Abstracts tagged "Adalimumab"

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: 2L • 2015 ACR/ARHP Annual Meeting
Baricitinib Versus Placebo or Adalimumab in Patients with Active Rheumatoid Arthritis (RA) and an Inadequate Response to Background Methotrexate Therapy: Results of a Phase 3 Study
Peter C. Taylor¹, Edward C. Keystone^2,3, D. van der Heijde⁴, Yoshiya Tanaka⁵, Taeko Ishii⁶, Kahaku Emoto⁶, Lili Yang⁶, Vipin Arora⁶, Carol L. Gaich⁶, Terence Rooney⁶, Douglas E. Schlichting⁶, William Macias⁶, Stephanie de Bono⁶ and Michael E. Weinblatt⁷, ¹Nuffield Dept. of Orthopaedics, Rheumatology and Musculoskeletal, Sciences, Kennedy Institute of Rheumatology, University of Oxford,, Oxford, United Kingdom, ²University of Toronto, Toronto, ON, Canada, ³Rebecca MacDonald Centre, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁴Leiden University Medical Center, Leiden, Netherlands, ⁵The First Dept. of Internal Medicine, University of Occupational & Environmental Health, Kitakyusyu, Japan, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷Brigham and Women’s Hospital, Boston, MA
Background/Purpose: In phase 3 studies, baricitinib (bari) improved disease activity in patients (pts) with active RA and an inadequate response (IR) to conventional synthetic DMARDs1…
Abstract Number: 3L • 2015 ACR/ARHP Annual Meeting
A Randomised Controlled Trial of the Clinical Effectiveness, Safety and Cost-Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis
Athimalaipet V Ramanan¹, Andrew D. Dick², Andrew McKay³, Ashley Jones⁴, Paula Williamson⁴, Sandrine Compeyrot-Lacassagne⁵, Ben Hardwick⁴, Helen Hickey⁴, Dyfrig Hughes⁶, Patricia Woo⁵, Diana Benton¹, Clive Edelsten⁵ and Michael W. Beresford⁷, ¹University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom, ²University of Bristol, Bristol Eye Hospital, Bristol, United Kingdom, ³Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, United Kingdom, ⁴Clinical Trials Research Centre, University of Liverpool, Liverpool, United Kingdom, ⁵Great Ormond Street Hospital, London, United Kingdom, ⁶Bangor University, Bangor, United Kingdom, ⁷University of Liverpool, Liverpool, United Kingdom
Background/Purpose: Uveitis associated with Juvenile Idiopathic Arthritis (JIA) is a major cause of morbidity with potentially sight-threatening complications. Despite current screening and (pre-biologic) therapeutic options,…
Abstract Number: 612 • 2015 ACR/ARHP Annual Meeting
Thromboembolic Events Are Not Associated with Anti-Adalimumab Antibodies
Gerd Burmester¹, Cem Gabay², Dilek Arikan³, Anabela Cardoso⁴, Jasmina Kalabic³, Nathan Pfeifer³, Nupun A. Varothai³, Stefan Florentinus⁵ and Josef S. Smolen⁶, ¹Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany, ²Rheumatology, Geneva University Hospital, Geneva, Switzerland, ³AbbVie, North Chicago, IL, ⁴Torre Oriente, AbbVie, Lisboa, Portugal, ⁵AbbVie Inc., North Chicago, IL, ⁶Department of Medicine 3, Division of Rheumatology, Medical University Vienna, Vienna, Austria
Background/Purpose: Treatment of rheumatoid arthritis (RA) with anti-Tumor Necrosis Factor (TNF) such as adalimumab may result in some patients (pts) developing anti-adalimumab antibodies (AAA). Findings…
Abstract Number: 651 • 2015 ACR/ARHP Annual Meeting
