Abstracts tagged "B cell targeting"

Abstract Number: 2486 • 2017 ACR/ARHP Annual Meeting
Rituximab Is an Attractive Proposition to Treat Difficult Active RA in Indian (Asia) Patients: Initial Results of a Non Commercial Initiative Using an Initial Regimen of Two 500 Mg Infusions (fortnightly) and a Third 500 Mg Infusion at 6 Weeks in Case of Inadequate Response(ACR 50)
Arvind Chopra¹, KIRAN ADAM², NACHIKET KULKARNI³, Anuradha Venugopalan⁴, Toktam Kainifard⁵ and Manjit Saluja⁶, ¹Center for Rheumatic Diseases, Pune, India, Pune, India, ²Rheumatology physician, PUNE, India, ³MD, DNB, PUNE, India, ⁴Rheumatology, R & D, Lab, Center for Rheumatic Diseases, Pune, India, ⁵Rheumatology, Consultant research and Dietitian, Pune, India, ⁶Rheumatology, Co-ordinator Research, Pune, India
Background/Purpose: Considering the huge burden of RA in India, the use of biologic DMARDs is miniscule. The major deterrents are cost, poor awareness and few…
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: 12L • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Atacicept in Patients with Systemic Lupus Erythematosus: Results of a 24-Week Randomized, Placebo-Controlled, Phase IIb Study
Joan T. Merrill¹, Daniel J. Wallace², Stephen Wax³, Amy Kao⁴, Patricia Fraser⁴, Wai Chin⁴ and David A. Isenberg⁵, ¹Oklahoma Medical Research Foundation, Oklahoma City, OK, ²University of California Los Angeles, Los Angeles, CA, ³EMD Serono, BIllerica, MA, ⁴EMD Serono, Billerica, MA, ⁵University College Hospital, London, London, United Kingdom

Background/Purpose: Atacicept targets B-cell stimulating factors BLyS and APRIL. In the APRIL-SLE trial, atacicept 150 mg was associated with reduced SLE flares in post-hoc analyses.1Methods:…
Abstract Number: 1087 • 2016 ACR/ARHP Annual Meeting
Nonmemory B Cell Signature Alterations in Belimumab Patients
Karina Marianne D. Torralba¹, Vaneet Sandhu², Abigail Benitez¹ and Sheila Lezcano³, ¹Rheumatology, Loma Linda University, Loma Linda, CA, ²Division of Rheumatology, Loma Linda University, Loma Linda, CA, ³Rheumatology, Loma Linda University Medical Center, Loma Linda, CA
Background/Purpose: Insight into B cell subset dynamics and homeostasis can provide a biological rationale for use of B cell targeted therapies in SLE patients. Using…
Abstract Number: 1091 • 2016 ACR/ARHP Annual Meeting
Synergistic Immunoregulatory Effects of IL-10 and TGF-β on Humoral Immunity
Toshihiko Komai¹, Tomohisa Okamura^1,2, Mariko Inoue¹, Yukiko Iwasaki¹, Kaoru Morita¹, Kazuhiko Yamamoto¹ and Keishi Fujio¹, ¹Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, ²Max Planck-The University of Tokyo Center for Integrative Inflammology, The University of Tokyo, Tokyo, Japan
Background/Purpose: We have previously identified CD4+CD25-Foxp3- regulatory T cells (Treg) that characteristically express lymphocyte-activation gene 3 (LAG3) produce IL-10. Recently we reported that these Treg…
Abstract Number: 1587 • 2016 ACR/ARHP Annual Meeting
A Phase 2a, 4-Week Double-Blind, Proof-of-Concept Efficacy and Safety Study of CC-292 Versus Placebo As Co-Therapy with Methotrexate in Active Rheumatoid Arthritis (RA)
Alan J Kivitz¹, Ramesh Gupta², Guillermo Valenzuela³, Edwin Smith⁴, Quaiser Rehman⁵, Hisham El Kadi⁶, Elizabeth Bretton⁷, Jacob A. Aelion⁸, Anurekh Chadha⁹, John Tesser¹⁰, Douglas Hough¹¹, Shimon Korish¹², Peter H. Schafer¹³, Garth Ringheim¹⁴, Donna Sutherland¹⁵ and Li LI¹⁶, ¹Altoona Arthritis & Osteo Ctr, Duncansville, PA, ²Private Practice, Memphis, TN, ³Integral Rheumatology & Immunology Specialists, Fort Lauderdale, FL, ⁴Rheumatology, Medical University of South Carolina, Charleston, SC, ⁵Rheumatology Clinic of Houston, Houston, TX, ⁶Arthritis & Osteoporosis Associates, Freehold, NJ, ⁷Albuquerque Clinical Trials, Albuquerque, NM, ⁸West Tennessee Research Institute, Jackson, TN, ⁹Department of Rheumatology, Austin Regional Clinic, Austin, TX, ¹⁰Arizona Arthritis and Rheumatology Research, PLLC, Pheonix, AZ, ¹¹Clinical Research, Celgene Corporation, Warren, NJ, ¹²33 Technology Drive, Celgene Corporation, Warren, NJ, ¹³Department of Translational Development, Celgene Corporation, Summit, NJ, ¹⁴Translational Medicine, Celgene Corporation, Summit, NJ, ¹⁵Clinical Research, Celgene Corporation, Summit, NJ, ¹⁶Biostatistics, Celgene Corporation, Summit, NJ
