| アブストラクト | BACKGROUND: Immune checkpoint inhibitors (ICIs) improve tumor prognosis but can induce immune-related adverse events. The rare but fatal Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) bring great clinical challenges, while real-world data on ICI-induced SJS/TEN are insufficient and require systematic pharmacovigilance evaluation. OBJECTIVE: To analyze the real-world reporting characteristics and risk signals of ICI-related SJS/TEN for clinical risk prevention and safe medication. METHODS: SJS/TEN adverse event reports from 2011 to 2025 were extracted and screened from the U.S. FDA Adverse Event Reporting System (FAERS). Patient baseline characteristics and clinical outcomes were analyzed. OpenVigil 2.1 was adopted to detect risk signals of PD-1, PD-L1, and CTLA-4 monotherapy as well as their combination regimens by calculating relevant indicators, especially the Reporting Odds Ratio (ROR) . RESULTS: A total of 829 valid ICI-associated SJS/TEN cases were included, mainly elderly patients aged 60-79 years from Japan, the United States and France. SJS/TEN cases were more common in males, while overlapping cases predominated in females. Case reports rose sharply after 2016 along with expanded ICI application, with an overall fatality rate of 31.2%. PD-1 and CTLA-4 inhibitors yielded positive risk signals (ROR=3.821, 3.677, respectively), with PD-1+CTLA-4 combination showing the strongest signal (ROR=4.784). Antibiotics and antibody-drug conjugates were correlated with higher SJS/TEN reporting frequency. CONCLUSIONS: ICI-induced SJS/TEN is rare but highly lethal. PD-1/CTLA-4 inhibitors and their combination regimens have definite SJS/TEN risk signals, and concomitant medications increase the relevant risks. Clinicians should identify high-risk patients early and avoid adverse drug interactions to improve patient prognosis. |
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| ジャーナル名 | Cutaneous and ocular toxicology |
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| Pubmed追加日 | 2026/7/13 |
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| 投稿者 | Zheng, Ziliang; Shen, Zhu |
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| 組織名 | Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital,;Guangdong Academy of Medical Sciences, Guangzhou, China.;Department of Dermatology, Guangdong Provincial People's Hospital (Guangdong;Academy of Medical Sciences), Southern Medical University, Guangzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42439822/ |
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