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Abstract Number: 962 • 2018 ACR/ARHP Annual Meeting
Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 6 Years: An Updated Integrated Safety Analysis
Mark C. Genovese¹, Josef S. Smolen², Tsutomu Takeuchi³, Terence P. Rooney⁴, Christina L. Dickson⁴, Xiao-Yan Yang⁴, Chadi Saifan⁴, Anabela Cardoso⁴, Maher Issa⁴, Taeko Ishii⁵ and Kevin Winthrop⁶, ¹Stanford University Medical Center, Palo Alto, CA, ²Division of Rheumatology, Department of Medicine 3, 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 and Science University, Portland, OR
Background/Purpose: Baricitinib (bari), an oral, selective inhibitor of Janus kinase (JAK) 1 and JAK 2, is approved for the treatment of moderately to severely active…
Abstract Number: 970 • 2018 ACR/ARHP Annual Meeting
Baricitinib in Patients with Systemic Lupus Erythematosus: Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study
Daniel J. Wallace¹, Richard Furie², Yoshiya Tanaka³, Kenneth C. Kalunian⁴, Marta Mosca⁵, Michelle Petri⁶, Thomas Dorner⁷, Mario H. Cardiel⁸, Ian N. Bruce⁹, Elisa Gomez¹⁰, Amy M. DeLozier¹⁰, Jonathan Janes¹⁰, Matthew D Linnik¹⁰, Stephanie de Bono¹⁰, Maria E. Silk¹⁰ and Robert W. Hoffman¹⁰, ¹Cedars-Sinai Medical Center/David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, ²Division of Rheumatology, Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, ³University of Occupational and Environmental Health, Kitakyushu, Japan, ⁴University of California at San Diego School of Medicine, La Jolla, CA, ⁵University of Pisa, Pisa, Italy, ⁶Medicine (Rheumatology), Johns Hopkins University School of Medicine, Baltimore, MD, ⁷Charité Universitätmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, ⁸Centro de Investigación Clínica de Morelia SC, Morelia, Mexico, ⁹Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester, United Kingdom, ¹⁰Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Baricitinib (Bari), an oral selective inhibitor of Janus kinase (JAK)1 and JAK2, has been approved for the treatment of RA in the Europe and…
Abstract Number: 1518 • 2018 ACR/ARHP Annual Meeting
Baricitinib and Tofacitinib in Real Life – Does Obesity Impact Response to Janus Kinase Inhibitor Therapy in Rheumatoid Arthritis?
Yvette Meißner¹, Lisa Baganz¹, Matthias Schneider², Ilka Schwarze³, Martin Feuchtenberger⁴, Angela Zink⁵ and Anja Strangfeld⁶, ¹Programme Area Epidemiology, German Rheumatism Research Center, Berlin, Germany, ²Policlinic for Rheumatology & Hiller Research Centre for Rheumatology, Department of Rheumatology & Hiller Research Unit, Medical Faculty, University Hospital, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany, ³Praxis internistische Rheumatologie, Leipzig, Germany, ⁴Rheumatologie/Klinische Immunologie, Kreiskliniken Altötting-Burghausen, Burghausen, Germany, ⁵Epidemiology Unit / Rheumatology and Clinical Immunology, German Rheumatism Research Centre (DRFZ) / Charité University Hospital, Berlin, Germany, ⁶Epidemiology, German Rheumatism Research Center, Berlin, Germany
Background/Purpose: The influence of obesity on treatment response of tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA) is described in literature, but data…
Abstract Number: 1530 • 2018 ACR/ARHP Annual Meeting
CRP Changes during Bacterial Infections in Baricitinib-Treated Patients with RA
Oliver Hendricks¹, Stavros Chrysidis², Jens Gerwien³, Chadi Saifan³, Francesco de Leonardis³, Pedro Lopez-Romero³, Jinglin Zhong⁴, Kevin Winthrop⁵ and Josef S. Smolen⁶, ¹King Chr.Xs Rheumatology Hospital, Graasten, Denmark, ²Rheumatology Department Sydvestjysk Sygehus, Esbjerg, Denmark, ³Eli Lilly and Company, Indianapolis, IN, ⁴Quintiles, Rockville, MD, ⁵Oregon Health Sciences University, Portland, OR, ⁶Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria
Background/Purpose: Baricitinib (BARI) is a selective inhibitor of Janus kinase 1/2, modulating responses to inflammatory cytokines, e.g. IL-6 or IFNs1. During acute inflammation, including those…
Abstract Number: 1536 • 2018 ACR/ARHP Annual Meeting
Mean Platelet Volume Changes with Baricitinib Indicate Reduced New Platelet Production in Baricitinib-Treated Rheumatoid Arthritis Patients
Jon T. Giles¹, Michael T. Nurmohamed², Henry M. Rinder³, Venkatesh Krishnan⁴, Brenda J. Crowe⁴, Chadi Saifan⁴ and Thomas Dörner⁵, ¹Columbia University, New York, NY, ²VU University Medical Center, Amsterdam, Netherlands, ³Yale University School of Medicine, New Haven, CT, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Charité Universitätsmedizin Berlin and Deutsches Rheuma-Forschungszentrum (DRFZ), Berlin, Germany
Background/Purpose: Transient increases in circulating platelets were observed in patients with RA treated with baricitinib, an oral selective Janus kinase 1/2 inhibitor, approved for the…
Abstract Number: 1894 • 2018 ACR/ARHP Annual Meeting
Baricitinib-Associated Changes in Type l Interferon Gene Signature during a 24-Week Phase-2 Clinical SLE Trial
Thomas Dörner¹, Yoshiya Tanaka², Michelle Petri³, Josef S. Smolen⁴, Ernst R. Dow⁵, Richard E. Higgs⁵, Robert J. Benschop⁵, Adam Abel⁵, Maria E. Silk⁵, Stephanie de Bono⁵ and Robert W. Hoffman⁵, ¹Charité Universitätsmedizin Berlin and Deutsches Rheuma-Forschungszentrum (DRFZ), Berlin, Germany, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Johns Hopkins University School of Medicine, Baltimore, MD, ⁴Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, ⁵Eli Lilly and Company, Indianapolis, IN
