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Abstract Number: 1396 • ACR Convergence 2021
Baricitinib in Relapsing Giant Cell Arteritis: A Prospective Open-Label Single-Institution Study
Matthew Koster¹, Cynthia Crowson², Rachel Giblon¹, Ali Duarte-Garcia¹, Jane Jaquith¹, Cornelia M. Weyand¹ and Kenneth Warrington³, ¹Mayo Clinic, Rochester, MN, ²Mayo Clinic, Eyota, MN, ³Mayo Clinic, Rochester, Minnesota
Background/Purpose: Pre-clinical giant cell arteritis (GCA) mouse models have demonstrated effective suppression of arterial wall lesional T-cells through inhibition of Janus kinase 3 (JAK3) and…
Abstract Number: 1618 • ACR Convergence 2021
Disease Flares in CANDLE/PRAAS with Dose Reductions of Baricitinib
Kader Cetin Gedik¹, Grace Materne², Ana Ortega-Villa³, Gina Montealegre Sanchez⁴, Adam Reinhardt⁵, Paul Brogan⁶, Yackov Berkun⁷, Sara Murias⁸, Maria Robles⁹, Susanne Schalm¹⁰, Adriana Almeida de Jesus¹¹ and Raphaela Goldbach-Mansky¹², ¹Translational Autoinflammatory Diseases Section (TADS)/NIAID/NIH, Bethesda, MD, ²Translational Autoinflammatory Diseases Section, NIAID/NIH, Bethesda, TN, ³Biostatistics Research Branch, Division of Clinical Research, NIAID/NIH, Bethesda, ⁴NIAID/NIH, Bethesda, MD, ⁵Boys Town National Research Hospital, Omaha, NE, ⁶UCL Institute of Child Health and Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom, ⁷Hadassah Hebrew University Medical Center, Jerusalem, Israel, ⁸Hospital Infantil La Paz, Madrid, Spain, ⁹Eskenazi Health Center, IndianaPolis, IN, ¹⁰Rheumatologie im Zentrum, Munich, Germany, ¹¹TADS/NIAID/NIH, Silver Spring, MD, ¹²NIH/NIAID, Potomac, MD
Background/Purpose: Patients with chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures /proteasome-associated autoinflammatory syndrome (CANDLE/PRAAS) respond to treatment with baricitinib but require higher exposure…
Abstract Number: 1676 • ACR Convergence 2021
Safety of Baricitinib in Japanese Patients with Rheumatoid Arthritis (RA): The 2020 Interim Report from All-case Post Marketing Surveillance in Clinical Practice
Takao Fujii¹, Tatsuya Atsumi², Nami Okamoto³, Nobunori Takahashi⁴, Naoto Tamura⁵, Atsuo Nakajima⁶, Ayako Nakajima⁷, Hiroaki Matsuno⁸, Naoto Tsujimoto⁹, Atsushi Nishikawa¹⁰, Taeko Ishii¹⁰, Tsutomu Takeuchi¹¹, Masataka Kuwana¹² and Michiaki Takagi¹³, ¹Department of Rheumatology and Clinical Immunology, Wakayama Medical University, Wakayama, Japan, ²Hokkaido University, Sapporo, Japan, ³Osaka Medical College, Takatsuki-city, Japan, ⁴Nagoya University Graduate School of Medicine, Nagoya, Japan, ⁵Department of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine, Tokyo, Japan, ⁶Ueno Touseki Clinic, Fukuoka, Japan, ⁷Center for Rheumatic Diseases, Mie University Hospital, Mie, Japan, ⁸Matsuno Clinic for Rheumatic Diseases, Toyama, Japan, ⁹Eli Lilly Japan K.K.,, Kobe, Japan, ¹⁰Eli Lilly Japan K.K., Kobe, Japan, ¹¹Div. Rheumatology, Keio University, Tokyo, Japan, ¹²Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan, ¹³Department of Orthopaedic Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan
Background/Purpose: An all-case post marketing surveillance (PMS) of baricitinib, that started in Sep 2017, collects safety and effectiveness for the first 24 weeks of treatment…
Abstract Number: 1688 • ACR Convergence 2021
Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 9.3 Years: An Updated Integrated Safety Analysis
