Abstracts tagged "biosimilars"

Abstract Number: 1549 • 2017 ACR/ARHP Annual Meeting
A Non-Medical Switch from Originator Infliximab to Biosimilar CT-P13 in 36 Patients with Ankylosing Spondylitis: 6 – Months Clinical Outcomes from the Czech Biologic Registry Attra
Šárka Forejtová¹, Jakub Zavada¹, Lenka Szczukova², Katerina Jarosova¹, Tom Philipp³ and Karel Pavelka⁴, ¹Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Czech Republic, Prague, Czech Republic, ²Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Brno, Czech Republic, ³Department of Rheumatology and Physiotherapy, Thomayer Hospital, Prague, Praha 4, Czech Republic, ⁴Institute of Rheumatology, Prague, Czech Republic, Prague, Czech Republic
Background/Purpose: A non-medical switch from originator (INX, Remicade) to biosimilar infliximab (CT-P13, Remsima) was conducted in 36 patients with ankylosing spondylitis (AS) in one clinical…
Abstract Number: 2800 • 2017 ACR/ARHP Annual Meeting
Long-Term Safety and Efficacy of Biosimilar Infliximab (CT-P13) after Switching from Originator Infliximab: Results from the 26-Week Open Label Extension of a Randomized Norwegian Trial
Guro Løvik Goll¹, Kristin Kaasen Jørgensen², Joe Sexton¹, Inge C Olsen³, Nils Bolstad⁴, Merete Lorentzen⁵, Espen A. Haavardsholm⁶, Cato Mork⁷, Jorgen Jahnsen⁸ and Tore K Kvien⁹, ¹Dept Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ²Dept Gastroenterology, Akershus University Hospital, Lørenskog, Norway, ³Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ⁴Department of Medical Biochemistry,, OUS-Radiumhospitalet, Oslo, Norway, ⁵Dept of Dermatology, Rikshospitalet, Oslo, Norway, ⁶Dept. of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, ⁷Dept of cancer and Molecular medicine, Norwegian University of Science and Technology, Trondheim, Norway, ⁸Dept of Gastroenterology, Akershus University Hospital, Lorenskog, Norway, ⁹Diakonhjemmet Hospital, Oslo, Norway
Background/Purpose: TNF-inhibitors (TNFi) have improved treatment of rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA) , Crohn’s disease (CD), ulcerative colitis (UC), and chronic plaque…
Abstract Number: 1550 • 2017 ACR/ARHP Annual Meeting
One-Year Clinical Outcomes in 1623 Patients with Inflammatory Arthritis Who Switched from Originator to Biosimilar Etanercept – an Observational Study from the Danish Danbio Registry
Bente Glintborg¹, Emina Omerovic¹, Kamilla Danebod¹, Dorte Vendelbo Jensen¹, Henrik Nordin¹, Anne Gitte Loft¹, Stavros Chrysidis¹, Johnny Lillelund Raun¹, Oliver Hendricks¹, Hanne Lindegaard¹, Jakob Espesen¹, Susanne Jakobsen¹, Inger Marie J. Hansen¹, Jolanta Grydehøj¹, Emil Dalgaard¹, Dorte Dalsgaard Pedersen¹, Natalia Manilo², Lis Smedegaard Andersen³, Salome Kristensen¹, Asta Linauskas¹, Niels Steen Krogh⁴ and Merete Lund Hetland⁵, ¹The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark, ²Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Frederiksberg, Copenhagen, Denmark, ³Department of Rheumatology, The DANBIO registry and the Danish Departments of Rheumatology, Copenhagen, Denmark, ⁴The DANBIO Registry, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, ⁵The DANBIO registry and the Danish Departments of Rheumatology, Glostrup, Denmark
Background/Purpose: According to Danish national guidelines issued in April 2016, a non-medical switch from originator (ETA, Enbrel) to biosimilar Etanercept (SB4, Benepali) (50 mg s.c.)…
Abstract Number: 2879 • 2017 ACR/ARHP Annual Meeting
Switching from Adalimumab to Chs-1420: A Randomized, Double-Blind Global Clinical Trial in Patients with Psoriasis and Psoriatic Arthritis
