A pharmacovigilance analysis of abrocitinib-related skin adverse events based on the FDA Adverse Event Reporting System (FAERS)

Abstract

In January 2022, the U.S. Food and Drug Administration (FDA) approved the marketing of abrocitinib, an oral small molecule selectively inhibiting Janus kinase, for the treatment of patients with recurrent moderate to severe atopic dermatitis. Despite the lack of long-term post-marketing safety studies, this drug was cited with a black box warning by the FDA for potentially increasing the risk of several severe adverse events (AEs). This retrospective pharmacovigilance disproportionality analysis study used data from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2022 to the first quarter of 2024, aiming to analyze the potential association between abrocitinib and skin AEs. Three disproportionality measurement were performed for data mining, including the reporting odd ratio method, the proportional reporting ratio method and the Medicines and Healthcare products Regulatory Agency method. Out of 3,269,835 AE reports extracted from the database, 699 cases of skin-related AEs were identified, where abrocitinib was implicated as the primary suspect drug. The patient demographic information, outcomes and report sources were analyzed. 34 kinds of positive risk signals were detected, many of which were unexpected safety signals. This study provided a scientific reference to understand the safety of abrocitinib in practical applications.