Abstracts tagged "Adalimumab"

Abstract Number: 482 • 2016 ACR/ARHP Annual Meeting
Comparison of Nonclinical Pharmacology, Pharmacodynamics and Efficacy Response of the Proposed Adalimumab Biosimilar GP2017 to Originator Adalimumab
Antonio Dasilva¹, Ulrich Kronthaler¹, Hans-Peter Hofmann², Vera Koppenburg¹, Melanie Baron³, Cornelius Fritsch⁴, Otmar Hainzl¹ and Andreas Seidl¹, ¹Sandoz Biopharmaceuticals, Holzkirchen, Germany, ²Pre-clinical, Sandoz Biopharmaceuticals, Holzkirchen, Germany, ³Clinical Development, Sandoz Biopharmaceuticals, Holzkirchen, Germany, ⁴Bioassay Support Global Development, Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Biosimilars are created to be essentially the same as their reference marketed biopharmaceuticals which have lost exclusivity, and they aim to offer more affordable…
Abstract Number: 1408 • 2016 ACR/ARHP Annual Meeting
Impact of Participation in the Adalimumab (Humira) Patient Support Program on Patient Reported Outcomes Among Patients with Rheumatoid Arthritis: Passion Study
Filip van Den Bosch¹, Andrew Östör², Siegfried Wassenberg³, Naijun Chen⁴, Chen Wang⁵, Vishvas Garg⁴ and Jasmina Kalabic⁶, ¹Rheumatology, Ghent University Hospital, Gent, Belgium, ²Addenbrooke's Hospital, Cambridge, United Kingdom, ³Rheumazentrum, Ratingen, Germany, ⁴AbbVie Inc, North Chicago, IL, ⁵AbbVie Inc., North Chicago, IL, ⁶AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
Background/Purpose: Patient (pt) Support Program (PSP) is offered to pts who are prescribed adalimumab (ADA) for their Rheumatoid arthritis (RA). How participation in a PSP…
Abstract Number: 2983 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, or Adalimumab in Patients with Active Psoriatic Arthritis and an Inadequate Response to Conventional Synthetic Dmards: A Randomized, Placebo‑Controlled, Phase 3 Trial
Philip J Mease¹, Stephen Hall², Oliver FitzGerald³, Désirée van der Heijde⁴, Joseph F Merola⁵, Francisco Avila-Zapata⁶, Dorata Cieślak⁷, Daniela Graham⁸, Cunshan Wang⁹, Sujatha Menon⁹, Thijs Hendrikx⁸ and Keith Kanik⁹, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²Cabrini Health and Monash University, Melbourne, VIC, Australia, ³Department of Rheumatology, St Vincent’s University Hospital and Conway Institute, University College, Dublin, Ireland, ⁴Leiden University Medical Center, Leiden, Netherlands, ⁵Brigham and Women's Hospital, Harvard Medical School, Boston, MA, ⁶Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.C.P., Yucatán, Mexico, ⁷Poznan University, Poznan, Poland, ⁸Pfizer Inc, Collegeville, PA, ⁹Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor under investigation for treatment of psoriatic arthritis (PsA). This study evaluated tofacitinib efficacy and safety vs placebo…
Abstract Number: 591 • 2016 ACR/ARHP Annual Meeting
Patient-Reported Outcomes for Etanercept Therapy in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment
Louis Bessette¹, Majed Khraishi², Alan J Kivitz³, Arunan Kaliyaperumal⁴, Rama Grantab⁵, Melanie Poulin-Costello⁵, Maya Isaila⁵ and David Collier⁴, ¹Rhumatology, Centre d’Ostéoporose et de Rhumatologie de Québec (CORQ), Québec, QC, Canada, ²Medical Consultants of West Newfoundland, Western Memorial Hospital, Corner Brook, NF, Canada, ³Altoona Center for Clinical Research, Duncansville, PA, ⁴Amgen Inc., Thousand Oaks, CA, ⁵Amgen Canada Inc., Mississauga, ON, Canada
Background/Purpose: When a tumor necrosis factor inhibitor (TNFi) fails in a patient with moderate to severe rheumatoid arthritis (RA), new American College of Rheumatology (ACR)…
Abstract Number: 1695 • 2016 ACR/ARHP Annual Meeting
