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Abstracts tagged "Biologics"

  • Abstract Number: 1001 • 2013 ACR/ARHP Annual Meeting

    Long-Term Effectiveness and Cost Per Effectively Treated Patient With Biologics Used In Rheumatoid Arthritis

    Vernon F. Schabert1, Jason Yeaw2, Jonathan Korn1, Caroleen Quach3, David J. Harrison4, Huifeng Yun5, George Joseph6, David H. Collier4 and Jeffrey R. Curtis7, 1IMS Health, Alexandria, VA, 2IMS Consulting Group, Alexandria, VA, 3Public Health Policy and Management, University of North Carolina at Chapel Hill, Gillings School of Public Health, Chapel Hill, NC, 4Amgen Inc., Thousand Oaks, CA, 5Epidemiology, University of Alabama at Birmingham, Birmingham, AL, 6Former Amgen Employee, Thousand Oaks, CA, 7Epidemiology, University of Alabama at Birmingham, School of Public Health, Birmingham, AL

    Background/Purpose: Previous work compared one-year cost per effectively treated patient with biologics for rheumatoid arthritis (RA) using a published, claims-based algorithm.1 Longer term comparisons are…
  • Abstract Number: 322 • 2013 ACR/ARHP Annual Meeting

    Ustekinumab Improves Physical Function, Quality Of Life, and Work Productivity Of Patients With Active Psoriatic Arthritis Who Were Methotrexate-naïve Or Previously Treated With Methotrexate Or Anti-Tumor Necrosis Factor Agent:Data From 2 Phase 3, Randomized, Placebo-Controlled Trials

    Proton Rahman1, Lluis Puig2, Alice B. Gottlieb3, Arthur Kavanaugh4, Iain B. McInnes5, Christopher T. Ritchlin6, Shu Li7, Yuhua Wang7, Ning Zhao8, Rita Ganguly8, Michael Song7, Alan M. Mendelsohn9 and Chenglong Han8, 1Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, 2Universitat Autònoma de Barcelona, Barcelona, Spain, 3Tufts Medical Center, Boston, MA, 4University of California, San Diego, La Jolla, CA, 5Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, 6Allergy, Immunology and Rheumatology, University of Rochester, Rochester, NY, 7Janssen Research & Development, LLC., Spring House, PA, 8Janssen Global Services, LLC., Malvern, PA, 9Immunology, Janssen Research & Development, LLC., Spring House, PA

    Background/Purpose: To examine the impact of ustekinumab (UST) treatment on patient reported outcomes in patients with active psoriatic arthritis (PsA) using week 24 data from…
  • Abstract Number: 2324 • 2013 ACR/ARHP Annual Meeting

    Persistence On Biologics Is Associated With Concomitant Methotrexate Use Among Rheumatoid Arthritis Patient

    Jie Zhang1, Fenglong Xie2, Elizabeth S. Delzell3, Huifeng Yun3, James Lewis4, Kevin Haynes5, Lang Chen6 and Jeffrey R. Curtis7, 1Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 2Rheumatology & Immunology, University of Alabama at Birmingham, Birmingham, AL, 3Epidemiology, University of Alabama at Birmingham, Birmingham, AL, 4Medicine, University of Pennsylvania, Philadelphia, PA, 5Clinical Epidemiology and Biostatistics, University of Pennsylvania., Philadelphia, PA, 6Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 7University of Alabama at Birmingham, Birmingham, AL

    Persistence on Biologics is Associated with Concomitant Methotrexate Use among Rheumatoid Arthritis Patient Background/Purpose: Concomitant methotrexate (MTX) is associated with improved treatment efficacy in randomized controlled…
  • Abstract Number: 1607 • 2013 ACR/ARHP Annual Meeting

    Two Year Follow-Up On Biologics Use In 13 Centers- Data From The International Registry For Biologics In Systemic Lupus Erythematosus

