Abstracts tagged "Adalimumab"

Abstract Number: 616 • 2016 ACR/ARHP Annual Meeting
ABP 501 Long-Term Safety/Efficacy: Interim Results from an Open-Label Extension Study
Stanley Cohen¹, Jose L. Pablos², Nan Zhang³, Warren Rizzo⁴, Gerhard Muller⁵, Devi Padmanaban⁶, Alan Kivitz⁷, Alan K. Matsumoto⁸ and Primal Kaur⁹, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Grupo de Enfermedades Inflamatorias y Autoinmunes, Instituto de Investigación Hospital 12 de Octubre (i+12), Madrid, Spain, ³Biosimilars, Amgen, Inc., Thousand Oaks, CA, ⁴Advanced Arthritis Care & Research, Scottsdale, AZ, ⁵Dept of Nephrology and Rheumatogy, University Medical Center Göttingen, Göttingen, NIEDERSACHSEN, Germany, ⁶Biosimilars, Amgen, Thousand Oaks, CA, ⁷Altoona Center for Clinical Research, Duncansville, PA, ⁸Rheumatology, Arthritis & Rheumatism Associate, Wheaton, MD, ⁹Amgen, Thousand Oaks, CA
Background/Purpose: This was a single-arm OLE of the parent study; the objective was to assess long-term safety and efficacy of ABP 501. The study…
Abstract Number: 2472 • 2016 ACR/ARHP Annual Meeting
Early DAS28 Drop Is a Predictor for Clinical Response to Anti-TNF Agents in Patients with Rheumatoid Arthritis: An Observational Study of a Real Life Inception Cohort
Ana C.M. Ribeiro¹, Karina Bonfiglioli², Renata Miossi², Carla G.S. Saad¹, Julio C. B. Moraes³, Mariana G Waisberg¹, Fernando Henrique Carlos de Souza¹, Nadia E Aikawa⁴, Leandro L. do Prado¹, Michelle Lopes¹, Luciana Seguro¹ and Eloisa Bonfá³, ¹Rheumatology Division, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil, ²Rheumatology Division, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, Brazil, ³Rheumatology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil, ⁴Pediatric Rheumatology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
Background/Purpose: Predictors of rheumatoid arthritis (RA) response to anti-TNF agents have been described. Except for certolizumab, the value of interim analysis before 24 weeks of…
Abstract Number: 3089 • 2016 ACR/ARHP Annual Meeting
Predicting the Response to TNF Inhibition or B Cell Depletion Therapy from Peripheral Whole Blood Gene Expression Profiles in Patients with Rheumatoid Arthritis
Duncan Porter¹, C. S. Goodyear², J. S. Nijjar¹, Martina Messow³, Stefan Siebert¹, Manikhandan Mudaliar⁴ and Iain B. McInnes⁵, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ²Institute of Infection, Immunity and Inflammation, College of Medicine, Veterinary Medicine and Life Sciences, University of Glasgow, Glasgow, United Kingdom, ³Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom, ⁴Glasgow Polyomics Facility, University of Glasgow, Glasgow, United Kingdom, ⁵Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, Great Britain
Background/Purpose: The ORBIT study demonstrated that rituximab is non-inferior to a TNFi-first strategy in biologic naive, sero-positive patients with active RA over 12 months (Lancet…
Abstract Number: 636 • 2016 ACR/ARHP Annual Meeting
Prospective, Intervention, Multicenter Study of Utility of Biologic Drug Monitoring with Respect to the Efficacy and Cost of Adalimumab Tapering in Patients with Rheumatic Diseases (34-week descriptive data)
