Abstracts tagged "Janus kinase (JAK)"

Abstract Number: 1904 • 2017 ACR/ARHP Annual Meeting
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Upadacitinib (ABT-494), a Selective JAK-1 Inhibitor, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Conventional Synthetic Dmards
Gerd R. Burmester¹, Joel Kremer², Filip van Den Bosch³, Yihan Li⁴, Yijie Zhou⁴, Ahmed A. Othman⁵, Aileen L. Pangan⁴ and Heidi S. Camp⁵, ¹Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, ²Albany Medical College, Albany, NY, ³Rheumatology, Ghent University Hospital, Gent, Belgium, ⁴AbbVie Inc., North Chicago, IL, ⁵AbbVie, North Chicago, IL
Background/Purpose: Upadacitinib (UPA) is an oral, selective JAK-1 inhibitor in development for the treatment of patients (pts) with moderate to severe rheumatoid arthritis (RA) and…
Abstract Number: 508 • 2017 ACR/ARHP Annual Meeting
Improved Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Who Failed Adalimumab or Placebo Treatment and Were Rescued with Baricitinib
Bruno Fautrel¹, Peter C. Taylor², Kaleb Michaud³, Himanshu Patel⁴, Baojin Zhu⁴, Carol L Gaich⁴, Jiaying Guo⁴, Amanda Quebe⁴ and Yoshiya Tanaka⁵, ¹Paris VI Pierre et Marie Curie University, Paris, France, ²Botnar Research Centre, University of Oxford, Oxford, United Kingdom, ³Rheumatology, National Data Bank for Rheumatic Diseases & University of Nebraska Medical Center, Omaha, NE, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
Background/Purpose: In the Phase 3 RA-BEAM study, baricitinib (BARI) 4 mg once daily showed significant clinical improvements compared with placebo (PBO) and adalimumab (ADA).1 Switching…
Abstract Number: 1909 • 2017 ACR/ARHP Annual Meeting
Long Term Safety of Filgotinib in the Treatment of Rheumatoid Arthritis: Week 84 Data from a Phase 2b Open-Label Extension Study
Mark C. Genovese¹, Arthur Kavanaugh², Kevin Winthrop³, Maria Greenwald⁴, Lucia Ponce⁵, Favio Enriquez Sosa⁶, Mykola Stanislavchuk⁷, Minodora Mazur⁸, Alberto Spindler⁹, Regina Cseuz¹⁰, Natalya Nikulenkova¹¹, Maria Glowacka-Kulesz¹², Istvan Szombati¹³, Anna Dudek¹⁴, Neelufar Mozaffarian¹⁵, Joy Greer¹⁵, Xiao Ding¹⁵, Pille Harrison¹⁶, Annegret Van der Aa¹⁶, René Westhovens¹⁷ and Rieke Alten¹⁸, ¹Stanford University Medical Center, Palo Alto, CA, ²Medicine, University of California, San Diego, La Jolla, CA, ³Oregon Health Sciences University, Portland, OR, ⁴Desert Medical Advances, Palm Desert, CA, ⁵Consulta Privada Dra. Lucia Ponce, Temuco, Chile, ⁶Clinstile SA de CV, Col., Mexico City, Mexico, ⁷Vinnitsa Regional Clinical Hospital, Vinnitsa, Ukraine, ⁸IMSP Inst. de Cardiologie, Chisinau, Moldova, The Republic of, ⁹Centro Médico Privado de Reumatología, Centro Médico Privado de Reumatología, Argentina, ¹⁰Revita Reumatologiai Rendelo, Budapest, Hungary, ¹¹Vladimir Reg Clin Hosp, Vladimir, Russian Federation, ¹²Silesiana Centrum Medyczne, Wroclawska, Poland, ¹³QUALICLINIC Kft., Budapest, Hungary, ¹⁴Centrum Medyczne AMED Warszawa Targówek, Warszawa, Poland, ¹⁵Gilead Sciences, Inc, Foster City, CA, ¹⁶Galapagos NV, Mechelen, Belgium, ¹⁷KU Leuven Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ¹⁸Internal Medicine, Rheumatology & Clinical Immunology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany
Background/Purpose: Filgotinib is an orally administered, selective inhibitor of Janus Kinase 1 (JAK1) currently in Phase 3 development for the treatment of rheumatoid arthritis (RA).…
