| アブストラクト | PURPOSE: Comparative real-world data on the spectrum of digestive inflammatory adverse reactions across ICI classes are limited. Existing evidence on immune-related Sjogren's syndrome/sialadenitis consists largely of case reports and small series. METHODS: We performed disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) database (2015-2023) to evaluate associations between ICIs and digestive inflammatory adverse reactions. Additionally, we conducted a systematic review up to July 2025 to identify published cases of ICI-associated Sjogren's syndrome/sialadenitis. RESULTS: PD-1 inhibitors (pembrolizumab and nivolumab) showed the strongest associations with immune-mediated oesophagitis and gastritis. Pembrolizumab was also highly associated with hepatobiliary events, including immune-mediated cholangitis (ROR 249.18, 95% CI 169.04-367.32) and hepatitis (ROR 85.51, 95% CI 73.22-99.86). In contrast, the CTLA-4 inhibitor ipilimumab exhibited the strongest signal for immune-mediated enterocolitis. Atezolizumab and ipilimumab were significantly associated with spontaneous bacterial peritonitis. Our systematic review identified 93 cases of ICI-associated Sjogren's syndrome/sialadenitis, predominantly in patients with melanoma or lung cancer receiving PD-1 inhibitors. CONCLUSION: PD-1 inhibitors are more strongly associated with upper GI and hepatobiliary inflammatory adverse reactions, whereas CTLA-4 inhibitors carry a higher risk of enterocolitis. These findings underscore the need for ICI-specific monitoring protocols. Early recognition and tailored management-including potential treatment interruption or corticosteroid use-are critical to minimizing severe outcomes. Clinicians should maintain a high index of suspicion for rare inflammatory adverse reactions such as sialadenitis, even as incidence remains low. These insights support more personalized risk-benefit assessment and inflammatory adverse reactions management in patients receiving ICIs. |
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| ジャーナル名 | Frontiers in pharmacology |
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| Pubmed追加日 | 2025/11/12 |
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| 投稿者 | Zou, Ya; Li, Qinchuan; Zhou, Lu; Lu, Yun; Wei, Hua; Zhou, Yan; Lin, Shibo; Guo, Xirui; Yan, Shihao; Wang, Hongju; Xie, Fangqing; Liu, Chun; Chen, Li |
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| 組織名 | Department of Clinical Pharmacology, Chengdu Second People's Hospital, Chengdu,;China.;Department of Pharmacy and Evidence Based Pharmacy Center, West China Second;University Hospital, Sichuan University, Chengdu, China Department of;Pharmacology, Faculty of Medicine, University of the Basque Country, UPV/EHU,;Leioa, Spain. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41221037/ |
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