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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…
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…

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

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

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