ACR Meeting Abstracts

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  • Abstract Number: 505 • 2019 ACR/ARP Annual Meeting

    Low-grade Total Rheumatoid Arthritis MRI Scoring System Can Predict Successful Half-dose Reduction of MTX in Patients with RA in Clinical Remission

    Takeshi Suzuki1, Marina Uchida 2, Shoshi Shinagawa 2, Machiko Mizushima 3, Takayasu Ando 3, Yutaka Gotou 3, Tomohiko Shibata 2 and Kimito Kawahata 4, 1Division of Rheumatology and Allergology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan, 2Division of Rheumatology, Department of Internal Medicine, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Kanagawa, Japan, 3Division of Rheumatology and Allergology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan, 4Rheumatology and Allergology, St. Marianna University School of Medicine, Tokyo, Japan

    Background/Purpose: It has been recommended that tapering csDMARDs should be considered if a patient is in persistent remission. However, methods for tapering csDMARDs, including MTX,…
  • Abstract Number: 506 • 2019 ACR/ARP Annual Meeting

    Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: FINCH1 Primary Outcome Results

    Bernard Combe1, Alan Kivitz 2, Yoshiya Tanaka 3, Désirée van der Heijde 4, Franziska Matzkies 5, Beatrix Bartok 5, Lei Ye 5, Ying Guo 5, Chantal Tasset 6, John Sundy 5, Neelufar Mozaffarian 5, Robert B.M. Landewé 7, Sang-Cheol Bae 8, Edward Keystone 9 and Peter Nash 10, 1CHU Montpellier, Montpellier University, Montpellier, France, 2Altoona Center for Clinical Research, Duncansville, PA, 3University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 4Leiden University Medical Center, Leiden, Netherlands, 5Gilead Sciences, Inc., Foster City, CA, 6Galapagos NV, Mechelen, Belgium, 7Amsterdam University Medical Center, Amsterdam, Netherlands, 8Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 9Mount Sinai Hospital and University of Toronto, Toronto, ON, Canada, 10University of Queensland, Brisbane, Queensland, Australia

    Background/Purpose: Filgotinib (FIL) is an orally administered, potent and selective inhibitor of Janus kinase 1 (JAK1) that has shown good efficacy and was well tolerated…
  • Abstract Number: 507 • 2019 ACR/ARP Annual Meeting

    Inhibition of Joint Destruction in Patients with Rheumatoid Arthritis Treated with Peficitinib in Combination with Methotrexate: A Randomized, Double-Blind, Placebo-Controlled Trial in Japan

    Tsutomu Takeuchi1, Yoshiya Tanaka 2, Mitsuhiro Rokuda 3, Hiroyuki Izutsu 3, Yuichiro Kaneko 3, Musashi Fukuda 3, Daisuke Kato 3 and Désirée van der Heijde 4, 1Keio University School of Medicine, Tokyo, Japan, 2University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 3Astellas Pharma, Inc., Tokyo, Japan, 4Leiden University Medical Center, Leiden, Netherlands

    Background/Purpose: Peficitinib (PEF), a novel oral Janus kinase (JAK) inhibitor, has demonstrated efficacy in Phase 3 studies of patients with RA (NCT02305849).1 We report the…
  • Abstract Number: 508 • 2019 ACR/ARP Annual Meeting

    Longer Term Safety and Efficacy of Peficitinib in Patients with Rheumatoid Arthritis After 22.7 Months Mean Treatment Exposure: Interim Data from a Long-Term, Open-Label Extension Study in Japan, Korea and Taiwan

    Tsutomu Takeuchi1, Yoshiya Tanaka 2, Sakae Tanaka 3, Atsushi Kawakami 4, Yeong-Wook Song 5, Yi-Hsing Chen 6, Mitsuhiro Rokuda 7, Hiroyuki Izutsu 7, Satoshi Ushijima 7, Yuichiro Kaneko 7, Yoshihiro Nakashima 7, Teruaki Shiomi 7 and Emi Yamada 7, 1Keio University School of Medicine, Tokyo, Japan, 2University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 3University of Tokyo, Tokyo, Japan, 4Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan, 5Seoul National University Hospital, Seoul, Republic of Korea, 6Taichung Veterans General Hospital, Taichung, Taiwan (Republic of China), 7Astellas Pharma, Inc., Tokyo, Japan