Jennifer Hodge, Hong Tang, Paula O'Connor and Barbara Finck, Coherus BioSciences, Inc., Redwood City, CA
Background/Purpose: CHS-1420 is a proposed biosimilar to adalimumab. A phase 3, randomized, double-blind, multicenter study evaluated the equivalence of CHS-1420 to adalimumab in patients with…
Abstract Number: 2260 • 2017 ACR/ARHP Annual Meeting
Communication Strategies Are Highly Important to Avoid Nocebo Effect When Performing Non-Medical Switch from Originator Product to Biosimilar Product: Danish Results from Applying the Parker Model a Qualitative 3-Step Research Model
Tanja Schjødt Jørgensen¹, Marie Skougaard¹, Hans Christian Asmussen^2,3, Anne Lee⁴, Peter C. Taylor⁵, Henrik Gudbergsen¹ and Lars Erik Kristensen¹, ¹The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen F, Denmark, ²NATiON, Copenhagen, Denmark, ³Communication IKH, Roskilde University, Roskilde, Denmark, ⁴University of Southern Denmark, Odense, Denmark, ⁵University of Oxford Botnar Research Centre, Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom
Background/Purpose: Introducing a non-medical switch from originator to a biosimilar product in the management of chronic arthritis, i.e. switching patients in remission or low disease…
Abstract Number: 2438 • 2017 ACR/ARHP Annual Meeting
Open Label Transitioning from Originator Etanercept to Biosimilar SB4 Compared to Continuing Treatment with Originator Etanercept in a Historical Cohort in Rheumatic Diseases in Daily Practice
L. Tweehuysen¹, V.J.B. Huiskes², B.J.F. Van den Bemt (PharmD, PhD)³, S. Teerenstra⁴, F.H.J. van den Hoogen⁵, C.H.M. van den Ende⁵ and A.A. Den Broeder⁵, ¹Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, ²Pharmacy, Sint Maartenskliniek, Nijmegen, Netherlands, ³Pharmacy, Sint Maartenskliniek and Radboudumc, Nijmegen, Netherlands, ⁴Biostatistics, Radboudumc, Nijmegen, Netherlands, ⁵Rheumatology, Sint Maartenskliniek and Radboudumc, Nijmegen, Netherlands
Background/Purpose: Blinded transitioning from originator infliximab (INX) to biosimilar CT-P13 was not inferior to continuing INX treatment.1 Open label mandatory transitioning resulted in a slightly…
Abstract Number: 2439 • 2017 ACR/ARHP Annual Meeting
Switching from RA Originator to Biosimilar in Routine Clinical Care: Early Data from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis
Diederik De Cock¹, Lianne Kearsley-Fleet¹, Kath Watson¹ and Kimme L. Hyrich^1,2, ¹Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, ²National Institute of Health Research Manchester Musculoskeletal Biomedical Research Centre, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom
Background/Purpose: Biosimilars, biopharmaceuticals assessed by regulatory agencies to have efficacy and safety similar to their reference products, were introduced to the UK market in February…
Abstract Number: 2441 • 2017 ACR/ARHP Annual Meeting
A Phase III, Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Similarities between LBEC0101 and Etanercept Reference Product in Terms of Efficacy and Safety in Patients with Active Rheumatoid Arthritis Inadequately Responding to Methotrexate
Hiroaki Matsuno^1,2, Masato Tomomitsu³, Atsushi Hagino³, Seonghye Shin⁴, Jiyoon Lee⁴ and Yeong Wook Song^5,6, ¹Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, ²Institute of Medical Science, Tokyo Medical University, Tokyo, Japan, ³Mochida Pharmaceutical Co.,Ltd., Tokyo, Japan, ⁴Clinical Development, LG Chem, Ltd., Seoul, Korea, Republic of (South), ⁵Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Seoul National University, Seoul, Korea, Republic of (South), ⁶Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, and College of Medicine, Medical Research Center, Seoul National University, Seoul, Korea, Republic of (South)
