Abstracts tagged "Late-Breaking 2016"

Abstract Number: 1L • 2016 ACR/ARHP Annual Meeting
The Cardiovascular Safety of Celecoxib Versus Ibuprofen or Naproxen in 24,081 Patients with Osteoarthritis or Rheumatoid Arthritis
M. Elaine Husni¹, Daniel H. Solomon², Katherine E Wolski³, Lisa M Wisniewski³, Steven E Nissen⁴ and on behalf of the PRECISION Trial Investigators, ¹Rheumatology, Cleveland Clinic, Cleveland, OH, ²Division of Rheumatology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ³Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, ⁴Cardiovascular Medicine, Chair, Cleveland Clinic, Cleveland, OH

*Both authors (Husni, Solomon)　contributed equally and will co present Background/Purpose: The relative cardiovascular (CV) safety of non-selective NSAIDs and selective COX-2 NSAIDs remains unclear. Given…
Abstract Number: 17L • 2016 ACR/ARHP Annual Meeting
Sofosbuvir Plus Daclatasvir for Hepatitis C Virus Associated Cryoglobulinemia Vasculitis
David Saadoun¹, yasmina ferfar¹, AS Bouyer², laurent alric³, christophe hezode⁴, SN Si Ahmed⁵, L Musset⁶, Luc De Saint Martin Pernot⁷, SN Pol⁸, Dominique Larrey⁹, T Poynard¹⁰ and Patrice Cacoub², ¹Sorbonne Universités, UPMC Univ Paris 06, UMR 7211, and Inflammation-Immunopathology-Biotherapy Department (DHU i2B), F-75005, Paris, France; Department of Internal Medicine and Clinical Immunology, F-75013, Paris, France, Paris, France, ²Sorbonne Universités, UPMC Univ Paris 06, UMR 7211, and Inflammation-Immunopathology-Biotherapy Department (DHU i2B), F-75005, Paris, France; Department of Internal Medicine and Clinical Immunology, F-75013, Paris, France, paris, France, ³Department of Internal Medicine-Digestive, Centre hospitalier universitaire Purpan, UMR 152 Toulouse 3 University, Toulouse, toulouse, France, ⁴Department of Hepatology, APHP, Hôpital Henri Mondor, Créteil, creteil, France, ⁵Department of Hepatology, Hôpital Orléans, Orléans, Orleans, France, ⁶Department of Immunology, UF d’Immunochimie et d’autoimmunité, APHP, Groupe Hospitalier Pitié-Salpétrière, Paris, France, paris, France, ⁷Department of internal medicine, CHRU Brest, Brest, France, ⁸Department of Hepatology, APHP, Hôpital Cochin, Paris, paris, France, ⁹Department of hepatology, CHRU Montpellier, France, montpellier, France, ¹⁰Department of Hepatology, APHP, Groupe Hospitalier Pitié-Salpétrière, Paris, paris, France

