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  • Abstract Number: 1319 • 2012 ACR/ARHP Annual Meeting

    Certolizumab Pegol Plus Methotrexate Is Similarly Effective in Active Rheumatoid Arthritis  Secondary Non-Responders to Anti-TNF Inhibitors: Post-Hoc Analysis of a Phase Iiib Trial

    Daniel Furst1, Saeed A. Shaikh2, Maria W. Greenwald3, Michael H. Schiff4, Barbara Bennett5, Owen Davies6, Fabienne Staelens7, Will Koetse8 and Philippe Bertin9, 1David Geffen School of Medicine, Div of Rheumatology, University of California at Los Angeles, Los Angeles, CA, 2Medicine, McMaster University, St Catharines, ON, Canada, 3Desert Medical Advances, Palm Desert, CA, 4Rheumatology Division, University of Colorado, Denver, CO, 5BABennett Consulting, LLC, Marietta, GA, 6UCB Pharma, Slough, United Kingdom, 7UCB Pharma, Brussels, Belgium, 8UCB Pharma, Rtp, NC, 9Service De Rhumatologie, Dupuytren Hospital, Limoges, France

    Background/Purpose: Certolizumab pegol (CZP) has demonstrated efficacy in patients (pts) with prior TNF inhibitor exposure.1 In the Doseflex trial two maintenance dosing regimens of CZP…
  • Abstract Number: 1320 • 2012 ACR/ARHP Annual Meeting

    Sarilumab, a Subcutaneously-Administered, Fully-Human Monoclonal Antibody Inhibitor of the IL-6 Receptor: Effects On Hemoglobin Levels in a Clinical Trial for the Treatment of Moderate-to-Severe Rheumatoid Arthritis

    Mark C. Genovese1, Roy Fleischmann2, Martine Jasson3, Allen R. Radin4, Jennifer Hamilton5 and Tom W.J. Huizinga6, 1Division of Rheumatology, Stanford University, Palo Alto, CA, 2Southwestern Medical Center at Dallas, University of Texas, Dallas, TX, 3Clinical Development, Sanofi-Aventis, Paris, France, 4Translational Medicine, Regeneron Pharmaceuticals Inc, Tarrytown, NY, 5Predictive Medicine, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 6Rheumatology, Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: Anemia of chronic disease, a common extra-articular manifestation of rheumatoid arthritis (RA), which has a substantial impact on patient function, is driven in part…
  • Abstract Number: 1321 • 2012 ACR/ARHP Annual Meeting

    C-Type Lectin Domain Family 4, Member C Gene Expression Level Helps Predict Future Clinical Response to Tabalumab Blockade of B Cell Activating Factor in Rheumatoid Arthritis

    Ernst R. Dow1, Poulabi Banerjee2, Michelle A. Penny1, Eric P. Nantz2, Sergey Stepaniants3, Anne Ho3, Wendy J. Komocsar2, Pierre-Yves Berclaz2 and Robert W. Hoffman1, 1Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, 2Eli Lilly and Company, Indianapolis, IN, 3Covance Genomics Laboratory LLC, Seattle, WA

    Background/Purpose: Patients with rheumatoid arthritis (RA) exhibit substantial variability in both the magnitude and duration of their clinical response to treatment.  Despite considerable research, no…
  • Abstract Number: 1322 • 2012 ACR/ARHP Annual Meeting

    Coadministration of ASP015K, a Novel Janus Kinase Inhibitor with Methotrexate Demonstrates Tolerability and Lack of Pharmacokinetic Interactions in Patients with Rheumatoid Arthritis

    Tong Zhu1, Kazuo Oda2, Udaya Valluri1, Bogie Moore1, Ying Cao1, Vishala Chindalore3 and Bola Akinlade4, 1Astellas Pharma Global Development, Inc., Northbrook, IL, 2Drug Metabolism Research Labs. Drug Discovery Research, Astellas Pharma Inc., Osaka, Japan, 3Pinnacle Research Group/Anniston Medical Clinic, Anniston, AL, 4Immunology Development, Astellas Pharma Global Development, Inc., Northbrook, IL

