Adverse events associated with brolucizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS)

ABSTRACT

Background

The safety information of brolucizumab primarily comes from clinical trials experience. This study aimed to explore the ocular and systemic adverse events (AEs) associated with brolucizumab among real-world patients through data mining the FDA Adverse Event Reporting System (FAERS) database.

Methods

AE reports submitted to the FAERS database between October 2019 and March 2023 were extracted. The reporting odds ratio was used to evaluate AE signals associated with brolucizumab.

Results

There were 4,380,839 AE reports extracted from the FAERS database, and 3,313 of which were with brolucizumab as primary suspected. A total of 150 ocular AE signals were identified. Ninety-nine were known ocular AEs listed in brolucizumab’ label, primarily including vision-related AEs, intraocular infections, and retinal disorders. Fifty-one were unexpected ocular AE signals, including keratic precipitates, retinal perivascular sheathing, dry eye, glaucoma, etc. Meanwhile, several serious systemic AE signals, including arterial thromboembolic events and rhinorrhea, were also identified.

Conclusions

Several unexpected ocular and systemic AE signals associated with brolucizumab were identified through data mining of the FAERS database.

KEYWORDS:

• Adverse event
• brolucizumab
• FAERS
• pharmacovigilance
• VEGF

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

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All the authors were involved in the study. X Xiong, X Zhang and T Huang contributed to the conception and study design. X Xiong and X Li were responsible for data collection. X Xiong and X Zhang were responsible for data analysis. X Xiong wrote the first draft of the manuscript and all authors participated in the revision of the manuscript. All authors read and approved the final version.

Ethical approval

Ethical approval was not needed because FAERS is a public anonymized database.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2322712

Additional information

Funding

This manuscript was funded by Shanghai Municipal Health Commission (No. 202140069).