ⁴Santa Maria della Misericordia Hospital, University of Udine, Udine, Italy
Background/Purpose: Belimumab, a monoclonal anti-B lymphocyte Stimulator (BLyS) antibody is preliminary found to be effective in Sjögren’s syndrome (SS) patients with moderate to high systemic…
Abstract Number: 666 • 2014 ACR/ARHP Annual Meeting
Approach to Discriminate Treatment Impact in Both Moderate and Severe SLE: The Atacicept Phase IIb Trial Design
Joan T. Merrill¹, Yong Li², Stephen D. Wax³ and Christopher Tehlirian⁴, ¹Clinical Pharmacology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ²R&D Global BioStatistics, EMD Serono, Billerica, MA, ³Global Clinical Development Center - Immunology, EMD Serono Inc, Rockland, MA, ⁴EMD Serono, Rockland, MA
Background/Purpose Increases in background treatment in SLE trials lead to high placebo group responses in patients with moderate but not those with high disease activity…
Abstract Number: 2836 • 2014 ACR/ARHP Annual Meeting
Effects of Blisibimod, an Inhibitor of B Cell Activating Factor, on Patient Reported Outcomes and Disease Activity in Patients with Systemic Lupus Erythematosus
Michelle Petri¹, Renee S. Martin², Colin Hislop², Morton A. Scheinberg³ and Richard Furie⁴, ¹Johns Hopkins University School of Medicine, Baltimore, MD, ²Anthera Pharmaceuticals Inc, Hayward, CA, ³Rheumatology Hospital Abreu Sodre Pesquisa Clínica, São Paulo, Brazil, ⁴Division of Rheumatology and Allergy-Clinical Immunology, North Shore - Long Island Jewish Health System, Great Neck, NY
Background/Purpose: To conduct secondary endpoint analyses of the effects of subcutaneously-administered blisibimod (A-623, AMG 623), an inhibitor of B-cell activating factor (BAFF), on patient-reported outcomes and…
Abstract Number: 2838 • 2014 ACR/ARHP Annual Meeting
Exploratory Analysis of Pharmacokinetic Effects of Atacicept in Patients with Moderate to Severe Systemic Lupus Erythematosus
David Wofsy¹, Caroline Gordon², Yong Li³, Stephen D. Wax⁴ and David Isenberg⁵, ¹Division of Rheumatology, University of California, San Francisco, CA, ²Rheumatology Research Group, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, ³R&D Global BioStatistics, EMD Serono, Billerica, MA, ⁴Global Clinical Development Center - Immunology, EMD Serono Inc, Rockland, MA, ⁵Centre for Rheumatology Research, University College Hospital London, London, United Kingdom
Background/Purpose: Atacicept is a fusion protein that inhibits B-cell stimulating factors BLyS and APRIL. We previously reported the clinical effects of atacicept in lupus patients…
Abstract Number: 2694 • 2014 ACR/ARHP Annual Meeting
B Lymphocyte Stimulator (BLyS) Promotes Dysregulated Monocyte Function in Systemic Lupus Erythematosus(SLE)
Eoghan M. McCarthy¹, Joan Ní Gabhann², Siobhán Smith², Lorraine O' Neill³, Eamonn S. Molloy⁴, Donough Howard¹, Paul G. O'Connell¹, S. Donnelly⁵, Grainne M. Kearns⁶ and Caroline Jefferies², ¹Rheumatology, Beaumont Hospital, Dublin, Ireland, ²Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland, Dublin, Ireland, ³Rheumatology, Dublin Academic Medical Centre, St. Vincent's University Hospital, Dublin, Ireland, ⁴Rheumatology, St. Vincent's University Hospital, Dublin 4, Ireland, ⁵Rheumatology, Mater Misericordiae University Hospital, Dublin 7, Ireland, ⁶Rheumatology Department, Beaumont Hospital, Dublin, Ireland
Background/Purpose SLE involves complex interactions between the innate and adaptive immune systems. Monocytes are increasingly recognised to play a key role in the dysregulated immune…

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