Abstracts tagged "biosimilars"

Abstract Number: 1116 • 2019 ACR/ARP Annual Meeting
Non-medical Switching from Reference to Biosimilar Etanercept – No Evidence for Nocebo Effect – a Retrospective Analysis of Real-life Data
Uta Kiltz¹, Styliani Tsiami ¹, Xenofon Baraliakos ² and Jürgen Braun ³, ¹Rheumazentrum Ruhrgebiet/Ruhr University Bochum, Herne, Germany, Herne, Germany, ²Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, Herne, Germany, ³Rheumazentrum Ruhrgebiet/Ruhr University, Herne, Germany
Background/Purpose: Real-world data about switching patients from originator product to a biosimilars are important to assess and to document the outcome of switches in clinical…
Abstract Number: 1118 • 2019 ACR/ARP Annual Meeting
US Community Rheumatologists’ Knowledge and Perceptions of Biosimilar Expanded Indication Approval by Extrapolation
Ting-Chun Yeh¹, Yolaine Jeune-Smith ¹, Eli Phillips ¹, Ajeet Gajra ¹ and Bruce Feinberg ¹, ¹Cardinal Health Specialty Solutions, Dublin, OH
Background/Purpose: To expand treatment options, increase access to life-saving medications, and lower healthcare costs through competition, the US Congress created an abbreviated licensure pathway for…
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…
Abstract Number: 559 • 2018 ACR/ARHP Annual Meeting
Radiographic Progression Based on Baseline Demographics and Disease Characteristics from Three TNF-Alpha Inhibitor Biosimilar Studies in Patients with Rheumatoid Arthritis
Josef S. Smolen¹, Young Mo Kang², Wan-Hee Yoo³, Paul Emery⁴, Michael E Weinblatt⁵, Edward C. Keystone⁶, Mark C. Genovese⁷, Gihyun Myung⁸, Evelyn Hong⁸, Inyoung Baek⁸ and Jeehoon Ghil⁸, ¹Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, ²Kyungpook National University School of Medicine, Daegu, Korea, Republic of (South), ³Chonbuk National University School of Medicine, Jeonju, Korea, Republic of (South), ⁴University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, ⁵Brigham and Women's Hospital, Boston, MA, ⁶Mount Sinai Hospital, Toronto, ON, Canada, ⁷Stanford University Medical Center, Palo Alto, CA, ⁸Samsung Bioepis Co., Ltd., Incheon, Korea, Republic of (South)
Background/Purpose: SB4, SB2, and SB5 are biosimilars of reference etanercept, infliximab, and adalimumab, respectively. Radiographic data were assessed using the modified Total Sharp Score (mTSS)…
Abstract Number: 977 • 2018 ACR/ARHP Annual Meeting
Nurse Led Safe Switching from Original Reference Product Infliximab to Biosimalar in Patients with Juvenile Idiopathic Arthritis and Uveitis – a Single Centre Experience Including Baseline and Post Switch Infliximab Levels and Antibodies
Andrew Fell¹, Emma Carson¹, Gillian Coyle¹, Neil Martin¹, Jo Walsh¹ and Janet Gardner-Medwin², ¹Paediatic Rheumatology, Royal hospital for Children, Glasgow, United Kingdom, ²School of Medicine, Dentistry & Nursing, Child Health, University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Original Reference Product (ORP) Infliximab lost market exclusivity in europe in early 2015. The Scottish National Health service (SNHS), runs a national procurement system…
Abstract Number: 1532 • 2018 ACR/ARHP Annual Meeting
Impact of Immunogenicity on Clinical Efficacy and Administration Related Reaction in TNF Inhibitors: A Pooled-Analysis from Three Biosimilar Studies in Patients with Rheumatoid Arthritis
Paul Emery¹, Michael E Weinblatt², Josef S. Smolen³, Edward C. Keystone⁴, Mark C. Genovese⁵, Jiri Vencovsky⁶, Jonathan Kay⁷, Evelyn Hong⁸ and Jeehoon Ghil⁸, ¹University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, ²Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ³Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, ⁴Mount Sinai Hospital, Toronto, ON, Canada, ⁵Stanford University Medical Center, Palo Alto, CA, ⁶Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Czech Republic, Prague 2, Czech Republic, ⁷UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, ⁸Samsung Bioepis Co., Ltd., Incheon, Korea, Republic of (South)
Background/Purpose: SB4, SB2, and SB5 are biosimilars of reference etanercept, infliximab, and adalimumab, respectively. The phase III randomized, double-blind clinical studies comparing the efficacy and…
Abstract Number: 1769 • 2018 ACR/ARHP Annual Meeting
Efficacy and Safety of Biomimic Rituximab in Granulomatosis with Polyangiitis – Experience from a Single Tertiary Care Centre in India
Aman Sharma¹, Sakshi Mittal², GSRSNK Naidu³, Saket Jha², Manish Rathi⁴, Vikas Sharma², Arghya Chattopadhyay⁵, Varun Dhir⁶, Kusum Sharma⁷, Ranjana Minz⁸, Ritambhra Nada⁹ and Sanjay Jain¹⁰, ¹Clinical Immunology and Rheumatology Services, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India, Chandigarh, India, ²Internal Medicine, PGIMER, Chandigarh, India, ³PGIMER, cHANDIGARH, India, ⁴Department of Nephrology,, Postgraduate Institute of Medical Education and Research, Chandigarh, India, ⁵PGIMER, Chandigarh, India, ⁶Internal Medicine (Rheumatology Unit), Postgraduate Institute of Medical Education and Research, Chandigarh, India, Chandigarh, India, ⁷Department of Medical Microbiology,, PGIMER,, Chandigarh, India, ⁸Department of Immunopathology,, PGIMER,, Chandigarh, India, ⁹Postgraduate Institute of Medical Education and Research, Chandigarh, India, ¹⁰Postgraduate Institute of Medical Education and Research, Chandigarh, India, CHANDIGARH, India
Background/Purpose: Though rituximab(RTX) has become a standard of care for remission induction and maintenance in Granulomatosis with Polyangiitis(GPA), there is very limited data on the…
Abstract Number: 1936 • 2018 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Efficacy, Safety and Immunogenicity of a Proposed Adalimumab Biosimilar (GP2017) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis
Piotr Wiland¹, Sławomir Jeka², Eva Dokoupilová^3,4, Juan Manuel Miranda Limón⁵, Julia Jauch-Lembach⁶, Anjali Thakur⁶, Halimuniyazi Haliduola⁶ and Norman B Gaylis⁷, ¹Wrocław Medical University, Wrocław, Poland, ²Collegium Medicum UMK, 2nd University Hospital, Bydgoszcz, Poland, ³MEDICAL PLUS s.r.o., Uherské Hradiště, Czech Republic, ⁴Faculty of Pharmacy, University of Veterinary and Pharmaceutical sciences, Brno, Czech Republic, ⁵RM Pharma Specialists, Mexico City, Mexico, ⁶Hexal AG, Holzkirchen, Germany, ⁷Arthritis & Rheumatic Disease Specialties, Aventura, FL
Background/Purpose: GP2017, a proposed adalimumab biosimilar, matched reference adalimumab (refADL) in preclinical and pharmacokinetics studies.1,2 The confirmatory efficacy and safety study in patients with plaque-type…
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…