    Background/Purpose: ASP015K is an oral Janus kinase (JAK) inhibitor with selectivity for JAK1/3 in development for treatment of rheumatoid arthritis (RA) and other autoimmune diseases.…
  • Abstract Number: 1323 • 2012 ACR/ARHP Annual Meeting

    Effects of Dose Escalation of Tocilizumab in Combination with Nonbiologic Disease-Modifying Antirheumatic Drugs: Sub-Analysis of a 24-Week Study in a United States Population

    M. E. Weinblatt1, Herbert S. B. Baraf2, Ara H. Dikranian3, Andrew M. Anisfeld4, Jenny Devenport4 and Sheldon Cooper5, 1Rheumatology & Immunology, Brigham & Women's Hospital, Boston, MA, 2Arthritis & Rheumatism Associates, Wheaton, MD, 3San Diego Arthritis Medical Clinic, San Diego, CA, 4Genentech, South San Francisco, CA, 5Rheum & Clinical Imm Unit, Univ Vermont College of Med, Burlington, VT

    Background/Purpose: In the US, the recommended starting dose of Tocilizumab (TCZ) is 4 mg/kg (q4w) with an increase to 8 mg/kg (q4w) based on clinical…
  • Abstract Number: 1324 • 2012 ACR/ARHP Annual Meeting

    Golimumab, A Human Anti-TNF Monoclonal Antibody, Administered Subcutaneously Every Four Weeks As Monotherapy in Patients with Active Rheumatoid Arthritis Despite Disease Modifying Antirheumatic Drug Therapy: Week 104 Results of Clinical, Radiographic and Safety Assessments

    Tsutomu Takeuchi1, Masayoshi Harigai2, Yoshiya Tanaka3, Hisashi Yamanaka4, Naoki Ishiguro5, Kazuhiko Yamamoto6, Minoru Kanazawa7, Yoshinori Murakami8, Toru Yoshinari9, Daniel Baker10, Nobuyuki Miyasaka11 and Takao Koike12, 1Keio University School of Medicine, Tokyo, Japan, 2Dept of Pharmacovigilance, Tokyo Medical and Dental University, Tokyo, Japan, 3The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 4Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 5Department of Orthopedic Surgery, Nagoya University, Graduate School & Faculty of Medicine, Nagoya, Aichi, Japan, 6Department of Allergy & Rheumatology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan, 7Director of Respiratory Center Professor of Respiratory, Medicine Saitama Medical University, Moroyama, Iruma-Gun, Saimata, Japan, 8Medical writing, Janssen Pharmaceutical KK, Tokyo, Japan, 92-6-18, Kitahama, Chuo-ku, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan, 10Janssen Research & Development, LLC., Spring House, PA, 11Department of Medicine and Rheumatology and Global Center of Excellence Program, Tokyo Medical and Dental University, Tokyo, Japan, 12Sapporo medical center NTT EC, Sapporo, Japan

    Golimumab, A Human Anti-TNF Monoclonal Antibody, Administered Subcutaneously Every Four Weeks as Monotherapy in Patients with Active Rheumatoid Arthritis Despite Disease Modifying Antirheumatic Drug Therapy:…
  • Abstract Number: 1325 • 2012 ACR/ARHP Annual Meeting

    Prevention of Joint Destruction in Patients with High Disease Activity or High C-Reactive Protein

    Yoshiya Tanaka1, Masayoshi Harigai2, Tsutomu Takeuchi3, Hisashi Yamanaka4, Naoki Ishiguro5, Kazuhiko Yamamoto6, Yutaka Ishii7, Daniel Baker8, Nobuyuki Miyasaka9 and Takao Koike10, 1The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, 2Dept of Pharmacovigilance, Tokyo Medical and Dental University, Tokyo, Japan, 3Keio University School of Medicine, Tokyo, Japan, 4Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 5Department of Orthopedic Surgery, Nagoya University, Graduate School & Faculty of Medicine, Nagoya, Aichi, Japan, 6Department of Allergy & Rheumatology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan, 7Medical Affaires, Janssen Pharmaceutical K.K, Tokyo, Japan, 8Janssen Research & Development, LLC., Spring House, PA, 9Department of Medicine and Rheumatology and Global Center of Excellence Program, Tokyo Medical and Dental University, Tokyo, Japan, 10Sapporo medical center NTT EC, Sapporo, Japan

