Dupilumab for infants with atopic dermatitis: Friendly administration tips to enhance adherence

IF 9.2 2区 医学 Q1 DERMATOLOGY
Emanuele Scala, Filomena Russo
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引用次数: 0

Abstract

Atopic dermatitis (AD) is a chronic inflammatory skin disease driven by type 2 immune responses involving cytokines such as IL-4 and IL-13. It is characterized by persistent pruritus and widespread skin lesions that significantly impact the quality of life (QoL) of both affected children and their caregivers. Disease onset typically occurs in childhood, with approximately 60% of cases presenting within the first year and nearly 80% before age six.1 Early prevention and effective management are therefore crucial, especially considering the limitations of systemic therapies in young children.

In a recent real-world study published in the JEADV, Lasek et al.2 report outcomes from the French Early Access Program (EAP) involving 198 children aged 6 months to 5 years with moderate-to-severe AD. Dupilumab, a monoclonal antibody targeting IL-4 and IL-13, was injected every 4 weeks at a dose of 200 mg for children weighing 5–15 kg and 300 mg for those weighing 15–30 kg. Children who reached 15 kg during treatment continued receiving the 200-mg dose.

By 6 months, approximately 84% of patients achieved an Investigator's Global Assessment (IGA) score of 0/1, indicating clear or almost clear skin. Additionally, 94.4%, 75.0% and 44.4% of patients achieved at least 50%, 75% and 90% improvement, respectively, on the Eczema Area and Severity Index (EASI 50/75/90). Meaningful reductions in pruritus were also noted, with about 67.6% of patients reporting a ≥4-point improvement in the Pruritus-Numerical Rating Scale (P-NRS) scores, highlighting the substantial benefit of dupilumab. These clinical improvements were accompanied by gains in QoL, as reflected by reductions in paediatric-specific measures, including the Infants' Dermatitis QoL Index (IDQOL; for children <4 years) and the Children's Dermatology Life Quality Index (CDLQI, for children ≥4 years). Mean score decreases of −6.9 and −8.8, respectively, indicate a substantial reduction in disease-related discomfort and psychosocial burden in this patient group.

The safety profile remained consistent with previous clinical trials,3, 4 with low rates of adverse events—primarily mild or moderate—and no new safety concerns identified. Notably, these findings extend beyond the typical 16-week duration of randomized trials, further supporting dupilumab as an effective and well-tolerated treatment for moderate-to-severe AD in very young children. However, caregivers should take special considerations into account.

To optimize adherence and ease the administration process, several strategies can help reduce the stress of injections for children.5 These include removing the syringe or prefilled pen from the refrigerator 30–45 minutes before injection to reduce discomfort caused by cold, applying a topical anaesthetic to reduce pain and using distraction techniques such as audiovisual media, toys or tactile objects to divert attention and alleviate anxiety. Having a supportive presence and involving an experienced healthcare professional for the first injection can further increase confidence and comfort for both children and caregivers. Together, these measures aim to improve the overall experience, reduce fear and promote treatment adherence.

Another important consideration before initiating dupilumab is the vaccination schedule. Clinical data on this matter remain limited,5 and specific guidelines for the use of live or live-attenuated vaccines in dupilumab-treated patients are still needed.

Despite the significant advances with dupilumab in young children with AD, several questions remain regarding the optimal timing for treatment discontinuation, long-term use, the potential for personalized dosing intervals and the possibility of modifying the natural course of AD. Long-term prospective studies in larger populations will be essential to address these knowledge gaps.

The authors have nothing to report.

Nothing to be disclosed.

Not applicable.

Not applicable.

Data sharing is not applicable to this article as no new data were created or analyzed in this study.

