Related Experiment Video
Updated: Jun 26, 2025
Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
Abrocitinib-associated adverse events: a real-world pharmacovigilance study using the FAERS database
1Department of Pharmacy, The First Affiliated Hospital of Ningbo University, Ningbo, China.
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.
Insights
This study analyzed real-world adverse events (AEs) for abrocitinib, a JAK1 inhibitor for atopic dermatitis. Eczema herpeticum showed a strong safety signal, while other rare AEs require clinical attention.
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.
More Related Videos
Related Concept Videos
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:11Clinical Trials: Overview