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

ABSTRACT

Background

Atopic dermatitis (AD) is a common chronic inflammatory skin disease. Janus kinase (JAK) modulates cytokines involved in AD pathophysiology, and JAK inhibitors have emerged as effective pharmacotherapeutic remedies for AD. Abrocitinib, an oral selective inhibitor of JAK1, is indicated for the management of moderate-to-severe AD. The current study evaluated the adverse events (AEs) associated with abrocitinib in a real-world setting.

Methods

To quantify the signals of abrocitinib-associated AEs, we used the US Food and Drug Administration Adverse Event Reporting System (FAERS) for this pharmacovigilance study with two established pharmacovigilance methods.

Results

A total of 1071 AEs of abrocitinib were investigated as the primary suspected from the FAERS to detect and characterize relevant safety signals. The analysis revealed 85 signals for abrocitinib. The most common AE for abrocitinib was drug ineffective. The signal strength of eczema herpeticum was 515.87 (277.80–957.98) and 510.59 (5148.65) and exhibited the highest strength for abrocitinib. Rare AEs such as aggravated condition, pruritus, and hypersensitivity were not listed on the label, and attention to these AEs is required.

Conclusion

The analysis of the AE signals may provide support for clinical monitoring and risk identification of abrocitinib.

KEYWORDS:

• Abrocitinib
• FAERS
• adverse events
• signal detection
• pharmacovigilance

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer was an investigator in the abrocitinib clinical trial program for AD and used the medication extensively. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Acknowledgment

The FAERS database was acknowledged by the authors since the study was based on the database.

Data availability statement

The FAERS database utilized in this study is available at https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.

Ethics statement

Institutional review board approval was waived for this study because FAERS is a public anonymized database.

Author contribution statement

Yu Sun drafted the manuscript and design the analysis. Tao Xu and Suyan Zhu contributed to the collection of data. Hongbin Xu revised the manuscript.

Additional information

Funding

This paper was funded by the special fund project for hospital pharmacy of the Zhejiang Pharmaceutical Association [2021ZYY40].