Dupilumab用于婴儿特应性皮炎:友好的给药提示,以提高依从性
特应性皮炎(AD)是一种慢性炎症性皮肤病,由涉及IL-4和IL-13等细胞因子的2型免疫反应驱动。它的特点是持续瘙痒和广泛的皮肤病变,显著影响受影响儿童及其照顾者的生活质量。疾病通常发生在儿童时期,大约60%的病例在第一年出现,近80%在6岁之前出现因此,早期预防和有效管理至关重要,特别是考虑到幼儿全身治疗的局限性。在JEADV最近发表的一项现实世界研究中,Lasek等人2报告了法国早期接触计划(EAP)的结果,该计划涉及198名6个月至5岁的中度至重度AD儿童。Dupilumab是一种靶向IL-4和IL-13的单克隆抗体,每4周注射一次,体重5-15公斤的儿童注射200毫克,体重15-30公斤的儿童注射300毫克。在治疗期间体重达到15公斤的儿童继续接受200毫克的剂量。6个月后,大约84%的患者达到了研究者整体评估(IGA)评分0/1,表明皮肤清晰或几乎清晰。此外,94.4%、75.0%和44.4%的患者在湿疹面积和严重程度指数(EASI 50/75/90)上分别达到至少50%、75%和90%的改善。瘙痒的显著减少也被注意到,约67.6%的患者报告瘙痒-数值评定量表(P-NRS)评分改善≥4分,突出了杜匹单抗的实质性益处。这些临床改善伴随着生活质量的提高,这反映在儿科特异性指标的降低上,包括婴儿皮炎生活质量指数(IDQOL,适用于儿童4岁以上)和儿童皮肤病生活质量指数(CDLQI,适用于儿童≥4岁)。平均得分分别下降- 6.9和- 8.8,表明该患者组疾病相关不适和心理社会负担大幅减少。安全性与先前的临床试验保持一致,不良事件发生率低(主要是轻度或中度),没有发现新的安全性问题。值得注意的是,这些发现超出了典型的16周随机试验持续时间,进一步支持dupilumab作为一种有效且耐受性良好的治疗幼童中重度AD的方法。然而,护理人员应该考虑到特殊的因素。为了优化依从性和简化给药过程,有几种策略可以帮助减少儿童注射的压力这些措施包括在注射前30-45分钟将注射器或预充笔从冰箱中取出,以减少因寒冷引起的不适,应用局部麻醉以减轻疼痛,并使用视听媒体、玩具或触觉物体等分散注意力的技术来转移注意力并减轻焦虑。有一个支持性的存在,并在第一次注射时让有经验的医疗保健专业人员参与,可以进一步增加儿童和护理人员的信心和舒适度。总之,这些措施旨在改善整体体验,减少恐惧并促进治疗依从性。在开始使用dupilumab之前,另一个重要的考虑因素是疫苗接种计划。关于这一问题的临床数据仍然有限,5并且仍然需要在dupilumumab治疗的患者中使用活疫苗或减毒活疫苗的具体指南。尽管dupilumab在老年痴呆症儿童治疗方面取得了重大进展,但关于最佳停药时间、长期使用、个性化给药间隔的潜力以及改变老年痴呆症自然病程的可能性,仍存在一些问题。在更大的人群中进行长期前瞻性研究对于解决这些知识差距至关重要。作者没有什么可报告的。没什么可透露的。不适用。不适用。数据共享不适用于本文,因为本研究没有创建或分析新的数据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
10.70
自引率
8.70%
发文量
874
审稿时长
3-6 weeks
期刊介绍: The Journal of the European Academy of Dermatology and Venereology (JEADV) is a publication that focuses on dermatology and venereology. It covers various topics within these fields, including both clinical and basic science subjects. The journal publishes articles in different formats, such as editorials, review articles, practice articles, original papers, short reports, letters to the editor, features, and announcements from the European Academy of Dermatology and Venereology (EADV). The journal covers a wide range of keywords, including allergy, cancer, clinical medicine, cytokines, dermatology, drug reactions, hair disease, laser therapy, nail disease, oncology, skin cancer, skin disease, therapeutics, tumors, virus infections, and venereology. The JEADV is indexed and abstracted by various databases and resources, including Abstracts on Hygiene & Communicable Diseases, Academic Search, AgBiotech News & Information, Botanical Pesticides, CAB Abstracts®, Embase, Global Health, InfoTrac, Ingenta Select, MEDLINE/PubMed, Science Citation Index Expanded, and others.
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