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Abstracts tagged "Adalimumab"

  • Abstract Number: 50 • 2017 Pediatric Rheumatology Symposium

    Tumor necrosis factor-α (TNFα) inhibitor-induced psoriasis in juvenile idiopathic arthritis (JIA) patients

    Daniel Groth1, Sivia Lapidus2, Simona Nativ2 and Maria Perez3, 1Goryeb Children's Hospital, Morristown, NJ, 2Pediatric Rheumatology, Goryeb Children's Hospital, Morristown, NJ, 3Pediatric Gastroenterology, Goryeb Children's Hospital, Morristown, NJ

    Background/Purpose: Occurrence of psoriasis while on TNFα antagonists is a paradoxical effect of agents that treat psoriasis, and is described in larger cohorts of inflammatory…
  • Abstract Number: 80 • 2017 Pediatric Rheumatology Symposium

    Treatment of Blau Syndrome with Biologic Therapy: A Single Center Case Series of Seven Patients Over Two Decades

    Jennifer Rammel1, Patricia Rosillo1, Tiphanie Vogel2 and Marietta de Guzman3, 1Department of Pediatrics, Division of Immunology, Allergy and Rheumatology, Baylor College of Medicine, Houston, TX, 2Department of Pediatrics, Division of Immunology, Allergy and Rheumatology and the Center for Human Immunology at Texas Children's Hospital., Baylor College of Medicine, Houston, TX, 3Department of Pediatrics, Division of Immunology, Allergy and Rheumatology, Baylor College of Medicine, Texas Children's Hospital, Houston, TX

    Background/Purpose: Blau syndrome is a rare autoinflammatory granulomatous disease that presents with fever, arthritis, dermatitis and uveitis. It results from mutations in NOD2, an intracellular…
  • Abstract Number: 45 • 2017 Pediatric Rheumatology Symposium

    Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn’s Disease

    Gerd Horneff1, Marieke M. B. Seyger2, Dilek Arikan3, Jasmina Kalabic4, Jaclyn K. Anderson3, Andreas Lazar5, David A. Williams3, Chen Wang3, Rita Tarzynski-Potempa3 and Jeffrey S. Hyams6, 1Asklepios Clinic, Sankt Augustin, Germany, 2Radboud University Nijmegen Medical Center, Nijmegen, Netherlands, 3AbbVie Inc., North Chicago, IL, 4AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, 5AbbVie Deutschland GmbH & Co. KG, North ChicagoLudwigshafen, IL, Germany, 6Connecticut Children’s Medical Center, Hartford, CT

    Background/Purpose:  Adalimumab (ADA) is a tumor necrosis factor (TNF) inhibitor used for treatment of chronic immune diseases. The safety of ADA treatment in pediatric patients…
  • 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 Bessette3,4, Yatish Setty5, William G. Bensen6 and Valencia P. Remple7,8, 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 Hoogen1,2, 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…
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