    Prevention of Joint Destruction in Patients with High Disease Activity or High C-reactive proteinBackground/Purpose: In Japan, 2 doses (50mg and 100mg) of golimumab (GLM) were…
  • Abstract Number: 1326 • 2012 ACR/ARHP Annual Meeting

    Efficacy of Different Biologic Agents for Improving Physical Function As Measured by the Health Assessment Questionnaire: A Meta-Analysis with Indirect Comparisons

    Lillian J. Barra1, Andrew Ha2, Louise Sun3, Catarina Fonseca4 and Janet E. Pope5, 1Medicine, Division of Rheumatology, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada, 2The University of Toronto, Toronto, ON, Canada, 3University of Ottawa, Ottawa, ON, Canada, 4Universidade de Lisboa, Lisbon, Portugal, 5Medicine, Divsion of Rheumatology, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada

    Background/Purpose:   The Health Assessment Questionnaire (HAQ) is a patient-centred, validated measure of physical function. It is predictive for disability, morbidity and mortality. The efficacy…
  • Abstract Number: 1327 • 2012 ACR/ARHP Annual Meeting

    Comparison of Four Different Intensive Treatment Strategies in Patients with Early Rheumatoid Arthritis in Korea

    Mi-Il Kang, Yoon Kang, Hee-Jin Park, Hyang-Sun Lee, Sang-Won Lee, Yong-Beom Park and Soo-Kon Lee, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea

    Background/Purpose:  The previous studies reported that intensive treatment-strategies, including biological agents and glucocorticoids, can improve the severity of early rheumatoid arthritis. However, there was no…
  • Abstract Number: 1328 • 2012 ACR/ARHP Annual Meeting

    The Higher and Faster Increasing Schedule of Methotrexate May Not Be the Best: The Accumulation of Intracellular Longer Chain Methotrexate Polyglutamates Was Facilitated by the Extra-Low-Dose Methotrexate Treatment

    Yoshinobu Koyama1, Kazunori Hase2, Daisuke Hidaka2, Shuji Nagano3, Toshiyuki Ota3 and Ayumi Uchino2, 1Division of Rheumatology, Okayama Red Cross General Hospital, Okayama, Japan, 2Iizuka Hospital, Iizuka, Japan, 3Center for Rheumatic Diseases, Iizuka Hospital, Iizuka, Japan

    Background/Purpose: Although data are conflicting with regard to the clinical utility of MTX polyglutamates (PGs) measurements as a predictor of the efficacy or toxicity in…
  • Abstract Number: 1329 • 2012 ACR/ARHP Annual Meeting

    Differential Effect of 4 and 8 Mg/Kg Tocilizumab in Combination with Methotrexate On Serum Biomarkers of Cartilage, Connective Tissue and Bone Turnover

    Anne C. Bay-Jensen1, Inger Byrjalsen2, Andrew Kenwright3, Thierry Sornasse4, Claus Christiansen5 and Morten Asser Karsdal6, 1Cartilage Biomarkers and Research, Nordic Bioscience, Herlev, Denmark, 2Research & Development, Nordic Bioscience, Herlev, Denmark, 3Roche, Welwyn Garden City, United Kingdom, 4Genentech, South San Francisco, 5CCBR, Ballerup, Denmark, 6Nordic Bioscience A/S, Herlev, Denmark

    Background/Purpose: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by poly-articular inflammation, cartilage loss, synovial inflammation, subchondral bone erosion, and joint space narrowing. In…
  • Abstract Number: 1330 • 2012 ACR/ARHP Annual Meeting

    High Body Mass Index Is Associated with Decreased Response to Initial Combination Therapy in Recent Onset RA Patients

    Marianne van den Broek1, L. Heimans2, S. le Cessie3, B. Siegerink3, H.K Ronday4, K.H. Han5, P.J.S.M. Kerstens6, T.W.J. Huizinga2, W.F. Lems7 and C.F. Allaart2, 1Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 3Medical statistics and Epidemiology, Leiden University Medical Center, Leiden, Netherlands, 4Rheumatology, Haga Hospital, The Hague, Netherlands, 5Rheumatology, MCRZ hospital, Rotterdam, Netherlands, 6Rheumatology, Jan van Breemen Research Institute | Reade, Amsterdam, Netherlands, 7Rheumatology, VU University medical center, Amsterdam, Netherlands

