Herpes virus reactivation induced by abrocitinib: A real-world pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database

Abstract

Purpose

Large real-world studies evaluating the association between abrocitinib and herpes virus reactivation are lacking. This objective of investigation was to delineate the characteristics of abrocitinib-associated herpes virus reactivation through the FDA Adverse Event Reporting System.

Results

Total of 56 reports were distinctly associated with herpes virus reactivation, with serious adverse events accounting for 67.86 %. Several noteworthy findings emerged: (1) female is associated with relatively high risk of herpes virus reactivation. (2) The proportion of herpes virus reactivation cases reported from the United States has decreased significantly compared to the overall reports. (3) The inclusion of dupilumab in combination regimens appeared to be associated with a comparatively reduced risk of herpes virus reactivation, while the risk of regimens containing baricitinib was increased.

Conclusion

These findings will help us to identify risk factors for herpes virus activation in atopic dermatitis patients, and facilitate the implementation of targeted measures to prevent and mitigate herpes virus activation.