澳大利亚银屑病患者的真实世界Guselkumab反应和药物生存:来自澳大利亚银屑病登记处的结果

IF 3.7 4区 医学 Q1 DERMATOLOGY
Nicholas Manuelpillai, Julie Armstrong, Fathima Ferial Ismail, Sara Vogrin, Debra Maranta, Andrea Puig, Barbara Radulski, Johannes S. Kern, Christopher S. Baker, Peter Foley
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引用次数: 0

摘要

目的:将Guselkumab的实际疗效、药物生存期和澳大利亚银屑病登记处(APR)的患者特征与III期VOYAGE 1试验的数据进行比较。方法:通过澳大利亚药物福利计划(PBS)处方的严重斑块型银屑病患者的数据来自apr,分析2018年9月4日至2022年10月1日规定时间点的人口统计学和治疗数据(包括银屑病面积和严重程度指数[PASI])。基线是第一次生物治疗开始时的PASI。APR和VOYAGE 1数据比较采用两样本t检验和卡方检验。使用Cox比例风险回归和Kaplan-Meier估计评估患者特征和药物生存/时间与PASI评分之间的关系。结果:102例患者入选;87.3% (n = 89)的患者先前接受过生物治疗,而在VOYAGE 1中,21.6%的患者接受过生物治疗。3个月、9个月、15个月和27个月时,APR患者的总药物生存期分别为99.0%、93.1%、83.3%和77.1%。9个月时,bionaïve患者的药物生存率为100%,生物经验患者的药物生存率为92.1%。在VOYAGE 1中,91.5%的患者在第48周(~ 11个月)内继续使用guselkumab。在APR中,基线时PASI中位数为24.0 (IQR: 17.9-32.2), 9个月时为1.1 (IQR: 0-2.7)。绝对PASI≤3和PASI90分别达到73.8%和64.8%。在VOYAGE 1中,76.3%的患者在第48周达到PASI90。Bionaïve APR组患者的药物生存期长于生物经验组。结论:Guselkumab在现实世界治疗牛皮癣是有效的,与RCT结果一致。尽管APR中有生物经验的患者比例高于VOYAGE 1,但药物保留率在27个月内仍然很高。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Real-World Guselkumab Response and Drug Survival in Australian Patients With Psoriasis: Results From the Australasian Psoriasis Registry

Real-World Guselkumab Response and Drug Survival in Australian Patients With Psoriasis: Results From the Australasian Psoriasis Registry

Aims: Guselkumab’s real-world efficacy, drug survival, and patient characteristics from the Australasian Psoriasis Registry (APR) were compared with the data from the Phase III VOYAGE 1 trial.

Methods: Data from patients with severe plaque psoriasis prescribed guselkumab through the Australian Pharmaceutical Benefits Scheme (PBS) were derived from the APR. Demographic and treatment data (including psoriasis area and severity index [PASI]) at defined timepoints from 4th September 2018 to 1st October 2022 were analyzed. The baseline was PASI at the commencement of the first biologic. APR and VOYAGE 1 data were compared using 2-sample t-tests and chi-square tests. Associations between patient characteristics and drug survival/time to PASI score were assessed using Cox proportional hazards regression and Kaplan–Meier estimates.

Results: 102 patients were eligible; 87.3% (n = 89) had received prior biologic therapy versus 21.6% patients in VOYAGE 1. Overall drug survival in APR was 99.0%, 93.1%, 83.3% and 77.1% at 3, 9, 15, and 27 months, respectively. At 9 months, drug survival was 100% for bionaïve and 92.1% for bioexperienced patients. In VOYAGE 1, 91.5% continued guselkumab through Week 48 (∼11 months). In the APR, the median PASI was 24.0 (IQR: 17.9–32.2) at baseline, and 1.1 (IQR: 0–2.7) at 9 months. Absolute PASI ≤ 3 and PASI90 were attained by 73.8% and 64.8%, respectively. In VOYAGE 1, 76.3% reached PASI90 at Week 48. Bionaïve patients in the APR had longer drug survival than bioexperienced.

Conclusions: Guselkumab was efficacious in the real-world treatment of psoriasis, consistent with RCT results. Drug retention rates were high through 27 months, despite a higher proportion of bioexperienced patients in the APR than in VOYAGE 1.

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来源期刊
Dermatologic Therapy
Dermatologic Therapy 医学-皮肤病学
CiteScore
7.00
自引率
8.30%
发文量
711
审稿时长
3 months
期刊介绍: Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.
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