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Abstract Number: 512 • 2017 ACR/ARHP Annual Meeting
Efficacy Response to Baricitinib Based on Baseline Characteristics in Patients Who Are Inadequate Responders to Conventional DMARD
Maxime Dougados¹, Terence P. Rooney², Li Xie², Rena Klar³, Christina L. Dickson², Ana Pinto Correia², Yoshiya Tanaka⁴, Michael Schiff⁵ and Edward C. Keystone⁶, ¹Department of Rheumatology, Rene Descartes University, Hôpital Cochin, Paris, France, ²Eli Lilly and Company, Indianapolis, IN, ³Quintiles IMS Holdings, Inc., Durham, NC, ⁴The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵University of Colorado, Greenwood Village, CO, ⁶University of Toronto, Toronto, ON, Canada
Background/Purpose: Rheumatoid arthritis (RA) is a chronic disease and some patients (pts) have an inadequate response (IR) to conventional DMARDs (csDMARDs). Baricitinib is an oral,…
Abstract Number: 513 • 2017 ACR/ARHP Annual Meeting
Time to Achieve Moderate/Low Disease Activity and Remission in RA Patients on Baricitinib Compared to Adalimumab, Methotrexate, and Placebo
Edward C. Keystone¹, Maxime Dougados², Eric M. Ruderman³, Baojin Zhu⁴, Pedro Lopez-Romero⁵, Hanne Lund⁶, Anabela Cardoso⁴, Douglas E. Schlichting⁴, Pindaro Martinez Osuna⁴, Robert Ortmann⁴ and Tore K. Kvien⁷, ¹University of Toronto, Toronto, ON, Canada, ²Rene Descartes University, Cochin Hospital, Paris, France, ³Northwestern University Feinberg School of Medicine, Chicago, IL, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Europe Research Center, Eli Lilly and Company, Madrid, Spain, ⁶Eli Lilly Norge A.S., Oslo, Norway, ⁷Diakonhjemmet Hospital, Oslo, Norway
Background/Purpose: Baricitinib (BARI), an oral, selective Janus kinase (JAK)1/2 inhibitor1, has shown efficacy in DMARD naïve RA patients (pts)2 and in pts with inadequate response…
Abstract Number: 530 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Baricitinib in Patients with Rheumatoid Arthritis: A Meta-Analysis of Randomized Controlled Trials
Sumit Kunwar¹, Christopher E. Collins² and Florina Constantinescu², ¹Rheumatology, MedStar Washington Hospital Center, washington, DC, ²Rheumatology, MedStar Washington Hospital Center, Washington, DC
Background/Purpose: Janus kinases (JAKs) play an important role in intracellular signaling for multiple cytokines in the pathogenesis of RA. Baricitinib is an oral, selective JAK…
Abstract Number: 531 • 2017 ACR/ARHP Annual Meeting
Comparative Effectiveness of Tofacitinib Versus Baricitinib in Rheumatoid Arthritis Using a Systematic Review and Network Meta-Analysis of Randomized Trials
Natalia Zamora^1,2,3, Maria A. Lopez-Olivo¹, Jean Tayar¹, Robin Christensen² and Maria Suarez-Almazor¹, ¹Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA, Houston, TX, ²Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, Copenhagen, Denmark, ³Reumatologia, Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, Buenos Aires, Argentina
Background/Purpose: To explore the comparative effectiveness of tofacitinib or baricitinib in patients with rheumatoid arthritis (RA) following a systematic review of randomized trials, by performing…
Abstract Number: 855 • 2017 ACR/ARHP Annual Meeting
Rapid and Sustained Pain Improvement in Rheumatoid Arthritis Patients Treated with Baricitinib Compared to Adalimumab or Placebo
Peter C. Taylor¹, Roy Fleischmann², Elizabeth Perkins³, Jeffrey Lisse⁴, Baojin Zhu⁴, Carol L Gaich⁴, Xiang Zhang⁴, Douglas E. Schlichting⁴, Christina L. Dickson⁴ and Tsutomu Takeuchi⁵, ¹NDORMS, University of Oxford, Oxford, United Kingdom, ²University of Texas Southwestern Medical Center, Dallas, TX, ³Rheumatology, Rheumatology Care Center, Birmingham, AL, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Keio University School of Medicine, Tokyo, Japan
Background/Purpose: Assessment of pain improvement during treatment for rheumatoid arthritis (RA) may help frame patient expectations and may be useful to clinical decision-making and discussions…
Abstract Number: 1821 • 2017 ACR/ARHP Annual Meeting
Dose Reduction of Baricitinib in Patients with Rheumatoid Arthritis Achieving Sustained Disease Control: Results of a Prospective Study
Tsutomu Takeuchi¹, Mark C. Genovese², Boulos Haraoui³, Zhanguo Li⁴, Li Xie⁵, Rena Klar⁶, Ana Pinto Correia⁵, Susan Otawa⁵, Pedro Lopez-Romero⁷, Inmaculada de la Torre⁵, Terence P. Rooney⁵ and Josef S. Smolen⁸, ¹Keio University School of Medicine, Tokyo, Japan, ²Stanford University Medical Center, Palo Alto, CA, ³Institut de Rhumatologie de Montreal, Montreal, QC, Canada, ⁴Peking University People's Hospital, Beijing, China, ⁵Eli Lilly and Company, Indianapolis, IN, ⁶Quintiles IMS Holdings, Inc., Durham, NC, ⁷Europe Research Center, Eli Lilly and Company, Madrid, Spain, ⁸Medical University of Vienna, Vienna, Austria
Background/Purpose: In patients (pts) with active RA and inadequate response (IR) to DMARDs, phase 3 studies demonstrated efficacy of baricitinib (2-mg and 4-mg). Larger, more…
Abstract Number: 1824 • 2017 ACR/ARHP Annual Meeting
Evaluation of Pneumococcal and Tetanus Vaccine Responses in Patients with Rheumatoid Arthritis Receiving Baricitinib: Results from a Long-Term Extension Trial Substudy
Kevin Winthrop¹, Clifton O. Bingham III², John D. Bradley³, Maher Issa³, Rena Klar⁴ and Cynthia E. Kartman³, ¹Oregon Health and Sciences University, Portland, OR, ²Rheumatology, Johns Hopkins University, Baltimore, MD, ³Eli Lilly and Company, Indianapolis, IN, ⁴Quintiles IMS Holdings, Inc., Durham, NC
Background/Purpose: Clinical guidelines recommend pneumococcal and tetanus vaccinations in patients (pts) with RA.1 Baricitinib (bari) is an oral, selective Janus kinase (JAK) 1/JAK 2 inhibitor…
Abstract Number: 1893 • 2017 ACR/ARHP Annual Meeting
Pharmacokinetics (PK), Pharmacodynamics (PD), and Proposed Dosing of Oral Janus Kinase (JAK)1 and JAK2 Inhibitor Baricitinib in Patients with IFN-Mediated Autoinflammatory Diseases (AIDs)
Hanna Kim¹, Kristina M. Brooks², Paul Wakim³, Mary Blake⁴, Stephen R. Brooks⁵, Gina A. Montealegre Sanchez⁶, Adriana Almeida de Jesus⁶, Yan Huang⁶, Wanxia Li Tsai⁷, Massimo G. Gadina⁴, Parag Kumar² and Raphaela Goldbach-Mansky⁶, ¹Pediatric Translational Research Branch, NIAMS/NIH, Bethesda, MD, ²Clinical Pharmacokinetics Research Unit, Pharmacy Department, NIH Clinical Center, Bethesda, MD, ³Biostatistics and Clinical Epidemiology Service, NIH Clinical Center, Bethesda, MD, ⁴Translational Immunology Section, Office of Science and Technology, NIAMS/NIH, Bethesda, MD, ⁵Biodata Mining and Discovery Section, Office of Science and Technology, NIAMS/NIH, Bethesda, MD, ⁶Translational Autoinflammatory Disease Studies (TADS), Laboratory of Clinical Investigation and Microbiology (LCIM), NIAID/NIH, Bethesda, MD, ⁷Translational Immunology, Office of Science and Technology, NIAMS/NIH, Bethesda, MD
Background/Purpose: JAK inhibitors reduce IFN-signaling ex vivo. We evaluated the PK and PD of the oral JAK1 and JAK2 inhibitor, baricitinib, from data collected in…
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: 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…