Peter C Taylor¹, Tsutomu Takeuchi², Gerd Burmester³, Patrick DUREZ⁴, Josef Smolen⁵, Walter Deberdt⁶, Jinglin Zhong⁷, Jorge Ross Terres⁶, Natalia Bello⁶ and Kevin Winthrop⁸, ¹University of Oxford, Oxford, United Kingdom, ²Div. Rheumatology, Keio University, Tokyo, Japan, ³Charité University Medicine Berlin, Berlin, Germany, ⁴Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Brussels, Belgium, ⁵Medical University of Vienna, Vienna, Austria, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷IQVIA, Morrisville, NC, ⁸Oregon Health & Science University, Portland, OR
Background/Purpose: Baricitinib (bari) is an oral selective Janus kinase (JAK)1/JAK 2 inhibitor approved for the treatment of adult patients with moderately to severely active rheumatoid…
Abstract Number: 1702 • ACR Convergence 2021
Efficacy and Safety of Baricitinib in B/tsDMARDs Naive and B/tsDMARDs-IR Patients with Rheumatoid Arthritis
MASAOMI YAMASAKI, Shin-Yokohama Arthritis and Rheumatology Clinic, Yokohama, Japan
Background/Purpose: Baricitinib, an oral selective inhibitor of Janus kinase (JAK) 1 and 2, improved signs and symptoms of rheumatoid arthritis(RA).We analyze efficacy and safety of…
Abstract Number: 1746 • ACR Convergence 2021
Baricitinib Decreases Anti-dsDNA and IgG Antibodies in Adults with Systemic Lupus Erythematosus from a Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial
Thomas Dörner¹, Ronald Van Vollenhaven², Andrea Doria³, Bochao Jia⁴, Damiano Fantini⁴, Jorge Ross Terres⁴, Maria Silk⁵, Stephanie de Bono⁴, Peter Fischer⁶ and Daniel Wallace⁷, ¹Charite Universitätsmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, ²University Medical Center, Amsterdam, Netherlands, ³University of Padova, Padova, Italy, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Eli Lilly and Company, Carmel, IN, ⁶Eli Lilly and Company, North Easton, MA, ⁷Cedars-Sinai, Los Angeles, CA
Background/Purpose: Baricitinib (BARI), an oral, selective Janus kinase (JAK)1 and JAK2 inhibitor, improved disease activity in adults with systemic lupus erythematosus (SLE) receiving standard background…
Abstract Number: 1763 • ACR Convergence 2021
Baricitinib Reduces Proinflammatory Serum Cytokines in Patients with Systemic Lupus Erythematosus 
Thomas Dörner¹, Yoshiya Tanaka², Daniel Wallace³, Damiano Fantini⁴, Alisa Koch⁴, Maria Silk⁵, Jorge Ross Terres⁴, Jonathan Sims⁴, Peter Fischer⁶ and Michelle Petri⁷, ¹Charite Universitätsmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, ²University of Occupational and Environmental Health, Kitakyushu, Japan, ³Cedars-Sinai, Los Angeles, CA, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵Eli Lilly and Company, Carmel, IN, ⁶Eli Lilly and Company, North Easton, MA, ⁷Johns Hopkins University School of Medicine, Baltimore, MD
Background/Purpose: Baricitinib, a Janus kinase (JAK)1/JAK2 inhibitor, improved disease activity in systemic lupus erythematosus (SLE) adults receiving standard background therapy in a phase 2 trial…
Abstract Number: 0202 • ACR Convergence 2020
Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 8.4 Years: An Updated Integrated Safety Analysis
Kevin Winthrop¹, Tsutomu Takeuchi², Gerd Burmester³, Patrick Durez⁴, Walter Deberdt⁵, Douglas Schlichting⁶, Scott Beattie⁶, Daojun Mo⁷, Chad Walls⁶ and Josef Smolen⁸, ¹Oregon Health & Science University, Portland, OR, ²Division of Rheumatology, Department of internal Medicine, School of Medicine, Keio University, Tokyo, Japan, ³Charité University Hospital Berlin, Berlin, Germany, ⁴Division of Rheumatology, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium, ⁵Eli Lilly and Company, Brussels, Belgium, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷Eli Lilly and Company, Carmel, IN, ⁸Medical University of Vienna, Vienna, Austria
