Abstracts tagged "FDA"

Abstract Number: 850 • 2017 ACR/ARHP Annual Meeting
Immune Checkpoint Inhibitors and Inflammatory Myopathies: Data from the US Food and Drug Administration Adverse Event Reporting System
Xerxes Pundole, Mohsin Shah, Noha Abdel-Wahab and Maria Suarez-Almazor, Section of Rheumatology and Clinical Immunology, Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA, Houston, TX
Background/Purpose: Immune checkpoint inhibitors have become standard of care for many malignancies. Although these therapies are effective, they can activate the immune system resulting in…
Abstract Number: 2921 • 2016 ACR/ARHP Annual Meeting
Patient Participation in Patient Reported Outcome Instrument Development in Systemic Sclerosis
John Pauling^1,2, Tracy M. Frech^3,4, Robyn T. Domsic⁵ and Marie Hudson^6,7, ¹Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom, ²Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ³Internal Medicine, Salt Lake City VAMC, Salt Lake, UT, ⁴Internal Medicine-Division of Rheumatology, University of Utah School of Medicine, SLC, UT, ⁵Medicine - Rheumatology, Univ of Pittsburgh Med Ctr, Pittsburgh, PA, ⁶Medicine, McGill University, Montreal, QC, Canada, ⁷Medicine/Rheumatology, Jewish General Hospital, Lady Davis Research Institute, Montreal, QC, Canada
Background/Purpose: The patient perspective captured using Patient-Reported Outcome (PRO) instruments provide valuable insight into the patient condition not always captured by physician-derived assessment tools. Target…
Abstract Number: 715 • 2014 ACR/ARHP Annual Meeting
The REAL Life with Lupus Study: Developing a Patient Reported Outcome Measure for Use in Clinical Trials and Clinical Care
R. Paola Daly¹, Sarah Gilman², Joan T. Merrill³, Leslie M. Hanrahan⁴, Alisha Ladenburg² and Anca Askanase⁵, ¹Research & Education, Lupus Foundation of America, Washington, DC, ²Lupus Foundation of America, Washington, DC, ³Department of Clinical Pharmacology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴Education & Research, Lupus Foundation of America, Washington, DC, ⁵Columbia University Medical Center, New York, NY
Background/Purpose: The goal of this study is to better understand how people with systemic lupus erythematosus (SLE) in the United States experience the disease. Results…

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