ACR Meeting Abstracts

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  • Abstract Number: 1628 • 2016 ACR/ARHP Annual Meeting

    Distinct Baseline Serum Molecular Profile and Pharmacodynamic Effects of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, in Asian-Pacific Patients with Active Rheumatoid Arthritis Despite DMARD or Anti-Tnfα Therapy Across Two Global Phase 3 Trials

    Bidisha Dasgupta1, Alice Walsh1, Kristen Sweet1, Nancy Peffer1, Carol Franks1, Keying Ma1, Martin Sims2, Kim Campbell1 and Matthew Loza1, 1Janssen Research & Development, LLC, Spring House, PA, 2GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom

    Background/Purpose:  Baseline differences in rheumatoid arthritis (RA) disease characteristics and molecular profile across populations may be a reflection of genetic variations and environmental factors such…
  • Abstract Number: 1629 • 2016 ACR/ARHP Annual Meeting

    Pharmacokinetics of ABT-494 with the Once-Daily Extended-Release Tablet Formulation Being Utilized in the Ongoing Rheumatoid Arthritis Phase 3 Trials

    Mohamed-Eslam Mohamed1, Jiewei Zeng2, In-Ho Song3 and Ahmed A. Othman3, 1Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, 2AbbVie, North Chicago, IL, 3AbbVie Inc., North Chicago, IL

    Background/Purpose: ABT-494 is a selective Janus Kinase 1 inhibitor. In two Phase 2b studies in subjects with rheumatoid arthritis, 6 mg and 12 mg twice-daily…
  • Abstract Number: 1630 • 2016 ACR/ARHP Annual Meeting

    Consistent Pharmacodynamic Effects of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, on Serum Analytes Across Four Phase 3 Clinical Trials in Rheumatoid Arthritis

    Matthew Loza1, Kristen Sweet1, Nancy Peffer1, Carol Franks1, Keying Ma1, Kim Campbell1, Martin Sims2 and Bidisha Dasgupta1, 1Janssen Research & Development, LLC, Spring House, PA, 2GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom

    Background/Purpose: The efficacy of sirukumab, an anti-IL-6 cytokine antibody, was evaluated in multiple phase 3 studies in patients with rheumatoid arthritis (RA)  (SIRROUND -M, -D,…
  • Abstract Number: 1631 • 2016 ACR/ARHP Annual Meeting

    Sarilumab Dose Reduction in an Open-Label Extension Study in RA Patients

    Mark C. Genovese1, Jon Fay2, Janie Parrino2, Doris Beyer3, Melitza Iglesias-Rodriguez4, Neil Graham2, Alex Boddy3, J-Abraham Simon5, Renata Martincova6 and Gerd R. Burmester7, 1Stanford University Medical Center, Palo Alto, CA, 2Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 3Sanofi Genzyme, Bridgewater, NJ, 4Sanofi Genzyme, Cambridge, MA, 5Köhler & Milstein Research, Yucatan, Mexico, 6Sanofi Genzyme, Prague, Czech Republic, 7Charité – University Medicine Berlin, Berlin, Germany

     Background/Purpose: Sarilumab is a human mAb blocking the IL-6Rα. In the phase 3 MOBILITY (NCT01061736) and TARGET (NCT01709578) studies, sarilumab (150 or 200 mg subcutaneously…
  • Abstract Number: 1632 • 2016 ACR/ARHP Annual Meeting

    Efficacy and Safety of Sarilumab in Subgroups of Patients with Rheumatoid Arthritis from 2 Phase 3 Studies

    Mark C. Genovese1, Roy Fleischmann2, Erin Mangan3, Janet van Adelsberg4, Melitza Iglesias-Rodriguez5, Deborah Dukovic6, Chunpeng Fan7 and Tom WJ Huizinga8, 1Stanford University Medical Center, Palo Alto, CA, 2Medicine, University of Texas Southwestern Medical Center, Dallas, TX, 3Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 4Clinical Science, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 5Sanofi Genzyme, Cambridge, MA, 6Sanofi Genzyme, Bridgewater, NJ, 7Biostatistics, Sanofi Genzyme, Bridgewater, NJ, 8Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: Sarilumab is a human mAb blocking the IL-6Rα. Efficacy of sarilumab + MTX was demonstrated in patients with RA and inadequate response to MTX…
  • Abstract Number: 1633 • 2016 ACR/ARHP Annual Meeting

    Clinical and Radiographic Outcomes after 3 Years of Sarilumab in Patients with Rheumatoid Arthritis

    Désirée van der Heijde1, Janet van Adelsberg2, Hubert van Hoogstraten3, Melitza Iglesias-Rodriguez4, Erin Mangan5, Neil Graham5, Deborah Dukovic3, Alberto Spindler6 and Mark C. Genovese7, 1Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2Clinical Science, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 3Sanofi Genzyme, Bridgewater, NJ, 4Sanofi Genzyme, Cambridge, MA, 5Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 6Rheumatology, Universidad Nacional Tucumán, Yerba Buena Tucuman, Argentina, 7Stanford University Medical Center, Palo Alto, CA