Background/Purpose: Baricitinib (bari) is an oral selective Janus kinase (JAK)1/JAK 2 inhibitor approved for the treatment of moderately to severely active rheumatoid arthritis (RA) in…
Abstract Number: 0203 • ACR Convergence 2020
Safety of Baricitinib in Patients with Rheumatoid Arthritis: Interim Report from All-Case Post‑Marketing Study in Clinical Use
Tatsuya Atsumi¹, Nami Okamoto², Nobunori Takahashi³, Naoto Tamura⁴, Atsuo Nakajima⁵, Ayako Nakajima⁶, Takao Fujii⁷, Hiroaki Matsuno⁸, Yuko Takahashi⁹, Fumie Inui⁹, Naoto Tsujimoto⁹, Atsushi Nishikawa⁹, Taeko Ishii⁹, Tsutomu Takeuchi¹⁰, Masataka Kuwana¹¹ and Michiaki Takagi¹², ¹Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapparo, Hokkaido, Japan, ²Department of Rheumatology and Allergy of Pediatrics, Osaka Medical College, Takatsuki, Osaka, Japan, ³Department of Orthopaedics/Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan, ⁴Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine, Bunkyō, Tokyo, Japan, ⁵Ueno Touseki Clinic, Kitasaku District, Nagano, Japan, ⁶Center for Rheumatic Diseases, Mie University Hospital, Tsu, Mie, Japan, ⁷Department of Rheumatology and Clinical Immunology, Wakayama Medical University, Wakayama, Wakayama, Japan, ⁸Matsuno Clinic for Rheumatic Diseases, Toyama, Toyama, Japan, ⁹Eli Lilly, Kobe, Hyogo, Japan, ¹⁰Division of Rheumatology, Department of internal Medicine, School of Medicine, Keio University, Tokyo, Japan, ¹¹Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Tokyo, Japan, ¹²Department of Orthopaedic Surgery, Yamagata University Faculty of Medicine, Yamagata, Yamagata, Japan
Background/Purpose: To evaluate the safety of baricitinib in rheumatoid arthritis (RA) patients in clinical use.Methods: An all-case post-marketing study of baricitinib, started in September 2017,…
Abstract Number: 0224 • ACR Convergence 2020
Efficacy of Long-term Treatment with Baricitinib 2 Mg in Patients with Active Rheumatoid Arthritis
Alvin Wells¹, Bochao Jia², Li Xie², Guillermo Valenzuela³, Edward C Keystone⁴, Zhanguo Li⁵, Amanda Quebe², Kirstin Griffing², Susan Otawa² and Boulos Haraoui⁶, ¹Aurora Rheumatology and Immunotherapy Center, Franklin, ²Eli Lilly and Company, Indianapolis, IN, ³Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁴Mount Sinai Hospital, Toronto, ON, Canada, ⁵Peking University People’s Hospital, Xicheng, Beijing, China (People's Republic), ⁶Institut de Rhumatologie de Montréal, Montreal, QC, Canada
Background/Purpose: The short-term efficacy of baricitinib was demonstrated previously.1,2 The objectives of this post-hoc analysis were to evaluate long-term efficacy of once-daily baricitinib 2 mg…
Abstract Number: 0453 • ACR Convergence 2020
Monitoring of BK Reactivation and Long-term Safety on JAK1/2 Inhibition with Baricitinib
Kader Cetin Gedik¹, Gema Souto Adeva², Jenna Wade¹, Gina Montealegre Sanchez³, Adriana de Jesus⁴ and Raphaela Goldbach-Mansky⁵, ¹Translational Autoinflammatory Disease Section (TADS)/NIAID/NIH, Bethesda, MD, ²Translational Autoinflammatory Disease Section (TADS)/NIAID/ NIH, Bethesda, ³Translational Autoinflammatory Disease Section (TADS)/NIAID/NIH, Rockville, MD, ⁴Translational Autoinflammatory Disease Section (TADS)/NIAID/NIH, Silver Spring, MD, ⁵Translational Autoinflammatory Disease Section (TADS)/NIAID/NIH, Potomac, MD
