Refined pharmacovigilance assessment of immune checkpoint inhibitors-related bullous pemphigoid: a multi-methodological approach utilizing FAERS database.

ABSTRACT:

Objectives

To evaluate the potential risk of bullous pemphigoid (BP) in patients treated with immune checkpoint inhibitors (ICIs) and to characterize ICI-related BP (irBP) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods

The present study conducted a disproportionality analysis leveraging FAERS database, spanning the first quarter (Q1) of 2004-2025 Q1. To ensure robust signal detection, we employed a quadruple analytical approach incorporating: (1) reporting odds ratio (ROR), (2) proportional reporting ratio, (3) Bayesian confidence propagation neural network, and (4) multi-item gamma Poisson shrinker algorithms. These methodologies were systematically applied to assess the potential risk of BP in patients treated

SUBMITTER: Wang Y 

PROVIDER: S-EPMC12819333 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature