Abstracts tagged "Biologics"

Abstract Number: 2058 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar Candidate (CT-P10) and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase I Randomized Controlled Trial over 72 Weeks
Dae-Hyun Yoo¹, Won Park², Chang-Hee Suh³, Seung-Cheol Shim⁴, Slawomir Jeka⁵, Fidencio Cons Molina⁶, Pawel Hrycaj⁷, Wolfgang Spieler⁸, Piotr Wiland⁹, Jan Brzezicki¹⁰, Eun Young Lee¹¹, Francisco G. Medina-Rodriguez¹², Pavel Shesternya¹³, Sebastiao Radominski¹⁴, Marina Stanislav¹⁵, Volodymyr Kovalenko¹⁶, Donghyuk Sheen¹⁷, Leysan Myasoutova¹⁸, Mie Jin Lim¹⁹, Jung-Yoon Choe²⁰, Taek S. Kwon²¹ and Sang Joon Lee²¹, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ³Department of Rheumatology, Ajou University Hospital, Suwon, South Korea, ⁴Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, ⁵University Hospital Nr 2 Dr. Jan Biziel, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Clinic of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, ⁶Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁷Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ⁸Osteologie und Rheumatologie, ZeFOR GmbH Zentrum für Forschung, Zerbst, Germany, ⁹Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, ¹⁰Wojewodzki Szpital Zespolony w Elablagu, Elblag, Poland, ¹¹Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea, ¹²Rheumatology, LaSalle University, Mexico City, Mexico, ¹³Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹⁴CETI-Centro de estudos em Terapias Inovadoras, Universidade Federal do Parana, Curitiba, Brazil, ¹⁵Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia, ¹⁶Section of Non-coronarogenic Myocardial Diseases and Clinical Rheumatology, National Scientific Center, Kiev, Ukraine, ¹⁷Rheumatology, Eulji University Hospital, Daejeon, South Korea, ¹⁸City Reumatology Center, Research Medical Complex Vashe Zdorovie, Kazan, Russia, ¹⁹Division of Rheumatology, Departments of Internal Medicine, Inha University Hospital, Incheion, South Korea, ²⁰Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, South Korea, ²¹CELLTRION, Inc., Incheon, South Korea
Background/Purpose: CT-P10 is a biosimilar candidate of innovator rituximab (RTX). PK profile and clinical data up to week 24 has been reported at ACR 20131.…
Abstract Number: 3171 • 2015 ACR/ARHP Annual Meeting
Combination Therapy with Denosumab and Biologic DMARD Associated with Higher Risk of Serious Infections Compared to Denosumab Alone and Biologic DMARD Alone
Ivana Parody¹, Luis Arias-Urdaneta², Ricardo Garcia Alemany² and Carlos Sesin², ¹Internal Medicine, Mount Sinai Medical Center, Miami Beach, FL, ²Vanguard Rheumatology Partners, Miami Beach, FL
Background/Purpose: Patients with RA and other rheumatologic disorders are at increased risk for osteoporotic fractures. Biologic DMARDs are an important treatment option for these patients.…
Abstract Number: 127 • 2015 ACR/ARHP Annual Meeting
Potential Use of Healthcare Databases for Post-Marketing Surveillance Registry: an Example Using Ustekinumab
Huifeng Yun¹, Shuo Yang², Fenglong Xie³, Lang Chen⁴, Kevin L. Winthrop⁵ and Jeffrey R. Curtis⁴, ¹Epidemiology, University of Alabama at Birmingham, Birmingham, AL, ²Clinical Immunology/Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ³Rheumatology & Immunology, University of Alabama at Birmingham, Birmingham, AL, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵Oregon Health and Science University, Portland, OR