    Ronald F. van Vollenhoven1, Melinda Mild2, Søren Jacobsen3, S. Bernatsky4, Daniel J. Wallace5, Sang-Cheol Bae6, Manuel Ramos-Casals7, Francisco J. García-Hernández8, R. Ramsey-Goldman9, Andrea Doria10, Marta Mosca11, Michelle A. Petri12, M Ayala-Gutiérrez13, J.G. Hanley14 and for The SLICC group15, 1Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), the Karolinska Institute, Stockholm, Sweden, 2Department of medicine, Karolinska Institutet, Stockholm, Sweden, 3Department of Rheumatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, 4Divisions of Rheumatology and Clinical Epidemiology, McGill University Health Centre, Montreal, QC, Canada, 5Cedars-Sinai Medical Center, Los Angeles, CA, 6Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 7Laboratorio de Enfermedades Autoinmunes Josep Font, Hospital Clínic, Barcelona, Spain, 8Internal Medicine, Hospital Virgen del Rocío, Sevilla, Spain, 9Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, 10Rheumatology Unit - Department of Medicine, University of Padova, Padova, Italy, 11Rheumatology Unit, University of Pisa, Pisa, Italy, 12Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 13Unidad de Enfermedades Autoinmunes, Servicio de Medicina Interna, Hospital Carlos Haya, Malaga, Spain, 14Division of Rheumatology, Halifax, NS, Canada, 15Department of Medicine, the Karolinska Institute, Stockholm, Sweden

    Background/Purpose: Only one biologic agent has been approved for use in SLE, but some are used off-label in various settings. To obtain systematic information regarding…
  • Abstract Number: 874 • 2013 ACR/ARHP Annual Meeting

    Sustained and Consistent Clinical Benefit With Intravenous Golimumab Therapy In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy:  Results Through 1-Year Of a Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

    Clifton O. Bingham III1, Rene Westhovens2, Alan M. Mendelsohn3, Lilianne Kim4, Kim Hung Lo4 and Michael E. Weinblatt5, 1Rheumatology, Johns Hopkins University, Baltimore, MD, 2Rheumatology, University Hospital KU Leuven, Leuven, Belgium, 3Immunology, Janssen Research & Development, LLC., Spring House, PA, 4Janssen Research & Development, LLC., Spring House, PA, 5Department of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA

      Background/Purpose: To report on sustainability and consistency of ACR component scores with intravenous (IV) golimumab (GLM) 2mg/kg+methotrexate (MTX) through wk52 in pts with active rheumatoid…
  • Abstract Number: 323 • 2013 ACR/ARHP Annual Meeting

    Safety Of Ustekinumab From The Placebo-Controlled Periods Of Psoriatic Arthritis and Psoriasis Clinical Developmental Programs

    Iain B. McInnes1, Kim Papp2, Lluis Puig3, Kristian Reich4, Christopher T. Ritchlin5, Bruce Strober6, Proton Rahman7, Arthur Kavanaugh8, Alan M. Mendelsohn9, Michael Song10, Daphne Chan10, Yaung-Kaung Shen10, Shu Li10 and Alice B. Gottlieb11, 1Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, 2Probity Research, Waterloo, ON, Canada, 3Universitat Autònoma de Barcelona, Barcelona, Spain, 4SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany, 5Allergy, Immunology and Rheumatology, University of Rochester, Rochester, NY, 6University of Connecticut, Farmington, CT, 7Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, 8University of California, San Diego, La Jolla, CA, 9Immunology, Janssen Research & Development, LLC., Spring House, PA, 10Janssen Research & Development, LLC., Spring House, PA, 11Tufts Medical Center, Boston, MA

    Background/Purpose:   To describe the short-term safety experience of UST during the double-blind, PBO-controlled portion of the PsA & PsO clinical developmental programs. Methods: Safety…
  • Abstract Number: 2325 • 2013 ACR/ARHP Annual Meeting

    Final 5-Year Safety and Efficacy Results Of a Phase 3, Randomized, Placebo-Controlled Trial Of Golimumab In Patients With Active Rheumatoid Arthritis Despite Previous Anti-Tumor Necrosis Factor Therapy