Methods: 47 adult female RA subjects were randomized 1:1 CC-292 375 mg PO daily or placebo (PBO). Subjects were required to have a diagnosis of…
Abstract Number: 2665 • 2016 ACR/ARHP Annual Meeting
Epratuzumab Treatment of Patients with Systemic Lupus Erythematosus and Secondary Sjogren’s Syndrome: An Exploratory Analysis of Phase 3 Studies
Jacques-Eric Gottenberg¹, Thomas Dörner², Hendrika Bootsma³, Valerie Devauchelle-Pensec⁴, Simon Bowman⁵, Gordana Kosutic⁶, Holger Bartz⁷, Marga Oortgiesen⁶, Anthony Shock⁸, Willem Koetse⁶, Catrinel Galateanu⁹, Sabine Bongardt⁷, Xavier Mariette¹⁰ and Caroline Gordon^11,12, ¹Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ²Department of Medicine/Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany, ³Department of Rheumatology and Clinical Immunology, University of Groningen, Groningen, Netherlands, ⁴Department of Rheumatology and Unit of Immunology, Brest University Medical School, Brest, France, ⁵Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom, ⁶UCB Pharma, Raleigh, NC, ⁷UCB Pharma, Monheim, Germany, ⁸UCB Pharma, Slough, United Kingdom, ⁹UCB Pharma, Brussels, Belgium, ¹⁰INSERM U1184, Université Paris-Sud, Paris, France, Le Kremlin Bicetre, France, ¹¹NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom, ¹²Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom
Background/Purpose: The EMBODY 1 (SL0009; NCT01262365) and EMBODY 2 (SL0010; NCT01261793) phase 3 studies investigated the efficacy and safety of epratuzumab (Emab; Immunomedics Inc), a…
Abstract Number: 3033 • 2016 ACR/ARHP Annual Meeting
Safety and Efficacy of Single Dose VAY736 (anti-BAFF-R mAb) in Patients with Primary Sjögren’s Syndrome (pSS)
Thomas Doerner¹, Maximilian Posch², Frank Wagner², Andreas Hueser², Thomas Fischer³, Louise Mooney⁴, Olivier Petricoul⁴, Paul Maguire⁴, Parasar Pal⁵, Julie Doucet⁴, Maciej Cabanski⁴, Esther Kamphausen⁴, Remi Kazma⁴ and Stephen Oliver⁴, ¹Rheumatology and Clinical Immunology, Charité – Universitätsmedizin, Berlin, Germany, ²Charité Research Organisation GmbH, Berlin, Germany, ³Institut für Radiologie und Kinderradiologie, Charité - Universitätsmedizin, Berlin, Germany, ⁴Novartis Pharma AG, Basel, Switzerland, ⁵Novartis Pharma AG, Hyderabad, India
Safety and efficacy of single dose VAY736 (anti-BAFFR mAb) in patients with primary Sjögren’s syndrome (pSS) T Dörner1, M Posch2, F. Wagner2, A Hüser2, T…
Abstract Number: 3105 • 2016 ACR/ARHP Annual Meeting
Relationships Between a Serum Biomarker of B Cell Differentiation and B Cell Activating Factor Suggest Possible Distinct Pathways of Response to Rituximab in Patients with Systemic Lupus Erythematosus
Ricardo Marques¹, Laura Heretiu², David A. Isenberg³, Maria J. Leandro³ and Geraldine Cambridge³, ¹Serviço de Medicina Interna B, Centro Hospitalar Universitário de Coimbra, Coimbra, Portugal, ²Medicine, Centre for Rheumatology, Division of Medicine, University College London, London, United Kingdom, ³Centre for Rheumatology, Division of Medicine, University College London, London, United Kingdom
Background/Purpose: Rituximab (RTX) has been used off-label in refractory SLE with variable clinical outcomes in different cohorts, with no predictive response markers available. However, the…