    High BMI is associated with decreased response to initial combination therapy in recent onset RA patients Background/Purpose: A diminished response to combination treatment with a fixed…
  • Abstract Number: 1331 • 2012 ACR/ARHP Annual Meeting

    Once Daily High Dose Regimens of GLPG0634 in Healthy Volunteers Are Safe and Provide Continuous Inhibition of JAK1 but Not JAK2

    Florence Namour1, René Galien1, Lien Gheyle2, Frédéric Vanhoutte3, Béatrice Vayssière1, Annegret Van der Aa3, Bart Smets3 and Gerben van 't Klooster3, 1Galapagos SASU, Romainville, France, 2SGS Clinical Pharmacology Unit, Antwerp, Belgium, 3Galapagos NV, Mechelen, Belgium

    Background/Purpose: GLPG0634 is an orally-available, selective inhibitor of Janus kinase 1 (JAK1) with an IC50 of 0.6 μM and a 30-fold selectivity over JAK2 in…
  • Abstract Number: 1332 • 2012 ACR/ARHP Annual Meeting

    The Incidence of Exacerbation of Pre-Existing Interstitial Lung Disease (ILD) Is Higher in TNF Blockers Than in Non-TNF Blockers in RA

    Tamao Nakashita1, Shinji Motojima2, Natsuki Fujio2 and Akira Jibatake3, 1Department of Rheumatology and Allergy, Kameda Medical Center, Kamogawa City, Japan, 2Department of Rheumatology and Allergy, Kameda Medical Center, Kamogawa city, Japan, 3Depertment of Rheumatology and Allergy, Kameda Medical Center, Kamogawa city, Japan

    Background/Purpose: Exacerbation of interstitial lung disease (ILD) is a problem when biologics are administrated in patients with RA, and not a few fatal cases have…
  • Abstract Number: 1333 • 2012 ACR/ARHP Annual Meeting

    The Predictive Value of CD64 Counts for Infectious Disease in Patients Treated with Tocilizumab On the Infectious Disease Risk Management Cohort (ACT4U-study)

    Atsushi Ihata1, Hiroyuki Hagiyama2, Shouhei Nagaoka3, Junichi Obata4, Kiyomitsu Miyachi5, Hidehiro Yamada6, Shunsei Hirohata7, Norihiko Koido8, Masaomi Yamasaki9, Kenichi Miyagi10, Shigeru Ohno11, Daiga Kishimoto1, Reikou Watanabe1, Takeaki Uehara12, Kaoru Takase1, Maasa Hama1, Ryusuke Yoshimi1, Atsuhisa Ueda1, Mitsuhiro Takeno1 and Yoshiaki Ishigatsubo1, 1Department of Internal Medicine and Clinical Immunology, Yokohama City University Graduate School of Medicine, Yokohama, Japan, 2Department of Rheumatology, Yokohama-city Bay Red Cross Hospital, Yokohama, Japan, 3Department of Rheumatology, Yokohama Minami Kyousai Hospital, Yokohama, Japan, 4Hikarichuo Clinic, Kawasaki, Japan, 5Keigu Clinic, Kawasaki, Japan, 6Internal Medicine, St. Marianna University, Kawasaki, Japan, 7Int Med/Rheumatol & Infec Dis, Kitasato University School of Medicine, Sagamihara, Japan, 8Kawasaki Rheumatism & Internal Medecine Clinic, Kawasaki, 9Internal Medicine, St Marianna University, Yokohama City Seibu Hospital, Yokohama, Japan, 10Miyagi Naika Clinic, Yokohama, 11Center for Rheumatic Diseases, Yokohama City University Medical Center, Yokohama, Japan, 12Department of Rheumatology, Chigasaki Municipal Hospital, Chigasaki, Japan

    Background/Purpose: An administration of tocilizumab (TCZ) rapidly suppresses inflammatory markers such as CRP and ESR, which makes the diagnosis of infection difficult. There is a…
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