    Josef S. Smolen1, Jonathan Kay2, Robert Landewé3, Eric L. Matteson4, Norman B. Gaylis5, Jürgen Wollenhaupt6, Frederick T. Murphy7, Chenglong Han8, Timothy A. Gathany8, Stephen Xu9, Yiying Zhou10, Elizabeth C. Hsia9 and Mittie K. Doyle9, 1Division of Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria, 2Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School, Worcester, MA, 3Clinical Immunology & Rheumatology, Academic Medical Center, University of Amsterdam and Atrium Medical Center, Heerlen, Netherlands, 4Rheumatology, Mayo Clinic, Rochester, MN, 5Arthritis & Rheumatic Disease Specialties, Aventura, FL, 6Schön Klinik Hamburg-Eilbek, Hamburg, Germany, 7Altoona Ctr for Clinical Research, Duncansville, PA, 8Janssen Global Services, LLC., Malvern, PA, 9Janssen Research & Development, LLC., Spring House, PA, 10Biostatistics, Janssen Research & Development, LLC., Spring House, PA

    Background/Purpose: GO-AFTER was the first multicenter, randomized, placebo (PBO)-controlled trial of the safety/efficacy of an anti-TNFα agent, GLM, in pts with active RA despite prior…
  • Abstract Number: 1534 • 2013 ACR/ARHP Annual Meeting

    Safety and Efficacy Of Golimumab, a Human Anti-Tumor Necrosis Factor Monoclonal Antibody Injected Subcutaneously Every 4 Weeks, In Chinese Patients With Active Ankylosing Spondylitis: 1-Year Results Of a Phase 3, Randomized, Placebo-Controlled Study

    Chunde Bao1, Feng Huang2, Muhammad Asim Khan3, Kaiyin Fei4, Zhong Wu4, Yanli Zhuang4, Timothy A. Gathany5, Chenglong Han5 and Elizabeth C. Hsia4, 1Shanghai Institute of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, 2Dept of Rheumatology, Chinese PLA General Hospital, Beijing, China, 3Medicine/ Rheumatology, Case Western Reserve University Hospital, Cleveland, OH, 4Janssen Research & Development, LLC., Spring House, PA, 5Janssen Global Services, LLC., Malvern, PA

    Background/Purpose: A multicenter, randomized, placebo (PBO)-controlled study of golimumab (GLM) was performed in Chinese pts with ankylosing spondylitis (AS). To assess efficacy and safety of…
  • Abstract Number: 800 • 2013 ACR/ARHP Annual Meeting

    A Strategy For Selecting Individuals With RA For Reduction Of Anti-TNF Therapy Using Combined Clinical and Ultrasound Assessment

    Christopher R. Holroyd1,2, Brian Davidson3, Sarah Bennett3, David Waghorn3, Caron Underhil3, Cyrus Cooper2, Antonia Calogeras3, Elaine M. Dennison4, Nicholas C. Harvey5, Ray Armstrong3, Stephan Gadola6 and Christopher J. Edwards7,8, 1Rheumatology, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, 2MRC Lifecourse Epidemiology Unit, Southampton, United Kingdom, 3University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, 4MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom, 5University of Southampton, MRC Lifecourse Epidemiology Unit, Southampton, United Kingdom, 6University of Southampton, Southampton, United Kingdom, 7NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, 8University of Southampton, Southampton, United Kingdom

    Background/Purpose: Reducing the dose of biological therapy may be possible for patients with rheumatoid arthritis (RA) who have achieved remission or low disease activity (LDA). …
  • Abstract Number: 324 • 2013 ACR/ARHP Annual Meeting

    Long-Term Safety Of Ustekinumab: 5 Years Of Follow-Up From The Psoriasis Clinical Development Program Including Patients With Psoriatic Arthritis

    Kim Papp1, Christopher E.M Griffiths2, Kenneth B. Gordon3, Mark Lebwohl4, Philippe O. Szapary5, Yasmine Wasfi5, Daphne Chan5, Yaung-Kaung Shen5, Vincent Ho6, Pierre-Dominique Ghislain7, Bruce Strober8 and Kristian Reich9, 1Probity Research, Waterloo, ON, Canada, 2Dermatology Centre, University of Manchester, Manchester, United Kingdom, 3Feinberg School of Medicine, Northwestern University, Chicago, IL, 4Mount Sinai Medical Center, New York, NY, 5Janssen Research & Development, LLC., Spring House, PA, 6University of British Columbia, Vancouver, BC, Canada, 77. Cliniques Universitaires Saint-Luc, Université Catholique de Louvain,, Brussels, Belgium, 8University of Connecticut, Farmington, CT, 9SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany

