ArticleJournal of gastroenterology2026
Vonoprazan is associated with a phenotype-specific increase in cholangitis reporting in immune checkpoint inhibitor-treated patients: a VigiBase pharmacovigilance study.
Article in Journal of gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundImmune checkpoint inhibitors (ICIs) can cause immune-related adverse events (irAEs), including cholangitis, a rare but clinically severe hepatobiliary phenotype. Whether potassium-competitive acid blockers (PCABs) such as vonoprazan are associated with hepatobiliary adverse-event reporting among ICI-treated patients remains unclear.
methodsWe performed a READUS-PV-compliant case-noncase disproportionality analysis using VigiBase, the WHO global individual case safety report database (inception through December 1, 2025; MedDRA v27.1). Adjusted reporting odds ratios (aRORs) were estimated for composite liver injury and a custom cholangitis-related endpoint for vonoprazan, proton pump inhibitors (PPIs), and histamine-2 receptor antagonists (H2RAs). The primary analysis was restricted to ICI-exposed reports and adjusted for age, sex, region, hepatotoxic co-medications, and ICI class. Sensitivity analyses addressed treatment intensity, microbiome-modifying co-medications, regional restriction, endpoint definition, sparse-data bias, and ICI subgroup. Six additional irAE categories were analyzed as comparator outcomes.
resultsAmong 295,671 ICI-exposed reports, 1098 co-reported vonoprazan and 1186 reports met the cholangitis-related endpoint. Cholangitis was reported in 35 of 1098 vonoprazan-exposed reports (3.19%) versus 0.39% of ICI reports without vonoprazan. Vonoprazan was associated with increased cholangitis reporting (aROR 2.79; 95% CI 1.93-4.02; P < 0.001; E-value 5.02), whereas PPIs and H2RAs showed no significant association. The association persisted across sensitivity analyses, including Western Pacific restriction, microbiome- and treatment-intensity adjustment, and PD-1/PD-L1 monotherapy. Comparator irAE associations were modest and heterogeneous.
conclusionsVonoprazan was associated with a phenotype-specific increase in cholangitis reporting among ICI-treated patients, a pattern absent with PPIs or H2RAs and unmatched across comparator irAEs. Prospective clinical validation is warranted.
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