Neoplasm Adverse Events Associated With Anti-Type 2 Biologics: An FAERS Database Pharmacovigilance Analysis Study.

BACKGROUND

Biologics targeting Type 2 immune responses, such as omalizumab (anti-IgE), dupilumab (anti-interleukin-4 receptor alpha, anti-IL-4Rα), benralizumab (anti-IL-5R), reslizumab, and mepolizumab (anti-IL-5), are increasingly used clinically. Emerging evidence suggests potential associations between biologics and neoplastic events.

METHODS

We analyzed the FDA Adverse Event Reporting System (FAERS) database reports for omalizumab, dupilumab, benralizumab, reslizumab, and mepolizumab from their respective market dates to Q1 2025. To enhance comparability, this analysis was restricted to the asthma indication for all 5 biologics. Neoplasm-related adverse events (AEs) were assessed using disproportionality analysis and multivariable logistic regression analysis.

RESULTS

A total of 2316 neoplasm-related AE reports were identified (974 omalizumab, 322 dupilumab, 369 benralizumab, and 651 mepolizumab). Increased reporting may reflect higher biologic use, reporting biases, or system inherent biases. The most common neoplasms reported for omalizumab, dupilumab, benralizumab, and mepolizumab were breast cancer (13.23%, 15.25%, 14.9%, 9.21%), malignant lung neoplasm (5.86%, 5.28%, 5.56%, 6.74%), and prostate cancer (3.29%, 5.87%, 3.54%, 5.06%). All biologics had significant disproportionality signals. Despite low reporting frequency, several neoplasms demonstrated strong signals with biologics of interest. Notably, dupilumab exhibited a strong and specific signal for cutaneous T-cell lymphoma (ROR = 6.1, 95% CI: 1.76-21.06). Similar patterns were likewise observed in the multivariable logistic regression analysis.

CONCLUSION

This pharmacovigilance study detected neoplasm-related disproportionality signals for anti-Type 2 biologics. Causality cannot be established due to spontaneous reporting limitations. Clinicians should be aware of these disproportionality signals and maintain vigilance during long-term clinical management of patients receiving anti-Type 2 biologic therapy to ensure optimal patient safety.