Abstracts tagged "Biologicals"

Abstract Number: 0204 • ACR Convergence 2020
Pharmacokinetics and Safety of CT-P17, a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar, in Comparison with EU-Approved Adalimumab and US-Licensed Adalimumab; Results of a Phase 1, Randomized, Double-blind, Three-arm, Single-dose Study in Healthy Subjects
KyungSang Yu¹, InJin Jang¹, HyeongSeok Lim², JangHee Hong³, MinGul Kim⁴, MinKyu Park⁵, Anhye Kim⁶, MinSoo Park⁷, JaeYong Chung⁸, JongLyul Ghim⁹, SeungHwan Lee¹, SeokKyu Yoon², InSun Kwon³, Daniel Furst*¹⁰, Edward C Keystone¹¹, SangJoon Lee¹², SungHyun Kim¹², YunJu Bae¹², JungBin Cha¹³, HyeJin Kang¹³ and Jonathan Kay¹⁴, ¹Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea, ²College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea, ³Chungnam National University Hospital, Daejeon, Republic of Korea, ⁴College of Medicine, Jeonbuk National University, Jeonbuk, Republic of Korea, ⁵Chungbuk National University Hospital, Cheongju, Republic of Korea, ⁶CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea, ⁷Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea, ⁸Seoul National University Bundang Hospital, Seongnam, Republic of Korea, ⁹Inje University Busan Paik Hospital, Busan, Republic of Korea, ¹⁰Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA, Los Angeles, CA, ¹¹Mount Sinai Hospital, Toronto, ON, Canada, ¹²Celltrion, Inc., Incheon, Republic of Korea, ¹³Celltion, Inc., Incheon, Republic of Korea, ¹⁴University of Massachusetts Medical School, Worcester, MA
Background/Purpose: CT-P17 was developed as the first biosimilar of the high concentration (100 mg/mL), citrate-free formulation of reference adalimumab. The purpose of this study was…
Abstract Number: 0347 • ACR Convergence 2020
In Two Phase-3 Trials, Guselkumab Reduced Fatigue over 52 Weeks in Patients with Psoriatic Arthritis and Demonstrated Independent Treatment Effects on Fatigue After Adjustment for Clinical Response (ACR20)
Proton Rahman¹, Philip Helliwell², Atul Deodhar³, Alexa Kollmeier⁴, Elizabeth Hsia⁵, Bei Zhou⁶, Xiwu Lin⁶, Chenglong Han⁶ and Philip Mease⁷, ¹Memorial University of Newfoundland, Department of Medicine, St John's, Canada, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Oregon Health & Science University, Portland, OR, ⁴Janssen Research & Development, LLC, La Jolla, CA, ⁵Janssen Research & Development, LLC and University of Pennsylvania Medical Center, Spring House, PA, ⁶Janssen Research & Development, LLC, Spring House, PA, ⁷Seattle Rheumatology Associates, P.L.L.C., Seattle, WA
Background/Purpose: DISCOVER 1 & 2 are phase-3 trials of guselkumab (GUS, an IL-23 inhibitor) in patients with psoriatic arthritis (PsA). In both trials, treatment with…
Abstract Number: 0447 • ACR Convergence 2020
Magnetic Resonance Imaging Characteristics in Patients with Spondyloarthritis and Clinical Diagnosis of Heel Enthesitis: Screening Data from a Phase 3 Trial
Xenofon Baraliakos¹, Philipp Sewerin², Eugenio De Miguel³, Christine Kleinmond⁴, Ankita Shekhawat⁵, Claudia Jentzsch⁶, Annette Wiedon⁷ and Frank Behrens⁸, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany, ²Department of Rheumatology & Hiller Research Unit, University Hospital Düsseldorf, Duesseldorf, Germany, ³Rheumatology Department, Hospital Universitario La Paz, Madrid, Spain, ⁴ClinProject GmbH, Eurasburg, Germany, ⁵Novartis Healthcare Private Limited, Hyderabad, Telangana, India, ⁶Novartis Pharma GmbH, Nuremberg, Germany, ⁷Novartis Pharma GmbH, Nurnberg, Germany, ⁸CIRI/Rheumatology & Fraunhofer TMP, Goethe University, Frankfurt, Germany