Background/Purpose: Underreporting and inherent deficiencies are common using spontaneous reports for post-marketing surveillance. The U.S. Food and Drug Administration (FDA) has recommended sponsors to collect…
Abstract Number: 732 • 2015 ACR/ARHP Annual Meeting
Decreased Disease Activity and Corticosteroid Usage and Improved Quality of Life during Belimumab Treatment in Patients with Systemic Lupus Erythematosus – a Prospective Real-Life Observational Study
Ioannis Parodis¹, Christopher Sjöwall², Andreas Jönsen³, Agneta Zickert¹, Martina Frodlund², Daniel Ramsköld¹, Anders A. Bengtsson³ and Iva Gunnarsson¹, ¹Department of Medicine, Rheumatology Unit, Karolinska Institutet, Stockholm, Sweden, ²Rheumatology/AIR, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden, ³Department of Clinical Sciences, Section of Rheumatology, Lund University, Lund, Sweden
Background/Purpose: Belimumab is the first biologic drug approved to treat Systemic Lupus Erythematosus (SLE). The efficacy of belimumab has been demonstrated through 2 phase III…
Abstract Number: 2141 • 2015 ACR/ARHP Annual Meeting
Risk of Cancer in Non-TNFi Biologics-Treated RA
Hjalmar Wadström¹, Johan Askling² and the ARTIS study group, ¹Clinical Epidemiology Unit, Department of Medicine, Karolinska Institute, Stockholm, Sweden, ²Clinical Epidemiology Unit and Rheumatology Unit, Department of Medicine, Karolinska Institute, Stockholm, Sweden
Background/Purpose: Immune incompetence may lower host surveillance against incipient tumours. Conversely, immune therapies have emerged as a promising therapeutic approach to cancer. Malignancies thus constitute…
Abstract Number: 3222 • 2015 ACR/ARHP Annual Meeting
Repeated Administration of Dapirolizumab Pegol (DZP) Appears Safe and Well Tolerated in Patients with Systemic Lupus Erythematosus (SLE) and Is Accompanied By an Improvement in Disease Activity: Results from a Phase 1 Study
Chris Chamberlain¹, Murray Urowitz^2,3, Julie Soranson¹, Mark Watling¹, Peter Colman¹, Olivier Harari¹, Thomas Dorner⁴ and Falk Hiepe⁴, ¹UCB Pharma, Slough, United Kingdom, ²University of Toronto, Toronto, ON, Canada, ³Rheumatology, U of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁴Charité – Universitätsmedizin, Berlin, Germany
Background/Purpose: CD40 ligand (CD40L) regulates interactions between T cells, B cells, and antigen presenting cells. Considerable evidence suggests CD40L blockade might provide an effective treatment…
Abstract Number: 139 • 2015 ACR/ARHP Annual Meeting
One-Year Cost of Etanercept, Adalimumab, and Infliximab per Treated Patient with Chronic Inflammatory Arthritides in US Veterans
Brian Sauer¹, Chia-Chen Teng², Tao He³, Jianwei Leng⁴, Chao-Chin Lu⁵, Jessica Walsh⁶, Neel Shah⁷, David J. Harrison⁸, Derek Tang⁹ and Grant W. Cannon¹⁰, ¹IDEAS Center and Division of Epidemiology, HSR&D SLC VA Medical Center and University of Utah, Salt Lake City, UT, ²HSR&D SLC VA Medical Center and University of Utah, Salt Lake City, UT, ³Salt Lake City Veteran Affairs and University of Utah Medical Centers, Salt Lake City, UT, ⁴Internal Medicine Division of Epidemiology, HSR&D SLC VA Medical Center and University of Utah, Salt Lake City, UT, ⁵Salt Lake City VA and University of Utah, Salt Lake City, UT, ⁶Division of Rheumatology, Salt Lake City Veteran Affairs and University of Utah Medical Centers, Salt Lake City, UT, ⁷1 Amgen Center Dr, Amgen Inc., Thousand Oaks, CA, ⁸Amgen Inc., Thousand Oaks, CA, ⁹Amgen, Inc., Thousand Oaks, CA, ¹⁰Division of Rheumatology, Salt Lake City VA Medical Center and University of Utah, Salt Lake City, UT