The Prediction of Long-Term Minimal Disease Activity and Its Benefits in Patients with Psoriatic Arthritis
Philip J. Mease¹, Arthur Kavanaugh², Laura C Coates³, Iain McInnes⁴, Maja Hojnik⁵, Ying Zhang⁶, Jaclyn K. Anderson⁶, Alex Dorr⁶ and Dafna Gladman⁷, ¹Rheumatology Research, Swedish Medical Center, Seattle, WA, ²University of California San Diego, La Jolla, CA, ³Leeds Teaching Hospitals Trust, Leeds, United Kingdom, ⁴University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow, United Kingdom, ⁵AbbVie, Ljubljana, Slovenia, ⁶AbbVie, North Chicago, IL, ⁷Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, ON, Canada
Background/Purpose: Minimal disease activity (MDA)1 is a clinically meaningful and comprehensive treatment target for psoriatic arthritis (PsA). The purpose was to determine if baseline (BL)…
Abstract Number: 2036 • 2015 ACR/ARHP Annual Meeting
Infliximab Versus Adalimumab in Severe Uveitis: Multicenter Study from the French Uveitis Network
Hélène Vallet¹, Pascal Sève², Lucie Biard³, Elodie Feurer⁴, Sophie Rivière⁵, Philip Bielfeld⁶, Laurent Perard⁷, Boris Bienvenu⁸, Sébastien Abad⁹, Aude Rigolet¹⁰, Alban Deroux¹¹, Antoinette Perlat¹², Damien Sène¹³, Isabelle Marie¹⁴, Emmanuel Heron¹⁵, Eric Hachulla¹⁶, Olivier Fain¹⁷, Gaëlle Clavel¹⁸, Jean Sibilia¹⁹, Nathalie Tieulié²⁰, Yoland Schoindre²¹, Jean Baptiste Fraison²², Guillaume Moulis²³, Thomas Papo²⁴, Gilles Blaison²⁵, Julie Gueudry²⁶, Olivier Lidove²⁷, Phuc LE Hoang²⁸, Catherine Chapelon²⁹, Mathieu Resche Regon³⁰, Patrice Cacoub¹³, Bahram Bodaghi²⁸ and David Saadoun³¹, ¹Internal medicine, DHU 2iB Internal Medicine Referal Center for Autoimmune diseases Pitie Hospital, Paris, France, ²Internal medicine, CHU Lyon, Lyon, France, ³Biostatistics, Saint-Louis Hospital, Paris, France, ⁴Internal Medicine, Hôpital de la Croix Rousse, Lyon, France, ⁵service de médecine interne A,, CHU de Montpellier, Montpellier Cedex 5, France, ⁶CHU de Dijon, Dijon, France, ⁷Hôpital Edouard Herriot, Lyon, France, ⁸Internal Medicine, Hospital Caen, Caen, France, ⁹Hôpital Avicenne, Bobigny, France, ¹⁰Médecine Interne 1, Hôpital Pitié-Salpêtrière, Paris, France, ¹¹Internal Medicine, CHU Grenoble, Grenoble, France, ¹²Internal medicine, CHU de Rennes, Rennes, France, ¹³Department of Internal Medicine, Pitié-Salpêtrière Hospital, Paris, France, ¹⁴Service de médecine interne, CHU de Rouen, Rouen, France., Rouen, France, ¹⁵Internal medicine, Hôpital des XV-XX, Paris, France, ¹⁶CHU Lille, Lille, France, ¹⁷Internal Medicine, Hospital J. Verdier, Bondy, France, ¹⁸Rheumatology, Fondation Rothschild, Paris, France, ¹⁹Rheumatology, Hôpital de Hautepierre, Strasbourg, France, ²⁰CHU Nice, Nice, France, ²¹Department de Internal Medicine and Clinical Immunology, Hôpital Pitié-Salpêtrière, AP-PH, UPMC, Paris, France, ²²Hôpital Jean Verdier, Bondy, France, ²³CHU Purpan, Toulouse, France, ²⁴CHU Bichat, Paris, France, ²⁵Internal Medicine, Hopital de Colmar, Colmar, France, ²⁶Ophtalmology, CHU de Rouen, Rouen, France, ²⁷Internal Medicine, Bichat-Claude Bernard Hospital, University Paris-7, Paris, France, ²⁸Ophtalmology, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié Salpétrière, Paris, France, ²⁹Department of Internal Medicine 2. Referal center for SLE/APS, CHU Pitié-Salpêtrière, Paris, France, ³⁰biostatistics Saint Louis Hospital, paris, France, ³¹Department of Internal Medicine and clinical Immunology. French National Reference Center for Autoimmune Diseases. DHU I2B (Inflammation, Immunotherapy and Biotherapy), UPMC, Paris VI, Hôpital Pitié Salpétrière, AP-HP, UPMC, Univ Paris 06, Paris, France
