Abrocitinib-associated adverse events: a real-world pharmacovigilance study using the FAERS database

Area of Science:

• Pharmacovigilance
• Dermatology
• Immunology

Background:

• Atopic dermatitis (AD) is a prevalent chronic inflammatory skin condition.
• Janus kinase (JAK) inhibitors, including abrocitinib, are effective treatments for moderate-to-severe AD.
• Real-world safety data for abrocitinib is crucial for clinical practice.

Purpose of the Study:

• To evaluate adverse events (AEs) associated with abrocitinib in a real-world setting.
• To identify and characterize safety signals for abrocitinib using pharmacovigilance methods.

Main Methods:

• Utilized the US Food and Drug Administration Adverse Event Reporting System (FAERS).
• Employed two established pharmacovigilance methodologies to quantify AE signals.
• Analyzed 1071 reported AEs where abrocitinib was the primary suspected cause.

Main Results:

• Identified 85 safety signals for abrocitinib.
• The most frequent AE was 'drug ineffective'.
• Eczema herpeticum exhibited the strongest safety signal; rare AEs like aggravated condition, pruritus, and hypersensitivity were noted but not labeled.

Conclusions:

• The identified AE signals support clinical monitoring of abrocitinib.
• This pharmacovigilance analysis aids in the risk identification for abrocitinib therapy.
• Attention to less common but significant AEs is warranted for patient safety.