Safety of Adalimumab: An Analysis of the FDA Adverse Event Reporting System (FAERS) Database

Abstract

Objective: This study aims to assess the safety profile of adalimumab and its biosimilars for each approved indication by analyzing adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS) database. Method: We conducted a retrospective pharmacovigilance analysis of AE reports documented from 2002 to 2022 in the FAERS database. This analysis included descriptive statistics and binary logistic regression analyses. We calculated reporting odds ratios (RORs) with 95% confidence intervals (CI) to investigate safety signals related to the disproportionate reporting of serious AEs for adalimumab and its biosimilars compared to currently available biological products for the same proposed indications. Results: A total of 543,873 AEs related to adalimumab treatment were reported, with 49.8% classified as serious. Hospitalization was the most frequently reported AE. Risk factors associated with serious AEs included age (≥60 years), male sex, and the concurrent use of adalimumab (ROR >1, P<0.05). Adalimumab exhibited a lower risk of serious AEs compared to abatacept, certolizumab, infliximab, or rituximab. Conversely, etanercept and ixekizumab showed lower odds of serious AEs than adalimumab (ROR <1, P<0.05). Conclusion: In summary, these findings suggest that adalimumab has a well-tolerated safety profile for approved indications when compared to currently available biological alternatives.