Background/Purpose: Anti-tumour necrosis factor (TNF) molecules have become a valuable addition to the therapeutic armamentarium for patients with severe uveitis. However, direct comparison of safety…
Abstract Number: 2038 • 2015 ACR/ARHP Annual Meeting
Adalimumab in Patients with Active, Noninfectious Uveitis Using High-Dose Corticosteroids
Antoine P. Brezin¹, Phillippe Kestelyn², Joachim Van Calster³, Glenn J. Jaffe⁴, Jennifer E. Thorne⁵, David Scales⁶, Pablo Franco⁷, Andrew D. Dick^8,9,10, Quan Dong Nguyen¹¹, Eric B. Suhler^12,13, Anne Camez¹⁴, Alexandra P. Song¹⁵, Martina Kron¹⁴, Samir Tari¹⁵, James T. Rosenbaum^16,17 and Arnd Heiligenhaus¹⁸, ¹Université Paris Descartes, Hôpital Cochin, Paris, France, ²Ghent University Hospital, Ghent, Belgium, ³University Hospitals Leuven, Leuven, Belgium, ⁴Duke University, Durham, NC, ⁵Johns Hopkins Medical Institute, Baltimore, MD, ⁶University of Texas Health Science Center, San Antonio, TX, ⁷Organización Médica de Investigación (OMI), Buenos Aires, Argentina, ⁸National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital, London, United Kingdom, ⁹University of Bristol, Bristol Eye Hospital, Bristol, United Kingdom, ¹⁰University College London, Institute of Ophthalmology, London, United Kingdom, ¹¹Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE, ¹²VA Portland Health Care System, Portland, OR, ¹³Casey Eye Institute, Oregon Health & Science Univ, Portland, OR, ¹⁴Abbvie Deutschland GmbH & Co KG, Ludwigshafen, Germany, ¹⁵AbbVie Inc., North Chicago, IL, ¹⁶Devers Eye Institute, Legacy Hospital system, Portland, OR, ¹⁷Casey Eye Institute, Oregon Health & Science University, Portland, OR, ¹⁸Department of Ophthalmology at St. Franziskus Hospital Muenster, University of Duisberg-Essen, Muenster, Germany
Background/Purpose: Corticosteroids, currently the mainstay of uveitis treatment, are associated with adverse events and are not always fully effective. Multiple reports describe the use of…
Abstract Number: 2039 • 2015 ACR/ARHP Annual Meeting
Effect of Adalimumab on Visual Functioning (VFQ-25) in Visual-1 Trial Patients with Non-Anterior Non-Infectious Uveitis
John Sheppard¹, Avani D. Joshi², Manish Mittal², Keith Betts³, Samir Tari², Yanjun Bao² and Andrew D Dick⁴, ¹Virginia Eye Consultants and Eastern Virginia Medical School, Norfolk, VA, ²AbbVie Inc., North Chicago, IL, ³Analysis Group, Inc., Boston, MA, ⁴University of Bristol, Bristol Eye Hospital, Bristol, United Kingdom
Background/Purpose: To compare the effects of adalimumab and placebo on the National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25) in subjects requiring high dose corticosteroids…
Abstract Number: 2054 • 2015 ACR/ARHP Annual Meeting
Randomized, Double-Blind, Phase 3 Study of Efficacy and Safety of ABP 501 Compared with Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