Background/Purpose: Hepatitis C virus (HCV) is the aetiological agent for most cases of cryoglobulinemia vasculitis. Interferon containing regimens are associated with important side effects and…
Abstract Number: 2L • 2016 ACR/ARHP Annual Meeting
Effect of Denosumab Compared with Risedronate in Glucocorticoid-Treated Individuals: Results from the 12-Month Primary Analysis of a Randomized, Double-Blind, Active-Controlled Study
K Saag¹, RB Wagman², P Geusens³, JD Adachi⁴, O Messina⁵, R Emkey⁶, R Chapurlat⁷, NS Daizadeh², N Pannacciulli² and WF Lems⁸, ¹University of Alabama at Birmingham, Birmingham, AL, USA, Birmingham, AL, ²Amgen Inc., Thousand Oaks, CA, ³Maastricht University, Maastricht, Netherlands, ⁴McMaster University, Hamilton, ON, Canada, ⁵Cosme Argerich Hospital, Buenos Aires, Argentina, ⁶Emkey Arthritis & Osteoporosis Clinic, Wyomissing, PA, ⁷Hôpital Edouard Herriot, Lyon, France, ⁸VU University Medical Centre, Amsterdam, Netherlands
Background/Purpose: Glucocorticoid (GC)-induced osteoporosis (GIOP) remains the most common secondary cause of osteoporosis. Despite approved therapies, many subjects do not receive GIOP prevention or treatment.…
Abstract Number: 18L • 2016 ACR/ARHP Annual Meeting
Primary CNS Vaculitis Vs Neurosarcoidosis: Can We Predict the Diagnosis with MRI?
Didem Saygin¹, Priya Sundaram-Simonelli², Leonard H. Calabrese³, Elisabeth Ray⁴, William Messner⁵, Stephen Jones², Jinny Tavee⁶ and Rula A Hajj-Ali⁷, ¹Cleveland Clinic, Cleveland, OH, ²Neuroradiology, Cleveland Clinic, Cleveland, OH, ³Rheumatic & Immunologic Disease, Cleveland Clinic, Cleveland, OH, ⁴Rheumatology, Cleveland Clinic, Cleveland, OH, ⁵Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, ⁶Neuromuscular diseases, Cleveland Clinic, Cleveland, OH, ⁷Rheumatic and Immunologic Dis, Cleveland Clinic, Cleveland, OH

