Abstracts tagged "biosimilars"

Abstract Number: 251 • 2019 ACR/ARP Annual Meeting
Long-term Financial Impact of Switching from Reference to Biosimilar Etanercept When Considering Short-term Formulary Management Costs in the US
Dylan Mezzio ¹, Edward Li² and Sanjeev Balu ³, ¹Xcenda, Pleasant Hill, CA, ²Sandoz Inc., Princeton, NJ, ³Sandoz Inc, Princeton, NJ
Background/Purpose: Biosimilars have enabled some US institutions and payers to achieve significant financial savings after implementing a formulary change from the reference biologic. However, within…
Abstract Number: 310 • 2019 ACR/ARP Annual Meeting
Efficacy, Immunogenicity and Cost Analysis of a Systematic Switch from Originator Infliximab to Biossimilar CT-P13 of All Patients with Inflamatory Arthritis from a Single Center
Ana Valido¹, Joana Silva-Dinis ², Maria João Saavedra ¹, Inês Iria ³, João Gonçalves ³, João Cruz ⁴, Nuno Bernardo ⁵ and João Eurico Fonseca ², ¹Serviço de Reumatologia e Doenças Ósseas Metabólicas, Hospital de Santa Maria, CHLN; Lisboa, Portugal., Lisbon, Portugal, ²Rheumatology and Bone Diseases Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte; Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa; Centro Académico de Medicina de Lisboa; Lisbon, Portugal., Lisbon, Portugal, ³Faculdade de Farmácia da Universidade de Lisboa; Portugal, Lisbon, Portugal, ⁴Associate Professor with Habilitation, Faculdade de Farmácia da Universidade de Lisboa, Portugal, Lisbon, Portugal, ⁵Unidade de Negociação – Serviço de Gestão de Compras, Hospital Santa Maria, CHLN, Lisboa, Portugal., Lisbon, Portugal
Background/Purpose: Biotechnological drugs are a fundamental resource for the treatment (Tx) of rheumatic patients (Pts). Biosimilar drugs are intended to be as effective as the…
Abstract Number: 514 • 2019 ACR/ARP Annual Meeting
A Pooled Analysis of 1-year Clinical Outcomes Among 6-month Responders and Non-responders from Three Randomized Controlled Studies of TNF Inhibitor Biosimilars in Patients with Rheumatoid Arthritis
Josef Smolen¹, Michael Weinblatt ², Paul Emery ³, Jung Yoon Choe ⁴, Jonathan Kay ⁵, Jieun Lee ⁶, Gihyun Myung ⁶, Hyoryeong Seo ⁶ and Jeehoon Ghil ⁶, ¹Medical University of Vienna, Vienna, Austria, ²Brigham and Women's Hospital, Boston, MA, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, ⁴Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, Republic of Korea, ⁵UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, ⁶Samsung Bioepis Co., Ltd., Incheon, Republic of Korea
Background/Purpose: SB4, SB2, and SB5 are biosimilars of etanercept, infliximab, and adalimumab. Phase III randomized, double-blind studies were conducted to compare efficacy and safety between…
Abstract Number: 519 • 2019 ACR/ARP Annual Meeting
Efficacy of Biosimilar Candidate ABP 710 in a Phase 3 Study in Subjects with Moderate to Severe RA: Additional Analysis Focusing on the ACR Individual Components
Mark Genovese¹, Juan Sanchez-Burson ², Éva Balázs ³, Andrea Everding ⁴, MyungShin Oh ⁵, Gary Fanjiang ⁵ and Stanley Cohen ⁶, ¹Stanford University, Stanford, CA, ²Hospital Infanta Luisa, Sevilla, Spain, ³Dr. Bugyi István Hospital, Szentes, Hungary, ⁴HRF Hamburger Rheuma Forschungszentrum, Hamburg, Germany, ⁵Amgen, Thousand Oaks, CA, ⁶Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: ABP 710 is being developed as a biosimilar to infliximab. Both ABP 710 and infliximab reference product (RP) inhibit tumor necrosis factor-alpha. Following demonstration…
