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古塞库单抗治疗中国中度至重度斑块状银屑病患者的长期疗效和安全性。

Long-term efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis.

作者信息

Zheng Jianfeng, Chen Wenjuan, Yi Xuemei, Yu Ning, Ding Yangfeng, Gao Yunlu

机构信息

Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.

Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China.

出版信息

Front Med (Lausanne). 2023 Dec 14;10:1285972. doi: 10.3389/fmed.2023.1285972. eCollection 2023.


DOI:10.3389/fmed.2023.1285972
PMID:38162889
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10755945/
Abstract

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.

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3809/10755945/c76554d9fbd6/fmed-10-1285972-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3809/10755945/2a6b0edbfd41/fmed-10-1285972-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3809/10755945/671701240c05/fmed-10-1285972-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3809/10755945/c76554d9fbd6/fmed-10-1285972-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3809/10755945/2a6b0edbfd41/fmed-10-1285972-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3809/10755945/671701240c05/fmed-10-1285972-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3809/10755945/c76554d9fbd6/fmed-10-1285972-g0003.jpg

相似文献

[1]
Long-term efficacy and safety of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis.

Front Med (Lausanne). 2023-12-14

[2]
A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 12-week efficacy, safety and speed of response from a randomized, double-blinded trial.

Br J Dermatol. 2020-6

[3]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2017-12-22

[4]
Five-year Maintenance of Clinical Response and Consistent Safety Profile for Guselkumab in Asian patients with Psoriasis from VOYAGE 1 and VOYAGE 2.

Dermatol Ther (Heidelb). 2023-11

[5]
Effectiveness of guselkumab in patients with moderate-to-severe plaque psoriasis: a retrospective study from China.

Eur J Dermatol. 2024-2-1

[6]
Long-Term Efficacy and Safety of Guselkumab for Moderate to Severe Psoriasis: A 3-Year Real-Life Retrospective Study.

Psoriasis (Auckl). 2022-7-14

[7]
Effectiveness and Safety of Guselkumab for the Treatment of Psoriasis in Real-World Settings at 52 weeks: A Retrospective, Observational, Multicenter Study from China.

Dermatol Ther (Heidelb). 2023-2

[8]
Guselkumab: Mid-term effectiveness, drug survival, and safety in real clinical practice.

Dermatol Ther. 2021-3

[9]
Real-life effectiveness and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: A 104-week multicenter retrospective study - IL PSO (ITALIAN LANDSCAPE PSORIASIS).

J Eur Acad Dermatol Venereol. 2023-5

[10]
Effectiveness and safety of guselkumab for the treatment of psoriasis in real-world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group.

Dermatol Ther. 2022-2

本文引用的文献

[1]
Effectiveness and Safety of Guselkumab for the Treatment of Psoriasis in Real-World Settings at 52 weeks: A Retrospective, Observational, Multicenter Study from China.

Dermatol Ther (Heidelb). 2023-2

[2]
Guselkumab is efficacious and safe in psoriasis patients who failed anti-IL17: a 52-week real-life study.

J Dermatolog Treat. 2022-8

[3]
Guselkumab Treatment Outcomes and Persistence in a Nationwide Real-world Cohort of Patients with Plaque Psoriasis.

Acta Derm Venereol. 2022-1-18

[4]
Consistent safety profile with up to 5 years of continuous treatment with guselkumab: Pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis.

J Am Acad Dermatol. 2022-4

[5]
Impact of previous biologic use and body weight on the effectiveness of guselkumab in moderate-to-severe plaque psoriasis: a real-world practice.

Ther Adv Chronic Dis. 2021-9-29

[6]
Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2.

Br J Dermatol. 2021-12

[7]
Effectiveness of anti-interleukin 23 biologic drugs in psoriasis patients who failed anti-interleukin 17 regimens. A real-life experience.

Dermatol Ther. 2021-1

[8]
Guselkumab: Short-term effectiveness and safety in real clinical practice.

Dermatol Ther. 2020-5

[9]
Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial.

Lancet. 2019-8-8

[10]
Safety of guselkumab in patients with moderate-to-severe psoriasis treated through 100 weeks: a pooled analysis from the randomized VOYAGE 1 and VOYAGE 2 studies.

Br J Dermatol. 2019-5

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