Adverse events with pemigatinib in the real world: a pharmacovigilance study based on the FDA Adverse Event Reporting System

ABSTRACT

Background

To data, there is insufficient large-scale data on the adverse events (AEs) of pemigatinib. Consequently, we conducted a pharmacovigilance study utilizing the Food and Drug Administration Adverse Event Reporting System (FAERS) database to investigate these AEs.

Research design and methods

The OpenVigil 2.1 was used to extract AE data from the FAERS database. Proportional reporting ratio (PRR), reporting odds ratios (ROR), and bayesian analysis confidence propagation neural network (BCPNN) were used to assess the association between pemigatinib and AEs. The clinical importance of AE signals were prioritized using a rating scale.

Results

A total of 848 AE reports were retrieved from the FAERS database, and 421 AE reports were identified after the data cleaning process. After accounting for indication bias and removal of medication errors, 59 positive signals were finally included. The 59 positive signals emerged in 11 system organ classes (SOCs). Besides, 19 positive AEs were classified as moderate clinical priority, while 40 were deemed weak in terms of priority. 9 positive AEs were not included in the drug label.

Conclusions

This study provided valuable evidence for clinicians to mitigate the risk of pemigatinib-related toxicities in the real world.

KEYWORDS:

• Pemigatinib
• adverse events
• pharmacovigilance
• FAERS
• disproportionality analysis

Declaration of interests

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 is a Consultant for Incyte. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2338250

Ethical approval and patient consent

Ethical approval was not required and patient data is anonymized.

Author contribution statement

DZ and XL conceived the study and performed the data analysis. DZ drafted the manuscript. DZ and JW revised the manuscript. All authors have read and approved the final manuscript.

Additional information

Funding

This paper was not funded.