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基于统计转换方法得出的绝对银屑病面积和严重程度指数(PASI)值≤1、2、3 或 5 对银屑病的生物治疗进行网络荟萃分析。

Network meta-analysis of biologic treatments for psoriasis using absolute Psoriasis Area and Severity Index values ≤1, 2, 3 or 5 derived from a statistical conversion method.

机构信息

Psoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.

Dermatology Centre, Salford Royal NHS Foundation Trust Hospital, Manchester NIHR Biomedical Research Centre, Manchester, UK.

出版信息

J Eur Acad Dermatol Venereol. 2021 May;35(5):1161-1175. doi: 10.1111/jdv.17130. Epub 2021 Feb 15.

Abstract

BACKGROUND

In practice, the goal of treatment for patients with psoriasis is to achieve almost clear or clear skin and maintain disease control, regardless of baseline disease severity. However, identifying absolute Psoriasis Area and Severity Index (PASI) values for new treatment goals is challenging, as most clinical trials report relative PASI 50, 75, 90 or 100 improvements but rarely absolute PASI values achieved.

OBJECTIVE

Our objective was to illustrate a statistical conversion method that was developed to derive absolute PASI values from available clinical trial data on relative PASI improvements. The results of network meta-analyses (NMAs) based on these derived data were then compared with those of NMAs based on the corresponding relative PASI improvement data for selected biologics for moderate-to-severe psoriasis.

METHODS

The PASI statistical conversion method was applied to relative PASI improvement data for 11 biologic treatment regimens and placebo at 12 weeks using data from 50 published studies. The respective proportions of patients reaching absolute PASI values ≤1, 2, 3 or 5 were then calculated. Frequentist NMAs (Rücker method) were subsequently used to compare efficacy results across relative and absolute PASI data.

RESULTS

The ranking of included treatment regimens for patients achieving absolute PASI 0 to 8 was aligned with results for relative PASI scores (from 100 to 60) at end of induction therapy. Across the range of PASI scores considered, the most effective treatment regimens based on both absolute and relative PASI NMAs were brodalumab 210 mg every 2 weeks and ixekizumab 80 mg every 2 weeks, followed by guselkumab 100 mg every 8 weeks and risankizumab 150 mg every 12 weeks.

CONCLUSION

Data generated using this mathematical model will be useful to inform ongoing scientific discussions on treatment goals in the absence of primary absolute PASI data for all available treatments for moderate-to-severe plaque psoriasis.

摘要

背景

在实践中,银屑病患者治疗的目标是实现皮肤几乎完全或完全清除,并维持疾病控制,无论基线疾病严重程度如何。然而,确定新治疗目标的绝对银屑病面积和严重程度指数(PASI)值具有挑战性,因为大多数临床试验报告相对 PASI 50、75、90 或 100 的改善,但很少报告绝对 PASI 值的改善。

目的

我们的目的是举例说明一种统计转换方法,该方法用于从现有关于相对 PASI 改善的临床试验数据中得出绝对 PASI 值。然后,基于这些衍生数据的网络荟萃分析(NMA)的结果与基于中度至重度银屑病选定生物制剂的相对 PASI 改善数据的 NMA 结果进行比较。

方法

使用来自 50 项已发表研究的数据,将 PASI 统计转换方法应用于 11 种生物治疗方案和安慰剂在 12 周时的相对 PASI 改善数据。然后计算达到绝对 PASI 值≤1、2、3 或 5 的患者的比例。随后使用频率论 NMA(Rücker 法)比较相对和绝对 PASI 数据的疗效结果。

结果

纳入治疗方案的患者达到绝对 PASI 0 至 8 的排名与诱导治疗结束时相对 PASI 评分(从 100 至 60)的结果一致。在考虑的 PASI 评分范围内,基于绝对和相对 PASI NMA 的最有效治疗方案是每 2 周 210mg 布罗达卢单抗和每 2 周 80mg 依奇珠单抗,其次是每 8 周 100mg 古塞库单抗和每 12 周 150mg 里西单抗。

结论

使用这种数学模型生成的数据将有助于在缺乏所有中度至重度斑块型银屑病可用治疗药物的主要绝对 PASI 数据的情况下,为正在进行的关于治疗目标的科学讨论提供信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c209/8248394/6c1a302c5941/JDV-35-1161-g001.jpg

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