Abstract Number: 509 • 2017 ACR/ARHP Annual Meeting
Long-Term Safety and Efficacy of Upadacitinib (ABT-494), an Oral JAK-1 Inhibitor in Patients with Rheumatoid Arthritis in an Open Label Extension Study
Mark C. Genovese¹, Joel Kremer², Sheng Zhong³ and Alan Friedman³, ¹Stanford University Medical Center, Palo Alto, CA, ²Albany Medical College, Albany, NY, ³AbbVie Inc., North Chicago, IL
Background/Purpose: Upadacitinib (UPA, ABT-494) is a selective, oral JAK-1 inhibitor studied in two phase 2 randomized controlled trials (RCTs) in patients (pts) with rheumatoid arthritis…
Abstract Number: 2219 • 2017 ACR/ARHP Annual Meeting
Remaining Pain in DMARD-Naive Rheumatoid Arthritis Patients Treated with Baricitinib and Methotrexate
Yvonne C. Lee¹, Paul Emery², John D. Bradley³, Baojin Zhu³, Carol L Gaich³, Zhihong Cai⁴, Amanda Quebe³, Anabela Cardoso³, Yun-Fei Chen³ and Roy Fleischmann⁵, ¹Department of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ²Leeds Musculoskeletal Biomedical Research Unit, LTHT Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds, Leeds, United Kingdom, ³Eli Lilly and Company, Indianapolis, IN, ⁴Eli Lilly Japan K.K., Kobe, Japan, ⁵University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Patient (pt)-reported pain is common in rheumatoid arthritis (RA), even in pts with good disease control1. This analysis evaluated pain control achieved by methotrexate…
Abstract Number: 510 • 2017 ACR/ARHP Annual Meeting
Association between Clinical Response and Normalization of Patient-Reported Outcome Measures in Rheumatoid Arthritis: Post-Hoc Analysis from Two Phase 2b Filgotinib Studies
Mark C. Genovese¹, Annegret Van der Aa², Corinne Jamoul², Chantal Tasset², Pille Harrison², René Westhovens³ and Arthur Kavanaugh⁴, ¹Stanford University Medical Center, Palo Alto, CA, ²Galapagos NV, Mechelen, Belgium, ³University Hospitals Leuven on behalf of the CareRA Study Group, Leuven, Belgium, ⁴Medicine, University of California, San Diego, La Jolla, CA
Background/Purpose: Filgotinib (GLPG0634, GS-6034) is an oral, selective JAK1 inhibitor that has demonstrated safety and efficacy data in two 24-week placebo-controlled phase 2B studies as…
Abstract Number: 2568 • 2017 ACR/ARHP Annual Meeting
Prophylactic and Therapeutic Administration of a JAK1-Selective Inhibitor Blocks and Reverses Nephritis and Sialadenitis in NZB/W-F1 Mice
Rachel Twomey¹, Stuart Perper¹, Susan Westmoreland¹, Terry Melim¹, Soumya Mitra¹, Zheng Liu¹, Manuel Duval¹, Carolyn Cuff², Andrew Long¹, Anthony Slavin² and Stephen Clarke¹, ¹AbbVie Inc, AbbVie Bioresearch Center, Worcester, MA, ²Immunology Discovery, AbbVie Inc, AbbVie Bioresearch Center, Worcester, MA
Background/Purpose: Signaling of most cytokine receptors occurs through the JAK-STAT pathway. This is true of cytokines linked to the etiology of systemic lupus erythematosus (SLE)…
Abstract Number: 511 • 2017 ACR/ARHP Annual Meeting
Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 5.5 Years: An Updated Integrated Safety Analysis
Mark C. Genovese¹, Josef S. Smolen², Tsutomu Takeuchi³, David Hyslop⁴, William L. Macias⁴, Terence P. Rooney⁴, Lei Chen⁴, Christina L. Dickson⁴, Jennifer Riddle Camp⁴, Tracy Cardillo⁴, Taeko Ishii⁵ and Kevin Winthrop⁶, ¹Stanford University Medical Center, Palo Alto, CA, ²Rheumatology, Medical University of Vienna, Vienna, Austria, ³Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Eli Lilly and Company, Kobe, Japan, ⁶Oregon Health & Science University, Portland, OR
