Is Safety Profile of Apremilast in Elderly Patients Same With That in Young and Middle-Aged Patients? A Real-World Disproportionality Analysis of the FDA Adverse Event Reporting System

Abstract

Background and Objective: Elderly individuals face heightened risks of infections, thrombosis, cardiovascular issues, and neoplasms, necessitating increased vigilance regarding adverse drug events (ADEs). The safety of apremilast in elderly patients has not been adequately explored in clinical trials. This study was to evaluate the safety profile of apremilast in young and middle-aged patients and elderly patients separately, through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: Reports in the FAERS from the third quarter of 2014 to the second quarter of 2023 were collected and analyzed. Disproportionality analyses (the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms) were employed to quantify the ADE signals of apremilast in the age groups of 18–65 years and over 65 years.

Results: After data cleaning, a total of 54,926 and 14,156 ADE reports were retrieved, with 66 and 61 ADE signals identified in young and middle-aged patients and in elderly patients, respectively. Several unexpected ADE signals not listed in the drug labeling information were detected, including pericarditis, increased cholesterol levels, liver injury, postoperative thrombosis, serum calcium, and parathyroid abnormalities. Furthermore, weight loss, psychiatric abnormalities, and infections in particular sites (ear, bursa mucosa, and central nervous system) were more significant in elderly patients.

Conclusions: The study indicated several unexpected ADEs through disproportionality analysis and highlighted unique safety features in the elderly group. These findings may assist clinicians in managing psoriasis with apremilast.