ACR Meeting Abstracts

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Abstracts tagged "rheumatoid arthritis (RA) and safety"

  • Abstract Number: 1553 • 2018 ACR/ARHP Annual Meeting

    An Analysis of Real-World Data on the Safety of Etanercept in Elderly Patients with Rheumatoid Arthritis

    Christopher J. Edwards1, Jack F Bukowski2, Sara Burns3, Heather Jones2, Ronald Pedersen2, Katherine Roshak2, Joan M Sopczynski2, Mazhar Thakur4 and Lisa Marshall2, 1University of Southampton, Southampton, United Kingdom, 2Pfizer, Collegeville, PA, 3Pfizer, Cambridge, MA, 4RegSafe Consulting Ltd, Wokingham, United Kingdom

    Background/Purpose: Both rheumatoid arthritis (RA) and older age are associated with a higher risk of comorbidities, and the appropriate treatment approach for older patients is…
  • Abstract Number: 1940 • 2018 ACR/ARHP Annual Meeting

    Reductions in Absolute Neutrophil Count (ANC) with Sarilumab Resulting in Dose Delays or Dose Decreases: Effects on Efficacy and Safety

    Jeffrey R. Curtis1, Gregory St. John2, Michael Pannucci2, Yong Lin3, José A. Maldonado-Cocco4, Tom W.J. Huizinga5, Marina Stanislav6 and Paul Emery7, 1University of Alabama, Birmingham, AL, 2Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 3Sanofi Genzyme, Bridgewater, NJ, 4Universidad de Buenos Aires, Buenos Aires, Argentina, 5Leiden University Medical Center, Leiden, Netherlands, 6Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russian Federation, 7University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom

    Background/Purpose: In sarilumab randomized controlled trials (RCTs), dose delay and/or reduction was recommended for management of patients who developed neutropenia Grade (G) 3 (ANC ≥500…
  • Abstract Number: 2509 • 2018 ACR/ARHP Annual Meeting

    Long-Term Treatment with Sarilumab Plus Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs): Pooled Safety and Efficacy with over 4 Years’ Treatment

    Mark C. Genovese1, Hubert van Hoogstraten2, Gregory St. John3, Qunming Dong2, Juan José Gómez-Reino4, José A. Maldonado-Cocco5, Juan Carlos Salazar6, Tom W.J. Huizinga7 and Gerd R. Burmester8, 1Stanford University Medical Center, Palo Alto, CA, 2Sanofi Genzyme, Bridgewater, NJ, 3Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 4Complejo Hospitalario Universitario de Santiago de Compostela, Santiago, Spain, 5School of Medicine, Buenos Aires University, Buenos Aires, Argentina, 6Riesgo de Fractura S.A - CAYRE, Bogotá, Colombia, 7Leiden University Medical Center, Leiden, Netherlands, 8Charité – University Medicine Berlin, Berlin, Germany

    Background/Purpose: EXTEND (NCT01146652) is an ongoing open-label extension study enrolling patients completing five sarilumab originator studies (MOBILITY [NCT01061736]; TARGET [NCT01709578]; ASCERTAIN [NCT01768572]; ACT11575 [NCT01217814]; ONE…
  • Abstract Number: 2516 • 2018 ACR/ARHP Annual Meeting

    Long-Term Maintenance of Response in Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol

    Alain Saraux1, René-Marc Flipo2, Francis Fagnani3, Gabrielle Cukierman4, Isabelle Bru4, Jean-Michel Joubert4, Jan-Christof Schuller5, Jacques Massol6 and Bernard Combe7, 1CHU La Cavale Blanche, Brest, France, 2Hôpital Roger Salengro, Lille, France, 3Cemka-Eval, Bourg-la-Reine, France, 4UCB Pharma, Colombes, France, 5UCB Pharma, Brussels, Belgium, 6CHU de Besançon, Besançon, France, 7CHU Lapeyronie, Montpellier, France