Pharmacological Monitoring of Adalimumab and Etanercept-Treated Psoriatic Arthritis Patients in Predicting Future Treatment Response
Meghna Jani¹, Hector Chinoy², Anne Barton² and on behalf of OUTPASS, ¹Centre for Musculoskeletal Research, The University of Manchester, Manchester, United Kingdom, ²Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom
Background/Purpose: Up to 40% of patients with inflammatory arthritis on TNF-α inhibitor (TNFi) treatment fail to respond either due to primary inefficacy or loss of…
Abstract Number: 2987 • 2016 ACR/ARHP Annual Meeting
Comparison of Certolizumab Pegol Versus Adalimumab: 2 Year Efficacy and Safety Results from a Superiority, Investigator-Blind, Head-to-Head Study
Roy Fleischmann¹, Gerd-Rüdiger Burmester², Bernard Combe³, Jeffrey R. Curtis⁴, Stephen Hall⁵, Boulos Haraoui⁶, Ronald van Vollenhoven⁷, Christopher Cioffi⁸, Cécile Ecoffet⁹, Lucian Ionescu⁹, Leon Gervitz¹⁰, Luke Peterson⁸ and Josef Smolen¹¹, ¹University of Texas Southwestern Medical Center at Dallas Metroplex Clinical Research Center, Dallas, TX, ²Charité – University Medicine Berlin, Berlin, Germany, ³Montpellier University Hospital, Montpellier, France, ⁴Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ⁵Cabrini Medical Centre, Monash University, Melbourne, Australia, ⁶Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada, ⁷Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands, ⁸UCB Pharma, Raleigh, NC, ⁹UCB Pharma, Brussels, Belgium, ¹⁰RA Patient Value Mission, UCB Pharma, Brussels, Belgium, ¹¹Medical University of Vienna and Hietzing Hospital, Vienna, Austria
Background/Purpose: Head-to-head comparisons of biological (b)DMARDs in the treatment of RA should provide rigorous evidence on the comparative efficacy of different treatments. Although there are…
Abstract Number: 602 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Switching Between Certolizumab Pegol and Adalimumab after Primary Anti-TNF Treatment Failure: 2-Year Results from a Randomized, Investigator-Blind, Superiority Head-to-Head Study
Roy Fleischmann¹, Gerd-Rüdiger Burmester², Bernard Combe³, Jeffrey R. Curtis⁴, Stephen Hall⁵, Boulos Haraoui⁶, Ronald van Vollenhoven⁷, Christopher Cioffi⁸, Cécile Ecoffet⁹, Lucian Ionescu¹⁰, Leon Gervitz¹¹, Luke Peterson⁸ and Josef Smolen¹², ¹University of Texas Southwestern Medical Center at Dallas Metroplex Clinical Research Center, Dallas, TX, ²Charité – University Medicine Berlin, Berlin, Germany, ³Montpellier University Hospital, Montpellier, France, ⁴The University of Alabama at Birmingham, Birmingham, AL, ⁵Cabrini Medical Centre, Monash University, Melbourne, Australia, ⁶Department of Medicine, Centre Hospitalier de l’Université de Montréal, Montreal, QC, Canada, ⁷Amsterdam Rheumatology and Immunology Center (ARC), Amsterdam, Netherlands, ⁸UCB Pharma, Raleigh, NC, ⁹UCB Pharma, Brussels, Belgium, ¹⁰Allée De La Recherche 60, UCB Pharma, Brussels, Belgium, ¹¹RA Patient Value Mission, UCB Pharma, Brussels, Belgium, ¹²Medical University of Vienna and Hietzing Hospital, Vienna, Austria
Background/Purpose: EULAR, ACR and treat-to-target guidelines recommend switching treatment in inadequate responders (IRs) to alternative therapy by Week (Wk) 12.1-3 Although any biological (b)DMARD can…
Abstract Number: 1696 • 2016 ACR/ARHP Annual Meeting
Minimal Disease Activity Is a Stable Measure of Therapeutic Response in Psoriatic Arthritis Patients Receiving Treatment with Adalimumab