Abstract Number: 2154 • 2018 ACR/ARHP Annual Meeting
Biosimilar Infliximab Treated-Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis in France: Characteristics and Clinical Outcomes
Hubert Marotte¹, NADIR MAMMAR² and Bruno Fautrel³, ¹University Hospital of Saint Etienne,, Saint Etienne, France, ²Pfizer, PARIS, France, ³Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), UMR S 1136, Sorbonne Université, GRC-UPMC 08, Paris, France
Background/Purpose: CT-P13 was the first monoclonal antibody biosimilar to infliximab (IFX) approved in France. Reflect trial has been set up to evaluate in real life…
Abstract Number: 2367 • 2018 ACR/ARHP Annual Meeting
Acceptance Rate and Sociological Factors Involved in the Switch from Originator to Biosimilar Etanercept (SB4)
Marc Scherlinger^1,2,3, Vincent Germain¹, Emmanuel Langlois⁴ and Thierry Schaeverbeke⁵, ¹Department of Rheumatology, Bordeaux University Hospital, Bordeaux, France, ²FHU ACRONIM, Bordeaux, France, ³Rheumatology, UMR CNRS 5164 - Immunoconcept, France, Bordeaux, France, ⁴CNRS-UMR 5116 Centre Emile Durkheim, Bordeaux, France, ⁵Department of Rheumatology, Bordeaux University Hospital, BORDEAUX, France
Background/Purpose: Biosimilars represent major potential savings while preserving treatment quality. However, few data are known on how to address the switch from originator to biosimilar…
Abstract Number: 2384 • 2018 ACR/ARHP Annual Meeting
Biosimilar Use in Young Adults with Juvenile Idiopathic Arthritis in Germany
Jens Klotsche¹, Martina Niewerth¹, Gerd Horneff² and Kirsten Minden^3,4, ¹Program Area Epidemiology, German Rheumatism Research Center, Berlin, Germany, ²Department of Pediatrics, Asklepios Clinics St. Augustin, Sankt Augustin, Germany, ³Charité–Universitätsmedizin Berlin, Berlin, Germany, ⁴German Rheumatism Research Center, Berlin, Germany
Background/Purpose: The first biosimilars have been approved for the treatment of juvenile idiopathic arthritis (JIA) in the last two years. To date, only a few…
Abstract Number: 2515 • 2018 ACR/ARHP Annual Meeting
Joint Damage Progression According to Disease Activity States in Patients with Rheumatoid Arthritis Treated with CT-P10 and Reference Rituximab: Up to 48 Weeks Results from Phase III Study
Chang-Hee Suh¹, Dae-Hyun Yoo², Won Park³, Seung-Cheol Shim⁴, Sang-Joon Lee⁵, Yun Ju Bae⁵, Sang Eun Han⁵ and Sang Mi Lee⁵, ¹Rheumatology, Ajou University School of Medicine, Suwon, Korea, Republic of (South), ²Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ³Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ⁴Division of Rheumatology, Department of Internal Medicine, Daejeon Rheumatoid & Degenerative Arthritis Center, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), ⁵CELLTRION, Inc., Incheon, Korea, Republic of (South)
Background/Purpose: CT-P10 is a biosimilar of the reference rituximab (RTX) and has been approved by several regulatory agencies including EMA. Pharmacokinetic and therapeutic equivalence from…
Abstract Number: 2521 • 2018 ACR/ARHP Annual Meeting
A Randomized, Double-Blind Phase III Study Comparing the Efficacy, Safety and Immunogenicity of PF-06438179/GP1111 (Ixifi™), an Infliximab Biosimilar, and Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Active RA: Results from Week 54 to Week 78