    Background/Purpose: Sarilumab is a human mAb blocking the IL-6Rα. Sarilumab + MTX demonstrated significant improvements in RA signs and symptoms, physical function, and inhibition of…
  • Abstract Number: 1634 • 2016 ACR/ARHP Annual Meeting

    Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks

    Chang-Hee Suh1, Alfredo Berrocal Kasay2, Elias Chalouhi El-Khouri3, Pedro Miranda4, Ljubinka Bozic Majstorovic5, Slawomir Jeka6, Pawel Hrycaj7, Dmytro Rekalov8, Piotr Wiland9, Andreas Krause10, Istvan Szombati11, Anna Mihailova12, Ihor Hospodarskyy13, Mariusz Piotrowski14, Seong-Ryul Kwon15, Eun-Young Lee16, Dae-Hyun Yoo17, Won Park18, Seung-Cheol Shim19, Sang-Joon Lee20 and Taek S. Kwon20, 1Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, The Republic of, 2ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, 3Clinica Internacional, Lima, Peru, 4Centro De Estudios Reumatológicos, Santiago, Chile, 5Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, 6Department of Rheumatology and Connective Tissue Diseases, 2nd University Hospital, CM UMK, Bydgoszcz, Poland, 7Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, 8Department of Internal Diseases, Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine, 9Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckigo, Wroclaw, Poland, 10Medical Centre for Rheumatology Berlin-Buch, Immanuel Krankenhaus Berlin, Berlin, Germany, 11QUALICLINIC Kft., Budapest, Hungary, 12Orto clinic Ltd., Riga, Latvia, 13Ternopil State Medical University, Ternopil, Ukraine, 14Rheumatology and Connective Tissue Diseases, Medical University of Lublin, Poland, Lublin, Poland, 15Internal Medicine/Rheumatology, Inha University Hospital, Incheon, South Korea, 16Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea, The Republic of, 17Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 18Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, 19Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, 20CELLTRION, Inc., Incheon, South Korea

    Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Result from Phase 3…
  • Abstract Number: 1635 • 2016 ACR/ARHP Annual Meeting

    Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks

    Dae-Hyun Yoo1, Ljubinka Bozic Majstorovic2, Alfredo Berrocal Kasay3, Elias Chalouhi El-Khouri4, Fedra Irazoque-Palazuelos5, Francisco Cons Molina6, Pedro Miranda7, Pavel Shesternya8, Francisco G. Medina-Rodriguez9, Piotr Wiland10, Slawomir Jeka11, Olena Garmish12, Pawel Hrycaj13, Dmytro Rekalov14, Natalia Fomina15, Devy Zisman16, Yong-Beom Park17, Young Mo Kang18, Chang-Hee Suh19, Seung Cheol Shim20, Sang Joon Lee21, Sung Young Lee22 and Won Park23, 1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 2Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, 3ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, 4Clinica Internacional, Lima, Peru, 5Centro de Invstigacion y Tratamiento Reumatologico S.C, Mexico City, Mexico, 6Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, 7Centro De Estudios Reumatológicos, Santiago, Chile, 8State Budgetary Educational Institution of High Professional Education "Krasnoyarsk state medical university n.a. professor V.F.Voino-Yasenetsky" Ministry of Health of Russian Federation, Krasnoyarsk, Russian Federation, 9Biologics Especializados SA, Mexico City, Mexico, 10Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckigo, Wroclaw, Poland, 11Department of Rheumatology and Connective Tissue Diseases, 2nd University Hospital, CM UMK, Bydgoszcz, Poland, 12Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, 13Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, 14Department of Internal Diseases, Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine, 15Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, 16The Lady Davis, Haifa, Israel, 17Dept of Internal Medicine, Severance Hospital, Seoul, Korea, The Republic of, 18Division of Rheumatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea, Republic of, 19Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, The Republic of, 20Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, 21CELLTRION, Inc., Incheon, South Korea, 22Clinical Planning Department, CELLTRION, Inc., Incheon, South Korea, 23Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea

    Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Result from Phase 3 Randomized Controlled Trial over 24…
  • Abstract Number: 1636 • 2016 ACR/ARHP Annual Meeting

    Decrease of Tocilizumab in Rheumatoid Arthritis in Remission : A Multicenter Study

    Renaud DESBARBIEUX, 59037, CHRU de Lille, Lille, France

    Background/Purpose:  The advent of biological therapies in rheumatoid arthritis has significantly reduced the activity of rheumatoid arthritis, leading to obtaining a remission in a significant…
  • Abstract Number: 1637 • 2016 ACR/ARHP Annual Meeting

    Real-World Use of Tofacitinib in Rheumatoid Arthritis: Data from the Swiss Clinical Quality Management RA Registry