Background/Purpose: Inflammation and pain at entheseal sites are the key clinical signs in patients (pts) with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).1 Magnetic resonance…
Abstract Number: 0607 • ACR Convergence 2020
The Evolution of Rheumatologist’s Practice in Response to the COVID19 Pandemic
Maria Bacalao¹, Kathryn Dao² and John Cush², ¹UT Southwestern, Dallas, TX, ²University of Texas Southwestern Medical School, Dallas, TX
Background/Purpose: The COVID19 pandemic was a turning point for Rheumatology. This survey of rheumatologists (rheums) assessed its impact on care delivery, patient counseling and drug…
Abstract Number: 0810 • ACR Convergence 2020
Long Term Remission Rates from a Biologic Clinic: 12 Year Real World Data
Kieran Murray¹, Matthew Turk², Yousef Alammari², Francis Young³, Phil Gallagher⁴, Tajvur Saber⁵, Sinead Maguire⁶, Finbar O'Shea⁶, Ursula Fearon⁷ and Douglas Veale⁸, ¹Saint Vincent's University Hospital, Dublin 4, Dublin, Ireland, ²Saint Vincent's University Hospital, Dublin 4, Ireland, ³Saint Vincent's University Hospital, Dublin 4, ⁴St Vincents University Hospital, UCD, Dublin, Ireland, ⁵Peshawar Rheumatology Clinic, Dabgari Garden, Northern Areas, Pakistan, ⁶St James' Hospital, Dublin, Ireland, ⁷Molecular Rheumatology, Trinity College Dublin, Dublin, Dublin, Ireland, ⁸EULAR Centre for Arthritis and Rheumatic Diseases, St Vincents University Hospital, UCD, Dublin, Dublin, Ireland
Background/Purpose: Biologic therapies are widely used and greatly improve outcomes in RA and PsA. Yet, our ability to predict long-term remission and persistence remains limited.…
Abstract Number: 0885 • ACR Convergence 2020
Impact of HLA-B27 Status on Clinical Outcomes in Patients with Ankylosing Spondylitis Treated with Secukinumab
Atul Deodhar¹, Philip Mease², Denis Poddubnyy³, Vibeke Strand⁴, Paula Machado⁵, Abhijit Shete⁶, Xiangyi Meng⁵ and Marina Magrey⁷, ¹Oregon Health & Science University, Portland, OR, ²Seattle Rheumatology Associates, P.L.L.C., Seattle, WA, ³Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁶Novartis Pharma AG, Basel, Switzerland, ⁷Case Western Reserve University School of Medicine, Cleveland, OH
Background/Purpose: Ankylosing spondylitis (AS) is strongly associated with the genetic marker HLA-B27. In patients with AS, negative HLA-B27 status is a predictor of worse response…
Abstract Number: 1155 • ACR Convergence 2020
Long-term Safety Profile of Anakinra in Patients with Systemic Juvenile Idiopathic Arthritis
Gabriella Giancane¹, Riccardo Papa¹, Sebastiaan Vastert², Francesca Bagnasco¹, Joost Swart¹, Pierre Quartier³, Jordi Anton⁴, Isabelle Kone Paut¹, Sylvia Kamphuis¹, Troels Herlin⁵, Helga Sanner¹, Fabrizio De Benedetti⁶, Elena Tsitsami⁷, Susan Mary Nielsen¹, Estefania Moreno¹, Chiara Pallotti¹, Karin Franck-Larsson⁸, Håkan Malmström⁸, Susanna Cederholm⁹, Nico Wulffraat¹ and Nicolino Ruperto¹⁰, ¹IRCCS Istituto Giannina Gaslini, PRINTO, Genoa, Italy, Genova, Italy, ²University Medical Center Utrecht, Utrecht, Netherlands, ³Necker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris, Paris, France, ⁴Sant Joan de Déu Hospital, Madrid, Spain, ⁵Aarhus University Hospital, Aarhus, Denmark, ⁶Division of Rheumatology, Laboratory of Immuno-Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy, Rome, Italy, ⁷Aghia Sophia Childrens Hospital, Athens, Greece, ⁸Swedish Orphan Biovitrum, Stockholm, Sweden, ⁹Sobi, Stockholm, Sweden, ¹⁰PRINTO, Istituto Giannina Gaslini, Genova, Italy
Background/Purpose: To evaluate the long-term safety profile of anakinra in patients with systemic juvenile idiopathic arthritis (sJIA)Methods: Data from patients with sJIA according to the…
