Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic.

IF 5.2 Q1 DERMATOLOGY Psoriasis (Auckland, N.Z.) Pub Date : 2021-02-11 eCollection Date: 2021-01-01 DOI:10.2147/PTT.S268462
Morten B Haulrig, Claus Zachariae, Lone Skov
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Abstract

Psoriasis is a chronic inflammatory skin disease that affects up to 1.2% of children and adolescents. The treatment options for childhood psoriasis are often based on the same principles as in adults. However, most data on safety and efficacy derive from adult studies, and only a few of the frequently used treatments have achieved approval for use in children. The aim of this study was to review the current literature on off-label treatments for psoriasis in children and adolescents. We searched PubMed and identified 50 studies on off-label treatments. Of these, 23 studies were clinical trials (four randomized). There are only a small number of available studies on off-label treatments for children and adolescents with psoriasis, and many of these are retrospective reviews with few participants. Despite the current lack of studies, we still recommend the use of unapproved treatments since we have clinical experience with treatments such as topical corticosteroids, vitamin D analogs, and methotrexate that have shown promising effects. Regular clinical trials are needed to investigate the safety and efficacy of unapproved treatments. Due to The Pediatric Investigation Plans issued by The European Union, new drugs developed by pharmaceutical companies are required to undergo clinical trials in a pediatric population to get their application for marketing authorization processed. This will hopefully lead to much more data on the efficacy and safety of the new treatments, including treatments for children and adolescents with psoriasis.

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小儿银屑病的标示外治疗:对临床的启示。
银屑病是一种慢性炎症性皮肤病,多达 1.2% 的儿童和青少年会患病。儿童银屑病的治疗方案通常采用与成人相同的原则。然而,大多数有关安全性和有效性的数据都来自成人研究,只有少数常用治疗方法获准用于儿童。本研究旨在回顾目前有关儿童和青少年银屑病标示外治疗的文献。我们检索了 PubMed,发现了 50 项关于标示外治疗的研究。其中 23 项研究为临床试验(4 项随机试验)。关于儿童和青少年银屑病患者标示外治疗的现有研究数量很少,而且其中许多研究都是回顾性综述,参与者很少。尽管目前缺乏研究,但我们仍建议使用未经批准的治疗方法,因为我们在外用皮质类固醇激素、维生素 D 类似物和甲氨蝶呤等治疗方法上积累了临床经验,并显示出良好的效果。我们需要定期进行临床试验,以研究未经批准的治疗方法的安全性和有效性。根据欧盟发布的《儿科调查计划》,制药公司开发的新药必须在儿科人群中进行临床试验,才能获得上市许可申请。这将有望获得更多有关新疗法疗效和安全性的数据,包括针对儿童和青少年银屑病患者的疗法。
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