    Background/Purpose: Peficitinib, a novel oral Janus kinase (JAK) inhibitor, demonstrated efficacy and an acceptable safety profile in a Phase 2b study (RAJ1 study, NCT01649999) and…
  • Abstract Number: 509 • 2019 ACR/ARP Annual Meeting

    Safety Profile of Upadacitinib in Rheumatoid Arthritis: Integrated Analysis from the SELECT Phase 3 Clinical Program

    Stanley Cohen1, Ronald van Vollenhoven 2, Kevin Winthrop 3, Cristiano A. Zerbini 4, Yoshiya Tanaka 5, Louis Bessette 6, Ying Zhang 7, Nasser Khan 8, Barbara Hendrickson 7, Jose Jeffrey Enejosa 7 and Gerd Burmester 9, 1Metroplex Clinical Research Center, Dallas, TX, 2Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, 3Oregon Health and Science University, Portland, OR, 4Centro Paulista de Investigação Clinica, São Paulo, Brazil, 5University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 6Laval University, Quebec City, QC, Canada, 7AbbVie Inc., North Chicago, IL, USA, North Chicago, IL, 8Abbvie Inc, North Chicago, IL, 9Charité—University Medicine Berlin, Berlin, Germany

    Background/Purpose: Upadacitinib (UPA), an oral JAK1-selective inhibitor, was evaluated in a comprehensive clinical program of 5 pivotal Phase 3 randomized-controlled trials (RCTs) across the full…
  • Abstract Number: 510 • 2019 ACR/ARP Annual Meeting

    Treatment with Upadacitinib Is Associated with Improvements in Reverse Cholesterol Transport in Patients with Rheumatoid Arthritis: Correlation with Changes in Inflammation and HDL Levels

    Christina Charles-Schoeman1, Thierry Sornasse 2 and Jeremy Sokolove 2, 1University of California, Los Angeles, CA, 2AbbVie Immunology Clinical Development, Redwood City

    Background/Purpose: Rheumatoid arthritis (RA) is a systemic inflammatory condition associated with increased rates of atherosclerotic progression via pathogenic remodeling of high-density lipoprotein (HDL)-associated proteins, resulting…
  • Abstract Number: 511 • 2019 ACR/ARP Annual Meeting

    A Comparative Analysis of Upadacitinib Monotherapy and Upadacitinib Combination Therapy for the Treatment of Rheumatoid Arthritis from Two Phase 3 Trials

    Maya H. Buch1, Alvin F. Wells 2, Andrea Rubbert-Roth 3, Manish Jain 4, Casey Schlacher 5, Heidi Camp 5, Yihan Li 5, Yanna Song 6 and Peter Nash 7, 1University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, 2Rheumatology and Immunotherapy Center, Franklin, 3Kantonsspital St. Gallen, St Gallen, Switzerland, 4Rheumatology, Great Lakes Clinical Trials, Great Lakes, 5AbbVie Inc., North Chicago, IL, 6AbbVie Inc., North Chicago, IL, USA, North Chicago, 7University of Queensland, Brisbane, Queensland, Australia

    Background/Purpose: Upadacitinib (UPA), a selective JAK1 inhibitor, has demonstrated efficacy and safety in patients with rheumatoid arthritis (RA) as monotherapy and in combination with conventional…
  • Abstract Number: 512 • 2019 ACR/ARP Annual Meeting

    Efficacy and Safety of Upadacitinib Monotherapy in MTX-naïve Patients with Early Active RA Receiving Treatment Within 3 Months of Diagnosis: A Post-hoc Analysis of the SELECT-EARLY

    Meliha Kapetanovic1, Maria Andersson 2, Alan Friedman 3, Tim Shaw 3, Yanna Song 4, Daniel Aletaha 5, Maya H. Buch 6, Ulf Müller-Ladner 7 and Janet Pope 8, 1Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Section of Rheumatology, Lund and Malmö, Sweden, Lund, Sweden, 2Abbvie AB, Solna, Sweden, 3AbbVie Inc., North Chicago, 4AbbVie Inc., North Chicago, IL, USA, North Chicago, 5Medical University of Vienna, Vienna, Austria, 6University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, 7Justus Liebig University Gießen, Department of Rheumatology and Clinical Immunology, Campus Kerckhoff, Bad Nauheim, Germany, Gießen, Hessen, Germany, 8Western University, London, ON, Canada

