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Abstract Number: 2352 • 2017 ACR/ARHP Annual Meeting
Cardiovascular Safety during Treatment with Baricitinib in Rheumatoid Arthritis
Michael Weinblatt¹, Peter C. Taylor², Gerd R. Burmester³, Sarah Witt⁴, Chadi Saifan⁴, Chad Walls⁵, Terence P. Rooney⁴, Lei Chen⁴ and Tsutomu Takeuchi⁶, ¹Brigham and Women’s Hospital, Boston, MA, ²NDORMS, University of Oxford, Oxford, United Kingdom, ³Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Eli Lilly and C ompany, Indianapolis, IN, ⁶Keio University School of Medicine, Tokyo, Japan
Background/Purpose: Baricitinib (BARI) is an oral selective inhibitor of Janus kinase (JAK)1 and JAK2 approved in the EU for the treatment of active RA. Patients…
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: 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: 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…
Abstract Number: 2870 • 2017 ACR/ARHP Annual Meeting
Ex Vivo Comparison of Baricitinib, Upadacitinib, Filgotinib, and Tofacitinib for Cytokine Signaling in Human Leukocyte Subpopulations
Iain B. McInnes¹, Richard Higgs², Jonathan Lee², William L. Macias², Songqing Na², Robert A. Ortmann², Guilherme Rocha², Thomas Wehrman³, Xin Zhang², Steven H. Zuckerman² and Peter C. Taylor⁴, ¹University of Glasgow, Glasgow, United Kingdom, ²Eli Lilly and Company, Indianapolis, IN, ³Primity Bio, Fremont, CA, ⁴NDORMS, University of Oxford, Oxford, United Kingdom
Background/Purpose: Baricitinib (bari), an oral selective Janus kinase (JAK) 1/2 inhibitor, has been approved in the EU for the treatment of adults with moderately to…
Abstract Number: 1585 • 2016 ACR/ARHP Annual Meeting
Previous Use of Conventional Disease-Modifying Antirheumatic Drugs and Response to Baricitinib
Arthur F. Kavanaugh¹, Ronald F. van Vollenhoven², David Muram³, Jahangir Alam³, Vipin Arora³, Ana Luisa de Macedo Pinto Correia³, Inmaculada de la Torre^3,4 and James R. O'Dell⁵, ¹UC San Diego School of Medicine, La Jolla, CA, ²Rheumatology Unit, Karolinska University Hospital, Solna, Sweden, ³Eli Lilly and Company, Indianapolis, IN, ⁴Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, ⁵Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE
Background/Purpose: Baricitinib (BARI), an oral JAK1/JAK2 inhibitor, is in development for patients (pts) with moderate to severe RA.1,2 The purpose of this post hoc analysis…
Abstract Number: 1586 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs: A United States Subpopulation Analysis from Two Phase 3 Trials
Alvin F. Wells¹, Maria Greenwald², John D. Bradley³, Jahangir Alam³, Vipin K. Arora³ and Cynthia E. Kartman³, ¹Rheumatology & Immunotherapy Center, Franklin, WI, ²Desert Medical Advances, Palm Desert, CA, ³Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Baricitinib (bari), an oral selective JAK1 and JAK2 inhibitor, has been shown to be safe and efficacious compared to placebo (PBO) in two Phase…
Abstract Number: 1590 • 2016 ACR/ARHP Annual Meeting
Safety and Efficacy of Baricitinib in Elderly Patients with Moderate to Severe Rheumatoid Arthritis
Roy Fleischmann¹, Jahangir Alam², Vipin Arora², John D. Bradley², Douglas E. Schlichting² and David Muram², ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Baricitinib (bari), an oral JAK1 and JAK2 inhibitor, is in development for patients (pts) with moderate to severe RA. Drug-related problems are common in…
Abstract Number: 1591 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Switching from Adalimumab to Baricitinib: Phase 3 Data in Patients with Rheumatoid Arthritis
Peter C. Taylor¹, Edward Keystone², Robert Ortmann³, Maher Issa³, Li Xie³, David Muram³, John D. Bradley³, Stephanie de Bono³, Terence Rooney³ and Yoshiya Tanaka⁴, ¹Kennedy Institute of Rheumatology, University of Oxford, Oxford, United Kingdom, ²Mount Sinai Hospital, Toronto, ON, Canada, ³Eli Lilly and Company, Indianapolis, IN, ⁴The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
Background/Purpose: Baricitinib (bari) is an oral JAK1/JAK2 inhibitor under investigation for the treatment of patients (pts) with moderate to severe RA.1-2 In the 52-week Phase…
Abstract Number: 1593 • 2016 ACR/ARHP Annual Meeting
Baricitinib for Rheumatoid Arthritis: A Systematic Review and Meta-Analysis
Natalia V. Zamora¹, Jean Tayar², Maria A. Lopez-Olivo³, Robin Christensen⁴ and Maria Suarez-Almazor⁵, ¹Section of Rheumatology and Clinical Immunology, The University of Texas, MD Anderson Cancer Center, Houston, TX, ²Department of Gentic Internal Medicine-AT & EC, The University of Texas, MD Anderson Cancer Center, Houston, TX, ³General Internal Medicine, The University of Texas, MD Anderson Cancer Center, Houston, TX, ⁴Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark, ⁵Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA., Houston, TX
Background/Purpose: Baricitinib is a small molecule inhibitor of the Janus kinase (JAK) pathways that reduce and modulate the production of inflammatory mediators and cytokines. We…
Abstract Number: 1599 • 2016 ACR/ARHP Annual Meeting
Speed of Onset of Effect on Patient-Reported Outcomes Assessed through Daily Electronic Patient Diaries in the Baricitinib Phase 3 RA Clinical Program
Peter C. Taylor¹, Grace C. Wright², Carol L. Gaich³, Amy M. DeLozier³, Stephanie de Bono³, Douglas E. Schlichting³, Terence Rooney³, Jiajun Liu³, Scott D. Beattie⁴ and Maxime Dougados⁵, ¹NDORMS, University of Oxford, Oxford, United Kingdom, ²NYU Langone Medical Center, New York, NM, ³Eli Lilly and Company, Indianapolis, IN, ⁴Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, ⁵Dept of Rheumatology, Cochin Hospital, Paris, France
Background/Purpose: Baricitinib (bari), an oral Janus kinase (JAK) 1/JAK2 selective inhibitor, has demonstrated clinical efficacy with a satisfactory safety profile when administered once daily in…
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: 2632 • 2016 ACR/ARHP Annual Meeting
Effects of Baseline Patient Characteristics on Baricitinib Efficacy in Patients with Rheumatoid Arthritis
Joel M. Kremer¹, Mark C. Genovese², David Muram³, Jinglin Zhong⁴, Jahangir Alam³ and Michael Schiff⁵, ¹Albany Medical College, Albany, NY, ²Stanford University Medical Center, Palo Alto, CA, ³Eli Lilly and Company, Indianapolis, IN, ⁴Quintiles, Rockville, MD, ⁵Rheumatology, University of Colorado, Denver, CO
Background/Purpose : This analysis assessed the effects of baseline patient characteristics on the response to baricitinib treatment in patients with rheumatoid arthritis (RA) and incomplete…
Abstract Number: 3023 • 2016 ACR/ARHP Annual Meeting
Lipid Profile and Effect of Statin Treatment in Pooled Phase 2 and Phase 3 Baricitinib Studies
Iain B. McInnes¹, Joel Kremer², Paul Emery³, Steven H. Zuckerman⁴, Giacomo Ruotolo⁴, Chadi Saifan⁴, Lei Chen⁴, Shayami Thanabalasundrum⁴, Sarah Witt⁴ and William Macias⁴, ¹Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, Great Britain, ²The Center for Rheumatology, Albany Medical College, Albany, NY, ³University of Leeds, Midlothian, United Kingdom, ⁴Eli Lilly and Company, Indianapolis, IN
Background/Purpose: In patients with active RA an increase in lipid analytes has been observed after treatment with janus kinase inhibitors and other disease-modifying antirheumatic drugs.1…
Abstract Number: 3027 • 2016 ACR/ARHP Annual Meeting
Herpes Zoster in Patients with Moderate to Severe Rheumatoid Arthritis Treated with Baricitinib
Kevin L. Winthrop¹, Stephen Lindsey², Michael Weinblatt³, Tsutomu Takeuchi⁴, David Hyslop⁵, Maher Issa⁵, Lei Chen⁵, John Bradley⁵, Christina Dickson⁵ and Roy Fleischmann⁶, ¹Oregon Health and Sciences University, Portland, OR, ²Ochsner Medical Center, Baton Rouge, LA, ³Division of Rheumatology, Immunology and Allergy, Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ⁴Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ⁵Eli Lilly and Company, Indianapolis, IN, ⁶Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Compared to the general population, RA patients (pts) have an increased risk of herpes zoster (HZ) due to their disease and various DMARD therapies…

