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司库奇尤单抗治疗重度慢性斑块型银屑病患者显示出较高的药物存活率和持续疗效:澳大利亚常规临床实践中的 21 个月分析(SUSTAIN 研究)。

Secukinumab treatment demonstrated high drug survival and sustained effectiveness in patients with severe chronic plaque psoriasis: 21-month analysis in Australian routine clinical practice (SUSTAIN study).

机构信息

Skin Health Institute, Carlton, Victoria, Australia.

The University of Melbourne, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.

出版信息

Australas J Dermatol. 2022 Aug;63(3):303-311. doi: 10.1111/ajd.13895. Epub 2022 Jul 9.

DOI:10.1111/ajd.13895
PMID:35809080
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9543110/
Abstract

BACKGROUND

Drug survival measures the rate and duration of adherence to a given therapeutic agent and evaluates its long-term effectiveness, safety, and real-world utility. The SUSTAIN study sought to establish the drug survival and effectiveness of secukinumab for patients with severe chronic plaque psoriasis (CPP) in the Australian clinical setting.

METHODS

Data of all patients (aged ≥18 years) from Australasian Psoriasis Registry (APR) treated with secukinumab were analysed. The primary objective was to describe the drug survival of secukinumab at 9 months. Key secondary objectives included drug survival of secukinumab at 3, 6, 15, and 21 months, stratified by biologic-naïve vs biologic-experienced patients; proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75/90/100 responses; and changes in health-related quality of life over time utilising the Dermatology Life Quality Index (DLQI).

RESULTS

Of 294 patients included in this analysis, 110 (37.4%) were biologic-naïve and 184 (62.6%) biologic-experienced. Kaplan-Meїer drug survival rates in biologic-naïve vs biologic-experienced patients were 0.92 vs. 0.86 (9 months) and 0.82 vs. 0.68 (21 months), respectively. The proportion of patients with PASI 75/90/100 responses for biologic-naïve vs. biologic-experienced was 100/87.7/38.4 vs 98.5/61.5/27.2 (9 months) and 100/81.0/41.7 vs. 98.4/62.0/24.2 (21 months), respectively. The mean (standard deviation [SD]) DLQI in biologic-naïve vs. experienced patients was 2.2 (4.1) vs. 3.1 (5.2) (9 months) and 1.4 (2.5) vs. 3.1 (5.3) (21 months). No new safety signals were observed.

CONCLUSIONS

Secukinumab demonstrated high drug survival and sustained effectiveness in Australian real-world setting, in biologic-naïve and biologic-experienced patients with severe CPP.

摘要

背景

药物生存衡量了患者对特定治疗药物的依从性的比率和持续时间,并评估其长期有效性、安全性和实际应用效果。SUSTAIN 研究旨在确定在澳大利亚临床环境中,司库奇尤单抗治疗重度慢性斑块型银屑病(CPP)患者的药物生存和疗效。

方法

对来自澳大利亚银屑病登记处(APR)的所有接受司库奇尤单抗治疗的年龄≥18 岁的患者数据进行了分析。主要目的是描述司库奇尤单抗在 9 个月时的药物生存情况。次要终点包括生物制剂初治患者和生物制剂经治患者的司库奇尤单抗 3、6、15 和 21 个月时的药物生存情况;达到银屑病面积和严重程度指数(PASI)75/90/100 应答的患者比例;以及利用皮肤病生活质量指数(DLQI)评估的随时间变化的健康相关生活质量的变化。

结果

在本分析中纳入的 294 例患者中,110 例(37.4%)为生物制剂初治,184 例(62.6%)为生物制剂经治。生物制剂初治患者和生物制剂经治患者的 Kaplan-Meier 药物生存曲线率分别为 0.92 比 0.86(9 个月)和 0.82 比 0.68(21 个月)。生物制剂初治患者和生物制剂经治患者的 PASI 75/90/100 应答比例分别为 100/87.7/38.4 比 98.5/61.5/27.2(9 个月)和 100/81.0/41.7 比 98.4/62.0/24.2(21 个月)。生物制剂初治患者和生物制剂经治患者的平均(标准差 [SD])DLQI 分别为 2.2(4.1)比 3.1(5.2)(9 个月)和 1.4(2.5)比 3.1(5.3)(21 个月)。未观察到新的安全性信号。

结论

在澳大利亚真实环境中,司库奇尤单抗在生物制剂初治和生物制剂经治的重度 CPP 患者中表现出较高的药物生存和持续疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/566d444f6141/AJD-63-303-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/851e6bb1633f/AJD-63-303-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/516bd1a62d34/AJD-63-303-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/51a9b107fb0d/AJD-63-303-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/566d444f6141/AJD-63-303-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/851e6bb1633f/AJD-63-303-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/516bd1a62d34/AJD-63-303-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/51a9b107fb0d/AJD-63-303-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc13/9543110/566d444f6141/AJD-63-303-g003.jpg

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Drug survival, discontinuation rates, and safety profile of secukinumab in real-world patients: a 152-week, multicenter, retrospective study.真实世界患者中司库奇尤单抗的药物生存情况、停药率和安全性特征:一项 152 周、多中心、回顾性研究。
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Long-Term Persistence Rate of Secukinumab in Psoriatic Patients: A Six-Year Multicenter, Real-World Experience, Retrospective Study.
司库奇尤单抗在银屑病患者中的长期持续治疗率:一项为期六年的多中心、真实世界经验回顾性研究。
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Drug Survival of IL-17 and IL-23 Inhibitors for Psoriasis: A Systematic Review and Meta-Analysis.银屑病中白介素-17 和白介素-23 抑制剂的药物生存:系统评价和荟萃分析。
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Long-term efficacy, safety, and drug survival of secukinumab in patients with psoriasis in Turkey: a retrospective analysis of real-world experience.司库奇尤单抗在土耳其银屑病患者中的长期疗效、安全性及药物留存率:一项基于真实世界经验的回顾性分析
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Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea.司库奇尤单抗在中度至重度斑块状银屑病成年患者中的真实世界安全性和有效性:韩国上市后监测结果
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Real-world evidence of secukinumab in psoriasis treatment - a meta-analysis of 43 studies.司库奇尤单抗治疗银屑病的真实世界证据——43项研究的荟萃分析
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Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study).司库奇尤单抗治疗中重度银屑病患者 5 年,疗效持久且安全性良好(SCULPTURE 扩展研究)。
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