Clinical Features, Treatment, and Outcomes of Sintilimab-induced Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis.

Abstract

To explore the clinical characteristics of sintilimab-induced Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and provide references for prevention, diagnosis, and treatment. Clinical reports of sintilimab-induced SJS/TEN published before March 31st, 2026 were collected by searching the database, and clinical data were extracted for retrospective analysis. Twenty-three men (69.7%) and ten women (30.3%) were included, with a median age of 66 years (range: 27, 82). The median time for the appearance of SJS/TEN was 20 days (range: 2, 240), and the median cycle was 1 cycle (range: 1, 17). Among these 33 patients, 72.7% were diagnosed with TEN, 15.2% with SJS, and 12.1% with SJS/TEN overlap. The main clinical symptoms were rash (75.0%), erosion (82.1%), bullae/blisters (78.6%), erythema (67.9%), epidermal detachment (57.1%), and pruritus (50.0%), high fever (46.4%), and ocular symptoms (35.7%). Furthermore, 57.6% of the patients experienced mucosal lesions, mainly affecting the mouth (89.5%), genitalia (57.9%), and conjunctiva (52.6%). Skin biopsy showed poptotic keratinocytes (83.3%), subepidermal blisters (50.0%), and inflammatory cell infiltration (100%). After discontinuing sintilimab and receiving systemic steroids and intravenous immunoglobulins (IVIG) treatment, 87.9% of the patients experienced improvement in skin symptoms, while 12.1% of the patients died from TEN. SJS/TEN is a rare and life-threatening cutaneous adverse reaction of sintilimab. During the use of sintilimab, clinicians should be aware of the possibility of SJS/TEN, especially within the first month. For patients diagnosed with SJS/TEN, sintilimab should be discontinued, and they should receive systemic steroids and IVIG treatment.