Safety assessment of brodalumab: Real world adverse event analysis from the FAERS database

Objective: This study aims to analyse adverse drug events (ADE) related to brodalumab from the first quarter of 2017 and the fourth quarter of 2023 from FAERS database. Methods: The ADE data related to brodalumab from 2017 Q1 to 2023 Q4 were collected. After standardizing the data, a variety of signal quantification techniques, including ROR, PRR, BCPNN, and MGPS were used for analysis. Results: Among the 6083 ADE reports with brodalumab as the primary suspected drug, 168 preferred terms (PT) of adverse reactions spanning 23 different system organ classes (SOC) were identified. Specifically, palmoplantar pustulosis(n = 8 , ROR 99.43, PRR 99.29, IC 6.6, EBGM 97.21), extranodal marginal zone b-cell lymphoma (malt type) (n = 3 , ROR 63.94, PRR 63.9, IC 5.98, EBGM 63.04)and calcium metabolism disorder(n = 3, ROR 259.37 , PRR 259.23 , IC 7.94 , EBGM 245.4) presented strong ADE signals, which aren't explicitly detailed in the drug's guidelines. Conclusion: Although brodalumab offers significant therapeutic advantages, it is also associated with a range of adverse reactions. Clinicians should diligently monitor for the onset of palmoplantar pustulosis, extranodal marginal zone B-cell lymphoma (MALT type), disturbances in calcium metabolism, and other potential complications during its clinical use.