Background/Purpose: Understanding the relative cost of tumor necrosis factor inhibitors (TNFi) can improve resource allocation from a payer’s perspective. Limited data exists in the VA…
Abstract Number: 890 • 2015 ACR/ARHP Annual Meeting
Anti-IgE Monoclonal Antibody in Refractory and/or Relapsing Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss): Data from 17 Patients
Marie Jachiet¹, Maxime Samson², Vincent Cottin³, Jean-Emmanuel Kahn⁴, Guillaume Le Guenno⁵, Philippe Bonniaud⁶, Laurence Bouillet⁷, Anne Gondouin⁸, Fatma Makhlouf⁷, Nadine Meaux Ruault⁹, Helder Gil⁸, Hervé Devilliers¹⁰, Boris Bienvenu¹¹, André Coste¹², Violaine Giraud¹³, Stephane Dominique¹⁴, Bertrand Godeau¹⁵, Xavier Puéchal¹⁶, Chahéra Khouatra¹⁷, Marc Ruivard¹⁸, Claire Le Jeunne¹⁹, Luc Mouthon²⁰, Loïc Guillevin²¹ and Benjamin Terrier¹⁶, ¹Dermatology, Cochin Hospital, Paris, France, ²Department of Internal Medicine and Clinical Immunology, Dijon University Hospital, Dijon, France, ³Division of Pneumology, Hôpital Louis-Pradel, Hospices Civils de Lyon, Lyon 1, Lyon, France, ⁴Internal Medicine, Foch Hospital, Suresnes, France, ⁵Internal Medicine department, Clermont-Ferrand, France, ⁶CHU, Dijon, France, ⁷CHU, Grenoble, France, ⁸CHU, Besancon, France, ⁹Internal Medicine and Clinical Immunology, CHU de Besançon, Besançon, France, ¹⁰Department of Internal Medicine and Systemic Diseases, Dijon University Hospital, Dijon, France, ¹¹Internal Medicine, Hospital Caen, Caen, France, ¹²CHI, Créteil, France, ¹³Hôpital Ambroise Paré, Boulogne Billancourt, France, ¹⁴Pneumology, Rouen University Hospital, Rouen, France, ¹⁵Henri Mondor, Créteil, France, ¹⁶Internal Medicine, National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, Paris, France, ¹⁷CHU Lyon, Lyon, France, ¹⁸CHU Clermont-Ferrand, Clermont–Ferrand, France, ¹⁹Department of Internal Medicine, Hotel-Dieu Hospital, AP-HP, Paris, Paris, France, ²⁰Department of Internal Medicine, Department of Internal Medicine, Cochin Hospital, Referent Center for Necrotizing Vasculitis and Systemic Sclerosis, Paris-Descartes University, AP-HP, Paris, France, ²¹Internal Medicine, Hopital Cochin, Paris, France
Background/Purpose: Omalizumab, an anti-IgE monoclonal antibody, has proven efficacy for the treatment of moderate-to-severe and severe-persistent allergic asthma and allergic rhinitis, with a favorable safety…
Abstract Number: 2316 • 2015 ACR/ARHP Annual Meeting
An Ethnographic Observational Study of the Biologic Initiation Conversation Between Rheumatologists and Biologic Naïve Rheumatoid Arthritis Patients
Nicholas Kottak¹, Melissa Rosenberg², Dennis Parenti³ and Shelly Kafka³, ¹Ethnographic Solutions, Washington, DC, ²Janssen Pharmaceuticals Inc, Horsham, PA, ³Janssen Scientific Affairs, LLC, Horsham, PA
Background/Purpose: To better understand how rheumatologists communicate the need to initiate biologic treatment and explain the risks and benefits, Janssen Pharmaceuticals initiated an ethnographic market…