    Background/Purpose: The safety and efficacy of certolizumab pegol (CZP) for treating patients (pts) with rheumatoid arthritis (RA) are well-established in a clinical trial setting.1,2 However,…
  • Abstract Number: 2525 • 2018 ACR/ARHP Annual Meeting

    Correlation Analysis between Sirukumab Exposure and Selected Safety Events Following Subcutaneous Administration Using Pooled Phase 3 Data in Rheumatoid Arthritis

    Yan Xu1, Yanli Zhuang1, Chuanpu Hu1, Benjamin Hsu2, Zhenhua Xu1, Amarnath Sharma1 and Honghui Zhou1, 1Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, 2Immunology Clinical Development, Janssen Research & Development, LLC, Spring House, PA

    Background/Purpose: To characterize the exposure-response (ER) relationship between systemic exposure to sirukumab (an anti- interleukin-6 [IL-6] human monoclonal antibody) and the occurrence of selected safety…
  • Abstract Number: 2527 • 2018 ACR/ARHP Annual Meeting

    Long-Term Safety with Sarilumab Plus Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and Sarilumab Monotherapy in Rheumatoid Arthritis (RA): An Integrated Analysis with 9,000 Patient-Years (Pt-Yrs) of Follow-up

    Roy Fleischmann1, Yong Lin2, Gregory St. John3, Désirée van der Heijde4, Chunfu Qiu2, Juan José Gómez-Reino5, José A. Maldonado-Cocco6, Marina Stanislav7, Bruno Seriolo8 and Gerd R. Burmester9, 1University of Texas Southwestern Medical Center, Dallas, TX, 2Sanofi Genzyme, Bridgewater, NJ, 3Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 4Leiden University Medical Centre, Leiden, Netherlands, 5IDIS, Complejo Hospitalario Universitario de Santiago, Santiago, Spain, 6School of Medicine, Buenos Aires University, Buenos Aires, Argentina, 7Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russian Federation, 8Department of Internal Medicine, University of Genova, Genova, Italy, 9Charité – University Medicine Berlin, Berlin, Germany

    Background/Purpose: Sarilumab has shown efficacy in RA both as monotherapy and in combination with csDMARDs in Phase 3 trials. We assessed long-term safety from the…
  • Abstract Number: 2529 • 2018 ACR/ARHP Annual Meeting

    Liver Function Test Levels with Sarilumab Treatment in Phase 3 Trials: Analysis By Baseline Liver Function Test (LFT) Level

    John Tesser1, Gregory St. John2, Toshio Kimura2, Stefano Fiore3, Maureen Rischmueller4, José A. Maldonado-Cocco5, Jürgen Braun6 and Jeffrey Kaine7, 1Arizona Arthritis & Rheumatology Associates, Glendale, AZ, 2Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 3Clinical Science, Sanofi Genzyme, Bridgewater, NJ, 4The University of Adelaide, Adelaide, Australia, 5Buenos Aires University School of Medicine, Buenos Aires, Argentina, 6Ruhr-University Bochum, Bochum, Germany, 7Sarasota Arthritis Research Center, Sarasota, FL

    Background/Purpose: Sarilumab showed efficacy in RA and superiority to placebo and adalimumab in Phase 3 trials. This post hoc analysis investigated LFT levels in three…
  • 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: 1259 • 2018 ACR/ARHP Annual Meeting

    Driving Performance and Safety in Rheumatoid Arthritis: A Systematic Review

    Daniel Zhou1, Ted R. Mikuls2, Cynthia Schmidt3, Bryant R. England4, Debra A Bergman5, Matthew Rizzo6, Jennifer Merickel6 and Kaleb Michaud7,8, 1Internal Medicine, University of Nebraska Medical Center, Omaha, NE, 2Internal Medicine, Division of Rheumatology, VA Nebraska-Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, NE, 3McGoogan Library of Medicine, University of Nebraska Medical Center, Omaha, NE, 4Rheumatology, VA Nebraska-Western Iowa Health Care System & University of Nebraska Medical Center, Omaha, NE, 5Division of Rheumatology, VA Nebraska-Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, NE, 6Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, 7Rheumatology, University of Nebraska Medical Center, Omaha, NE, 8FORWARD, The National Databank for Rheumatic Diseases, Wichita, KS