Stanley B. Cohen¹, Mark C. Genovese², Ernest H. Choy³, Fernando Perez-Ruiz⁴, Jose L. Pablos⁵, Nan Zhang⁶ and Primal Kaur⁷, ¹Metroplex Clinical Research Center, Dallas, TX, ²Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA, ³Cardiff University, Institute of Infection and Immunity, Tenovus Building, University Hospital of Wales, Cardiff, United Kingdom, ⁴Servicio de Reumatología, Vizcaya, Spain, ⁵Instituto de Investigacion Hospital, Madrid, Spain, ⁶Biosimilars, Amgen, Inc., Thousand Oaks, CA, ⁷Amgen, Inc., Thousand Oaks, CA
Background/Purpose: ABP 501 is being developed as a biosimilar candidate to adalimumab (Humira®), a fully human recombinant monoclonal antibody. Evidence from analytical comparisons indicates that…
Abstract Number: 2059 • 2015 ACR/ARHP Annual Meeting
Tumor Necrosis Factor Inhibitor Tapering Induced Radiographic Progression Is Driven By Weighted Mean Disease Activity over Time, Not Flaring or Lower TNFi Exposition
Alfons A. den Broeder¹, Chantal A.M. Bouman¹, Aatke van der Maas², Frank H.J. van den Hoogen¹, Noortje van Herwaarden¹ and R. Landewe³, ¹Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, ²Hengstdal 3, Sint Maartenskliniek, Nijmegen, Netherlands, ³Department of Internal Medicine, Division of Rheumatology, University Hospital Maastricht, Maastricht, Netherlands
Background/Purpose: DRESS, a randomized controlled strategy trial (RCT)1investigating disease activity guided tapering of etanercept and adalimumab compared to usual care in RA patients, indicated that…
Abstract Number: 2431 • 2015 ACR/ARHP Annual Meeting
Long-Term Safety of Adalimumab Treatment in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis and Enthesitis-Related Arthritis
Daniel Lovell¹, Nicolino Ruperto², Daniel J. Kingsbury¹, Rubén Burgos-Vargas², Tomoyuki Imagawa³, G Horneff², Pierre Quartier⁴, Steven Goodman¹, Andreas Reiff¹, Edward H. Giannini¹, Anabela Cardoso⁵, Jaclyn K. Anderson⁶, Nupun A. Varothai⁶, Jasmina Kalabic⁶ and Alberto Martini², ¹PRCSG, Cincinnati, OH, ²PRINTO, IRCCS G. Gaslini, Genova, Italy, ³Kanagawa Children’s Medical Center, Yokohama City, Japan, ⁴Hopital Necker-Enfants Malades, Paris, France, ⁵AbbVie, Amadora, Portugal, ⁶AbbVie, North Chicago, IL
Background/Purpose: The long-term safety of anti-tumor necrosis factor (TNF) drugs is particularly important in pediatric patients (pts) who may require prolonged treatment of their inflammatory…
Abstract Number: 2727 • 2015 ACR/ARHP Annual Meeting
BI 695501, a Proposed Biosimilar for Adalimumab, Shows Bioequivalence to Adalimumab Reference Products in a Randomized, Double-Blind Phase I Trial in Healthy Subjects
Christopher Wynne¹, Magdalena Petkova², Ferdinand Rombout³, Niklas Czeloth³, Mario Altendorfer³, Benjamin Lang⁴, Francois-Xavier Frapaise³ and Rod Ellis-Pegler⁵, ¹Christchurch Clinical Studies Trust, Christchurch, New Zealand, ²SGS, CPU Antwerpen, Antwerp, Belgium, ³Boehringer Ingelheim, Ingelheim, Germany, ⁴Boehringer Ingelheim, Biberach an der Riss, Germany, ⁵Auckland Clinical Studies Limited, Auckland, New Zealand
Background/Purpose: BI 695501 is a proposed adalimumab biosimilar currently in development and was evaluated for pharmacokinetic (PK) similarity to both US-licensed and EU-approved reference products.…

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