Analysis of clinical characteristics of tislelizumab-induced Stevens-Johnson syndrome/toxic epidermal necrolysis in the Chinese population: a systematic review.

[OBJECTIVE] Tislelizumab frequently induces cutaneous immune-related adverse events (cirAEs), among which Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) are rare but potentially life-threatening cutaneous reaction. The clinical characteristics of SJS/TEN induced by tislelizumab remain unclear.

[METHODS] This systematic review aims to clarify the clinical manifestations, therapeutic interventions, and outcomes of tislelizumab-related SJS/TEN in Chinese patients. Published case reports of SJS/TEN induced by tislelizumab were systematically collected (up to 10 May 2025). A total of 21 articles and 22 patients were included.

[RESULTS] A total of 22 patients were included, consisting of 14 males and 8 females, aged 42-81 years, with a median age of 71 years and a mean age of 68.59 ± 9.10 years. Lung cancer was the most common primary disease, affecting 12 patients (54.55%). 7 patients were treated with tislelizumab alone, while 15 underwent combination therapy (chemotherapy, radiotherapy, or targeted therapy). The time from treatment initiation to SJS/TEN onset ranged from 12 to 138 days. 20 patients experienced pain to varying degrees, with early symptoms primarily manifesting as erythema and rash. Mucocutaneous involvement was observed in 12 patients, and fever occurred in 11 patients. After drug discontinuation and symptomatic supportive care, the symptoms of 20 patients improved. Two patients died - one of septic shock and another of acute coronary syndrome.

[CONCLUSIONS] This indicates that tislelizumab-related SJS/TEN mostly occurs days to months after treatment. Clinical practice should strengthen the evaluation and monitoring of early cutaneous adverse reactions, with timely detection and intervention to ensure safe medication use for patients.