    Background/Purpose: Automobile driving represents an instrumental activity of daily living (IADL). Symptoms accompanying RA, including fatigue, joint pain and stiffness, decreased strength, reduced mobility, and…
  • Abstract Number: 1263 • 2018 ACR/ARHP Annual Meeting

    Develop a Master Algorithm for Drug Withdraw Strategy in Reduction of Adverse Events – a Machine Learning Model from the Smart System of Disease Management (SSDM)

    Yan Zhao1, Jing Yang2, Jianlin Huang3, Hua Wei4, Yongfu Wang5, Rong Mu6, Xiaoxia Zuo7, Hongzhi Wang8, Xinwang Duan9, Jing Xue10, Hongsheng Sun11, Bin Wu12, Lirong Kang5, Feng Wei13, Cundong Mi14, Yanping Zhao15, Yang Li16, Haiying Chen17, Zhenbin Li18, Qingliang Meng19, Yuhua Jia20, Hui Xiao20 and Fei Xiao20, 1Rheumatology, Peking Union Medical College Hospital, Beijing, China, 2Department of rheumatology, Central Hospital of MianYang, Sichuan, Mian Yang, China, 3Department of rheumatology, The Sixth Hospital Affiliated to Sun yat-sen University, Guangzhou, China, 4Northern Jiangsu People's Hospital, Yangzhou, China, 5The First Affiliated Hospital of BaoTou Medical College, Baotou, China, 6Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China, 7Xiangya Hospital Central South University, Changsha, China, 8The First Hospital of Jiaxing, Jiaxing, China, 9Department of rheumatology, The Second Affiliated Hospital of Nanchang University, Nanchang, China, 1088 Jiefang Road, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, 11Department of Rheumatology and Immunology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China, 12Department of Rheumatology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China, 13JIANGMEN CENTRAL HOSPITAL, AFFILIATED JIANGMEN HOSPITAL OF SUN YAT-SEN UNIVERSITY, Jiangmen, China, 14The Second Affiliated Hospital of Guangxi Medical University, Nanning, China, 15The First Affiliated Hospital of Harbin Medical University, Harbin, China, 16The Second Affiliated Hospital of Harbin Medical University, Harbin, China, 17The third hospital of hebei medical university, Shijiazhuang, China, 18Peace Hospital, Shijiazhuang, China, 19Henan Province Hospital of TCM, Zhengzhou, China, 20Shanghai Gothic Internet Technology Co., Ltd., Shanghai, China

    Background/Purpose: Combination therapy with DMARDs for treating RA is considered as standard of care. However, certain rates of adverse events (AEs) are unavoidable. The stigma…
  • Abstract Number: 1511 • 2018 ACR/ARHP Annual Meeting

    The Relationship between Lipid Profile Changes and Inflammation across the Phase 3 Sarilumab Rheumatoid Arthritis (RA) Developmental Program

    Christina Charles-Schoeman1, Gregory St. John2, Henry Leher2, Toshio Kimura2, Hubert van Hoogstraten3, Michael T. Nurmohamed4, Miguel Angel González-Gay5 and Edward C. Keystone6, 1Rheumatology, UCLA David Geffen School of Medicine, Los Angeles, CA, 2Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 3Sanofi Genzyme, Bridgewater, NJ, 4VU University Medical Center, Amsterdam, Netherlands, 5University Hospital Marques de Valdecilla, Santander, Spain, 6University of Toronto and Mount Sinai Hospital, Toronto, ON, Canada

    Background/Purpose: Sarilumab showed superiority to placebo and adalimumab in Phase 3 trials. Serum lipids may be reduced in the setting of chronic inflammation associated with…
  • Abstract Number: 1517 • 2018 ACR/ARHP Annual Meeting

    Integrated Safety Analysis across Phase 3 Clinical Studies Including the Controlled and Uncontrolled Periods for Intravenous Golimumab in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