Abstract Number: 1358 • ACR Convergence 2020
Certolizumab Pegol Efficacy in Patients with Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status
Atul Deodhar¹, Lianne Gensler², Stephen Hall³, Philip Robinson⁴, Bengt Hoepken⁵, Lars Bauer⁵, Thomas Kumke⁵ and Walter Maksymowych⁶, ¹Oregon Health & Science University, Portland, OR, ²University of California San Francisco, San Francisco, CA, ³Cabrini Medical Centre, Monash University and Emeritus Research, Malvern, Victoria, Australia, ⁴University of Queensland, Herston, Queensland, Australia, ⁵UCB Pharma, Monheim am Rhein, Germany, ⁶University of Alberta, Edmonton, AB, Canada
Background/Purpose: This post-hoc analysis from the phase 3 C-axSpAnd study aimed to evaluate whether the response to certolizumab pegol (CZP) in non-radiographic axial spondyloarthritis (nr-axSpA)…
Abstract Number: 1605 • ACR Convergence 2020
Knowledge of Biosimilars and Perceptions of Biosimilar Naming Conventions in Clinical Practice
Criswell Lavery¹, Marianna Olave², Charles Leonard¹, Vincent Lo Re¹, Jonathan Kay³ and Joshua Baker¹, ¹University of Pennsylvania, Philadelphia, PA, ²Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, ³University of Massachusetts Medical School, Worcester, MA
Background/Purpose: The market introduction of biosimilars has generated the need for novel biologic naming conventions, in part to support pharmacovigilance. We evaluated the familiarity of…
Abstract Number: 2011 • ACR Convergence 2020
Olokizumab Improves Patient Reported Outcomes in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate: Results from the Double-Blind, Randomized Controlled Phase III Study
Evgeny Nasonov¹, Saeed Fatenejad², Mariana Ivanova³, Diana Krechikova⁴, Sofia Kuzkina⁵, Alexey Maslyanskiy⁶, Tatiana Plaksina⁷, Mikhail Samsonov⁵, Marina Stanislav¹, Tamara Tyabut⁸, Irina Vinogradova⁹, Sergey Yakushin¹⁰, Elena Zonova¹¹ and Mark Genovese¹², ¹FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova", Moscow, Russia, ²SFC Medica, LLC, Charlotte, NC, ³UMHAT St. Ivan Rilski, Clinic of Rheumatology, Sofia, Bulgaria, ⁴Non-governmental Healthcare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways"”, Smolensk, Russia, ⁵JSC “R-Pharm”, Moscow, Russia, ⁶SBHI "North-West Federal Medical Research Center n.a. V.A.Almazov", Saint Petersburg, Russia, ⁷SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. P.A.Semashko", Nizhny Novgorod, Russia, ⁸Belarusian Medical Academy of Postgraduate Education, Minsk, Russia, ⁹Ulyanovsk Regional Clinical Hospital, Ulyanovsk, Russia, ¹⁰Ryazan State Medical University, Ryazan, Russia, ¹¹Novosibirsk State Medical University, State Clinical Polyclinic, Novosibirsk, Russia, ¹²Stanford University Medical Center, Palo Alto, CA
Background/Purpose: We previously reported positive efficacy and safety results of olokizumab (OKZ), an interleukin-6-inhibitor, in patients with RA inadequately controlled by MTX (NCT02760368; CREDO-1) [Nasonov…
Abstract Number: 0206 • ACR Convergence 2020
Fifty-Two Week Outcomes of Biologic-Naïve RA Patients Treated with Subcutaneous Abatacept in Japanese Multicenter Investigational Study (ORIGAMI Study)
Naoto Tamura¹, Eiichi Tanaka², Eisuke Inoue³, Yuri Yoshizawa⁴, Shigeru Matsumoto⁵, Hisashi Yamanaka⁶ and Masayoshi Harigai⁷, ¹Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Bunkyō, Tokyo, Japan, ²Department of Rheumatology, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan, ³Department of Rheumatology, Tokyo Women’s Medical University School of Medicine; Showa University Research Administration Center, Showa University, Tokyo, Japan, ⁴Bristol-Myers Squibb K.K., Tokyo, Japan, ⁵Ono Pharmaceutical Co., Ltd., Tokyo, Japan, ⁶Department of Rheumatology, Tokyo Women’s Medical University School of Medicine; Rheumatology, Sanno Medical Center, Tokyo, Japan, ⁷Department of Rheumatology, Tokyo Women’s Medical University School of Medicine, Shinjuku-ku, Tokyo, Japan