Abstract Number: 140 • 2015 ACR/ARHP Annual Meeting
Identifying Psoriatic Arthritis and Ankylosing Spondylitis Patients Responsible for the Highest Costs of Care: Data from a Large US Cohort
Jacqueline B. Palmer, Yunfeng Li, Vivian Herrera and Minlei Liao, Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: The economic burden of psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in the biologics era is not well understood in the US population. Using…
Abstract Number: 956 • 2015 ACR/ARHP Annual Meeting
The Addition of One or More Biologics to Methotrexate in Children with Juvenile Idiopathic Arthritis Increases the Incidence of Infections and Other Adverse Events
Joost Swart¹, Angela Pistorio², Francesca Bovis³, Ekaterina Alexeeva⁴, Michael Hofer⁵, Susan Nielsen⁶, Jordi Anton⁷, Alessandro Consolaro⁸, Violeta Vladislava Panaviene⁹, Valda Stanevicha¹⁰, Maria Trachana¹¹, Constantin Ailioaie¹², Florence Uettwiller¹³, Fabrizio De Benedetti¹⁴, Elena Tsitsami¹⁵, Berit Flato¹⁶, Pavla Dolezalová¹⁷, Tamás Constantin¹⁸, Troels Herlin¹⁹, Sylvia Kamphuis²⁰, Sujata Sawhney²¹, Despoina Maritsi²², Veronika Vargova²³, Luca Villa⁸, Chiara Pallotti⁸, Angelo Ravelli³, Alberto Martini²⁴, Nico Wulffraat²⁵, Nicolino Ruperto²⁶ and on behalf of for PRINTO, ¹Pediatric Rheumatology, Wilhelmina Children's Hospital/ UMC Utrecht, Utrecht, Netherlands, ²Servizio di Epidemiologia e Biostatistica, Istituto Giannina Gaslini, Genoa, Italy, ³Istituto Giannina Gaslini, Genoa, Italy, ⁴Rheumatology, Scientific Center of Children's Health of RAMS, Moscow, Russia, ⁵Pediatrie, Unité Romande de Rhumatologie Pédiatrique, Hospitalier Universitaire Vaudois, Lausanne, Switzerland, ⁶Pediatric Rheumatology Unit, Juliane Marie Centret, Rigshospitalet, Copenhagen, Denmark, ⁷Unitat de Reumatologia Pediàtrica, Hospital Sant Joan de Déu, Barcelona, Spain, ⁸Pediatria II - Reumatologia, PRINTO, Istituto Giannina Gaslini, Genoa, Italy, ⁹Centre of Pediatrics, Vilnius University, Vilnius, Lithuania, ¹⁰Department of Paediatrics, Riga Stradins University, Riga, Latvia, ¹¹1st Department of Pediatrics, Aristotle University, Thessaloniki, Greece, ¹²II Pediatric Clinic, Private Medical Clinic, IASI, Romania, ¹³Unité d'Immunologie, Hématologie et Rhumatologie Pediatrique, Université Paris-Descartes, IMAGINE Institute, Hôpital Necker-Enfants Malades, Paris, France, ¹⁴Reumatologia, Ospedale Pediatrico Bambino Gesù, Roma, Italy, ¹⁵First Department of Pediatrics, Children Hospital Aghia Sophia, Athens, Greece, ¹⁶Rheumatology, Oslo University Hospital, Oslo, Norway, ¹⁷Pediatric Rheumatology Unit, Department of Pediatrics and Adolescent Medicine, General University Hospital in Prague, Prague, Czech Republic, ¹⁸Unit of Paediatric Rheumatology, 2nd Dpt of Pediatrics, Semmelweis University, Budapest, Hungary, ¹⁹Department of Pediatrics, Aarhus University Hospital, Aarhus N, Denmark, ²⁰Pediatric Rheumatology, Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands, ²¹Paediatric rheumatology, Sir Ganga Ram Hospital, New Delhi, India, ²²2nd Department of Academic Pediatrics, Athens Medical School, university of Athens, Athens, Greece, ²³1st Department of Paediatrics and Adolescent Medicine, Šafarik University and Children Faculty Hospital in Košice, Kosice, Slovakia, ²⁴Istituto G. Gaslini, Pediatria II, PRINTO, and University of Genoa, Genoa, Italy, ²⁵Pediatric rheumatology, Wilhelmina Children's Hospital/ UMC Utrecht, Utrecht, Netherlands, ²⁶Istituto G. Gaslini, Pediatria II, PRINTO, Genoa, Italy
