Association Between DPPs-4 Inhibitors and Bullous Pemphigoid: Reporting Odds Ratio Analysis Using EudraVigilance...

Area of Science:

• Pharmacovigilance
• Dermatology
• Endocrinology

Background:

• Bullous pemphigoid (BP) is an autoimmune blistering skin disease.
• Previous studies suggest a link between dipeptidyl peptidase 4 (DPP-4) inhibitors and BP, but findings are controversial.
• Risk factors associated with this link require further investigation.

Purpose of the Study:

• To statistically assess the association between DPP-4 inhibitors and BP using EudraVigilance data.
• To identify risk factors in patients exposed to DPP-4 inhibitors who developed BP.
• To compare findings with data from the FDA Adverse Event Reporting System (FAERS).

Main Methods:

• A retrospective, case/control observational study design.
• Utilized European EudraVigilance database (2007-2024) with over 11 million reports.
• Analyzed association using reporting odds ratios (ROR) and Fisher's exact test.

Main Results:

• A significant association was found between DPP-4 inhibitor use and BP development (ROR=153.5).
• Key risk factors identified: male gender (58.6%), age 65-85 (43.3%), type 2 diabetes (30.4%), and vildagliptin use (44.2%).
• Results were consistent with prior FAERS database analysis.

Conclusions:

• Evidence supports an association between gliptin (DPP-4 inhibitor) consumption and BP development.
• Disproportionality measures were higher in the exposed group.
• BP may manifest after months of exposure, necessitating dermatological monitoring.