Mogamulizumab‐Associated Autoimmune Diseases: Insights From FAERS Database Analysis

Abstract

ABSTRACT Background Mogamulizumab is a monoclonal antibody targeting the C‐C chemokine receptor 4, used to treat T‐cell malignancies such as cutaneous T‐cell lymphoma, adult T‐cell leukemia/lymphoma, and peripheral T‐cell lymphoma. However, real‐world studies on mogamulizumab‐associated adverse events (AEs) are limited. Methods Disproportionality analyses were performed to assess the safety profile of mogamulizumab based on data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database for the period spanning from October 2018 to December 2023. The research investigated demographic characteristics, the onset timing of AEs, and the safety implications associated with mogamulizumab use. Results A total of 1182 significant preferred terms were identified among the 3661 mogamulizumab‐associated AE reports collected from the FAERS database. The frequently reported AEs including rash, infusion‐related reaction, and pyrexia were in line with drug instruction. Notably, several unexpectedly significant AEs were also found, including pemphigoid (ROR = 5.69 [95% CI 1.83–17.66]), unstable angina (ROR = 20.56 [95% CI 8.54–49.5]), bulbar palsy (ROR = 238.36 [95% CI 75.22–755.31]), myositis (ROR = 12.65 [95% CI 5.67–28.19]), and various autoimmune diseases such as autoimmune hepatitis (ROR = 21.33 [95% CI 11.08–41.07]), myocarditis (ROR = 15.29 [95% CI 8.67–26.97]), glomerulonephritis (ROR = 22.49 [95% CI 7.24–69.9]), nephrotic syndrome (ROR = 7.63 [95% CI 2.46–23.67]), myasthenia gravis (ROR = 8.54 [95% CI 3.2–22.77]), and autoimmune thyroiditis (ROR = 11.81 [95% CI 3.8–36.68]). Conclusion This study replicated previously identified AEs associated with mogamulizumab and uncovered additional signals of AEs, particularly emphasizing the risks associated with autoimmune diseases. It is essential to exercise vigilance in monitoring the occurrence of these AEs during the use of mogamulizumab in clinical practice.

Keywords

• adverse events
• disproportionality analyses
• Food and Drug Administration Adverse Event Reporting System
• mogamulizumab