经典和生物系统性药物在银屑病中的生存情况:BIOBADADERM 登记处的结果和批判性分析。

Survival of classic and biological systemic drugs in psoriasis: results of the BIOBADADERM registry and critical analysis.

机构信息

Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain.

Department of Dermatology, Hospital Universitario La Princesa, Madrid, Spain.

出版信息

J Eur Acad Dermatol Venereol. 2016 Nov;30(11):1942-1950. doi: 10.1111/jdv.13682. Epub 2016 Jun 22.

Abstract

BACKGROUND

Few reported studies compare drug survival in moderate-to-severe psoriasis vulgaris.

OBJECTIVES

To describe and compare drug survival of systemic drugs, including biologic agents (infliximab, etanercept, adalimumab and ustekinumab) and classical drugs (acitretin, ciclosporin and methotrexate) in moderate-to-severe psoriasis.

METHODS

This was a multicenter, prospective, cohort study of patients receiving systemic therapies between 2008 and 2013 in 12 hospitals in Spain. Baseline data and drug discontinuation were collected. Drug survival is presented using Kaplan-Meier survival curves. We compared adjusted risk ratios of serious adverse events (AEs) with results of survival analysis for AEs.

RESULTS

A total of 1956 patients were included for analysis (1240 exposed to biologics during follow-up and 1076 to classic therapies). Median follow-up time was 3.3 years (0.0-5.1 years). There were 2209 discontinuations out of 3640 therapy cycles started. The main reason for discontinuation was lack of efficacy (36.4%) and remission (27.2%). Biologics showed a higher drug survival than classics and the pattern of survival results for all outcomes (positive or negative) were very similar. Adjusted risk ratios of serious AEs did not agree with results of survival analysis.

LIMITATIONS

A limitation is that this is an observational study with potential selection bias.

CONCLUSION

Survival as a proxy measure of drug safety in psoriasis is inadequate.

摘要

背景

鲜有研究比较中重度寻常型银屑病患者的药物生存率。

目的

描述并比较中重度寻常型银屑病患者使用包括生物制剂(英夫利昔单抗、依那西普、阿达木单抗和乌司奴单抗)和传统药物(阿维 A、环孢素和甲氨蝶呤)的药物生存率。

方法

这是一项多中心、前瞻性队列研究,纳入了 2008 年至 2013 年期间在西班牙 12 家医院接受系统性治疗的患者。收集了基线数据和停药情况。采用 Kaplan-Meier 生存曲线表示药物生存率。我们比较了严重不良事件(AE)的调整风险比与 AE 生存分析结果。

结果

共纳入 1956 例患者进行分析(1240 例在随访期间接受生物制剂治疗,1076 例接受经典治疗)。中位随访时间为 3.3 年(0.0-5.1 年)。在开始的 3640 个治疗周期中,有 2209 个周期停药。停药的主要原因是疗效不佳(36.4%)和缓解(27.2%)。生物制剂的药物生存率高于经典药物,且所有结局(阳性或阴性)的生存结果模式非常相似。严重 AE 的调整风险比与生存分析结果不一致。

局限性

这是一项观察性研究,存在潜在的选择偏倚。

结论

将生存率作为银屑病药物安全性的替代指标是不充分的。

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