Background/Purpose: LBEC0101 has been developed as a biosimilar to the etanercept reference product (ETN-RP). This study was to evaluate the similarities between LBEC0101 and ETN-RP…
Abstract Number: 2445 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks
Seung-Cheol Shim¹, Ljubinka Bozic Majstorovic², Alfredo Berrocal Kasay³, Elias Chalouhi El-Khouri⁴, Fedra Irazoque-Palazuelos⁵, Francisco Cons Molina⁶, Francisco G. Medina-Rodriguez⁷, Pedro Miranda⁸, Pavel Shesternya⁹, Jose Chavez Corrales¹⁰, Piotr Wiland¹¹, Slawomir Jeka¹², Olena Garmish¹³, Pawel Hrycaj¹⁴, Natalia Fomina¹⁵, Won Park¹⁶, Chang-Hee Suh¹⁷, Sang-Joon Lee¹⁸, Sung Young Lee¹⁹ and Dae-Hyun Yoo²⁰, ¹Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), ²Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, ³ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, ⁴Clinica Internacional, Lima, Peru, ⁵Centro de Invstigacion y Tratamiento Reumatologico S.C, Mexico City, Mexico, ⁶Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁷Rheumatology, LaSalle University, Mexico City, Mexico, ⁸Centro De Estudios Reumatológicos, Santiago, Chile, ⁹Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹⁰Clinica San Borja, Lima, Peru, ¹¹Department and Clinic of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland, ¹²2nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, ¹³Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, ¹⁴Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ¹⁵Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, ¹⁶Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ¹⁷Ajou University School of Medicine, Suwon, Korea, Republic of (South), ¹⁸CELLTRION, Inc., Incheon, Korea, Republic of (South), ¹⁹Clinical Planning Department, CELLTRION, Inc., Incheon, Korea, Republic of (South), ²⁰Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South)
Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to…
Abstract Number: 2447 • 2017 ACR/ARHP Annual Meeting
Effectiveness and Tolerability of Benepali in Rheumatoid Arthritis Patients Switched from Enbrel
Sarah Dyball¹, Victoria Hoskins², Sharon Christy-Kilner² and Sahena Haque³, ¹Rheumatology, University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom, ²University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom, ³Rheumatology department, University Hospitals of South Manchester NHS Foundation Trust, Manchester, United Kingdom
Background/Purpose: Benepali, the etanercept biosimilar, is licenced in the UK for rheumatoid arthritis (RA) and costs less than Enbrel. This study aimed to evaluate the…
Abstract Number: 2461 • 2017 ACR/ARHP Annual Meeting
Rituximab Is Effective in the Treatment of Rheumatoid Arthritis Irrespective of Body Mass Index; Up to 48 Weeks Results from Phase 3 Study
Dae-Hyun Yoo¹, Won Park², Chang-Hee Suh³, Seung-Cheol Shim⁴, Sang-Joon Lee⁵, Yun Ju Bae⁵, Chan Park⁵ and Noo Ri Han⁵, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ²Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ³Ajou University School of Medicine, Suwon, Korea, Republic of (South), ⁴Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), ⁵CELLTRION, Inc., Incheon, Korea, Republic of (South)
Background/Purpose: High body mass index (BMI) is known to be associated with inadequate clinical response to anti-TNF agents in RA patients.1 However, there are limited…
Abstract Number: 2484 • 2017 ACR/ARHP Annual Meeting
When Etanercept Switch Fails – Clinical Considerations
