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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…
Abstract Number: 3208 • 2016 ACR/ARHP Annual Meeting
Preliminary 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, Paul Brogan³, Dawn C. Chapelle⁴, Hanna Kim⁴, Samantha Judd⁴, Bahar Kost⁴, Michelle O'Brien⁴, Wendy Goodspeed⁵, Robert A. Colbert⁴, Meryl Waldman⁶, Deborah L. Stone⁷, Ling Gao⁸, JA Dare⁸, Susanne Schalm⁹, Thomas L. Klausmeier¹⁰, Sara Murias¹¹, Yackov Berkun¹², Diane Brown¹³, John D. Carter¹⁴, Fehime K Eroglu¹⁵, A. Zlotogorski¹⁶, Philip Hashkes¹⁷, Helmut Wittkowski¹⁸, Suzanne Ramsey¹⁹, Seza Ozen²⁰, Adriana Almeida de Jesus²¹ and Raphaela Goldbach-Mansky²², ¹NIAID/NIH, Bethesda, MD, ²Rheumatology, Children's Hosp of Omaha/UNMC, Omaha, NE, ³UCL Institute of Child Health and Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom, ⁴NIAMS/NIH, Bethesda, MD, ⁵Office of the Clinical Director, NIAMS/NIH, Bethesda, MD, ⁶NIDDK/NIH, Bethesda, MD, ⁷NHGRI/NIH, Bethesda, MD, ⁸University of Arkansas for Medical Sciences, Little Rock, AR, ⁹LMU Munich, Munich, Germany, ¹⁰Riley Hospital for Children, Indianapolis, IN, ¹¹Hospital Infantil La Paz, Madrid, Spain, ¹²Hadassah-Hebrew University Medical Center, Jerusalem, Israel, ¹³Children's Hospital Los Angeles, Los Angeles, CA, ¹⁴Division of Rheumatology, University of South Florida, Tampa, FL, ¹⁵Department of Pediatrics, Hacettepe University Hospitals, Ankara, Turkey, ¹⁶Department of Dermatology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel, ¹⁷Pediatric Rheumatology, Shaare Zedek Medical Center, Jerusalem, Israel, ¹⁸Pediatrics, University of Muenster, Muenster, Germany, ¹⁹Pediatric Rheumatology, IWK Health Centre, Halifax, NS, Canada, ²⁰Department of Pediatrics, Hacettepe University Faculty of Medicine, Ankara, Turkey, ²¹National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, MD, ²²Translational Autoinflammatory Disease Studies, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, MD
Background/Purpose: Chronically elevated serum IP-10 (CXCL10) levels, and a prominent “interferon (IFN)-response gene signature” in patients with chronic neutrophilic dermatosis with lipodystrophy and elevated temperatures…
Abstract Number: 2L • 2015 ACR/ARHP Annual Meeting
Baricitinib Versus Placebo or Adalimumab in Patients with Active Rheumatoid Arthritis (RA) and an Inadequate Response to Background Methotrexate Therapy: Results of a Phase 3 Study
Peter C. Taylor¹, Edward C. Keystone^2,3, D. van der Heijde⁴, Yoshiya Tanaka⁵, Taeko Ishii⁶, Kahaku Emoto⁶, Lili Yang⁶, Vipin Arora⁶, Carol L. Gaich⁶, Terence Rooney⁶, Douglas E. Schlichting⁶, William Macias⁶, Stephanie de Bono⁶ and Michael E. Weinblatt⁷, ¹Nuffield Dept. of Orthopaedics, Rheumatology and Musculoskeletal, Sciences, Kennedy Institute of Rheumatology, University of Oxford,, Oxford, United Kingdom, ²University of Toronto, Toronto, ON, Canada, ³Rebecca MacDonald Centre, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁴Leiden University Medical Center, Leiden, Netherlands, ⁵The First Dept. of Internal Medicine, University of Occupational & Environmental Health, Kitakyusyu, Japan, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷Brigham and Women’s Hospital, Boston, MA
Background/Purpose: In phase 3 studies, baricitinib (bari) improved disease activity in patients (pts) with active RA and an inadequate response (IR) to conventional synthetic DMARDs1…
Abstract Number: 485 • 2015 ACR/ARHP Annual Meeting
Evaluate the Dose Efficacy Response Relationship of Baricitinib in Patients with Rheumatoid Arthritis
Xin Zhang, Laiyi Chua, C. Steven Ernest II, William Macias, Terence Rooney and Lai San Tham, Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Baricitinib (Bari) is an oral inhibitor of Janus kinases (JAK) selective for JAK 1 and 2. It has demonstrated dose-dependent efficacy in patients with…
