Abstracts tagged "rheumatoid arthritis (RA) and safety"

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 Michaud^7,8, 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. Harrold^1,2, Jenny Griffith³, Heather J Litman⁴, Bernice Gershenson¹, Syed Islam³, Christine J Barr², Dianlin Guo³, Patrick Zueger⁵, Jonathan Fay³ and Jeffrey Greenberg^2,6, 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…
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,…

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