BioDrugs (2018) 32:377–390 https://doi.org/10.1007/s40259-018-0285-2 OR IGINAL RESEARCH ARTIC L E Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS) 1 1 1 • • • Ariane G. S. Araujo Helena H. L. Borba Fernanda S. Tonin 1 2 1 1 • • • Luana Lenzi Rafael Venson Roberto Pontarolo Astrid Wiens Published online: 5 June 2018 Springer International Publishing AG, part of Springer Nature 2018 Abstract Objective The aim of this study was to identify signals of Introduction The molecular and pharmacological com- disproportionate reporting (SDR) of clinical relevance plexity of biologic disease-modifying antirheumatic drugs related to the use of biologic drugs approved for RA and used for the management of rheumatoid arthritis (RA) other autoimmune diseases. favors the occurrence of adverse drug reactions (ADRs), Methods All suspected ADRs registered in the FDA which should be constantly monitored in post-marketing Adverse Event Reporting System between January 2003 safety studies. and June 2016 were collected. The reporting odds ratio was used as a measure of disproportionality to identify possible SDRs related to biologics. Those involving important medical events and designated medical events (DME) were
BioDrugs – Springer Journals
Published: Jun 5, 2018
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