Safety assessment of apremilast: real-world adverse event analysis from the FAERS database

Apremilast, a unique oral immunomodulatory phosphodiesterase 4 inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of psoriasis and psoriatic arthritis (PsA). But there is a lack of real-world studies on the safety of apremilast in large numbers of people. This research employs the FAERS database to assess the real-world safety profile of apremilast to evaluate the association between apremilast and adverse events, which can guide drug monitoring and clinical practice. Our study collected adverse event reports listing apremilast as the primary suspect drug from the first quarter of 2012 to the first quarter of 2024. We utilized multiple disproportionality analysis methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), to evaluate adverse events associated with apremilast. A comprehensive analysis yielded 124,734 reports identifying apremilast as the primary suspect drug, encompassing 252,677 preferred terms (PT) for adverse reactions distributed across 27 system organ class (SOC) categories. Apart from the adverse reactions already mentioned in the drug label, this study identified some new clinically valuable potential adverse reactions, such as vomiting, depression, suicidal ideation, weight decreased, decreased appetite, nasopharyngitis, dyspepsia, abdominal pain, gastrooesophageal reflux disease, abdominal distension, migraine, insomnia, memory impairment, muscle spasms, musculoskeletal stiffness and so on. Our study provide new safety information for the clinical use of apremilast and establish a framework and insights for its further safety evaluation.