Abstracts Archive - Page 1708 of 2607 - ACR Meeting Abstracts

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 Folkersen^3,4, 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 Rosado^1,2, 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…
Abstract Number: 1643 • 2016 ACR/ARHP Annual Meeting
Tofacitinib: Treatment Outcomes in Seropositive Versus Seronegative Patients in a Phase 3 RA Population
Paul Bird¹, Stephen Hall², Peter Nash³, Carol A Connell⁴, Kenneth Kwok⁵, David Witcombe⁶ and Krishan Thirunavukkarasu⁶, ¹University of New South Wales, Sydney, Australia, Sydney, NSW, Australia, ²Cabrini Health and Monash University, Melbourne, VIC, Australia, ³Department of Medicine, University of Queensland, Brisbane, QLD, Australia, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc, New York, NY, ⁶Pfizer Australia, Sydney, NSW, Australia
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This study examined response to treatment with tofacitinib 5 mg or 10…
Abstract Number: 1644 • 2016 ACR/ARHP Annual Meeting
Dose Selection of Filgotinib, a Selective JAK1 Inhibitor, for Rheumatoid Arthritis Phase 3 Studies: Exposure-DAS28 and ACR Modeling Approach
Namour Florence¹, Paul Diderichsen², Eugène Cox², Shringi Sharma³ and Chantal Tasset⁴, ¹Galapagos SASU, Romainville, France, ²Quantitative Solutions-Certara, Breda, Netherlands, ³Gilead Sciences, Foster City, CA, ⁴Galapagos NV, Mechelen, Belgium
Background/Purpose: Filgotinib is an oral, selective Janus kinase 1 (JAK1) inhibitor showing good efficacy and safety in Phase 2B studies in rheumatoid arthritis (RA) patients. The…
Abstract Number: 1645 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of ASP5094, an Anti-Alpha-9-Integrin Monoclonal Antibody, Following Single Intravenous Doses in Healthy Subjects
Tianli Wang¹, Christopher Lademacher², Paul Blahunka², Corrie Howieson², Txheng Yang², Tomasz Wojtkowski², Mina Kikuchi² and Robert Townsend², ¹Clinical Pharmacology and Exploratory Development, Astellas Pharma Global Development, Inc., Northbrook, IL, ²Astellas Pharma Global Development, Inc., Northbrook, IL
Background/Purpose: ASP5094 is a recombinant humanized anti-alpha-9 integrin IgG1 monoclonal antibody (mAb) under development for the treatment of rheumatoid arthritis. This first-in-human placebo‑controlled single ascending‑dose…
Abstract Number: 1646 • 2016 ACR/ARHP Annual Meeting
Discontinuation of Methotrexate or Glucocorticoids in Patients with Rheumatoid Arthritis Treated with Tofacitinib: Clinical Efficacy Data from Long-Term Extension Studies
Roy Fleischmann¹, Jürgen Wollenhaupt², Stanley Cohen¹, Michael Weinblatt³, Lisy Wang⁴, Haiyun Fan⁵, John Andrews⁶, Liza Takiya⁵ and Eustratios Bananis⁵, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ³Brigham and Women’s Hospital, Boston, MA, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc, Collegeville, PA, ⁶Pfizer Inc, New York, NY
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. In a post-hoc analysis of the tofacitinib RA long-term extension (LTE) studies,…

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