    Background/Purpose: Early treatment of RA within the therapeutic window (0-3 months from symptom onset), has been associated with improved clinical outcomes and physical function. However,…
  • Abstract Number: 513 • 2019 ACR/ARP Annual Meeting

    Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis: Results at 48 Weeks

    Josef Smolen1, Paul Emery 2, William Rigby 3, Yoshiya Tanaka 4, Juan Ignacio Vargas 5, Nemanja Damjanov 6, Manish Jain 7, Yunxia Sui 8, Jose Jeffrey Enejosa 9, Aileen Pangan 10, Heidi Camp 9 and Stanley Cohen 11, 1Medical University of Vienna, Vienna, Austria, 2Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, 3Dartmouth-Hitchcock Medical Center, Lebanon, 4University of Occupational and Environmental Health Japan, Kitakyushu, Japan, 5Quantum Research, Puerto Varas, Chile, 6Institute of Rheumatology, Belgrade University School of Medicine, Belgrade, Serbia, Belgrade, Serbia, 7Rheumatology, Great Lakes Clinical Trials, Great Lakes, 8AbbVie Inc., Chicago, 9AbbVie Inc., North Chicago, IL, 10AbbVie Inc., North Chicago, 11Metroplex Clinical Research Center, Dallas, TX

    Background/Purpose: In the SELECT-MONOTHERAPY trial, upadacitinib (UPA), an oral JAK1-selective inhibitor, showed efficacy when used as monotherapy over 14 weeks (wks) in rheumatoid arthritis (RA)…
  • Abstract Number: 514 • 2019 ACR/ARP Annual Meeting

    A Pooled Analysis of 1-year Clinical Outcomes Among 6-month Responders and Non-responders from Three Randomized Controlled Studies of TNF Inhibitor Biosimilars in Patients with Rheumatoid Arthritis

    Josef Smolen1, Michael Weinblatt 2, Paul Emery 3, Jung Yoon Choe 4, Jonathan Kay 5, Jieun Lee 6, Gihyun Myung 6, Hyoryeong Seo 6 and Jeehoon Ghil 6, 1Medical University of Vienna, Vienna, Austria, 2Brigham and Women's Hospital, Boston, MA, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, 4Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, Republic of Korea, 5UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, 6Samsung Bioepis Co., Ltd., Incheon, Republic of Korea

    Background/Purpose: SB4, SB2, and SB5 are biosimilars of etanercept, infliximab, and adalimumab. Phase III randomized, double-blind studies were conducted to compare efficacy and safety between…
  • Abstract Number: 515 • 2019 ACR/ARP Annual Meeting

    Clinical Responses in Patients with Inadequate Response to bDMARDs upon Treatment with Upadacitinib

    Michael Weinblatt1, Glen Thomson 2, Kun Chen 3, Sebastian Meerwein 4, Casey Schlacher 5 and John Cush 6, 1Brigham and Women's Hospital, Boston, MA, USA, Boston, MA, 2CIADS Research, Winnipeg, Canada, 3AbbVie Inc., North Chicago, 4AbbVie GmbH Co. KG, Ludwigshafen, Germany, Wiesbaden, Germany, 5AbbVie Inc., North Chicago, IL, 65Baylor University Medical Center, Dallas

    Background/Purpose: Upadacitinib (UPA), a JAK1-selective inhibitor, demonstrated efficacy in the SELECT-BEYOND study in patients (pts) with moderate to severe rheumatoid arthritis (RA) on a stable…
  • Abstract Number: 516 • 2019 ACR/ARP Annual Meeting

    Impact of Baseline Demographics and Disease Activity on Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib

