Zheng Jianfeng, Chen Wenjuan, Yi Xuemei, Yu Ning, Ding Yangfeng, Gao Yunlu
Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.
Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China.
Front Med (Lausanne). 2023 Dec 14;10:1285972. doi: 10.3389/fmed.2023.1285972. eCollection 2023.
BACKGROUND: Randomized controlled trials indicated guselkumab, the first anti-interleukin-23 monoclonal antibody, is efficacious in plaque psoriasis. However, guselkumab's performance in real life is scarcely examined, especially in China. OBJECTIVES: This work aimed to assess the long-term effectiveness of guselkumab in actual clinical practice in China. METHODS: A retrospective study was performed for plaque psoriasis cases administered guselkumab in Shanghai Skin Disease Hospital between January 2020 and September 2022. RESULTS: A total of 37 patients were included (29 men, 78.4%), with a mean follow-up period of 72.3 ± 26.7 weeks (range of 12-108 weeks). At baseline, clinical examination revealed a mean PASI of 12.3 ± 7.1, a mean BSA of 17.1 ± 18.1, and a mean DLQI of 7.7 ± 4.3. Twenty-two (62.9%) and 17 (48.6%) cases achieved PASI 90 and PASI 100 responses at week 28. From weeks 60 to 92, >80% of cases achieved PASI 90 and PASI 100 responses. Regarding safety, no cases of serious AEs were recorded. A total of nine cases (24.3%) had different abnormal results in , and two were T-SPOT positive. There was no hepatitis B virus or tuberculosis outbreak in these patients. CONCLUSION: This real-life study confirmed the long-term efficacy and safety of guselkumab in daily clinical practice.
背景:随机对照试验表明,首款抗白细胞介素-23单克隆抗体古塞库单抗在斑块状银屑病中有效。然而,古塞库单抗在现实生活中的表现鲜有研究,尤其是在中国。 目的:本研究旨在评估古塞库单抗在中国实际临床实践中的长期疗效。 方法:对2020年1月至2022年9月在上海市皮肤病医院接受古塞库单抗治疗的斑块状银屑病患者进行回顾性研究。 结果:共纳入37例患者(29例男性,占78.4%),平均随访期为72.3±26.7周(范围为12 - 108周)。基线时,临床检查显示平均银屑病面积和严重程度指数(PASI)为12.3±7.1,平均体表面积(BSA)为17.1±18.1,平均皮肤病生活质量指数(DLQI)为7.7±4.3。22例(62.9%)和17例(48.6%)患者在第28周时达到PASI 90和PASI 100缓解。从第60周到92周,超过80%的患者达到PASI 90和PASI 100缓解。关于安全性,未记录到严重不良事件病例。共有9例(24.3%)患者在 检查结果异常,2例T-SPOT呈阳性。这些患者中未发生乙型肝炎病毒或结核病爆发。 结论:这项现实生活研究证实了古塞库单抗在日常临床实践中的长期疗效和安全性。
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