Frank Behrens¹, Michaela Koehm², Eva Christina Schwaneck³, Marc Schmalzing⁴, Holger Gnann⁵, Gerd Greger⁶, Hans-Peter Tony⁷ and Harald Burkhardt¹, ¹Division of Rheumatology and Fraunhofer IME-Project-Group Translational Medicine and Pharmacology, Goethe University, Frankfurt, Germany, ²Division of Rheumatology and Fraunhofer IME-Project-Group Translational Medicine and Pharmacology, Goethe University, Frankfurt/Main, Germany, ³Rheumatology/Immunology, Medical Clinic II, University Clinic Wuerzburg, Wuerzburg, Germany, ⁴Rheumatology/Clinical Immunology, Medical Clinic II, University Clinic Wuerzburg, Würzburg, Germany, ⁵Abteilung Biostatistik, GKM Gesellschaft für Therapieforschung mbH, München, Germany, ⁶AbbVie Deutschland GmbH & Co.KG, Wiesbaden, Germany, ⁷Rheumatology/Immunology, Medical Clinic II, University Clinic Wuerzburg, Würzburg, Germany
Background/Purpose: Minimal disease activity (MDA) is an important goal for patients with rheumatologic disorders, including psoriatic arthritis (PsA). The assessment of MDA could potentially help…
Abstract Number: 3009 • 2016 ACR/ARHP Annual Meeting
Safety and Effectiveness of Adalimumab±Methotrexate for the Treatment of Polyarticular Juvenile Idiopathic Arthritis
Daniel J Lovell¹, Nicola Ruperto², Carol Wallace¹, Mary Toth¹, Ivan Foeldvari², John Bohnsack¹, Diana Milojevic¹, C. Egla Rabinovich¹, Daniel Kingsbury¹, Katherine Marzan¹, Pierre Quartier³, Kirsten Minden², Elizabeth Chalom¹, Gerd Horneff², Rolf M. Kuester², Jason Dare¹, Miriam Heinrich⁴, Hartmut Kupper⁴, Jasmina Kalabic⁴, Hermine I. Brunner¹, Alberto Martini² and on behalf of PRINTO and PRCSG, ¹PRCSG, Cincinnati, OH, ²PRINTO-IRCCS, Genova, Italy, ³Hopital Necker-Enfants Malades, Paris, France, ⁴AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
Background/Purpose: Juvenile Idiopathic Arthritis (JIA) is the most common chronic inflammatory rheumatic diseases of childhood. Due to their long-term safety and efficacy, biologic disease modifying…
Abstract Number: 605 • 2016 ACR/ARHP Annual Meeting
Assessment of Comparative Immunogenicity in Biosimilar Development: Immunogenicity and Pharmacokinetics Following a Single Dose of M923, a Proposed Biosimilar for Reference Adalimumab (HUMIRA®), Compared with US- and EU-Sourced Reference Adalimumab in Healthy Subjects
Jan Hillson¹, Tim Mant², Tanmoy Ganguly³, William Avery³, Molly Rosano³, Carolyn Huntenburg³, Donna Palmer⁴, Siddesh Darne⁴, Borislava Pavlova⁴, Jennifer Doralt⁴, Russell Reeve⁵, Niti Goel⁵, Doris Weilert⁵, Paul Rhyne⁶, John Caminis⁴ and James Roach³, ¹Clinical Research, Momenta Pharmaceuticals, Inc., Cambridge, MA, ²Quintiles Drug Research Unit at Guy's Hospital, London, London, United Kingdom, ³Momenta Pharmaceuticals, Inc., Cambridge, MA, ⁴Shire, Cambridge, MA, ⁵Quintiles, Inc., Durham, NC, ⁶Q2 Solutions, Marietta, GA
Background/Purpose: 324 healthy volunteers were randomized 1:1:1 to receive a single 40 mg dose of M923, US-sourced reference adalimumab, or EU-sourced reference adalimumab by subcutaneous…
Abstract Number: 1735 • 2016 ACR/ARHP Annual Meeting
Canadian Humira Post-Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA): Interim Analysis
Majed Khraishi¹, Boulos Haraoui², Louis Bessette^3,4, Yatish Setty⁵, William G. Bensen⁶ and Valencia P. Remple^7,8, ¹Department of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ²Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada, ³Faculty of Medicine, Laval University, Quebec, QC, Canada, ⁴Centre Hospitalier de l'Université Laval, Quebec, QC, Canada, ⁵Grey Bruce Health Services, Owen Sound, ON, Canada, ⁶Department of Medicine, Division of Rheumatology, McMaster University, Hamilton, ON, Canada, ⁷AbbVie Corporation, Montreal, QC, Canada, ⁸School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada
Background/Purpose: COMPLETE-PsA is an ongoing observational study planning to enroll 670 psoriatic arthritis (PsA) patients (pts) from ~40 sites across Canada. Main objectives are to…