Iñigo Gorostiza¹, Eduardo Úcar Angulo², Catalina Gómez Arango², Clara Eugenia Perez³, Juan Ramon De Dios⁴, Belen Alvarez⁴, Ana Ruibal Escribano^4,5, Claudia Stoye⁴, Margarida Vasques⁴, Joaquin Belzunegui Otano⁶, Antonio Escobar⁷, Ziortza Trancho⁸, Ainhoa Ruiz del Agua⁹, Lorena Del Rio⁹, Antonio Martínez⁹ and Daniel Nagore⁹, ¹Research Department, Hospital Universitario de Basurto, Bilbao, Spain, ²Rheumatology, Rheumatology Department, Basurto University Hospital, Bilbao, Spain, ³Rheumatology, Hospital Universitario de Basurto, Bilbao, Spain, ⁴Rheumatology, Hospital Universitario de Araba, Vitoria, Spain, ⁵Rheumatology, Hospital Universitario de Araba, Vittoria, Spain, ⁶Donostia University Hospital, San Sebastian, Spain, ⁷Unidad de Investigación, Red de Investigación en Servicios de Salud en enfermedades crónicas (REDISSEC), Hospital Universitario de Basurto, Bilbao, Spain, ⁸Unidad de Investigación, Hospital Universitario de Basurto, Bilbao, Spain, ⁹R&D, Progenika-Grifols, Derio, Spain
Background/Purpose: Adalimumab (ADL) dose tapering based on clinical assessment is a usual practice especially in patients who have achieved clinical remission. The primary aim of…
Abstract Number: 2482 • 2016 ACR/ARHP Annual Meeting
Long Term Drug Survival of Adalimumab and Etanercept Treatment for Rheumatoid Arthritis with and without Methotrexate
I.M Visman¹, MJ l'Ami², Gertjan Wolbink³ and Mike T. Nurmohamed^4,5, ¹Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, Netherlands, ²Amsterdam Rheumatology and immunology Center, Reade, Amsterdam, Netherlands, ³Rheumatology, Amsterdam Rheumatology and immunology Center, location Reade, Amsterdam, Netherlands, ⁴Rheumatology, Reade, Amsterdam Rheumatology and immunology Center, Amsterdam, Netherlands, ⁵Rheumatology, Amsterdam Rheumatology and immunology Center, VU University medical center, Amsterdam, Netherlands
Background/Purpose: Tumor necrosis factor alpha (TNF-α) inhibitors are effective, safe and widely used treatment for rheumatoid arthritis (RA). The therapy is often started in combination…
Abstract Number: 638 • 2016 ACR/ARHP Annual Meeting
A Randomized, Open-Label, Single-Dose, Parallel-Group Trial to Determine the Pharmacokinetics, Safety and Immunogenicity of GP2017, a Proposed Adalimumab Biosimilar, Following a Single Subcutaneous Injection By an Autoinjector or Prefilled Syringe in Healthy Male Subjects
Ellen Schuck¹, Julia Jauch¹, Alison Balfour¹, Jennifer Storck¹, Martin Rieger¹, Paul Martin¹, Andrej Skerjanec¹ and Maria Velinova², ¹Hexal AG, Holzkirchen, Germany, ²PRA Health Sciences, Zuidlaren, Netherlands
Background/Purpose: The purpose of this study was to describe the pharmacokinetics (PK), safety and immunogenicity of GP2017, a proposed adalimumab biosimilar, administered as a single…
Abstract Number: 2488 • 2016 ACR/ARHP Annual Meeting
A Randomised Controlled Trial Evaluating the Effect of Adalimumab upon Biomarkers of Cardiovascular Risk in ACPA-Positive Rheumatoid Arthritis
Stephen Oakley^1,2, Gabor Major^3,4, David Mathers⁵, John van der Kallen⁶, Mark Collins⁷, Marc Toh⁸, Siva Ratnarajah⁸, Theo de Malmanche⁹ and Niloofar Esmaili¹⁰, ¹Rheumatology, Hunter New England Local Health District, New Lambton, Australia, ²School of Medicine & Public Health, University of Newcastle, Newcastle, Australia, ³Medicine, University of Newcastle, Newcastle, Australia, ⁴Rheumatology, Bone and Joint Institute, John Hunter Hospital NSW Australia, Newcastle, Australia, ⁵Rheumatology, Hunter New England Local Health District, Georgetown, Australia, ⁶Georgetown Arthritis, Georgetown, Australia, ⁷Private Practice, Broadmeadow, Australia, ⁸Rheumatology, Private Practice, Newcastle, Australia, ⁹Immunology, Hunter New England Local Health District, New Lambton, Australia, ¹⁰Rheumatology, Hunter New England Health, Newcastle, Australia
