Abstracts tagged "Biologics"

Abstract Number: 341 • 2013 ACR/ARHP Annual Meeting
Impact Of Persistent Minimal Disease Activity On Long-Term Outcomes In Psoriatic Arthritis: Results From 5 Years Of The Long Term Extension Of a Randomized, Placebo-Controlled, Study
Arthur Kavanaugh¹, Iain B. McInnes², Philip J. Mease³, Gerald G. Krueger⁴, Dafna D. Gladman⁵, Stephen Xu⁶, Linda Tang⁷ and Katrien van Beneden⁸, ¹University of California, San Diego, La Jolla, CA, ²Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ³Division of Rheumatology Research, Swedish Medical Center and University of Washington, Seattle, WA, ⁴School of Medicine, University of Utah, Salt Lake City, UT, ⁵University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁶Janssen Research & Development, LLC., Spring House, PA, ⁷Janssen Research & Development, LLC., Horsham, PA, ⁸Janssen Biologics Europe, Leiden, Netherlands
Impact of persistent minimal disease activity on long-term outcomes in psoriatic arthritis: Results from 5 years of the long term extension of a randomized, placebo-controlled,…
Abstract Number: 2339 • 2013 ACR/ARHP Annual Meeting
Patient Evaluations Of Subcutaneous Golimumab Delivery By Autoinjector (SmartJect®) For Treatment Of Rheumatoid Arthritis
H Schulze-Koops¹, R Giacomelli², W Samborski³, S Rednic⁴, M Herold⁵, R Yao⁶, M Govoni⁷, N Vastesaeger⁸ and HH Weng⁶, ¹University of Munich, Munich, Germany, ²Università degli Studi dell'Aquila, L'Aquila, Italy, ³Ortopedyczno-Rehabilitacyjny Szpital Kliniczny, Wielkopolskie, Poland, ⁴University of Medicine & Pharmacy, Cluj-Napoca, Romania, ⁵Internal Medicine VI, Medical University of Innsbruck, Innsbruck, Austria, ⁶Merck & Co., Inc., Whitehouse Station, NJ, ⁷MSD Italy, Rome, Italy, ⁸Merck Sharp & Dohme, Brussels, Belgium
Background/Purpose: Self-injection of subcutaneous (SC) golimumab (GLM) using an autoinjector device may be useful for patients with rheumatoid arthritis (RA), especially if they have functional…
Abstract Number: 1695 • 2013 ACR/ARHP Annual Meeting
Ustekinumab Is Effective In Inhibiting Radiographic Progression In Patients With Active Psoriatic Arthritis: Integrated Data Analysis Of Two Phase 3, Randomized, Placebo-Controlled Studies
Iain B. McInnes¹, Christopher T. Ritchlin², Proton Rahman³, Lluis Puig⁴, Alice B. Gottlieb⁵, Michael Song⁶, Bruce Randazzo⁶, Shu Li⁶, Yuhua Wang⁶, Alan M. Mendelsohn⁷ and Arthur Kavanaugh⁸, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ²Allergy, Immunology and Rheumatology, University of Rochester, Rochester, NY, ³Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ⁴Universitat Autònoma de Barcelona, Barcelona, Spain, ⁵Tufts Medical Center, Boston, MA, ⁶Janssen Research & Development, LLC., Spring House, PA, ⁷Immunology, Janssen Research & Development, LLC., Spring House, PA, ⁸University of California San Diego, San Diego, CA
Background/Purpose: We describe the effect of ustekinumab (UST), an IL-12/23 p40 inhibitor, on inhibition of progression of structural damage in patients with active psoriatic arthritis…
Abstract Number: 1024 • 2013 ACR/ARHP Annual Meeting
Modeling The Benefit Risk Profiles Of a New Janus Kinase Inhibitor Tofacitinib Compared Tottumour Necrosis Factor Inhibitor Biologic Treatments Incorporating Conjoint Derived Patient Preference Weights
Michael P. Ingham¹, Shannon Cartier², Raphael J. DeHoratius³, Jack McGowan⁴ and Eric Sabot², ¹Janssen Scientific Affairs, LLC, Horsham, PA, ²Optum, Eden Prairie, MN, ³Medical Affairs, Janssen Services, LLC, Horsham, PA, ⁴Janssen Services, LLC, Horsham, PA
Background/Purpose: Tofacitinib (Tofa) was recently approved in the U.S. There are no data comparing the benefit risk profile of Tofa to tumor necrosis factor inhibitors…
Abstract Number: 320 • 2013 ACR/ARHP Annual Meeting
Sustained Improvement In Health-Related Quality Of Life, Work Productivity, Employability, and Reduced Healthcare Resource Utilization Of Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Golimumab: 5-Year Results From 3 Phase III Studies
Chenglong Han¹, Arthur Kavanaugh², Mark C. Genovese³, Benjamin Hsu⁴, Atul A. Deodhar⁵ and Elizabeth C. Hsia⁴, ¹Janssen Global Services, LLC., Malvern, PA, ²University of California, San Diego, La Jolla, CA, ³Division of Rheumatology, Stanford University, Palo Alto, CA, ⁴Janssen Research & Development, LLC., Spring House, PA, ⁵Div of Arthritis & Rheum OP-09, Oregon Health & Science University, Portland, OR
Background/Purpose: To summarize changes from baseline in health-related quality of life (HRQOL), impact of disease on work productivity, employability, and healthcare resource utilization among patients…
Abstract Number: 2348 • 2013 ACR/ARHP Annual Meeting
Long Term Safety Of Intravenous Golimumab and Comparisons With Subcutaneous Golimumab In Rheumatologic Conditions: Results From The 120-Day Safety Report Of a Phase 3 Trial Of Intravenous Golimumab
Rene Westhovens¹, Clifton O. Bingham III², Michael E. Weinblatt³, Roy Fleischmann⁴, Edward C. Keystone⁵, Elizabeth C. Hsia⁶, Benjamin Hsu⁶, Lilianne Kim⁶, Surekha Mudivarthy⁶, Michael Mack⁷, Neil Goldstein⁶, Jürgen Braun⁸, Arthur Kavanaugh⁹, Alan M. Mendelsohn¹⁰ and Jonathan Kay¹¹, ¹Rheumatology, University Hospital KU Leuven, Leuven, Belgium, ²Rheumatology, Johns Hopkins University, Baltimore, MD, ³Department of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ⁴University of Texas Southwestern Medical Center, Dallas, TX, ⁵Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁶Janssen Research & Development, LLC., Spring House, PA, ⁷Biostatistics, Janssen Research & Development, LLC., Spring House, PA, ⁸PsAID taskforce, EULAR, Zurich, Switzerland, ⁹University of California San Diego, San Diego, CA, ¹⁰Immunology, Janssen Research & Development, LLC., Spring House, PA, ¹¹UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA
Background/Purpose: To describe safety profile of IV GLM in RA from the Ph3 GLM IV program. AE rates of interest are indirectly compared to…
Abstract Number: 1700 • 2013 ACR/ARHP Annual Meeting
Which Are The Most Common Disease Modifying Antirheumatic and Biologic Treatment Pathways For Rheumatoid Arthritis Patients?
Sofia Pedro¹, Frederick Wolfe¹, James O' Dell² and Kaleb Michaud³, ¹National Data Bank for Rheumatic Diseases, Wichita, KS, ²Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, ³Rheumatology, National Data Bank for Rheumatic Diseases & University of Nebraska Medical Center, Omaha, NE
Background/Purpose: While guidelines and cost effectiveness analyses assume limited pathways for RA treatment, there is little known about what occurs in clinical practice. We sought…
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…

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