Abstracts tagged "drug safety monitoring"

Abstract Number: 2357 • 2019 ACR/ARP Annual Meeting
Methotrexate Liver Toxicity in a Large Randomized Controlled Trial
Daniel Solomon¹, Nina Paynter ², Anna Rutherford ², Robert Glynn ³, Jean MacFadyen ⁴, Fengxin Lu ⁴, Chang Xu ⁴, Elizabeth Karlson ⁴ and Paul Ridker ², ¹Brigham and Women´s Hospital, Div. of Rheumatology, Immunology and Allergy, Boston, MA, ²Brigham and Women's Hospital, Boston, ³Harvard Medical School - Boston, MA, Boston, MA, ⁴Brigham and Women's Hospital, Boston, MA
Background/Purpose: Liver test abnormalities are known to predict liver pathology in patients using methotrexate (MTX). Monitoring guidelines for MTX suggest frequent assessment of liver tests…
Abstract Number: 2874 • 2019 ACR/ARP Annual Meeting
Comparison of Malignancy and Mortality Rates Between Tofacitinib and Biologic DMARDs in Clinical Practice: Five-Year Results from a US-Based Rheumatoid Arthritis Registry
Joel Kremer¹, Clifton Bingham ², Laura Cappelli ², Jeffrey Greenberg ³, Ann Madsen ⁴, Jamie Geier ⁴, Jose L. Rivas ⁵, Alina Onofrei ⁶, Christine Barr ⁶, Dimitrios Pappas ⁷, Heather Litman ⁶, Kimberly Dandreo ⁶, Andrea Shapiro ⁸, Carol Connell ⁹ and Arthur Kavanaugh ¹⁰, ¹Albany Medical College, Albany, NY, ²Johns Hopkins University, Baltimore, MD, ³Corrona, LLC; NYU School of Medicine, Waltham, MA, ⁴Pfizer Inc, New York, NY, ⁵Pfizer SLU, Madrid, Spain, ⁶Corrona, LLC, Waltham, MA, ⁷Columbia University, New York, NY, ⁸Pfizer Inc, Peapack, NJ, ⁹Pfizer Inc, Groton, CT, ¹⁰University of California, San Diego School of Medicine, La Jolla, CA
Background/Purpose: Real-world evidence (RWE) is key to understanding post-approval long-term safety of medications. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA.…
Abstract Number: 215 • 2017 ACR/ARHP Annual Meeting
Clinical Pharmacist As Part of the Interprofessional Team Improves Quality of Care in Patients with Rheumatic Disease
Jessica Farrell¹, Lee S. Shapiro¹ and Mitchell Miller², ¹The Center for Rheumatology, Albany, NY, ²Albany College of Pharmacy and Health Sciences, Albany, NY
Background/Purpose: Successful multidisciplinary models exist for the management of chronic diseases such as diabetes, cardiovascular disease, infectious diseases, kidney disease and psychiatric illnesses. A multidisciplinary…
Abstract Number: 740 • 2016 ACR/ARHP Annual Meeting
Patient Adherence with Mycophenolate Mofetil Therapy in a Systemic Lupus Erythematosus Cohort: A Multi-Factorial Assessment
Maryam Ghaderi-Yeganeh¹, Ann Biehl², Zerai G. Manna³, Alice Fike⁴ and Sarfaraz Hasni³, ¹National Institutes of Arthritis, Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, ²Department of Pharmacy, National Institutes of Health Clinical Center, Bethesda, MD, ³National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, ⁴Office of the Clinical Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD
Background/Purpose: Lack of adherence to treatment recommendations is a serious confounder to assessment of treatment efficacy for systemic lupus erythematosus (SLE). Estimates of nonadherence with…
Abstract Number: 2526 • 2016 ACR/ARHP Annual Meeting
TNF Blocker Concentrations or Detection of Antibodies Against Anti-TNF before a Tapering Process Are Not Predictive to Relapse
Hubert Marotte^1,2, Mélanie Rinaudo-Gaujous³, Stéphane Paul^3,4 and Bruno Fautrel⁵, ¹SAINBIOSE INSERM U1059 and Rheumatology department, University of Lyon and University Hospital of Saint Etienne, Saint Etienne, France, ²Rheumatology Department, University Hospital of Saint-Etienne, Saint-Etienne, France, ³Laboratory of Immunology and immunomonitoring, CIC CIE3 Inserm Vaccinology, GIMAP EA3064, Hôpital Nord, Saint-Etienne, France, ⁴Centre Hospitalier Universitaire de Saint-Étienne, Saint-Étienne, France, ⁵Rheumatology, Pitié Salpêtrière Hospital, Paris, France
Background/Purpose: The goal of rheumatoid arthritis (RA) strategy is to reach remission or at least a low disease activity. When this goal is reached, no…
Abstract Number: 127 • 2015 ACR/ARHP Annual Meeting
Potential Use of Healthcare Databases for Post-Marketing Surveillance Registry: an Example Using Ustekinumab
Huifeng Yun¹, Shuo Yang², Fenglong Xie³, Lang Chen⁴, Kevin L. Winthrop⁵ and Jeffrey R. Curtis⁴, ¹Epidemiology, University of Alabama at Birmingham, Birmingham, AL, ²Clinical Immunology/Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ³Rheumatology & Immunology, University of Alabama at Birmingham, Birmingham, AL, ⁴University of Alabama at Birmingham, Birmingham, AL, ⁵Oregon Health and Science University, Portland, OR
Background/Purpose: Underreporting and inherent deficiencies are common using spontaneous reports for post-marketing surveillance. The U.S. Food and Drug Administration (FDA) has recommended sponsors to collect…

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