Abstracts tagged "APRIL"

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: 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: 1765 • 2018 ACR/ARHP Annual Meeting
Cerebrospinal Fluid Biomarker of Disease Activity: Significance in ANCA-Related Hypertrophic Pachymeningitis
Yasuhiro Shimojima¹, Dai Kishida² and Yoshiki Sekijima², ¹Department of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine, Matsumoto, Japan, ²Department of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine, Matsumoto, Japan
Background/Purpose: Hypertrophic pachymeningitis (HP), which becomes the cause of chronic headache, seizure, and cranial neuropathy, is an inflammatory disorder demonstrating focal and diffuse thickening 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: 28 • 2017 ACR/ARHP Annual Meeting
Sapril and Sbcma As Potential Biomarkers of B Cell Hyperactivation in Rheumatoid Arthritis: A Cluster Analysis Approach
Javier Rodríguez-Carrio¹, Mercedes Alperi-López², Patricia López¹, Francisco Javier Ballina-García³ and Ana Suárez¹, ¹Area of Immunology, Department of Functional Biology, University of Oviedo, Oviedo, Spain, ²Department of Rheumatology, Hospital Universitario Central de Asturias, Asturias, Spain, ³Department of Rheumatology, Hospital Universitario Central de Asturias, Oviedo, Spain
Background/Purpose: B cell compartment plays a key role in the pathogenesis of rheumatoid arthritis (RA). Activation and survival of B cell largely rely on the…
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: 2586 • 2017 ACR/ARHP Annual Meeting
Exposure-Response Modelling and Exposure-Safety Modelling Analyses in Two Phase II Studies of Atacicept in SLE
Orestis Papasouliotis¹, Oezkan Yalkinoglu¹, Cristina Vazquez-Mateo², Stephen Wax³, Amy H. Kao², Peter Chang³, Patricia Fleuranceau-morel² and Lisa Mahnke², ¹Merck KGaA, Darmstadt, Germany, ²EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ³EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), BIllerica, MA
Background/Purpose: Atacicept targets the B-cell stimulating factors BLyS and APRIL, and has been shown to reduce SLE disease activity. Our analyses evaluated the exposure-response and…
Abstract Number: 654 • 2016 ACR/ARHP Annual Meeting
The Level of B-Cell Active Cytokines and Soluble B-Cell Activating Factor/a Proliferation-Inducing Ligand Receptors in Patients with Primary Sjogren’s Syndrome
You Jung Ha¹, Jaehyung Hur¹, Sang Wan Chung¹, Eun Ha Kang², Yeong Wook Song^3,4 and Yun Jong Lee⁵, ¹Division of Rheumatology, Department of Internal Medicine, Division of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea, ²Division of Rheumatology, Department of Internal Medicine, Division of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea, The Republic of, ³WCU Department of Molecular Medicine and Biopharmaceutical Sciences, Medical Research Institute, WCU Department of Molecular Medicine and Biopharmaceutical Sciences, Medical Research Institute, Seoul National University College of Medicine, Seoul, Korea, The Republic of, ⁴Department of Internal Medicine, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea, ⁵Division of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea
Background/Purpose: Primary Sjögren`s syndrome (pSS) is an autoimmune diseases characterized by lymphocytic infiltration of exocrine glands and dysregulated proliferation and differentiation of B cells. Two…
Abstract Number: 1110 • 2015 ACR/ARHP Annual Meeting
A Proliferative Inducing Ligand (APRIL) Promotes IL-10 Production of Human B Cells
Charlotte Hua¹, Rachel Audo², Nataliya Yeremenko³, Dominique Baeten⁴, Michael Hahne², Bernard Combe⁵, Jacques Morel⁵ and Claire I. Daien⁵, ¹Department of Rheumatology, Lapeyronie Hospital and Montpellier University, Montpellier, France, ²IGMM-CNRS UMR5535, Montpellier, France, ³Academic medical center, University of Amsterdam, Amsterdam, France, ⁴1Academic Medical Center / University of Amsterdam, Amsterdam, Netherlands, ⁵Department of rheumatology, Lapeyronie Hospital and Montpellier University, Montpellier, France
Background/Purpose: B cells may have a negative regulatory role, mainly mediated by interleukin 10 (IL-10). We recently showed that regulatory B-cell functions are impaired in…
Abstract Number: 1109 • 2015 ACR/ARHP Annual Meeting
Co-Crystal Structure of TACI and APRIL-BAFF-BAFF Heteromer Suggests That Charged Residues in APRIL and BAFF Dictate Their Receptor Binding Affinities
Xuliang Jiang¹, Thomas Tan², Klaus Maskos³, Alfred Lammens³, Pascal Schneider⁴ and Wolf Palinksy⁵, ¹Research and Development Institute, EMD Serono, Billerica, MA, ²EMD Serono Research, Billerica, MD, ³Proteros Biostructures GmbH, Planegg, Germany, ⁴Biochemistry, University of Lausanne, Epalinges, Switzerland, ⁵Global Biotech Development, Merck Serono, Aubonne, Switzerland
Background/Purpose: The human B cell survival factor, B cell activation factor (BAFF), and its closely related homologue, a proliferation-inducing ligand (APRIL), modulate B cell functions…
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: 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: 2797 • 2013 ACR/ARHP Annual Meeting
B-Lymphocyte Stimulator and A Proliferation Inducing Ligand In Lupus Nephritis: Low Serum Levels Of BLyS Predict Treatment Response
Ioannis Parodis¹, Agneta Zickert¹, Elisabet Svenungsson², Vivianne Malmström² and Iva Gunnarsson¹, ¹Department of Medicine, Rheumatology Unit, Karolinska Institutet, Stockholm, Sweden, ²Rheumatology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
Background/Purpose: B-lymphocytes have a pivotal role in the pathogenesis of Systemic Lupus Erythematosus (SLE). B-Lymphocyte Stimulator (BLyS) has an important role in the activation, differentiation…

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