    Diego Kyburz1, Myriam Riek2, Lisa Herzog3, Almut Scherer3, Cem Gabay4, Jean Dudler5, Pascal Zufferey6 and Axel Finckh7, 1Department of Biomedicine, Experimental Rheumatology, University of Basel, 4051 Basel, Switzerland, 2SCQM foundation, zurich, Switzerland, 3SCQM Foundation, Zurich, Switzerland, 4Rheumatology, Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland, 5Rheumatology, HFR Fribourg - Hôpital Cantonal, Fribourg, Switzerland, 6Department of Rheumatology, University Hospital Lausanne, Lausanne, Switzerland, 7Rheumatology Division, University Hospital of Geneva, Geneva, Switzerland

    Background/Purpose: The oral Janus kinase inhibitor Tofacitinib (Tofa) has been licensed in Switzerland 2013 for the treatment of patients with moderate to severe rheumatoid arthritis…
  • Abstract Number: 1638 • 2016 ACR/ARHP Annual Meeting

    Antibody Mediated Immunity Drives Response to Methotrexate Treatment in Rheumatoid Arthritis Patients

    Boel Brynedal1, Helga Westerlind2, Lasse Folkersen3,4, Leonid Padyukov5, Nancy Vivar5, Anca I Catrina6, Lars Klareskog5 and Louise Berg5, 1Section of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Karolinska, Sweden, 2Section of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, 3Department of Medicine, Karolinska Institutet, Stockholm, Sweden, 4Department of Systems Biology, Technical University of Denmark, Lyngby, Denmark, 5Rheumatology Unit, Department of Medicine, Karolinska Institutet and Karolinska Hospital, Stockholm, Sweden, 6Rheumatology Unit, Department of Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden

    Background/Purpose: Methotrexate (MTX) is the first line treatment for Rheumatoid Arthritis (RA) in Sweden, but one third of patients do not experience satisfying treatment response.…
  • Abstract Number: 1639 • 2016 ACR/ARHP Annual Meeting

    Interchangeability of Innovator Rituximab and Its Biosimilar: Results from International Controlled Comparative 1-Year Study in Patients with Active Rheumatoid Arthritis

    Eugeniy Nasonov1, Vadim Mazurov2, Tatiana Plaksina3, Olga Nesmeyanova4, Larisa Knyazeva5, Anna Eremeeva6, Ekaterina Chernyaeva6 and Roman Ivanov6, 1Scientific Institute of Rheumatology named after Nasonova V.M., Moscow, Russian Federation, 2North-West State Medical University named after I.I.Mechnikov, Saint Petersburg, Russian Federation, 3Nizhegorodskaya Regional Hospital, Nizhniy Novgorod, Russian Federation, 4Chelyabinskaya Regional Hospital, Chelyabinsk, Russia, 5Kursk State Medical University, Kursk, Russian Federation, 6JSC BIOCAD, Saint Petersburg, Russian Federation

    Background/Purpose:  Development of biosimilar monoclonal antibodies should not be limited by evaluation of quality, efficacy and safety in comparison with innovator biological product. Interchangeability assessment…
  • Abstract Number: 1640 • 2016 ACR/ARHP Annual Meeting

    Effect of BMI on Baricitinib Efficacy: Pooled Analysis from Two Phase 3 Rheumatoid Arthritis Clinical Trials

    Cristiano A.F Zerbini1, David Muram2, Vipin K. Arora2, Jahangir Alam2 and Jeffrey R. Curtis3, 1Centro Paulista de Investigação Clinica, São Paulo, Brazil, 2Eli Lilly and Company, Indianapolis, IN, 3Division Clinical Immunology & Rheumatology, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose : The efficacy of some rheumatoid arthritis (RA) therapies is reduced among patients with high BMI. This analysis assessed the effects of baseline BMI…
  • Abstract Number: 1641 • 2016 ACR/ARHP Annual Meeting

    Survival of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis

    Zulema Rosales Rosado1,2, Leticia León1, Dalifer Freites Núñez2, Judit Font Urgelles2, Cynthia Milagros León Cárdenas2, Cristina Vadillo Font2, Luis Rodriguez Rodriguez1, Juan A Jover Jover2 and Lydia Abásolo Alcázar1, 1Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain, 2Rheumatology, Hospital Clínico San Carlos, Madrid, Spain

    Background/Purpose:  After more than twenty years using Disease Modifying Drugs (DMARDs) is widely known their efficacy in the treatment of Rheumatoid Arthritis (RA) but it…
  • Abstract Number: 1642 • 2016 ACR/ARHP Annual Meeting

    Pharmacokinetic-Pharmacodynamic Analysis of GS-4059-Mediated Bruton’s Tyrosine Kinase Inhibition

    Justin D. Lutz1, Cara Nelson2, Helen Yu2, Albert Liclican2, Joy Feng2, Andrew Billin2, Brian E. Schultz2, Mark Bresnik2 and Anita Mathias2, 1Department of Clinical Pharmacology, Gilead Sciences, Foster City, CA, 2Gilead Sciences, Foster City, CA

    Background/Purpose: GS-4059 is a covalent inhibitor of Bruton’s Tyrosine Kinase (BTK) under development for the treatment of rheumatoid arthritis (RA) and oncology. This work aimed…
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