    Background/Purpose: Ustekinumab(UST) is approved for moderate-to-severe psoriasis (PsO), and is currently in Phase 3 development for psoriatic arthritis (PsA). We report the long-term safety experience…
  • Abstract Number: 2283 • 2013 ACR/ARHP Annual Meeting

    The Evolving Use Of Biologic Monotherapy In Rheumatoid Arthritis and Its Impact On Patient Outcomes

    Laurent Chanroux, Katrina Johnson and Joan Casellas, Therapy Watch, The Research Partnership, London, United Kingdom

    Background/Purpose: The aim of our study is to understand whether the use of biologic monotherapy among rheumatoid arthritis (RA) patients is increasing and whether this…
  • Abstract Number: 1482 • 2013 ACR/ARHP Annual Meeting

    Survival Of Biological Treatment In Chronic Inflammatory Arthritis: A Preliminary Analysis Of 13 Years Of Follow Up In Clinical Practice

    Gabriela Ávila1, Sara Marsal1, Arnald Alonso1, Carolina Diaz2, Estefanía Quesada-Masachs2, María López-Lasanta1 and Isabel Acosta3, 1Rheumatology Research Group, Vall d'Hebron Hospital Research Institute, Barcelona, Spain, 2Rheumatology, University Hospital Vall d'Hebron, Barcelona, Spain, 3Vall d'Hebron Hospital Research Institute, Barcelona, Spain

    Background/Purpose: The wide use of biological therapies (BTs) has largely modified the therapeutic approach in Chronic Inflammatory Arthritis (CIA). These relatively new drugs have different…
  • Abstract Number: 717 • 2013 ACR/ARHP Annual Meeting

    Patients With Rheumatoid Arthritis Have Impaired Candida Albicans Specific Th17 Responses But Preserved Oral Candida Albicans Protective Immunity

    Shrinivas Bishu1, E. Wern Su2, Erich Wikerson3, Donald M. Jones4, Kelly A. Reckley5, Sarah L. Gaffen3 and Marc C. Levesque6, 1Department of Medicine, Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh, Pittsburgh, PA, 2Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, 3Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, 4Rheumatology & Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, 5Department of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, 6Division of Rheumatology and Clinical Immunology, University of Pittsburgh Department of Medicine, Pittsburgh, PA

    Background/Purpose: Rheumatoid arthritis (RA) patients are susceptible to infections, even after controlling for the effects of medications.  Recent data suggest an important role for the…
  • Abstract Number: 292 • 2013 ACR/ARHP Annual Meeting

    Body Surface Area-Based Dosing Approach Produced Comparable Golimumab Exposure Across Different Age Ranges After Subcutaneous Administration Of Golimumab In Pediatric Patients With Juvenile Idiopathic Arthritis

    Jocelyn H. Leu1, Alan M. Mendelsohn2, Joyce Ford1, Hugh M. Davis1 and Zhenhua Xu1, 1Janssen Research & Development, LLC., Spring House, PA, 2Immunology, Janssen Research & Development, LLC., Spring House, PA

    Background/Purpose:   To evaluate the pharmacokinetics (PK) of body surface area (BSA)-adjusted dosing of SC golimumab 30 mg/m2 every 4 weeks (q4w) + methotrexate (MTX)…
  • Abstract Number: 2269 • 2013 ACR/ARHP Annual Meeting

    Patient Reported Pain: A Predictor Of Outcomes In Rheumatoid Arthritis From The Consortium Of Rheumatology Researchers Of North America Registry

    Dimitrios A. Pappas1, Chitra K. Karki2, Chin Lee3, George W. Reed4, Ping He5 and Sarah Al Sawah3, 1Columbia University, New York, NY, 2Corrona, LLC., Southborough, MA, 3Eli Lilly and Company, Indianapolis, IN, 4CORRONA, Inc., Southborough, MA, 5UMASS Medical School, Worcester, MA

    Background/Purpose:  Pain is a hallmark of rheumatoid arthritis (RA). The extent to which patient reported pain in RA is related to patterns of biologic treatment…
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