Abstract Number: 1045 • 2015 ACR/ARHP Annual Meeting
Baricitinib, Methotrexate, or Baricitinib Plus Methotrexate in Patients with Early Rheumatoid Arthritis Who Had Received Limited or No Treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs): Phase 3 Trial Results
Roy Fleischmann¹, Tsutomu Takeuchi², Douglas E. Schlichting³, William L. Macias³, Terence Rooney³, Sirel Gurbuz³, Ivaylo Stoykov³, Scott D. Beattie³, Wen-Ling Kuo³ and M Schiff⁴, ¹Rheumatology, Metroplex Clinical Research Center, Dallas, TX, ²Keio University School of Medicine, Tokyo, Japan, ³Eli Lilly and Company, Indianapolis, IN, ⁴School of Medicine, University of Colorado, Denver, CO
Background/Purpose: In 2 completed phase 3 studies, baricitinib (bari) improved disease activity with a satisfactory safety profile in patients (pts) with moderately-to-severely active RA who…
Abstract Number: 1046 • 2015 ACR/ARHP Annual Meeting
Previous Biologic Disease-Modifying Antirheumatic Drug (bDMARD) Exposure and Efficacy and Safety Analysis from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitors
Mark C. Genovese¹, Joel M. Kremer², Cynthia Kartman³, Douglas E. Schlichting³, Li Xie³, Tara Carmack⁴, William L. Macias³ and Josef S. Smolen⁵, ¹Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA, ²Center for Rheumatology, Albany, NY, ³Eli Lilly and Company, Indianapolis, IN, ⁴Quintiles, Durham, NC, ⁵Department of Rheumatology, Medical University of Vienna, Vienna, Austria
Background/Purpose: Baricitinib, an oral inhibitor of JAK1/JAK2, improved disease activity with an acceptable safety profile in a phase 3 study (RA-BEACON) of patients with active…
Abstract Number: 1047 • 2015 ACR/ARHP Annual Meeting
Characterization of Changes in Lymphocyte Subsets in Baricitinib-Treated Patients with Rheumatoid Arthritis in Two Phase 3 Studies
Paul Emery¹, Iain McInnes², Mark C. Genovese³, Josef S. Smolen⁴, Joel Kremer⁵, Maxime Dougados⁶, Douglas E. Schlichting⁷, Terence Rooney⁷, Maher Issa⁷, Stephanie de Bono⁷, William L. Macias⁷, Veronica Rogai⁷, Steven H. Zuckerman⁷ and Peter C. Taylor⁸, ¹Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Leeds, United Kingdom, ²Glasgow Biomedical Research Centre, Glasgow, United Kingdom, ³Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Department of Rheumatology, Medical University of Vienna, Vienna, Austria, ⁵Albany Medical College, Albany, NY, ⁶Paris-Descartes University, Paris, France, ⁷Eli Lilly and Company, Indianapolis, IN, ⁸Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford Botnar Research Centre, Oxford, United Kingdom
Background/Purpose: Baricitinib (bari) is an oral, reversible inhibitor of Janus kinase (JAK)1/JAK2 being developed as QD treatment for patients (pts) with RA. In phase (ph)…

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

Preliminary 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

Baricitinib Versus Placebo or Adalimumab in Patients with Active Rheumatoid Arthritis (RA) and an Inadequate Response to Background Methotrexate Therapy: Results of a Phase 3 Study

Evaluate the Dose Efficacy Response Relationship of Baricitinib in Patients with Rheumatoid Arthritis

Baricitinib, Methotrexate, or Baricitinib Plus Methotrexate in Patients with Early Rheumatoid Arthritis Who Had Received Limited or No Treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs): Phase 3 Trial Results

Previous Biologic Disease-Modifying Antirheumatic Drug (bDMARD) Exposure and Efficacy and Safety Analysis from a Phase 3 Study of Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitors

Characterization of Changes in Lymphocyte Subsets in Baricitinib-Treated Patients with Rheumatoid Arthritis in Two Phase 3 Studies

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