Abstract: 【Abstract】 Objective To summarize clinical characteristics and prognosis of immune checkpoint inhibitor （ICI）-related Stevens-Johnson syndrome （SJS）/toxic epidermal necrolysis （TEN）. Methods A retrospective analysis was conducted on patients diagnosed with ICI-related SJS/TEN in Zhongda Hospital, Southeast University from January 2018 to October 2023. Data on clinical manifestations, laboratory examinations, treatment and prognosis of the patients were analyzed. Results A total of 9 patients were diagnosed with ICI-related SJS/TEN, including 8 males and 1 female, with the onset age ranging from 58 to 77 （67.56 ± 7.33） years. ICI were applied to all the 9 patients before onset of SJS/TEN. The latent period was 6 - 261 d, and the median duration was 76 d. All the patients presented with erythema as initial lesions, 3 cases with target lesions, 6 with blisters, and 5 cases with a positive Nikolsky's sign. Oral mucosal damage occurred in 7 cases, eye damage occurred in 6 cases, and urogenital damage occurred in 6 cases. All the 9 cases were treated with systematic glucocorticoids, 7 cases with intravenous immunoglobulin and 7 cases with antibiotics. Eight cases recovered and 1 case died. Among 6 patients followed for an average of 6.92 months, none achieved complete or partial remission, 3 died and 3 experienced disease progression. Conclusions ICI-related SJS/TEN occurred with a relatively long latent period, and all the cases presented with erythema initially, with mucosal damage present in most of the cases. Management required discontinuation of ICI, and most patients recovered with corticosteroids and intravenous immunoglobulin, however, the prognosis for the primary malignancy remained poor.

Key words: Stevens-Johnson syndrome, Epidermal necrolysis, toxic, Immune checkpoint inhibitors, Drug-related side effects and adverse reactions, Therapy, Prognosis