Stanley Cohen¹, Alan J. Kivitz², Michael Tee³, Carol Cronenberger⁴, Min Zhang⁵, Sarah Hackley⁶, Karl Schumacher⁷ and Muhammad I. Rehman⁸, ¹Metroplex Clinical Research Center, LLC, Dallas, TX, ²Altoona Center for Clinical Research, Duncansville, PA, ³Department of Medicine, Medical Center Manila and University of the Philippines, Manila, Philippines, ⁴Pfizer Inc, Collegeville, PA, ⁵Pfizer Inc, La Jolla, CA, ⁶Pfizer Ltd, Sandwich, United Kingdom, ⁷Global Clinical Development, Biopharmaceuticals, Sandoz Biopharmaceuticals, Holzkirchen, Germany, ⁸Pfizer Inc, Andover, MA
Background/Purpose: PF-06438179/GP1111 (IFX-PF) is an infliximab (IFX) biosimilar for the treatment of immune-mediated inflammatory diseases, including RA. This randomized, double-blind, comparative clinical study evaluated the…
Abstract Number: 2522 • 2018 ACR/ARHP Annual Meeting
Biosimilar BI 695501 and Adalimumab Reference Product (RP) Have Similar Efficacy and Safety in Patients (pts) with Moderately-to-Severely Active Rheumatoid Arthritis (RA): Long-Term Results from a Phase IIIb Extension Study (VOLTAIRE®-RAext)
Stanley Cohen¹, Niklas Czeloth², Eric Lee³, Piotr A. Klimiuk⁴, Nuala Peter⁵ and Girish Jayadeva², ¹Metroplex Clinical Research Center, Dallas, TX, ²Boehringer Ingelheim, Ingelheim a.R., Germany, Ingelheim, Germany, ³Inland Rheumatology, Upland, CA, ⁴Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny, Bialystok, Poland, ⁵Boehringer Ingelheim, Biberach a.d.R., Germany, Ingelheim a.R., Germany
Background/Purpose: Clinical equivalence of BI 695501 to the adalimumab RP has been shown in pts with moderately-to-severely active RA in the Phase III VOLTAIRE®-RA study…
Abstract Number: 2526 • 2018 ACR/ARHP Annual Meeting
Revealing and Addressing Knowledge Gaps Regarding Biosimilars in Rheumatology Practice with Targeted Continuing Education and Patient Surveys
Katie Robinson and Robert Esgro, Vindico Medical Education, Thorofare, NJ
Background/Purpose: With the recent introduction of biosimilars in the US market, providers lack knowledge of how these agents compare to reference biologics and the implications…
Abstract Number: 2532 • 2018 ACR/ARHP Annual Meeting
The Efficacy and Drug Survival of the Biosimilar Infliximab (CT–P13) Compared to the Original Reference Infliximab in Inflammatory Rheumatic Diseases; Results from the Turkbio Registry
Sadettin Uslu¹, Gerçek Can¹, Soner Senel², Ediz Dalkiliç³, Nevsun Inanc⁴, Servet Akar⁵, Sinem Burcu Kocaer¹, Merih Birlik¹, Sedat Capar⁶, Nurullah Akkoc⁷ and Fatos Onen¹, ¹Rheumatology, Dokuz Eylul University Faculty of Medicine, İzmir, Turkey, ²Rheumatology, Kayseri Erciyes University, Faculty of Medicine, Kayseri, Turkey, ³Rheumatology, Uludag University Faculty of Medicine, Bursa, Turkey, ⁴Rheumatology, Marmara University, School of Medicine, Istanbul, Turkey, ⁵Rheumatology, Izmir Katip Celebi University, School of Medicine, Rheumatology, Izmir, Turkey, ⁶Dokuz Eylül University Faculty of Statistics, Izmir, Turkey, ⁷Rheumatology, İzmir, Turkey, İzmir, Turkey
Background/Purpose: Biosimilar infliximab (CT-P13) has been used to treat patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in Turkey since 2013.The…