Background/Purpose: Rheumatoid Arthritis (RA) is associated with increased cardiovascular (CV) risk. The mechanisms of CV disease in RA remain poorly understood. Observational data suggest that…
Abstract Number: 62 • 2016 ACR/ARHP Annual Meeting
Increased Frequency of Anti-Drug Antibodies in Patients Carrying Compatible IgG1 Allotypes and Treated with Anti-TNF Antibodies
Antonio Gonzalez¹, Rosario Lopez-Rodriguez¹, Ana Martinez², Chamaida Plasencia-Rodriguez², Andrea Jochems², Dora Pascual-Salcedo² and Alejandro Balsa², ¹Instituto Investigacion Sanitaria-Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, ²Instituto de Investigación Hospital Universitario La Paz (IDIPAZ), Madrid, Spain
Background/Purpose: One of the causes of insufficient response to biological drugs is the production of anti-drug antibodies (ADA) (1). These antibodies can decrease the effectiveness…
Abstract Number: 641 • 2016 ACR/ARHP Annual Meeting
Reduction of Concomitant Oral Methotrexate or Corticosteroids in Combination Treatment with Adalimumab Does Not Affect Effectiveness in Patients with Rheumatoid Arthritis
Edward Keystone¹, Ferdinand Breedveld², Arthur Kavanaugh³, Ying Zhang⁴, Iain Sainsbury⁴ and Jasmina Kalabic⁵, ¹Mt. Sinai Hospital, University of Toronto, Toronto, ON, Canada, ²Leiden University Medical Center, Leiden, Netherlands, ³Univ of California San Diego, San Diego, CA, ⁴AbbVie Inc., North Chicago, IL, ⁵AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
Background/Purpose: In rheumatoid arthritis (RA) patients (pts) receiving corticosteroids (CS) or methotrexate (MTX) with an anti-TNF, such as adalimumab (ADA), the concomitant CS or MTX…
Abstract Number: 2504 • 2016 ACR/ARHP Annual Meeting
Impaired Vasodilator Function in Rheumatoid Arthritis Patients Who Flared Due to Stopping Adalimumab or Etanercept
Gerard A Rongen¹, Iris van Ingen² and Tim L Jansen^3,4, ¹Internal Medicine/Pharmacology and Toxicology, Radboud UMC, Nijmegen, Netherlands, ²Rheumatology, RadboudUMC, Nijmegen, Netherlands, ³Rheumatology, VieCuri Medical Centre, Venlo, Netherlands, ⁴Scientific IQ HealthCare, Radboud UMC, Nijmegen, Netherlands
Background/Purpose: Chronic inflammation in rheumatoid arthritis (RA) is associated with an increased cardiovascular risk, possibly due to disrupted vascular vasodilation. Within 12 weeks adalimumab and…
Abstract Number: 63 • 2016 ACR/ARHP Annual Meeting
Identification of Immune Gene Modules in Good Responders to Adalimumab in Rheumatoid Arthritis
James OIiver¹, Darren Plant², Gisela Orozco¹, Samantha Smith¹, Kimme L. Hyrich³, Ann Morgan⁴, John Isaacs⁵, Anthony G. Wilson⁶ and Anne Barton^1,2, ¹Arthritis Research UK, Centre for Genetics and Genomics, Centre for Musculoskeletal Research, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, United Kingdom, ²NIHR Manchester Musculoskeletal BRU, Central Manchester Foundation Trust, Manchester, United Kingdom, ³Arthritis Research UK, Centre for Epidemiology, Centre for Musculoskeletal Research, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, United Kingdom, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, Great Britain, ⁵Institute of Cellular Medicine, Newcastle University and National Institute for Health Research Newcastle Biomedical Research Centre at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle, United Kingdom, ⁶UCD School of Medicine and Medical Science, Conway Institute, University College Dublin, Dublin, Ireland