Cardiovascular Safety during Treatment with Baricitinib in Rheumatoid Arthritis

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

Tuberculosis, Potential Opportunistic Infections, and Other Infections of Interest in Patients with Moderate to Severe Rheumatoid Arthritis in the Baricitinib Program

Microarray Pathway Analysis Comparing Baricitinib and Adalimumab in Moderate to Severe Rheumatoid Arthritis Patients, from a Phase 3 Study

Ex Vivo Comparison of Baricitinib, Upadacitinib, Filgotinib, and Tofacitinib for Cytokine Signaling in Human Leukocyte Subpopulations

Previous Use of Conventional Disease-Modifying Antirheumatic Drugs and Response to Baricitinib

Efficacy and Safety of Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs: A United States Subpopulation Analysis from Two Phase 3 Trials

Safety and Efficacy of Baricitinib in Elderly Patients with Moderate to Severe Rheumatoid Arthritis

Efficacy and Safety of Switching from Adalimumab to Baricitinib: Phase 3 Data in Patients with Rheumatoid Arthritis

Baricitinib for Rheumatoid Arthritis: A Systematic Review and Meta-Analysis

Speed of Onset of Effect on Patient-Reported Outcomes Assessed through Daily Electronic Patient Diaries in the Baricitinib Phase 3 RA Clinical Program

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

Effects of Baseline Patient Characteristics on Baricitinib Efficacy in Patients with Rheumatoid Arthritis

Lipid Profile and Effect of Statin Treatment in Pooled Phase 2 and Phase 3 Baricitinib Studies

Herpes Zoster in Patients with Moderate to Severe Rheumatoid Arthritis Treated with Baricitinib

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