Abstract Number: 3011 • 2016 ACR/ARHP Annual Meeting
Long-Term Outcomes after Disease Activity Guided Tapering of Tumor Necrosis Factor Inhibition in Rheumatoid Arthritis: 3 Year Data of a Randomised Controlled Pragmatic Non Inferiority Strategy Study
Alfons A. den Broeder¹, Chantal A.M. Bouman¹, Frank H.J. van den Hoogen^1,2, Jaap Fransen², Ronald F. van Vollenhoven³, Johannes W.J. Bijlsma⁴, Aatke van der Maas¹ and Noortje van Herwaarden¹, ¹Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, ²Rheumatology, Radboud University Medical Center, Nijmegen, Netherlands, ³Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, ⁴Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands
Long-term Outcomes After Disease Activity Guided Tapering of TNF Inhibitors in Rheumatoid Arthritis: 3 Year Data of a Randomized Controlled Pragmatic Non Inferiority Strategy Study…
Abstract Number: 608 • 2016 ACR/ARHP Annual Meeting
Initial Intensive Therapy of Adalimumab and Methotrexate Is Associated with Long-Term Structural Remission and Low Disease Activity after Adalimumab Discontinuation Is Maintained up to 3 Years in Japanese Patients: Hopeful-3 Study
Yoshiya Tanaka¹, Hisashi Yamanaka², Naoki Ishiguro³, Nobuyuki Miyasaka⁴, Katsuyoshi Kawana⁵, Naoki Agata⁵ and Tsutomu Takeuchi⁶, ¹University of Occupational and Environmental Health, Kitakyushu, Japan, ²Tokyo Women's Medical University, Tokyo, Japan, ³Department of Orthopedic Surgery, Nagoya University, Graduate School & Faculty of Medicine, Nagoya, Japan, ⁴Tokyo Medical and Dental University, Tokyo, Japan, ⁵Abbvie GK, Tokyo, Japan, ⁶Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan
Background/Purpose: Methods: Of 172 patients enrolled, 135 (ADA continuation, n=61; ADA discontinuation, n=74) with DAS28–CRP at both week 52 (start of HOPEFUL-2) and week 208…
Abstract Number: 2251 • 2016 ACR/ARHP Annual Meeting
Secukinumab Vs Adalimumab for the Treatment of Ankylosing Spondylitis: A Cost per Responder Analysis at 52 Weeks from the US Perspective
Jessica Walsh¹, Efthalia Nikoglou², Gunda Praveen³, Yujin Park⁴ and Steffen Jugl⁵, ¹University of Utah School of Medicine, Salt Lake City, UT, ²Novartis Ireland, Ltd, Dublin, Ireland, ³Novartis Healthcare Pvt. Ltd., Hyderabad, India, Hyderabad, India, ⁴Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁵Novartis Pharma AG, Basel, Switzerland
Secukinumab vs adalimumab for the treatment of ankylosing spondylitis: A cost per responder analysis at 52 weeks from the US perspectiveJessica Walsh1, Efthalia Nikoglou2, Praveen…
Abstract Number: 3014 • 2016 ACR/ARHP Annual Meeting
Tapering of Adalimumab Based on Therapeutic Drug Monitoring in Rheumatoid Arthritis
Merel J. l'Ami¹, Anneke F. Marsman¹, Charlotte LM Krieckaert¹, Mike T. Nurmohamed^2,3, Jill Ruwaard¹, Ingrid M. Visman¹, Eva L. Kneepkens¹ and Gertjan Wolbink^1,4, ¹Rheumatology, Amsterdam Rheumatology and immunology Center, location Reade, Amsterdam, Netherlands, ²Rheumatology, Amsterdam Rheumatology and immunology Center, Location VU University Medical Center, Amsterdam, Netherlands, Amsterdam, Netherlands, ³Rheumatology, Amsterdam Rheumatology and immunology Center, location Reade, Amsterdam, Netherlands, Amsterdam, Netherlands, ⁴Immunopathology, Sanquin Research and Landsteiner Laboratory Academic Medical Center, Amsterdam, Netherlands
Background/Purpose: Treatment with biologicals is based on the principle of ‘one size fits all’ without taking differences into account for dosing schemes, patients’ characteristics and…

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