Abstract Number: 259 • 2016 ACR/ARHP Annual Meeting
Rituximab in Refractory Cardiac Sarcoidosis – Single Center Experience
Megan Krause¹, Leslie T. Cooper Jr.², Panithaya Chareonthaitawee³ and Shreyasee Amin¹, ¹Rheumatology, Mayo Clinic, Rochester, MN, ²Cardiology, Mayo Clinic, Jacksonville, FL, ³Cardiology, Mayo Clinic, Rochester, MN
Background/Purpose: Cardiac sarcoidosis is a life threatening condition for which there is limited data to guide optimal steroid-sparing agents. B-cells have been reported to…
Abstract Number: 764 • 2016 ACR/ARHP Annual Meeting
Atacicept: Integrated Safety Profile from Phase II Randomized Placebo-Controlled Studies in Autoimmune Diseases
Patricia Fraser, Wai Chin and Amy Kao, EMD Serono, Billerica, MA
Background/Purpose: Atacicept, a recombinant fusion protein, targets both BLyS (B lymphocyte stimulator) and APRIL (a proliferation-inducing ligand), B cell activating factors involved in the pathogenesis…
Abstract Number: 940 • 2016 ACR/ARHP Annual Meeting
A Trial of XmAb®5871, a Reversible Inhibitor of CD19+ Cells, in IgG4-Related Disease
John H. Stone¹, Zachary S. Wallace², Cory A. Perugino³, Ana D. Fernandes⁴, Paul A. Foster⁵ and Debra J. Zack⁵, ¹Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, ²Rheumatology Unit, Massachusetts General Hospital, Boston, MA, ³Rheumatology, Massachusetts General Hospital, Boston, MA, ⁴Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA, ⁵Xencor, Inc., San Diego, CA
Background/Purpose: IgG4-related disease (IgG4-RD) is an immune-mediated condition responsible for fibro-inflammatory lesions that can lead to irreversible damage. No approved therapies for IgG4-RD exist. We…
Abstract Number: 2139 • 2015 ACR/ARHP Annual Meeting
Results of a Phase 1b/2a Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XmAb®5871 in Patients with Rheumatoid Arthritis (RA)
Debra Zack¹, Maria Jaraczewska Baumann², Mariusz Korkosz³, Gabriella Suljok⁴, Petr Sramek⁵, Bernadette Rojkovich⁶, Stafan Daniluk⁷, Janos Bartalos⁸ and Paul Foster¹, ¹Xencor, Inc., San Diego, CA, ²NZOZ Centrum Medyczne HCP, Poznan, Poland, ³Malopolskie Centrum Medyczne, The University Hospital in Krakow, Krakow, Poland, ⁴Drug Research Center Ltd., Baltonfüred, Hungary, ⁵PRA CZ, Praha, Czech Republic, ⁶Polyclinic of the Hospitaller Brothers of St John of God, Budapest, Hungary, ⁷NZOZ Center of Osteoporosis and Osteoarticular Diseases, Bialystok, Poland, ⁸PRA Hungary Ltd, Budapest, Hungary
Background/Purpose: XmAb®5871 is a humanized Fc engineered monoclonal antibody that binds to the B cell restricted surface antigen CD19 and has enhanced Fc binding to…
Abstract Number: 1812 • 2015 ACR/ARHP Annual Meeting
The First Randomized Control Trial to Evaluate the Effectiveness of Bortezomib for Refractory Systemic Lupus Erythematosus
Tomonori Ishii¹, Yoshiya Tanaka², Atsushi Kawakami³, Kazuyoshi Saito², Kunihiro Ichinose⁴, Yuko Shirota⁵, Hiroshi Fujii⁵, Yoko Fujita⁶, Yukiko Kamogawa⁵, Tomoaki Machiyama⁵, Kanae Akita⁵ and Hideo Harigae⁵, ¹Department of Clinical Trial Implementation, Tohoku University Hospital, Clinical Research, Innovation and Education Center, Sendai, Japan, ²The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ³Department of Immunology and Rheumatology, Nagasaki University, Nagasaki, Japan, ⁴Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan, ⁵Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan, ⁶Department of Hematolgy and Rheumatolgy, Tohoku University Graduate School of Medicine, Sendai, Japan
Background/Purpose: Systemic lupus erythematosus (SLE) is a disease characterized by production and deposition of anti-dsDNA antibody. In recent years, treatment methods targeting antibody-producing B cell…