Background/Purpose: In the phase 2 study JAHH (NCT02708095), treatment with baricitinib (bari), an oral selective Janus kinase 1/2 inhibitor approved for the treatment of RA,…
Abstract Number: 2035 • 2018 ACR/ARHP Annual Meeting
Effect of Baricitinib on Joint-Related Biomarkers in Patients with Moderate-to-Severe Rheumatoid Arthritis
Christian S. Thudium¹, Anne C. Bay-Jensen¹, Suntara Cahya², Ernst R. Dow², Morten A. Karsdal¹, Alisa E. Koch², Wenling Zhang² and Robert J. Benschop², ¹Nordic Bioscience, Herlev, Denmark, ²Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Baricitinib (bari) is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK2. In the phase 3 study RA-BUILD (NCT01721057), once-daily bari yielded…
Abstract Number: 2531 • 2018 ACR/ARHP Annual Meeting
Assessment of Pain Relief with Baricitinib By Treatment History in Patients with Refractory Rheumatoid Arthritis
Janet E. Pope¹, Amanda Quebe², Baojin Zhu², Luna Sun², Carol L. Gaich², Francesco de Leonardis², Anabela Cardoso² and Mark C. Genovese³, ¹St. Joseph's Health Care, Divsion of Rheumatology, London, ON, Canada, ²Eli Lilly and Company, Indianapolis, IN, ³Stanford University Medical Center, Palo Alto, CA
Background/Purpose: Baricitinib (BARI) 2 mg and 4 mg once daily demonstrated significant clinical improvements compared to placebo in the phase 3 study of RA patients…
Abstract Number: 2815 • 2018 ACR/ARHP Annual Meeting
Cardiovascular Safety – Update from up to 6 Years of Treatment with Baricitinib in Rheumatoid Arthritis Clinical Trials
Michael Weinblatt¹, Peter C. Taylor², Gerd R. Burmester³, Chadi Saifan⁴, Chad D. Walls⁴, Maher Issa⁴, Terence P. Rooney⁴ and Tsutomu Takeuchi⁵, ¹Brigham and Women’s Hospital, Boston, MA, ²Botnar Research Centre, Univ of Oxford, Oxford, United Kingdom, ³Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
Background/Purpose: Baricitinib (BARI), a selective inhibitor of Janus kinases, is approved in >40 countries for the treatment of active rheumatoid arthritis (RA) in adults. Patients…
Abstract Number: 409 • 2017 ACR/ARHP Annual Meeting
An Evaluation of Absolute Neutrophil Count As a Biomarker of Inflammatory and Clinical Disease Activity in Baricitinib-Treated Patients
Iain B. McInnes¹, Lee S. Simon², Robert J. Moots³, Vipin K. Arora⁴, John D. Bradley⁴ and David Muram⁴, ¹University of Glasgow, Glasgow, United Kingdom, ²SDG LLC, Cambridge, MA, ³University of Liverpool, Liverpool, UK, Liverpool, United Kingdom, ⁴Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Rheumatoid arthritis (RA) patients (pts) tend to have higher absolute neutrophil count (ANC) values compared to healthy individuals.1 Baricitinib (BARI), an oral, selective Janus…
Abstract Number: 415 • 2017 ACR/ARHP Annual Meeting
Baricitinib Reduces GlycA Levels in Phase 2 and Phase 3 Clinical Trials in Patients with Moderate to Severe Rheumatoid Arthritis
Joel Kremer¹, Paul Emery², Margery A. Connelly³, James D. Otvos⁴, Steven H. Zuckerman⁵, Giacomo Ruotolo⁵, Lei Chen⁵, Maher Issa⁵, William L. Macias⁵ and Iain B. McInnes⁶, ¹Albany Medical College, Albany, NY, ²Leeds MSK Biomed/Chapel Allerton Hospital, Leeds, United Kingdom, ³Laboratory Corporation of America Holdings (LabCorp), Morrisvile, NC, ⁴Laboratory Corporation of America Holding (LabCorp), Morrisville, NC, ⁵Eli Lilly and Company, Indianapolis, IN, ⁶University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Baricitinib (bari) is an oral selective inhibitor of Janus kinase (JAK) 1/JAK2.1 In the European Union, bari is approved for the treatment of moderate…
Abstract Number: 499 • 2017 ACR/ARHP Annual Meeting
Assessment of Early Improvement in Pain and Other ACR Components As Predictors for Achieving Low Disease Activity or Remission in Three Phase 3 Trials of RA Patients Treated with Baricitinib
Michael Weinblatt¹, Mark C. Genovese², Joel Kremer³, Luna Sun⁴, Himanshu Patel⁴, Alisa Koch⁴, David Muram⁴, Jeffrey R. Curtis⁵, Cynthia J. Larmore⁴ and Baojin Zhu⁴, ¹Brigham and Women’s Hospital, Boston, MA, ²Stanford University Medical Center, Palo Alto, CA, ³The Center for Rheumatology, Albany Medical College, Albany, NY, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: The purpose of this analysis was to assess whether early improvement in ACR components could act as predictors of low disease activity (LDA)…
Abstract Number: 502 • 2017 ACR/ARHP Annual Meeting
Reduction in Disease Activity in Patients with RA and an Inadequate Response to MTX: Baricitinib Compared to Adalimumab and Placebo
Peter Nash¹, Janet E. Pope², Anabela Cardoso³, Marta Casillas³, Douglas E. Schlichting³, Baojin Zhu³, Scott D. Beattie³ and Josef S. Smolen⁴, ¹University of Queensland, Brisbane, Australia, ²St. Joseph's Health Care, London, ON, Canada, ³Eli Lilly and Company, Indianapolis, IN, ⁴Rheumatology, Medical University of Vienna, Vienna, Austria
Background/Purpose: Baricitinib (BARI), is an oral Janus kinase (JAK)1/JAK2 selective inhibitor for treatment of patients with moderately to severely active RA. RA-BEAM was a phase…
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: 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…

Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 6 Years: An Updated Integrated Safety Analysis

Baricitinib in Patients with Systemic Lupus Erythematosus: Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study

Baricitinib and Tofacitinib in Real Life – Does Obesity Impact Response to Janus Kinase Inhibitor Therapy in Rheumatoid Arthritis?

CRP Changes during Bacterial Infections in Baricitinib-Treated Patients with RA

Mean Platelet Volume Changes with Baricitinib Indicate Reduced New Platelet Production in Baricitinib-Treated Rheumatoid Arthritis Patients

Baricitinib-Associated Changes in Type l Interferon Gene Signature during a 24-Week Phase-2 Clinical SLE Trial

Effect of Baricitinib on Joint-Related Biomarkers in Patients with Moderate-to-Severe Rheumatoid Arthritis

Assessment of Pain Relief with Baricitinib By Treatment History in Patients with Refractory Rheumatoid Arthritis

Cardiovascular Safety – Update from up to 6 Years of Treatment with Baricitinib in Rheumatoid Arthritis Clinical Trials

An Evaluation of Absolute Neutrophil Count As a Biomarker of Inflammatory and Clinical Disease Activity in Baricitinib-Treated Patients

Baricitinib Reduces GlycA Levels in Phase 2 and Phase 3 Clinical Trials in Patients with Moderate to Severe Rheumatoid Arthritis

Assessment of Early Improvement in Pain and Other ACR Components As Predictors for Achieving Low Disease Activity or Remission in Three Phase 3 Trials of RA Patients Treated with Baricitinib

Reduction in Disease Activity in Patients with RA and an Inadequate Response to MTX: Baricitinib Compared to Adalimumab and Placebo

Improved Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Who Failed Adalimumab or Placebo Treatment and Were Rescued with Baricitinib

Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 5.5 Years: An Updated Integrated Safety Analysis

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