Off-label prescriptions for atopic dermatitis in Europe

被引：26

作者：

Bieber, T. ^{[1
]}

Straeter, B. ^{[2
,3
]}

机构：

[1] Univ Bonn, Dept Dermatol & Allergy, D-53105 Bonn, Germany

[2] Univ Bonn, Master Course Drug Regulatory Affairs, D-53105 Bonn, Germany

[3] Straeter Lawyers, Bonn, Germany

来源：

ALLERGY | 2015年 / 70卷 / 01期

关键词：

atopic dermatitis; off-label use; regulation; systemic therapy; CRITICAL-APPRAISAL; POSITION PAPER; ECZEMA; GUIDELINES; MANAGEMENT; DIAGNOSIS; CHILDREN; AZATHIOPRINE; OMALIZUMAB; EFFICACY;

D O I：

10.1111/all.12498

中图分类号：

R392 [医学免疫学];

学科分类号：

100108 [医学免疫学];

摘要：

Moderate-to-severe forms of atopic dermatitis (AD) have a substantial impact on the quality of life of patients and their relatives, carrying a significant socioeconomic burden. They often require a systemic therapy, and ciclosporine A (CsA) is the only medicinal product approved for this indication in a limited number of European countries. However, due to the safety profile of CsA and its approval conditions, this treatment can only be prescribed for a limited period of time. Thus, moderate-to-severe forms of AD represent a significant unmet medical need and are subject to off-label prescriptions. Besides giving some insights into the approval procedures for medicinal products in the European Union, this short review is aimed to provide some relevant background information for off-label prescription in AD. It also provides a clinical algorithm for the off-label prescription of systemic immunosuppressants in AD, discusses the apparent dilemma between approval and guidelines, and finally suggests practical rules to be considered in the context of off-label prescription.

引用

页码：6 / 11

页数：6

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