Background/Purpose: Baricitinib (bari), an oral, selective inhibitor of Janus kinase (JAK) 1 and JAK 2, is approved in the EU for the treatment of moderately…
Abstract Number: 2758 • 2017 ACR/ARHP Annual Meeting
Response to JAK1/2 Inhibition with Baricitinib in “Candle”, “Savi” and “Candle-like” Diseases. a New Therapeutic Approach for Type I IFN-Mediated Autoinflammatory Diseases
Gina A. Montealegre Sanchez¹, Adam Reinhardt², Suzanne Ramsey³, Helmut Wittkowski⁴, Philip J Hashkes⁵, Sara Murias⁶, Yackov Berkun⁷, Susanne Schalm⁸, Jason A Dare⁹, Diane Brown¹⁰, Deborah L. Stone¹¹, Ling Gao⁹, Thomas L. Klausmeier¹², John D. Carter¹³, Robert Colbert¹⁴, Dawn C. Chapelle¹⁵, Hanna Kim¹⁵, Samantha Dill¹⁵, Adriana Almeida de Jesus¹, Paul Wakim¹⁶, A. Zlotogorski¹⁷, Seza Ozen¹⁸, Paul Brogan¹⁹ and Raphaela Goldbach-Mansky¹, ¹Translational Autoinflammatory Disease Studies (TADS), Laboratory of Clinical Investigation and Microbiology (LCIM), NIAID/NIH, Bethesda, MD, ²Faculty of Physicians of the University of Nebraska Medical Center, College of Medicine, Nebraska, NE, ³Pediatric Rheumatology, IWK Health Centre, Dalhousie University, Halifax, NS, Canada, ⁴Department of Pediatric Rheumatology and Immunology, University of Muenster, Muenster, Germany, ⁵Pediatrics Rheumatology; Shaare Zedek Medical Center, Jerusalem, Israel, ⁶Hospital Infantil La Paz, Madrid, Spain, ⁷Hadassah-Hebrew University Medical Center, Jerusalem, Israel, ⁸Hauner Children's Hospital LMU, Munich, Germany, ⁹University of Arkansas for Medical Sciences, Little Rock, AR, ¹⁰Division Of Rheumatology MS #60, Children's Hospital Los Angeles, Los Angeles, CA, ¹¹NHGRI/NIH, Bethesda, MD, ¹²Riley Hospital for Children, Indianapolis, IN, ¹³Division of Rheumatology, University of South Florida, Tampa, FL, ¹⁴NIAMS/NIH, Bethesda, MD, ¹⁵Pediatric Translational Research Branch, NIAMS/NIH, Bethesda, MD, ¹⁶Biostatistics and Clinical Epidemiology Service, NIH Clinical Center, Bethesda, MD, ¹⁷Department of Dermatology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel, ¹⁸Department of Pediatrics, Division of Rheumatology, Hacettepe University Faculty of Medicine, Ankara, Turkey, ¹⁹UCL Institute of Child Health and Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom
Background/Purpose: Monogenic autoinflammatory interferonopathies, including chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures (CANDLE) and STING-associated vasculopathy with onset in infancy (SAVI), present with…
Abstract Number: 519 • 2017 ACR/ARHP Annual Meeting
Filgotinib, a Selective Janus Kinase 1 Inhibitor, Has No Effect on QT Interval in Healthy Subjects
Kacey Anderson¹, Hao Zheng², Chohee Yun³, Ellen Kwan⁴, Ann Qin¹, Florence Namour⁵, Brian P. Kearney¹ and Yan Xin¹, ¹Clinical Pharmacology, Gilead Sciences, Inc., Foster City, CA, ²Gilead Sciences, Inc., Foster City, CA, ³Clinical Research, Gilead Sciences, Inc, Foster City, CA, ⁴Clinical Operations, Gilead Sciences, Inc, Foster City, CA, ⁵Galapagos NV, Romainville, France
Background/Purpose: Filgotinib is a potent and selective Janus kinase 1 (JAK1) inhibitor being developed to treat inflammatory diseases. Safety pharmacology studies and Phase 1 studies…
Abstract Number: 2787 • 2017 ACR/ARHP Annual Meeting
Tuberculosis, Potential Opportunistic Infections, and Other Infections of Interest in Patients with Moderate to Severe Rheumatoid Arthritis in the Baricitinib Program
