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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.

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/fc13/9543110/851e6bb1633f/AJD-63-303-g002.jpg

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