Background/Purpose: Neurosarcoidosis and primary angiitis of central nervous system (PACNS) are inflammatory diseases affecting central nervous system, with overlapping clinical and pathological characteristics. Differentiating between…
Abstract Number: 3L • 2016 ACR/ARHP Annual Meeting
Comparative Cardiovascular Safety of Tocilizumab Vs Etanercept in Rheumatoid Arthritis: Results of a Randomized, Parallel-Group, Multicenter, Noninferiority, Phase 4 Clinical Trial
Jon T. Giles¹, Naveed Sattar², Sherine E. Gabriel³, Paul M. Ridker⁴, Steffen Gay⁵, Charles Warne⁶, David Musselman⁷, Laura Brockwell⁶, Emma Shittu⁶, Micki Klearman⁷ and Thomas Fleming⁸, ¹Columbia University, College of Physicians and Surgeons, New York, NY, ²Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom, ³Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, ⁴Center for Cardiovascular Disease Prevention, Harvard Medical School, Boston, MA, ⁵University Hospital Zurich, Department of Rheumatology, Zurich, Switzerland, ⁶Roche Products Ltd., Welwyn Garden City, United Kingdom, ⁷Genentech, South San Francisco, CA, ⁸University of Washington, Department of Biostatistics, Seattle, WA
Background/Purpose: Treatment of rheumatoid arthritis (RA) with tocilizumab (TCZ), a humanized monoclonal antibody directed against the IL-6 receptor, is associated with clinical efficacy and marked…
Abstract Number: 19L • 2016 ACR/ARHP Annual Meeting
Biosimilar Infliximab (CT-P13) Is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway
Guro Løvik Goll^1,2, Inge C Olsen³, Kristin K Jorgensen⁴, Merete Lorentzen⁵, Nils Bolstad⁶, Espen A. Haavardsholm⁷, Knut EA Lundin⁸, Cato Mork⁹, Jorgen Jahnsen⁴, Tore K Kvien³ and the NOR-SWITCH study group, ¹Dept of Rheumatoogy, Diakonhjemmet Hospital, Oslo, Norway, ²Department of Rheumathology, Diakonhjemmet Hospital, Oslo, Norway, ³Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ⁴Dept of Gastroenterology, Akershus University Hospital, Lorenskog, Norway, ⁵Dept of Dermatology, Rikshospitalet, Oslo, Norway, ⁶Department of Medical Biochemistry,, OUS-Radiumhospitalet, Oslo, Norway, ⁷Diakonhjemmet Hospital, Oslo, Norway, ⁸Dept of gastroenterology, Rikshospitalet, Oslo, Norway, ⁹Dept of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway
Background/Purpose: TNF-inhibitors (TNFi) have improved treatment of spondyloarthritis (SpA), rheumatoid arthritis (RA), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC), and chronic plaque…
Abstract Number: 4L • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety Results of Guselkumab, an Anti-IL23 Monoclonal Antibody, in Patients with Active Psoriatic Arthritis over 24 Weeks: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study
Atul A. Deodhar¹, Alice B Gottlieb², Wolf-Henning Boehncke³, Bin Dong⁴, Yuhua Wang⁴, William Barchuk⁵, Xie Xu⁵ and Elizabeth C. Hsia⁴, ¹Oregon Health & Science University, Portland, OR, ²Department of Dermatology, New York Medical College, Valhalla, NY, ³Department of Dermatology,, Geneva University Hospital, Geneva, Switzerland, ⁴Janssen Research & Development, LLC, Spring House, PA, ⁵Janssen Research & Development, LLC, San Diego, CA
Background/Purpose: To evaluate the efficacy, safety, and tolerability of guselkumab (GUS), a fully human monoclonal antibody against the p19 subunit of IL-23, in patients (pts)…
Abstract Number: 5L • 2016 ACR/ARHP Annual Meeting
Speed of Remission with the Use of Voclosporin, MMF and Low Dose Steroids: Results of a Global Lupus Nephritis Study
Mary Anne Dooley¹, William Pendergraft III², Ellen M. Ginzler³, Nancy J. Olsen⁴, James Tumlin⁵, Brad H. Rovin⁶, Frédéric A. Houssiau⁷, David Wofsy⁸, David A. Isenberg⁹, Neil Solomons¹⁰, Robert Huizinga¹¹ and AURA Study Group, ¹Dooley Rheumatology, Chapel Hill Doctors, Chapel Hill, NC, ²Kidney Center, University of North Carolina, Chapel Hill, NC, ³Rheumatology, SUNY Downstate Medical Center, Brooklyn, NY, ⁴Medicine/Rheumatology, Penn State Hershey Medical Center, Hershey, PA, ⁵Nephrology, University of Tennessee College of Medicine, Chattanooga, TN, ⁶Ohio State University Medical Center, Columbus, OH, ⁷Rheumatology, Pôle de Maladies Rhumatismales, Université catholique de Louvain, Brussels, Belgium, ⁸Rheumatology, University of California, San Francisco, San Francisco, CA, ⁹Centre for Rheumatology Research, University College Hospital London, UK, London, United Kingdom, ¹⁰Aurinia Pharmaceuticals Inc., Victoria, BC, Canada, ¹¹Clinical Affairs, Aurinia Pharmaceuticals Inc., Victoria, BC, Canada
Background/Purpose: Voclosporin (VCS) is a novel CNI intended for use in the treatment of autoimmune diseases such as lupus nephritis. VCS’s unique structure allows for…
Abstract Number: 6L • 2016 ACR/ARHP Annual Meeting
Myeloablative Autologous Transplantation of CD34+ -Selected Hematopoietic Stem Cells (HSCT) Vs Monthly Intravenous Cyclophosphamide (CYC) for Severe Scleroderma with Internal Organ Involvement: Outcomes of a Randomized North American Clinical Trial
Keith Sullivan¹, Lynette Keyes-Elstein², Peter McSweeney³, Ashley Pinckney², Beverly Welch⁴, Maureen D Mayes⁵, Richard Nash³, Leslie J. Crofford⁶, Sharon Castina², Linda Griffith⁷, Ellen Goldmuntz⁸ and Daniel E. Furst⁹, ¹Duke University, Durham, NC, ²Rho, Inc, Chapel Hill, NC, ³Colorado Blood Cancer Institute, Denver, CO, ⁴6610 Rockledge Dr., NIAID/NIH, Bethesda, MD, ⁵Department of Internal Medicine - Rheumatology, University of Texas-McGovern Medical School, Houston, TX, ⁶Medicine, Vanderbilt University Medical Center, Nasville, TN, ⁷NIAID, NIH, Bethesda, MD, ⁸NIAID, National Institutes of Health, Bethesda, MD, ⁹David Geffen School of Medicine at UCLA, Los Angeles, CA
Background/Purpose: Therapeutic options for diffuse cutaneous systemic sclerosis (dcSSc) are limited. The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial was a multicenter study designed to…
Abstract Number: 7L • 2016 ACR/ARHP Annual Meeting
Overall Reduction in Acute Flares during Treatment with Febuxostat Compared with Placebo over 2 Years in Patients with Early Gout
Nicola Dalbeth¹, Kenneth G. Saag², William Palmer³, Hyon K. Choi³, Barbara Hunt⁴, Patricia MacDonald⁴, Ulrich Thienel⁵ and Lhanoo Gunawardhana⁴, ¹University of Auckland, Auckland, New Zealand, ²University of Alabama at Birmingham, Birmingham, AL, ³Massachusetts General Hospital/Harvard Medical School, Boston, MA, ⁴Takeda Pharmaceuticals International, Deerfield, IL, ⁵RRD International, Rockville, MD