Background/Purpose: Long-term clinical benefit and patient-reported outcomes (PRO) of subcutaneously-injected abatacept (ABA) in patients with RA in a real-world setting are of therapeutic interest. We…
Abstract Number: 0348 • ACR Convergence 2020
Biologics History and Sex Are Linked to Golimumab Discontinuation in Axial Spondyloarthritis: A Sub-Analysis of the Post-Registration GO-Practice Study
Philippe Bertin¹, Philippe Goupille², Florence Tubach³, Eric Lespessailles⁴, Naoual Harid⁵, Saannya Sequeira⁶, Jean-Marie Fayette⁶, Bruno Fautrel⁷ and Rene-Marc Flipo⁸, ¹Limoges University Hospital, Limoges, France, ²CHU Tours, department of rheumatology, Tours, France, ³Pierre Louis Institute of Epidemiology and Public Health, INSERM 1136, Sorbonne University and Centre of Pharmacoepidemiology, Pitié Salpêtrière Hospital, APHP.Sorbonne University, Paris, Ile-de-France, France, ⁴Regional Hospital and University of Orleans, Orléans, France, ⁵MSD France Puteaux, Puteaux, Ile-de-France, France, ⁶ClinSearch, Malakoff, Ile-de-France, France, ⁷Sorbonne University, INSERM, IPLES; Pitié-Salpêtrière Hospital, Paris, Ile-de-France, France, ⁸Lille University Hospital, Lille, France
Background/Purpose: Golimumab (GLM) is the latest anti-TNFα to be indicated for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The post-registration GO-PRACTICE…
Abstract Number: 0454 • ACR Convergence 2020
Anticytokine Therapies for Inflammatory Rheumatic Disease (IRD) Are Associated with Reduced Hospitalisation Following Community COVID-19 Infection; Results of the Trinity Rheumatology and Covid-19 Registry – TRACR
Rachael Flood¹, Richard Conway², David Kane¹ and Ronan Mullan¹, ¹Tallaght University Hospital, Dublin, Ireland, ²St James's Hospital, Dublin, Ireland
Background/Purpose: Anticytokine biological disease modifying anti-rheumatic drugs (bDMARD), which are widely prescribed for Inflammatory Rheumatological Diseases (IRD) are currently undergoing clinical trials for the treatment…
Abstract Number: 0621 • ACR Convergence 2020
Effectiveness of Screening in Patients with Rheumatic Disease Before Commencing Biologic Therapy and Risk of Active Tuberculosis
Sultana Abdulaziz¹, Suzan Attar², Wael Bajhammoh³, Eman Alsindi³, Eman Bakhashwain⁴ and Doaa Ayish⁵, ¹King Fahd Hospital, Jeddah, Saudi Arabia, ²King Abdulaziz University, Jeddah, Saudi Arabia, ³King Fahad Hospital, Jeddah, Saudi Arabia, ⁴East Jeddah Hospital, Jeddah, Saudi Arabia, ⁵Prince Mohammed Bin Nasser Hospital, Gizan, Saudi Arabia
Background/Purpose: Treatment with biologic therapy has been associated with a high risk of reactivation of latent tuberculosis (TB ). Preventive strategies for tuberculosis remain a…
Abstract Number: 0813 • ACR Convergence 2020
Treatment Outcomes in Patients with Seropositive versus Seronegative Rheumatoid Arthritis in Czech Registry ATTRA Treated with JAK Inhibitors
Karel Pavelka¹ and Zlatuše Křístková², ¹Institute of Rheumatology and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic, ²Institute of Biostatistics and Analyses, Ltd., Brno, Czech Republic
Background/Purpose: Seropositivity / seronegativity in RA may have influence on response to bDMARDs or tsDMARDs. There is incomplete knowledge of differences in efficacy of JAK…

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