Volume 52, Issue 2 pp. 309-316
ORIGINAL ARTICLE

Immune checkpoint inhibitor-associated bullous pemphigoid: A retrospective and real-world study based on the United States Food and Drug Administration adverse event reporting system

Haowen Tan

Haowen Tan

Office of Good Clinical Practice, Wuzhou Red Cross Hospital, Wuzhou, China

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Xiubi Chen

Xiubi Chen

Center for Adverse Drug Reaction Monitoring of Mianyang, Mianyang, China

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Ying Chen

Ying Chen

Office of Good Clinical Practice, Wuzhou Red Cross Hospital, Wuzhou, China

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Xuan Ou

Xuan Ou

Office of Good Clinical Practice, Wuzhou Red Cross Hospital, Wuzhou, China

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Tao Yang

Tao Yang

Information Technology Center, Open University, Ziyang, China

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Xida Yan

Corresponding Author

Xida Yan

Department of Pharmacy, Central Hospital, Mianyang, China

Correspondence

Xida Yan, Department of Pharmacy, Mianyang Central Hospital, Mianyang 621000, China.

Email: [email protected]

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First published: 26 October 2024
Citations: 3

Abstract

This study aimed to describe bullous pemphigoid (BP) associated with immune checkpoint inhibitors (ICIs) reported in the United States Food and Drug Administration adverse event reporting system (FAERS). We obtained reports of ICI-associated BP from the first quarter of 2011 to the first quarter of 2024 in the FAERS database. The reporting odds ratio (ROR) method of the disproportionality analysis was performed to assess the potential risk for ICI-associated BP. We also described the clinical characteristics of ICI-associated BP and evaluated the time to onset (TTO) of BP developed after treatment with ICIs. Eight hundred and six cases of ICI-associated BP were gathered, in which 56.58% of the patients were aged 65 years or older. The majority of patients were male, accounting for 68.49% of all cases. The prevalent potential cancer type was skin cancer (31.64%). The results of the disproportionality analysis showed that males (ROR = 2.10 [1.78–2.49]), patients aged 65 or older (ROR = 2.13 [1.79–2.55]), and patients with skin cancer (ROR = 2.08 [1.80–2.43]) were more likely to develop ICI-associated BP. In comparison to cytotoxic T-lymphocyte-associated antigen 4 inhibitor and programmed cell death ligand 1 inhibitor, programmed cell death 1 inhibitor-associated BP has a higher risk of development (ROR = 24.45 [22.52–26.56]). ICI-associated BP had a median TTO of 204 days (interquartile range 57–426 days). ICI-associated BP is a rare but important immune-related adverse event. Our study provided helpful information to help medical professionals further understand ICI-associated BP.

CONFLICT OF INTEREST STATEMENT

Authors declare no conflict of interests for this article.

DATA AVAILABILITY STATEMENT

There is data available from the FAERS database (https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html).

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