杜匹单抗对特应性皮炎患儿体重影响的前瞻性观察研究

Denis V. Zaslavsky, Alexey V. Taganov, Elena S. Bolshakova, Elena S. Manylova, Daria V. Kozlova
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引用次数: 0

摘要

背景:Dupilumab是俄罗斯联邦批准用于6岁以上儿童的生物治疗组中的一种药物。由于最近引入临床实践,出现了可能与使用该药物有关的各种临床效应的新报告,但未在说明书中列出。因此,dupilumab对成人特应性皮炎患者体重增加可能有影响的病例已被报道。我们记录了接受dupilumab治疗的儿童体重变化大于平均体重增加。 目的:该研究的目的是评估接受dupilumab治疗一年的中重度特应性皮炎患者的体重变化。材料与方法:对2022年1 - 12月28例中重度特应性皮炎患儿进行观察。所有患者均按照治疗特应性皮炎的临床指南接受dupilumab治疗。在研究之前和结束时,对患者的疾病严重程度、身高、体重、体重指数进行了评估,并对睡眠质量和低过敏性饮食的依从性进行了调查。患者分为2个年龄组:610岁和1113岁。测量结果在每个年龄组中分别进行评估,并与百分位表相关。 结果:研究纳入28例6 ~ 13岁的中度伴发患者[女孩18例(64.3%),男孩10例(35.7%),平均年龄10.25岁]。39.3%)和重度(n = 17;60.7%)特应性皮炎病程(平均SCORAD为57.3 4.6)。观察期结束时,第一年龄组体重增加5.8 kg;第二组3.06公斤;而第一个年龄组的体重指数增加了1.65;第二组是0.23。根据调查结果,在开始阶段,19名(67.86%)观察项目参与者注意到存在睡眠障碍,17名(60.71%)患者遵循低过敏性饮食。在观察期结束时,15/19(78.94%)患者的睡眠质量有所改善,12/17(70.59%)患者的饮食有所改善。结论:首次提出了在儿科人群中使用杜匹单抗治疗特应性皮炎与体重增加之间可能存在关联的数据。药物对体重增加的确切作用机制尚不清楚,但其积极作用是扩大饮食,使睡眠正常化,改善心理背景,从而使体重相对于最初的不足而增加。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Prospective observation study of the effect of dupilumab on the body weight of children with atopic dermatitis
BACKGROUND: Dupilumab is a drug from the group of biological therapy approved for use in children from 6 years of age in Russian Federation. Due to the recent introduction into clinical practice, appear new reports about various clinical effects that may be associated with the use of the drug, but are not listed in the instructions. Thus, cases of the possible effect of dupilumab on weight gain in adult patients with atopic dermatitis have been reported. We recorded a weight change greater than the average weight gain in children treated with dupilumab. AIM: The aim of the study was to evaluate the change in the weight of patients with moderate to severe atopic dermatitis treated with dupilumab for a year. MATERIALS AND METHODS: From January to December 2022 28 children with moderate and severe atopic dermatitis were under observation. All patients were treated with dupilumab in accordance with clinical guidelines for the treatment of atopic dermatitis. Before and at the end of the study, patients were assessed for the severity of the disease, height, body weight, the body mass index, as well as a survey about the quality of sleep and compliance with a hypoallergenic diet. Patients were divided into 2 age groups: 610 years old and 1113 years old. The results of measurements were evaluated separately in each age group and were correlated with centile tables. RESULTS: The study included 28 patients aged 6 to 13 years [18 girls (64.3%) and 10 boys (35.7%), mean age 10.25 years] with moderate (n = 11; 39.3%) and severe (n = 17; 60.7%) course of atopic dermatitis (mean SCORAD 57.3 4.6). At the end of the observation period, weight gain in the first age group was 5.8 kg; in the second group 3.06 kg; while the body mass index increased in the first age group by 1.65; in the second group by 0.23. According to the results of the survey at the initiation stage 19 (67.86%) participants in the observational program noted the presence of sleep disorders, 17 (60.71%) patients followed a hypoallergenic diet. At the end of the observation period 15/19 (78.94%) patients noted an improvement in the quality of sleep, 12/17 (70.59%) patients indicated an increase in the diet. CONCLUSIONS: The first data on a probable association between the treatment of atopic dermatitis with dupilumab and weight gain in the pediatric population are presented. The exact mechanism of the drug effect on weight gain is not clear, but the positive effect is to expand the diet, normalize sleep and improve the psychological background, which leads to an increase in body weight in relation to its initial shortage.
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