Wu Zhaoquan, Li Xiting, Huang Rui, He Binsheng, Wang Chunjiang
College of Pharmacy, Changsha Medical University, No. 1501 Leifeng Avenue, Xiangjiang New District, Changsha, Hunan, 410219, China.
Hunan Provincial Key Laboratory of the Research and Development of Novel Pharmaceutical Preparations, Changsha Medical University, Changsha, Hunan, 410219, China.
Invest New Drugs. 2025 Feb;43(1):74-80. doi: 10.1007/s10637-024-01499-z. Epub 2025 Jan 3.
The understanding of pembrolizumab-induced Stevens-Johnson syndrome (SJS) /toxic epidermal necrolysis (TEN) primarily derives from case reports, leaving specific clinical features largely unknown. This study aims to investigate the clinical characteristics associated with pembrolizumab-induced SJS/TEN and to encourage the judicious use of pembrolizumab. Retrieve reports on pembrolizumab induced SJS/TEN before September 30, 2024 for retrospective analysis. Twenty-four (57.1%) and 18 (42.9%) patients were enrolled, with a median age of 65 years (range 32, 81). The median time to onset of SJS/TEN was 15 days (range 2, 180), and the median cycle was 1 cycle (range 1, 9). The most prevalent skin symptoms included erythema (66.7%), rash (64.3%), bullae/blisters (50.0%), and epidermal detachment (42.9%). Skin biopsy findings primarily revealed epidermal necrosis (42.9%), keratinocyte necrosis (35.7%), subepidermal bulla/blister (19.0%), and perivascular inflammatory cell infiltration (47.6%). Following the cessation of the drug and subsequent treatment, 85.7% of patients showed symptom improvement, while 14.3% succumbed to the condition. SJS/TEN represents a rare but potentially fatal adverse reaction to pembrolizumab. Clinicians should consider SJS/TEN in patients presenting with fever, erythematous rash, or mucosal involvement. Timely identification and management of SJS/TEN can significantly reduce morbidity and mortality.
对帕博利珠单抗诱发的史蒂文斯-约翰逊综合征(SJS)/中毒性表皮坏死松解症(TEN)的认识主要源于病例报告,其具体临床特征大多未知。本研究旨在调查与帕博利珠单抗诱发的SJS/TEN相关的临床特征,并鼓励谨慎使用帕博利珠单抗。检索2024年9月30日前关于帕博利珠单抗诱发SJS/TEN的报告进行回顾性分析。纳入了24例(57.1%)和18例(42.9%)患者,中位年龄为65岁(范围32至81岁)。SJS/TEN的中位发病时间为15天(范围2至180天),中位疗程为1个疗程(范围1至9个疗程)。最常见的皮肤症状包括红斑(66.7%)、皮疹(64.3%)、大疱/水疱(50.0%)和表皮剥脱(42.9%)。皮肤活检结果主要显示表皮坏死(42.9%)、角质形成细胞坏死(35.7%)、表皮下水疱/大疱(19.0%)和血管周围炎性细胞浸润(47.6%)。停药及后续治疗后,85.7%的患者症状改善,14.3%的患者病情恶化。SJS/TEN是帕博利珠单抗一种罕见但可能致命的不良反应。临床医生应在出现发热、红斑皮疹或黏膜受累的患者中考虑SJS/TEN。及时识别和处理SJS/TEN可显著降低发病率和死亡率。