Background/Purpose: Baricitinib has been used to treat pediatric patients (pts) with Type 1 Interferonopathies1. Safety profile including BK viral reactivation in urothelium and pharmacokinetic model…
Abstract Number: 0848 • ACR Convergence 2020
Delineation of a Proinflammatory Cytokine Profile Targeted by Janus Kinase 1/2 Inhibition Using Baricitinib in a Phase 2 Systemic Lupus Erythematosus Trial
Thomas Dörner¹, Yoshiya Tanaka², Michelle Petri³, Josef Smolen⁴, Daniel Wallace⁵, Brenda Crowe⁶, Ernst Dow⁶, Richard Higgs⁶, Guilherme Rocha⁶, Robert Benschop⁶, Maria Silk⁶, Stephanie de Bono⁶, Robert Hoffman⁶ and Damiano Fantini⁶, ¹DRFZ and Charité University Hospitals, Berlin, Germany, ²The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ³Johns Hopkins University School of Medicine, Timonium, MD, ⁴Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria, ⁵Cedars-Sinai Medical Center/UCLA, Los Angeles, CA, ⁶Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Given the unmet clinical needs in systemic lupus erythematosus (SLE), including poor disease control and drug toxicities, new therapies are needed. In a phase…
Abstract Number: 1228 • ACR Convergence 2020
Baricitinib 2-mg Provides Greater Improvements in Patient-Reported Outcomes Across All Disease Activity Levels Compared to Placebo: Post-hoc Analyses of RA-BEACON and RA-BUILD Trials
Clifton Bingham III¹, Bochao Jia², Jianmin Wu², Amanda Quebe², Carol Kannowski², Susan Otawa², Yun-Fei Chen², Kirstin Griffing², Dongyi He³ and Dalton Sholter⁴, ¹Johns Hopkins University, Baltimore, MD, ²Eli Lilly and Company, Indianapolis, IN, ³Shanghai Guanghua Hospital, Shanghai, Shanghai, China (People's Republic), ⁴University of Alberta, Edmonton, AB, Canada
Background/Purpose: Baricitinib (BARI) improved patient-reported outcomes (PROs) in patients with insufficient response or intolerance to ≥1 tumor necrosis factor inhibitors (TNFi) or other biological disease-modifying…
Abstract Number: 1235 • ACR Convergence 2020
Radiographic Progression of Structural Joint Damage over 5 Years of Baricitinib Treatment in Patients with Rheumatoid Arthritis: Results from RA-BEYOND
Désirée van der Heijde¹, Cynthia E Kartman², Li Xie², Scott Beattie², Douglas Schlichting², Patrick Durez³, Yoshiya Tanaka⁴ and Roy Fleischmann⁵, ¹Leiden University Medical Center, Leiden, Netherlands, ²Eli Lilly and Company, Indianapolis, IN, ³Division of Rheumatology, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium, ⁴The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: Baricitinib (BARI) is an oral, reversible and selective Janus kinase 1 and 2 inhibitor. Treatment with once-daily oral BARI resulted in low rates of…
Abstract Number: 1558 • ACR Convergence 2020
Cinematic Rendering Enables Depiction of Bone Anabolic Effects in Patients Treated with Baricitinib
Sara Bayat¹, David Simon², Louis Schuster², Georg Schett³ and Arnd Kleyer², ¹Department of Internal Medicine 3, Friedrich-Alexander University (FAU) Erlangen-Nuremberg and Universitätsklinikum Erlangen, Erlangen, Germany, ²Department of Internal Medicine 3, Friedrich-Alexander University (FAU) Erlangen-Nuremberg and Universitätsklinikum Erlangen, Erlangen, Bayern, Germany, ³Friedrich-Alexander-Universität Erlangen- Nuremberg, Erlangen, Germany
Background/Purpose: Preclinical studies show that tsDMARDs such as baricitinib may be a therapeutic agent for bone anabolic effects by increasing osteoblast function in inflammatory conditions.[1]…

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