Efficacy Response to Baricitinib Based on Baseline Characteristics in Patients Who Are Inadequate Responders to Conventional DMARD

Time to Achieve Moderate/Low Disease Activity and Remission in RA Patients on Baricitinib Compared to Adalimumab, Methotrexate, and Placebo

Efficacy and Safety of Baricitinib in Patients with Rheumatoid Arthritis: A Meta-Analysis of Randomized Controlled Trials

Comparative Effectiveness of Tofacitinib Versus Baricitinib in Rheumatoid Arthritis Using a Systematic Review and Network Meta-Analysis of Randomized Trials

Rapid and Sustained Pain Improvement in Rheumatoid Arthritis Patients Treated with Baricitinib Compared to Adalimumab or Placebo

Dose Reduction of Baricitinib in Patients with Rheumatoid Arthritis Achieving Sustained Disease Control: Results of a Prospective Study

Evaluation of Pneumococcal and Tetanus Vaccine Responses in Patients with Rheumatoid Arthritis Receiving Baricitinib: Results from a Long-Term Extension Trial Substudy

Pharmacokinetics (PK), Pharmacodynamics (PD), and Proposed Dosing of Oral Janus Kinase (JAK)1 and JAK2 Inhibitor Baricitinib in Patients with IFN-Mediated Autoinflammatory Diseases (AIDs)

Remaining Pain in DMARD-Naive Rheumatoid Arthritis Patients Treated with Baricitinib and Methotrexate

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

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