Abstract Number: 2534 • 2018 ACR/ARHP Annual Meeting
Impact of Block Switch to Biosimilar Etanercept in Practice, Accross Different Rheumatic Diseases
Luisa Brites¹, Flavio Costa², João Freitas³, Mariana Luis⁴, Margarida Coutinho⁴, Mariana Santiago³, Cátia Duarte⁵, Maria Joao Salvador⁴ and José António P. da Silva⁶, ¹Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal, ²Rheumatology Department, Centro Hospitalar e Universitario de Coimbra, Coimbra, Portugal, ³Rheumatology, Centro Hospitalar e Universitário de Coimbra, CHUC-EPE, Coimbra, Portugal, ⁴Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal, ⁵Faculty of Medicine, Universidade de Coimbra, Coimbra, Portugal, ⁶Department of rheumatology, Centro Hospitalar e Universitário de Coimbra (SRHUC), Coimbra, Portugal
Background/Purpose: Biosimilars of biotechnological agents represent an important opportunity to increase accessibility to these medications. Clinicians still maintain reservations regarding the similarity of their efficacy…
Abstract Number: 2617 • 2018 ACR/ARHP Annual Meeting
Prolonged Effectiveness of a 12 Week Regimen of Biosimilar Adalimumab in Indian (Asian) Patients Suffering from Symptomatic Acute-Chronic Ankylosing Spondylitis (AS)
Arvind Chopra¹, Nagnath Khadke², Manjit Saluja³, Toktam Kainifard⁴ and Anuradha Venugopalan⁵, ¹Center for Rheumatic Diseases, Pune, India, ²Rheumatolgy, Consultant, Pune, India, ³Rheumatology, Research Co-ordinator, Pune, India, ⁴Rheumatology, Consultant research and Dietitian, Tehran, Iran (Islamic Republic of), ⁵Rheumatology, R & D, Lab, Center for Rheumatic Diseases, Pune, India
Background/Purpose: On regulatory approval in India, challenging socioeconomics and infection prone scenario compelled us to seek prolonged effectiveness of short term anti-TNF therapeutic regimen (Chopra…
Abstract Number: 216 • 2018 ACR/ARHP Annual Meeting
Inflectra and Remicade Use and Cost in Canada Under Provincial Drug Plans in 2016
Cristiano S. Moura¹, Denis Choquette², Gilles Boire³, Vivian P. Bykerk⁴, Carter Thorne⁵, Walter P. Maksymowych⁶, Peter Lakatos⁷, Talat Bessissow⁸, Larry Svenson⁹, Laura Targownik¹⁰, Waqqas Afif⁸ and Sasha Bernatsky¹¹, ¹The Centre for Outcomes Research and Evaluation (CORE), McGill University Health Centre, Montreal, QC, Canada, ²Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, QC, Canada, ³Rheumatology Division, Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke and Universite de Sherbrooke, Sherbrooke, QC, Canada, ⁴Hospital for Special Surgery, New York, NY, ⁵University of Toronto, Newmarket, ON, Canada, ⁶Department of Medicine, CaRE Arthritis and University of Alberta, Edmonton, Canada, Edmonton, AB, Canada, ⁷Medicine, Gastroenterology, McGill University, Montreal, QC, Canada, ⁸Gastroenterology, McGill University, Montreal, QC, Canada, ⁹Division of Preventive Medicine, University of Alberta, Edmonton, AB, Canada, ¹⁰Gastroenterology, University of Manitoba, Winnipeg, MB, Canada, ¹¹Divisions of Rheumatology and Clinical Epidemiology, The Research Institute of the McGill University Health Centre, Montreal, QC, Canada
Background/Purpose: Inflectra (infliximab) was the first biosimilar for inflammatory bowel disease and/or arthritis, approved by Health Canada on the belief that it is as safe…

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