Valeria Antoniou, Elena Thomaidou, Ekatherine Prokopiou
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The studies were analyzed in terms of drug effectiveness (using EASI, IGA and SCORAD scoring systems) and safety profile (presence and occurrence of adverse events).</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>EASI, SCORAD, and IGA scores were significantly improved in patients receiving dupilumab treatment irrespective of dosage. Conjunctivitis was the most consistently and commonly reported adverse event in both clinical trials (relative risk; RR = 2.4, 95% confidence interval [CI] [1.20, 4.84], <i>p</i> = 0.01) and real-life studies (10.8% of patients). Injection-site reactions and nasopharyngitis demonstrated an increased, yet nonsignificant RR. Compared to placebo, dupilumab exhibited a reduced RR of 36% in AD exacerbations (95% CI [0.43, 0.94], <i>p</i> = 0.0234) and 44% in skin infections (95% CI [0.36, 0.88], <i>p</i> = 0.0106).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Dupilumab appears to be a promising drug in the treatment of moderate to severe AD in pediatric population, with noticeable improvement in outcome scores. 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引用次数: 0
摘要
背景/目的 特应性皮炎(AD)是一种慢性炎症性皮肤病,通常在儿童早期发病。尽管目前已确立了许多治疗方法,但其疗效往往参差不齐,而且并不总是充分的。杜必鲁单抗是首个获准用于治疗儿童重症过敏性皮炎的生物制剂。在这篇综述中,我们旨在介绍目前有关杜比单抗在儿科人群中的有效性和安全性的数据。 方法 在PubMed、ScienceDirect和clinicaltrials.gov上进行了系统检索,从中纳入了三项临床试验和四项实际研究。从药物有效性(采用 EASI、IGA 和 SCORAD 评分系统)和安全性(不良反应的存在和发生)方面对这些研究进行了分析。 结果 无论剂量大小,接受杜比鲁单抗治疗的患者的 EASI、SCORAD 和 IGA 评分均有明显改善。在临床试验(相对风险;RR = 2.4,95% 置信区间 [CI] [1.20,4.84],p = 0.01)和实际研究(10.8% 的患者)中,结膜炎都是最常见的不良事件。注射部位反应和鼻咽炎的RR有所增加,但不显著。与安慰剂相比,杜匹单抗可使 AD 恶化的 RR 降低 36%(95% CI [0.43,0.94],p = 0.0234),皮肤感染的 RR 降低 44%(95% CI [0.36,0.88],p = 0.0106)。 结论 杜匹单抗似乎是一种治疗儿童中重度AD的有前途的药物,其疗效评分有明显改善。在不良反应中,结膜炎是最常见的一种,但没有长期或危及生命的不良反应报告。
Dupilumab Efficacy and Safety Assessment in the Treatment of Atopic Dermatitis in Pediatric Patients: A Systematic Review
Background/Objectives
Atopic dermatitis (AD) is a chronic inflammatory skin condition, commonly first occurring in early childhood. Although many treatments have currently been established, their effectiveness often varies, and it is not always adequate. The first biologic agent approved in the pediatric population, in severe AD cases, is dupilumab. In this review we aim to present the current data on dupilumab effectiveness and safety in the pediatric population.
Methods
Systematic search was conducted throughout PubMed, ScienceDirect, and clinicaltrials.gov, from which three clinical trials and four real-life studies were included. The studies were analyzed in terms of drug effectiveness (using EASI, IGA and SCORAD scoring systems) and safety profile (presence and occurrence of adverse events).
Results
EASI, SCORAD, and IGA scores were significantly improved in patients receiving dupilumab treatment irrespective of dosage. Conjunctivitis was the most consistently and commonly reported adverse event in both clinical trials (relative risk; RR = 2.4, 95% confidence interval [CI] [1.20, 4.84], p = 0.01) and real-life studies (10.8% of patients). Injection-site reactions and nasopharyngitis demonstrated an increased, yet nonsignificant RR. Compared to placebo, dupilumab exhibited a reduced RR of 36% in AD exacerbations (95% CI [0.43, 0.94], p = 0.0234) and 44% in skin infections (95% CI [0.36, 0.88], p = 0.0106).
Conclusions
Dupilumab appears to be a promising drug in the treatment of moderate to severe AD in pediatric population, with noticeable improvement in outcome scores. Among the adverse events, conjunctivitis is the most common; however, no long-term or life-threatening events were reported.