Background/Purpose: Treatment of juvenile idiopathic arthritis (JIA) has greatly changed in the past 15 years thanks to the introduction of biologic agents but little is…
Abstract Number: 2488 • 2015 ACR/ARHP Annual Meeting
Impact of Protocolized Tight Control and Biological Dose Optimization in Daily Clinical Practice: Results of a Pilot Implementation Study
Nienke Lesuis¹, George Bruyn², Paul Baudoin², Lieke Nieboer³ and Alfons den Broeder¹, ¹Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, ²Rheumatology, MC Zuiderzee, Lelystad, Netherlands, ³rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands
Background/Purpose: It is possible to optimize and reduce the individual dose of biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in patients with rheumatic diseases, in combination…
Abstract Number: 433 • 2015 ACR/ARHP Annual Meeting
Rheumatoid Arthritis (RA) Biologic Switching and Cycling in a Large US Managed Care Population
Machaon Bonafede¹, Jeffrey R. Curtis², Donna McMorrow¹, Chieh-I Chen³ and George J. Joseph⁴, ¹Truven Health Analytics, Cambridge, MA, ²Immunology & Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ³Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁴Global Health Economics & Outcomes Research (HEOR), Sanofi, Bridgewater, NJ
Background/Purpose: A majority of RA patients who switch from a tumor necrosis factor inhibitor (TNFi) to another biologic disease-modifying anti-rheumatic drug (DMARD) are TNFi cyclers…
Abstract Number: 1204 • 2015 ACR/ARHP Annual Meeting
Measuring the Effectiveness of Patient Education of Patients Receiving Injectable Biologic Medications
Victoria Ruffing¹, Ana-Maria Orbai² and Clifton O. Bingham III³, ¹Medicine JHAAC, Johns Hopkins University, Baltimore, MD, ²Rheumatology, Johns Hopkins University, Baltimore, MD, ³Johns Hopkins University, Baltimore, MD
Background/Purpose: Injectable biologic medications have become part of the routine treatment rheumatoid arthritis (RA), and other inflammatory arthritides. These medications are associated with potentially serious…
Abstract Number: 2521 • 2015 ACR/ARHP Annual Meeting
Pregnancies in Patients with Long-Standing Rheumatoid Arthritis and Biologic DMARD Treatment: Course of Disease during Pregnancy and Pregnancy Outcomes
Anja Strangfeld¹, Dagmar Pattloch¹, Madlen Spilka², Bernhard Manger³, Brigitte Krummel-Lorenz⁴, Annett Gräßler⁵, Joachim Listing⁶ and Angela Zink^1,7, ¹Epidemiology, German Rheumatism Research Center, Berlin, Germany, ²German Rheumatism Research Center, Berlin, Germany, ³Rheumatologist, Scientific Advisory Board, Erlangen, Germany, ⁴Rheumatologist, Frankfurt, Germany, ⁵Rheumatologist, Pirna, Germany, ⁶Epidemiologiy, German Rheumatism Research Center, Berlin, Germany, ⁷Rheumatology and Clinical Immunology, Charité University Medicine, Berlin, Germany
Background/Purpose: The assumption of spontaneous remission among pregnant women with rheumatoid arthritis (RA) is common. Nevertheless, prospectively collected data describing the course of disease activity…

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