Background/Purpose: No clinical trials have previously investigated the frequency of acute flares in early gout or the benefit of instituting urate-lowering therapy (ULT) earlier in…
Abstract Number: 8L • 2016 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Placebo-Controlled Study of Bimagrumab in Patients with Sporadic Inclusion Body Myositis
Anthony A. Amato¹, Umesh Badrising², Olivier Benveniste³, Merrilee Needham⁴, Hector Chinoy⁵, Min Wu⁶, Barbara Koumaras⁶, Ana de Vera⁷, Dimitris A. Papanicolaou⁶ and Michael G. Hanna⁸, ¹Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ²Department of Neurology, Leiden University Medical Center, Leiden, Netherlands, ³Department of Internal Medicine, Pitié-Salpêtrière Hospital, Pierre et Marie-Curie University, Paris, France, ⁴Fiona Stanley Hospital, IIID Murdoch University and Notre Dame University, Perth, Australia, ⁵Centre for Musculoskeletal Research, NIHR Manchester Musculoskeletal Biomedical Research Unit, The University of Manchester, Manchester, United Kingdom, ⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁷Novartis Pharma AG, Basel, Switzerland, ⁸MRC Centre for Neuromuscular Diseases, UCL Institute of Neurology, London, United Kingdom

Background/Purpose: Bimagrumab (BYM338) is a novel fully human monoclonal antibody that binds competitively to activin type II receptors with greater affinity than natural inhibitory ligands…
Abstract Number: 9L • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Canakinumab in Patients with Colchicine-Resistant Familial Mediterranean Fever, Hyper-Immunoglobulin D Syndrome/Mevalonate Kinase Deficiency and TNF Receptor-Associated Periodic Syndrome: 40 Week Results from the Pivotal Phase 3 Umbrella Cluster Trial
Fabrizio De Benedetti¹, Joost Frenkel², Inmaculada Calvo³, Marco Gattorno⁴, Michel Moutschen⁵, Pierre Quartier⁶, Ozgur Kasapcopur⁷, Seza Ozen⁸, Jordi Anton⁹, Isabelle Koné-Paut¹⁰, Helen Lachmann¹¹, Hal M. Hoffman¹², Eldad Ben-Chetrit¹³, Anna Shcherbina¹⁴, Michaël Hofer¹⁵, Philip J Hashkes¹⁶, Andrew Zeft¹⁷, Karine Lheritier¹⁸, Yankun Gong¹⁹, Antonio Speziale¹⁸ and Guido Junge¹⁸, ¹Division of Rheumatology, Ospedale Pediatrico Bambino Gesù IRCCS, Rome, Italy, ²University Medical Center Utrecht, Utrecht, Netherlands, ³Pediatric Rheumatology, Hospital Universitario i Politecnic La Fe, Valencia, Spain, ⁴Pediatric Rheumatology, G. Gaslini Institute, Genoa, Italy, ⁵C.H.U. Sart-Tilman, Liege, Belgium, ⁶Necker-Enfants Malades Hospital, Paris, France, ⁷Department of Pediatric Rheumatology, Cerrahpasa Medical School, Istanbul University, Istanbul, Turkey, ⁸Department of Pediatrics, Division of Rheumatology, Hacettepe University Children's Hospital, Ankara, Turkey, ⁹Hospital Sant Joan de Déu, Barcelona, Spain, ¹⁰Department of Paediatric Rheumatology, Hôpital Kremlin Bicetre, University of Paris SUD, Paris, France, ¹¹UK National Amyloidosis Centre, University College London Medical School, London, United Kingdom, ¹²University of California, San Diego, La Jolla, CA, ¹³Rheumatology Unit, Hadassah—Hebrew University Medical Center, Jerusalem, Israel, ¹⁴Immunology, Federal Research and Clinical Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation, ¹⁵Unité romande d’immuno-rhumatologie pédiatrique, CHUV, University of Lausanne, Lausanne, Switzerland, ¹⁶Pediatrics Rheumatology; Shaare-Zedek Medical Center, Jerusalem, Israel, ¹⁷Pediatrics Rheumatology, Cleveland Clinic, Cleveland, OH, ¹⁸Novartis Pharma AG, Basel, Switzerland, ¹⁹Beijing Novartis Pharma Co. Ltd., Beijing, China