Oliver Hendricks and Kim Hørslev-Petersen, King Christian X's Hospital for Rheumatic Diseases, University of Southern Denmark, Institute of Regional Health Research, Denmark, Graasten, Denmark
Background/Purpose: On January 14th 2016 EMA approved the biosimilar Etanercept (SB4, Benepali) for clinical use. A non-medical switch from originator Etanercept (ETA, Enbrel) to SB4…
Abstract Number: 2492 • 2017 ACR/ARHP Annual Meeting
The Long-Term Safety and Durability of Response of Chs-0214, a Proposed Biosimilar to Etanercept: An Open-Label Safety Extension Study
Ingrid Louw¹, Alan J. Kivitz², Tsutomu Takeuchi³, Yoshiya Tanaka⁴, Satoshi Nakashima⁵, Jennifer Hodge⁶, Hong Tang⁶, Paula O'Connor⁶ and Barbara Finck⁶, ¹Panorama Medical Centre, Cape Town, South Africa, ²Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ³Keio University School of Medicine, Tokyo, Japan, ⁴School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Daiichi Sankyo, Tokyo, Japan, ⁶Coherus BioSciences, Inc., Redwood City, CA
Background/Purpose: CHS-0214 is a proposed biosimilar to etanercept for the treatment of rheumatoid arthritis and other auto-immune diseases. Two randomized, double-blind studies demonstrated equivalence of…
Abstract Number: 2795 • 2017 ACR/ARHP Annual Meeting
Comparison of Switching from the Originator Rituximab to the Biosimilar Rituximab GP2013 or Re‑Treatment with the Originator Rituximab in Patients with Active Rheumatoid Arthritis: Safety and Immunogenicity Results from a Multicenter, Randomized, Double-Blind Study
Hans-Peter Tony¹, Hendrik Schulze-Koops², Klaus Krüger³, Stanley B Cohen⁴, Alan J. Kivitz⁵, Slawomir Jeka⁶, Edit Vereckei⁷, Liyi Cen⁸ and Dmitrij Kollins⁸, ¹Department of Internal Medicine 2, Rheumatology and Clinical Immunology, University Hospital Würzburg, Würzburg, Germany, ²Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany, ³Praxiszentrum St. Bonifatius München, München, Germany, ⁴Metroplex Clinical Research Centre, Dallas, TX, ⁵Altoona Center for Clinical Research, Duncansville, PA, ⁶2nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, ⁷National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, ⁸Clinical Development, Sandoz, a Novartis Division, Holzkirchen, Germany
Background/Purpose: GP2013, is a biosimilar to European Union (EU) approved reference rituximab (RTX), developed in a stepwise approach that adheres to stringent biosimilar development guidelines.…
Abstract Number: 2796 • 2017 ACR/ARHP Annual Meeting
A Randomized, Double Blind Trial over 52 Weeks to Demonstrate Bioequivalence of GP2013 and Reference Rituximab in Patients with Rheumatoid Arthritis
Josef S. Smolen¹, Stanley B Cohen², Morton Scheinberg³, Tamas Shisha⁴, Dmitrij Kollins⁴, Peijuan Zhu⁵, Liyi Cen⁴, Alan J. Kivitz⁶, Andra Rodica Balanescu⁷, Juan J. Gomez-Reino⁸ and Hans-Peter Tony⁹, ¹Medical University Vienna, Division of Rheumatology, Department of Internal Medicine III, Vienna, Austria, ²Metroplex Clinical Research Centre, Dallas, TX, ³Rheumatology, Hospital Israelita Albert Einstein, Sao Paulo, Brazil, ⁴Clinical Development, Sandoz, a Novartis Division, Holzkirchen, Germany, ⁵Clinical Pharmacology, Sandoz, a Novartis Division, NJ, NJ, ⁶Altoona Center for Clinical Research, Duncansville, PA, ⁷Research Center of Rheumatic Diseases, “Sf. Maria” Hospital, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania, ⁸BIOBADASER, Santiago, Spain, Santiago de Compostela, Spain, ⁹Department of Internal Medicine 2, Rheumatology and Clinical Immunology, University Hospital Würzburg, Würzburg, Germany
Background/Purpose: Rituximab (RTX) is a mAB indicated for the treatment of RA in patients with inadequate response to anti-TNF therapy. The current study compares the…