    Michael Weinblatt1, Eduardo Mysler 2, Andrew Östör 3, Aaron Broadwell 4, Slawomir Jeka 5, Kendall Dunlap 6, Jessica Suboticki 6, Jose Jeffrey Enejosa 6, Barbara Hendrickson 6, Sheng Zhong 6, Katya Cherny 6 and Grace Wright 7, 1Brigham and Women's Hospital, Boston, MA, USA, Boston, MA, 2Organización Medica de Investigación, Buenos Aires, Argentina, Buenos Aires, Argentina, 3Cabrini Medical Centre, Monash University, Malvern, Australia, Malvern, Australia, 4Rheumatology and Osteoporosis Specialists, Shreveport, LA, USA, Shreveport, LA, 5University Hospital Bydgoszcz no 2, CM UMK, Bydgoszcz, Poland, 6AbbVie Inc., North Chicago, IL, USA, North Chicago, IL, 7New York University Langone Medical Center, New York, NY, USA, New York

    Background/Purpose: Upadacitinib (UPA), an oral selective JAK1 inhibitor, has demonstrated favorable efficacy and acceptable safety in five Phase 3 global studies in patients with moderately…
  • Abstract Number: 517 • 2019 ACR/ARP Annual Meeting

    A Subgroup Analysis of Clinical Efficacy Response and Quality of Life Outcomes from Phase 3 Study of Filgotinib in Patients with Inadequate Response to Biologic DMARDs

    Mark Genovese1, Kurt de Vlam 2, Jacques-Eric Gottenberg 3, Beatrix Bartok 4, Iyabode Tiamiyu 4, Ying Guo 4, Chantal Tasset 5, John Sundy 4, David Walker 6, Tsutomu Takeuchi 7 and Kenneth Kalunian 8, 1Stanford University, Stanford, CA, 2Department of Rheumatology, Universitair Ziekenhuis Leuven, Leuven, Belgium, 3Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, 4Gilead Sciences, Inc., Foster City, CA, 5Galapagos NV, Mechelen, Belgium, 6Northumbria Healthcare, Northumbria, United Kingdom, 7Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan, 8Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA

    Background/Purpose: There is an unmet medical need to treat RA in patients who have failed prior biologic DMARD treatments (biologic DMARD inadequate response; bDMARD-IR), some…
  • Abstract Number: 518 • 2019 ACR/ARP Annual Meeting

    Upadacitinib in Patients with Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological DMARDs: Results at 60 Weeks

    Mark Genovese1, Bernard Combe 2, Stephen Hall 3, Andrea Rubbert-Roth 4, Sheng Zhong 5, Sebastian Meerwein 6, Aileen Pangan 7 and Roy Fleischmann 8, 1Stanford University, Stanford, CA, 2CHU Montpellier, Montpellier University, Montpellier, France, 3Monash University and Emeritus Research, Melbourne, Australia, 4Kantonsspital St. Gallen, St Gallen, Switzerland, 5AbbVie Inc., North Chicago, IL, USA, North Chicago, IL, 6AbbVie GmbH Co. KG, Ludwigshafen, Germany, Wiesbaden, Germany, 7AbbVie Inc., North Chicago, 8Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX

    Background/Purpose: In patients (pts) with active rheumatoid arthritis (RA) and inadequate response or intolerance to bDMARDs, treatment with upadacitinib (UPA), a JAK1-selective inhibitor resulted in…
  • Abstract Number: 519 • 2019 ACR/ARP Annual Meeting

    Efficacy of Biosimilar Candidate ABP 710 in a Phase 3 Study in Subjects with Moderate to Severe RA: Additional Analysis Focusing on the ACR Individual Components

    Mark Genovese1, Juan Sanchez-Burson 2, Éva Balázs 3, Andrea Everding 4, MyungShin Oh 5, Gary Fanjiang 5 and Stanley Cohen 6, 1Stanford University, Stanford, CA, 2Hospital Infanta Luisa, Sevilla, Spain, 3Dr. Bugyi István Hospital, Szentes, Hungary, 4HRF Hamburger Rheuma Forschungszentrum, Hamburg, Germany, 5Amgen, Thousand Oaks, CA, 6Metroplex Clinical Research Center, Dallas, TX

    Background/Purpose: ABP 710 is being developed as a biosimilar to infliximab. Both ABP 710 and infliximab reference product (RP) inhibit tumor necrosis factor-alpha. Following demonstration…
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