Background/Purpose: Evidence points to the role of abnormal IL-1β production in familial Mediterranean fever (FMF), hyper-immunoglobulin D syndrome/mevalonate kinase deficiency (HIDS/MKD) and TNF receptor-associated periodic…
Abstract Number: 10L • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Patients with Active Psoriatic Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitors: OPAL Beyond, a Randomized, Double Blind, Placebo-Controlled, Phase 3 Trial
Dafna D Gladman¹, William Rigby², Valderilio F Azevedo³, Frank Behrens⁴, Ricardo Blanco⁵, Andrzej Kaszuba⁶, Elizabeth Kudlacz⁷, Cunshan Wang⁷, Sujatha Menon⁷, Thijs Hendrikx⁸ and Keith S Kanik⁷, ¹University of Toronto, Toronto, ON, Canada, ²Rheumatology, Dartmouth-Hitchcock Med Ctr, Lebanon, NH, ³Federal University of Parana and Edumed Health Research Center and Biotech, Curitiba, Brazil, ⁴Johann Wolfgang Goethe University, Frankfurt, Germany, ⁵Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Santander, Spain, ⁶Specialstyczne Gabinety Lerkarskie "DERMED", Lodz, Poland, ⁷Pfizer Inc, Groton, CT, ⁸Pfizer Inc, Collegeville, PA

Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor under investigation for treatment of PsA. In this first study of tofacitinib in patients (pts) with active…
Abstract Number: 11L • 2016 ACR/ARHP Annual Meeting
BMS-986165 Is a Highly Potent and Selective Allosteric Inhibitor of Tyk2, Blocks IL-12, IL-23 and Type I Interferon Signaling and Provides for Robust Efficacy in Preclinical Models of Systemic Lupus Erythematosus and Inflammatory Bowel Disease
Kathleen Gillooly¹, Yifan Zhang¹, Xiaoxia Yang¹, Adriana Zupa-Fernandez¹, Lihong Cheng¹, Joann Strnad¹, Mark Cunningham², Elizabeth Heimrich¹, Xiadi Zhou¹, Jing Chen³, Charu Chaudhry³, Sha Li³, Kim McIntyre¹, Julie Carman⁴, Ryan Moslin⁵, Stephen Wrobleski⁵, David Weinstein⁵ and James Burke¹, ¹Immunosciences Discovery Biology, Bristol-Myers Squibb, Princeton, NJ, ²Bristol-Myers Squibb, Princeton, NJ, ³Leads Discovery & Optimization, Bristol-Myers Squibb, Princeton, NJ, ⁴Discovery Translational Sciences Group, Bristol-Myers Squibb, Princeton, NJ, ⁵Immunosciences Discovery Chemistry, Bristol-Myers Squibb, Princeton, NJ

Background/Purpose: Tyk2 mediates signaling downstream of the receptors for IL-12, IL-23 and Type I interferons, all key drivers of autoimmune disorders such as SLE. BMS-986165,…
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:…

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