关键词: 皮炎, 特应性, 度普利尤单抗, 胸腺基质淋巴细胞生成素, 治疗结果

Abstract: 【Abstract】 Objective To evaluate the clinical efficacy and safety of dupilumab in patients with moderate-to-severe atopic dermatitis across different age groups and to assess changes in serum thymic stromal lymphopoietin （TSLP） levels following treatment. Methods This was a prospective cohort study. Patients aged ≥ 6 years with moderate-to-severe atopic dermatitis who attended the Department of Dermatology, People's Hospital of Ningxia Hui Autonomous Region, between January and June 2023 were enrolled. According to age, the patients were divided into a childern group （< 18 years）, a middle-aged group （18 - 60 years）, and an elderly group （≥ 60 years）. Eligible patients meeting the predefined inclusion and exclusion criteria received dupilumab treatment. The Eczema Area and Severity Index （EASI）, Numerical Rating Scale （NRS） for pruritus, and Dermatology Life Quality Index/Children's Dermatology Life Quality Index （DLQI/cDLQI） scores were recorded at weeks 0, 4, 8, 12, and 16. Serum TSLP levels were measured at weeks 0, 4, and 16. Adverse events and their management during treatment were also documented. Comparisons among groups were performed using the chi-square test or repeated-measures analysis of variance. Results A total of 97 patients completed the 16-week treatment, including 54 males and 43 females, aged 8 - 92 years. There were 23 patients in the child and adolescent group, 42 in the middle-aged group, and 32 in the elderly group. At weeks 4, 12, and 16, the proportions of patients achieving EASI75 in the children group （21.74%, 95.65%, and 100%, respectively） were higher than those in the elderly group （0%, 62.50%, and 65.63%, respectively; all P < 0.05）. At week 16, the proportions of patients achieving EASI75 were 100% in the children group, 95.24% in the middle-aged group, and 65.63% in the elderly group. In all 3 groups, EASI, NRS, and DLQI/cDLQI scores at weeks 4 - 16 were significantly lower than baseline values （all P < 0.05）, with the most pronounced reductions occurring during the first 4 weeks of treatment. Serum TSLP levels differed significantly among the 3 groups over time （P < 0.05）. In all groups, serum TSLP levels at weeks 4 and 16 were significantly lower than baseline levels （all P < 0.05）. During treatment, allergic conjunctivitis occurred in 2 adolescent patients, transient headache occurred in 1 child, and pain at the injection site during the first administration was reported by 3 patients. Conclusions Dupilumab demonstrated significant clinical efficacy and a favorable safety profile in patients with moderate-to-severe atopic dermatitis across different age groups. Serum TSLP levels decreased markedly after treatment.

Key words: Dermatitis, atopic, Dupilumab, Thymic stromal lymphopoietin, Treatment outcome