Dupilumab induced ocular surface diseases: an analysis of FAERS database, literature review and disease-gene interaction networks.

Background: Adverse events (AE) in dupilumab-induced ocular surface diseases (DIOSD) have raised concerns regarding its safety. The objective of this study was to evaluate DIOSD by employing database analysis and clinical case review, along with mechanism analysis.

Research design and methods: Database AE data were extracted from FAERS from 2017 Quarter 1 (Q1) to 2023 Q1. Disproportionality analyses were performed to identify the risk signals associated with DIOSD. Case reports/case series reported on DIOSD from March 2017 to June 2023 were collected for a literature review. The mechanisms of DIOSD were investigated through disease-gene interaction network analysis.

Results: A total of 85 signals related to DIOSD were detected from FAERS. The most reported AE was 'dry eye' (n = 3503, ROR 20.32, 95% CI: 19.53-21.14). There were 36 articles, including 201 cases showing the evidence of DIOSD, with an average age of 43 years. About 64.18% patients suffered from severe atopic dermatitis, and 48.26% were reported with a previous ocular history. The mechanisms study suggested that tumor necrosis factor plays an important role in DIOSD.

Conclusions: Our findings support that dupilumab use is associated with exacerbation or new-onset OSD. Particular attention should be focused on eye symptoms during dupilumab use.