Steven-Johnson Syndrome/Toxic Epidermal Necrolysis is Associated with PD-1/PD-L1 Inhibitors Usage: A Case Series.

Aims/Background The increasing adoption of inhibitors of programmed cell death-1 (PD-1) and its ligand, programmed death-ligand 1 (PD-L1), in the treatment of multiple cancer types in China has started to garner broader attention due to the occurrence of immune-related adverse events (irAEs), especially life-threatening skin reactions such as Steven-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN). Isolated case reports have described SJS/TEN associated with PD-1/PD-L1 inhibitors usage. In this paper, we presented a series of cases of SJS/TEN following the use of PD-1/PD-L1 inhibitors in a dermatology hospital located in Zhejiang Province of China in the past several years, summarizing characteristics of these cases and providing a reference of management. Methods We retrospectively reviewed all the medical records of inpatients diagnosed with SJS/TEN in the Hangzhou Third People's Hospital from 2012 to 2024. We analyzed and compared the situation of SJS/TEN onset, types of PD-1/PD-L1 inhibitors used, score of severity, laboratory findings, and essential therapies of the patients who had received PD-1/PD-L1. Results We identified 12 SJS/TEN patients who had been treated with PD1/PD-L1 inhibitors: sintilimab had been used in six patients; tislelizumab in two cases; toripalimab, keytruda and cadonilimab each in one case; and an unknown prescription in one case. The longest duration between the first PD-1/PD-L1 inhibitor dose and the SJS/TEN diagnosis recorded was nine months whereas the shortest was 11 days. Half of the selected patients received chemotherapy at the same time. More than two types of therapies were applied to the cases, except for two cases with mild SJS. Conclusion This study unveils a potential, under-recognized cause of SJS/TEN in the cancer patients after analyzing the cases of SJS/TEN in cancer patients with prior exposure to PD-1/PD-L1 inhibitors. This paper also provides clue about the prominent features of SJS/TEN aforesaid, offering insights on the effective management measures for optimizing clinical safety.

Efficacy of Modified Qufeng Runmian Powder () on Acne Vulgaris with Syndromes of Dampness and Blood Stasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

OBJECTIVE: To evaluate the efficacy and safety of a Chinese medicine (CM) Modified Qufeng Runmian Powder (, MQFRMP) for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis. METHODS: In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo, with 110 cases in each group. MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks, respectively. The primary index of efficacy was the effective rate according to the acne severity score (ASS). The secondary indices of efficacy included the changes in the dermatology life quality index (DLQI) score, VISIA scores (spots, pores, brown spots, porphyrins and red areas) and skin assessment (skin pH, sebum amount and hydration) according to a SOFT skin multianalyzer. RESULTS: (1) Follow-up: a total of 204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group. (2) Effective rate: the total effective rate of the treatment group was significantly higher than the control group [83.5% (86/103) vs. 31.7% (32/101), P<0.01)] with 95% confidence interval of 39.3%-66.4%. (3) DLQI: DLQI scores were significantly decreased the treatment and control groups (both P<0.01), but the treatment group was more obvious than the placebo group (P<0.01). (4) VISIA scores: the scores of spots, brown spots and red areas in the treatment group decreased compared with baseline (P<0.05). In the control group, the scores of brown spots and pores decreased compared with baseline (P<0.05). The improvement was more obvious in the treatment group than in the control group for all items (P<0.05). (5) Skin assessment: the pH and sebum score in the both groups decreased drastically compared with the baseline (all P<0.01), however, the improvement was more obvious in the treatment group than in the control group (P<0.01). The hydration amount in the two groups showed no statistically significant difference compared with the baseline (both P>0.05). (6) Safety: two cases of mild drug allergy were observed in the treatment group. CONCLUSION: MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis. (No. ChiCTR1900020479).