Kevin Winthrop¹, Stephen Lindsey², Masayoshi Harigai³, John D. Bradley⁴, Lei Chen⁴, David L. Hyslop⁴, Maher Issa⁴, Atsushi Nishikawa⁵, Sarah Witt⁴, Christina L. Dickson⁴ and Maxime Dougados⁶, ¹Oregon Health & Science University, Portland, OR, ²Ochsner Health Center, Baton Rouge, LA, ³Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Lilly Japan K.K., Kobe, Japan, ⁶Rene Descartes University, Cochin Hospital, Paris, France
Background/Purpose: Baricitinib (bari) is an oral selective Janus kinase (JAK) 1 and JAK2 inhibitor approved in the EU for the treatment (trt) of moderately to…
Abstract Number: 534 • 2017 ACR/ARHP Annual Meeting
Effect of Baseline MTX Dose on Clinical Efficacy and Safety in Rheumatoid Arthritis Patients Treated with Filgotinib: Post-Hoc Analysis from a Phase 2B Study
René Westhovens¹, Annegret Van der Aa², Corinne Jamoul², Chantal Tasset² and Pille Harrison², ¹KU Leuven Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ²Galapagos NV, Mechelen, Belgium
Background/Purpose: Filgotinib (GLPG0634, GS-6034) is an oral, selective JAK1 inhibitor that has demonstrated safety and efficacy data in two 24-week placebo-controlled phase 2B studies as…
Abstract Number: 2850 • 2017 ACR/ARHP Annual Meeting
Jakinibs Decrease Chronic Low Back Pain and Increase Function: A Proof of Concept Trial
Maria Greenwald¹ and JoAnn Ball², ¹Desert Medical Advances, Palm Desert, CA, ²rheumatology, Desert Medical Advances, Palm Deseret, CA
Background/Purpose: Low back pain (LBP) is ubiquitous and estimated to affect 26% of Americans in any 3 month period. Why would rheumatoid arthritis patients be…
Abstract Number: 645 • 2017 ACR/ARHP Annual Meeting
An Oral Tyk2 Inhibitor Effectively Suppresses the Development of Murine Th17 Cells In Vivo and Prevents Joint Damage in Experimental Ankylosing Spondylitis
Eric Gracey^1,2, Melissa Lim², Zoya Qaiyum¹, Yuriy Baglaenko^1,2, Wenyan Miao³, Craig Masse³, William Westlin³ and Robert D Inman^1,4, ¹Department of Immunology, University of Toronto, Toronto, ON, Canada, ²Toronto Western Hospital, University Health Network, Toronto, ON, Canada, ³Nimbus Therapeutics, Cambridge, MA, ⁴Toronto Western Hospital, University Health Network, toronto, ON, Canada
Background/Purpose: Th17 cells play an important role in the pathogenesis of ankylosing spondylitis (AS). Tyk2, a member of the Janus Kinase (JAK) family of signaling…
Abstract Number: 2866 • 2017 ACR/ARHP Annual Meeting
Microarray Pathway Analysis Comparing Baricitinib and Adalimumab in Moderate to Severe Rheumatoid Arthritis Patients, from a Phase 3 Study
Paul Emery¹, Peter C. Taylor², Michael Weinblatt³, Yoshiya Tanaka⁴, Edward C. Keystone⁵, Ernst R. Dow⁶, Richard Higgs⁶, William L. Macias⁶, Guilherme Rocha⁶, Terence P. Rooney⁶, Douglas E. Schlichting⁶, Steven H. Zuckerman⁶ and Iain B. McInnes⁷, ¹Leeds MSK Biomed/Chapel Allerton Hospital, Leeds, United Kingdom, ²NDORMS, University of Oxford, Oxford, United Kingdom, ³Brigham and Women’s Hospital, Boston, MA, ⁴The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵University of Toronto, Toronto, ON, Canada, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷University of Glasgow, Glasgow, United Kingdom
Background/Purpose: In RA-BEAM (NCT01710358), baricitinib (BARI), an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2, yielded significant improvements in patients (pts) with…

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