    Arthur Kavanaugh1, Atul A. Deodhar2, Sergio Schwartzman3, Shelly Kafka4, Soumya D Chakravarty5, Elizabeth C Hsia6, Diane D. Harrison7, Jocelyn Leu7, Yiying Zhou7, Kim Hung Lo7 and M. Elaine Husni8, 1University of California, San Diego, School of Medicine, La Jolla, CA, 2Oregon Health & Science U, Portland, OR, 3Weill Cornell Medical College, New York, NY, 4Janssen Scientific Affairs, LLC, Horsham, PA, 5Janssen Scientific Affairs, LLC/Drexel University School of Medicine, Horsham/Phila, PA, 6Janssen Reseach & Development, LLC/ U of Pennsylvania School of Medicine, Spring House/Philadelphia, PA, 7Janssen Research & Development, LLC, Spring House, PA, 8Orthopedic and Rheumatologic Institute, Cleveland Clinic, Cleveland, OH

    Background/Purpose: The GO-FURTHER, GO-VIBRANT, and GO-ALIVE randomized controlled trials evaluated the efficacy and safety of intravenous (IV) golimumab (GLM) in patients (pts) with active rheumatoid…
  • Abstract Number: 1529 • 2018 ACR/ARHP Annual Meeting

    Long-Term, Real-World Safety of Adalimumab in Rheumatoid Arthritis

    Leslie R. Harrold1,2, Jenny Griffith3, Heather J Litman4, Bernice Gershenson1, Syed Islam3, Christine J Barr2, Dianlin Guo3, Patrick Zueger5, Jonathan Fay3 and Jeffrey Greenberg2,6, 1University of Massachusetts Medical School, Worcester, MA, 2Corrona, LLC, Waltham, MA, 3AbbVie, Inc., North Chicago, IL, 4Corrona LLC, Waltham, MA, 5AbbVie Inc., North Chicago, IL, 6New York University School of Medicine, New York, NY

    Background/Purpose: The incidence of adverse events (AE) among rheumatology medication users has not been well documented in real-world disease registry datasets in the US.  We…
  • Abstract Number: 1534 • 2018 ACR/ARHP Annual Meeting

    Comparative Risk of Diabetes Mellitus in Rheumatoid Arthritis Patients Treated with Different Biologics- a Cohort Study

    Rishi J. Desai1, Sara Dejene2, Yinzhu Jin2, Jun Liu3 and Seoyoung C. Kim2, 1Division of Pharmacoepidemiology and Pharmacoeconimics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 2Brigham and Women's Hospital, Boston, MA, 3Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA

    Background/Purpose: Patients with rheumatoid arthritis (RA) often develop diabetes mellitus (DM), potentially due to aggravated systemic inflammation. Reducing inflammation with disease-modifying antirheumatic drugs (DMARD) may…
  • Abstract Number: 1552 • 2018 ACR/ARHP Annual Meeting

    No Effect of Concomitant Glucocorticoid Therapy on Efficacy and Safety of Tocilizumab Monotherapy Found in Rheumatoid Arthritis Clinical Trials

    Mary Safy1, Johannes W. G. Jacobs1, Michael Edwardes2, Maria JH de Hair1, Xavier M Teitsma1, Paco MJ Welsing1, Michelle EA Borm3, Yves Luder4, Jacob van Laar1, Attila Pethö-Schramm4 and Johannes W. J. Bijlsma5, 1Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, the Netherlands, Utrecht, Netherlands, 2Everest Clinical Research, Markham, ON, Canada, 3Roche Nederland BV, Woerden, Netherlands, 4F. Hoffmann-La Roche, Basel, Switzerland, 5Rheumatology & Clinical Immunology department University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands

    No effect of concomitant glucocorticoid therapy on efficacy and safety of tocilizumab monotherapy in rheumatoid arthritis clinical trialsM. Safy1, J.W.G. Jacobs1, M. Edwardes2, M.J.H. de…
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