Assessment of Adverse Events of Teplizumab: A Real-world Pharmacovigilance Study Based on the FDA Adverse Event Reporting System.

Purpose: To identify teplizumab-related adverse events (AEs) for type 1 diabetes mellitus from the United States Food and Drug Administration (US FDA) Adverse Event Reporting System database, enhancing the understanding of teplizumab safety in clinical settings.

Methods: AEs were extracted from the US FDA Adverse Event Reporting System database spanning from 2004Q1 to 2024Q4. The reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation, neural network, and empirical Bayes geometric mean methods were used to ensure the robustness of the adverse reaction signals.

Findings: A total of 847 AEs were identified, and 34 significant disproportionate preferred terms that met the requirements of 4 methods were obtained, involving 9 system categories. The most affected system organ classes were skin and subcutaneous tissue disorders (ROR = 3.24; 95% CI, 2.69-3.9), investigations (ROR = 2.77; 95% CI, 2.30-3.34), gastrointestinal disorders (ROR = 1.83; 95% CI, 1.51-2.21), and general disorders and administration site conditions (ROR = 1.43; 95% CI, 1.21-1.67) ranking by the ROR signal strength. The median time to onset of teplizumab-related AEs was 3.77 days (interquartile range = 0.00-4.00 days), and most AEs occurred within the first 30 days.

Implications: This study offers an enhanced comprehension of the potential AEs that could be induced by teplizumab, thereby furnishing invaluable insights for its clinical application.