Background/Purpose: Despite the revolutionary impact of TNF inhibitor (TNFi) therapy in rheumatoid arthritis (RA), up to 40% of patients fail to respond adequately. Whilst non-responder…
Abstract Number: 698 • 2016 ACR/ARHP Annual Meeting
Performance of Modified Minimal Disease Activity (MDA) in Patients with Peripheral Spondyloarthritis
Laura C. Coates¹, Sonya Abraham², William Tillett³, Philip J Mease⁴, Sofia Ramiro⁵, Yinglin Xia⁶, Xin Wang⁷, Aileen L. Pangan⁷ and In-Ho Song⁷, ¹University of Leeds, Leeds, United Kingdom, ²NIHR/Wellcome CRF, Imperial College Healthcare NHS Trust, London, United Kingdom, ³Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ⁴Swedish Medical Center and University of Washington, Seattle, WA, ⁵Leiden University Medical Center, Leiden, Netherlands, ⁶University of Illinois at Chicago, Chicago, IL, ⁷AbbVie Inc., North Chicago, IL
Background/Purpose: Due to lack of validated outcome measures in non-psoriatic peripheral spondyloarthritis (pSpA), recent studies in this patient (pt) population have used varying endpoints [1].…
Abstract Number: 2526 • 2016 ACR/ARHP Annual Meeting
TNF Blocker Concentrations or Detection of Antibodies Against Anti-TNF before a Tapering Process Are Not Predictive to Relapse
Hubert Marotte^1,2, Mélanie Rinaudo-Gaujous³, Stéphane Paul^3,4 and Bruno Fautrel⁵, ¹SAINBIOSE INSERM U1059 and Rheumatology department, University of Lyon and University Hospital of Saint Etienne, Saint Etienne, France, ²Rheumatology Department, University Hospital of Saint-Etienne, Saint-Etienne, France, ³Laboratory of Immunology and immunomonitoring, CIC CIE3 Inserm Vaccinology, GIMAP EA3064, Hôpital Nord, Saint-Etienne, France, ⁴Centre Hospitalier Universitaire de Saint-Étienne, Saint-Étienne, France, ⁵Rheumatology, Pitié Salpêtrière Hospital, Paris, France
Background/Purpose: The goal of rheumatoid arthritis (RA) strategy is to reach remission or at least a low disease activity. When this goal is reached, no…
Abstract Number: 80 • 2016 ACR/ARHP Annual Meeting
Impact of a Patient Support Program on Abandonment of Adalimumab Treatment Initiation in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis
Philip Mease¹, Manish Mittal², Martha Skup², Matthew Davis³, Arijit Ganguli², Scott Johnson³ and Michael Schiff⁴, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²AbbVie Inc., North Chicago, IL, ³Medicus Economics, LLC, Milton, MA, ⁴University of Colorado, Greenwood Village, CO
Background/Purpose: Treatment abandonment (failure to start therapy after prescription) is common among patients (pts) prescribed specialty pharmaceuticals. AbbVie offers a pt support program (PSP) for…
Abstract Number: 700 • 2016 ACR/ARHP Annual Meeting
Incidence of Inflammatory Bowel Disease Events in Adalimumab (HUMIRA) Clinical Trials Across Indications
Jeffrey R. Curtis¹, Dirk Elewaut², Su Chen³, Maja Hojnik⁴, Navit Naveh⁵ and Jaclyn K. Anderson³, ¹Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ²VIB Inflammation Research Center, University of Ghent, Ghent, Belgium, ³AbbVie Inc., North Chicago, IL, ⁴AbbVie, Ljubljana, Slovenia, ⁵AbbVie, Hod HaSharon, Israel
Background/Purpose: Adalimumab (ADA) is approved for treatment of Crohn’s disease (CD) and ulcerative colitis (UC); therefore, it is postulated that new onset or flare of…

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