Biologics and Small Molecule Targeted Therapies for Pediatric Alopecia Areata, Psoriasis, Atopic Dermatitis, and Hidradenitis Suppurativa in the US: A Narrative Review

Children Pub Date : 2024-07-25 DOI:10.3390/children11080892
Robin C. Yi, Shannon K. Moran, Hannah Y. Gantz, Lindsay C. Strowd, Steven R. Feldman
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Abstract

Background: The management of pediatric dermatological conditions such as alopecia areata (AA), psoriasis, atopic dermatitis (AD), and hidradenitis suppurativa (HS) has significantly evolved with the introduction of biologics and small molecule targeted therapies. The advancement in understanding the immunopathogenesis of these chronic skin conditions has led to the development and approval of novel biologics and small molecule therapies. Initially approved by the United States Food and Drug Administration (FDA) for adults, most of these therapies are now being evaluated in clinical trials for safety and efficacy in adolescents and children, expanding new treatment options for pediatric patients. The role of the FDA in drug approval is multifaceted from drug inception, ensuring that research, data, and evidence show that the proposed drug is effective and safe for the intended use. Objective: The goal of this review article is to provide an overview of the recently FDA-approved and potential biologic and oral small molecule therapies in clinical trials for AA, psoriasis, AD, and HS in pediatric patients. Methods: The search for this review included keywords in ClinicalTrials.gov, PubMed, and Google Scholar for the latest research and clinical trials relevant to these conditions and treatments without the PRISMA methodology. Results: For pediatric AA, ritlecitinib is FDA-approved, while baricitinib and updacitinib are in phase 3 clinical trials for pediatric approval. The FDA-approved drugs for pediatric psoriasis include secukinumab, ustekinumab, ixekizumab, etanercept, and apremilast. Other phase 3 clinical trials for pediatric psoriasis include risankizumab, guselkumab, tildrakizumab, brodalumab, and deucravacitinib. For pediatric AD, the FDA-approved drugs are dupilumab, tralokinumab, abrocitinib, and upadacitinib, with many other drugs in phase 3 trials. Adalimumab is an FDA-approved biologic for pediatric HS, with various clinical trials ongoing for adults. The approved biologics and small molecule therapies had higher efficacy and improved safety profiles compared to traditional medications. Conclusions: With numerous ongoing trials, the success of these clinical trials could lead to their inclusion in treatment guidelines for these chronic skin conditions. Biologics and small molecule therapies offer new avenues for effective disease management, enabling personalized therapeutic interventions and improving pediatric health outcomes.
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美国治疗小儿脱发、银屑病、特应性皮炎和化脓性湿疹的生物制剂和小分子靶向疗法:叙述性综述
背景:随着生物制剂和小分子靶向疗法的引入,对异位性脱发(AA)、银屑病、特应性皮炎(AD)和化脓性扁桃体炎(HS)等儿科皮肤病的治疗发生了显著变化。随着对这些慢性皮肤病免疫发病机理认识的不断深入,新型生物制剂和小分子疗法得到了开发和批准。美国食品和药物管理局(FDA)最初批准这些疗法用于成人,目前正在对其中大多数疗法在青少年和儿童中的安全性和有效性进行临床试验评估,从而为儿科患者提供了更多新的治疗选择。美国食品及药物管理局在药物审批中的作用是多方面的,从药物一开始就确保研究、数据和证据表明拟议的药物对预期用途是有效和安全的。目的:这篇综述文章的目的是概述 FDA 最近批准的和潜在的生物和口服小分子疗法,这些疗法正在临床试验中,用于治疗儿童患者的 AA、银屑病、AD 和 HS。方法:本综述的搜索包括 ClinicalTrials.gov、PubMed 和 Google Scholar 中与这些病症和治疗方法相关的最新研究和临床试验的关键词,不使用 PRISMA 方法。结果对于儿科AA,利特西替尼已获得FDA批准,而巴利昔替尼和updacitinib正在进行儿科批准的3期临床试验。FDA 批准的儿科银屑病药物包括 secukinumab、ustekinumab、ixekizumab、etanercept 和 apremilast。其他针对小儿银屑病的 3 期临床试验包括 risankizumab、guselkumab、tildrakizumab、brodalumab 和 deucravacitinib。对于儿科 AD,FDA 批准的药物有 dupilumab、tralokinumab、abrocitinib 和 upadacitinib,还有许多其他药物正在进行 3 期试验。阿达木单抗是 FDA 批准用于儿童 HS 的生物制剂,目前正在对成人进行各种临床试验。与传统药物相比,已获批准的生物制剂和小分子疗法具有更高的疗效和更好的安全性。结论:目前正在进行多项试验,这些临床试验的成功可将其纳入这些慢性皮肤病的治疗指南。生物制剂和小分子疗法为有效的疾病管理提供了新途径,实现了个性化治疗干预,改善了儿科健康状况。
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