度普利尤单抗用于6~17岁儿童中重度特应性皮炎的疗效及安全性:单中心、前瞻性、开放性研究

Efficacy and safety of dupilumab in treatment of moderate-to-severe atopic dermatitis among children aged 6-17:a single-center,prospective,open-label study

目的观察Dupilumab(度普利尤单抗)治疗6~17岁儿童中重度特应性皮炎(atopic dermatitis,AD)的疗效及安全性。方法采用前瞻性、开放性研究,纳入2021年8月至2022年3月重庆医科大学附属儿童医院皮肤科门诊就诊的6~17岁中重度AD患者,基线体重≥15~<60 kg度普利尤单抗首剂600 mg皮下注射,之后300 mg每4周一次;体重≥60 kg首剂600 mg皮下注射,之后300 mg每2周一次。评价治疗前后特应性皮炎评分(scoring atopic dermatitis,SCORAD)、湿疹面积及严重程度指数(eczema area and severity index,EASI)、研究者整体评估(investigator global assessment,IGA)、瘙痒/睡眠NRS(数字评分量表)及实验室指标。结果共纳入完成16周治疗的中重度AD患者52例,平均年龄(9.9±2.8)岁;与基线相比,第16周治疗后SCORAD、EASI、IGA、瘙痒及睡眠NRS评分较基线明显下降(52.8±15.3 vs.18.3±6.6,22.7±9.9 vs.6.0±5.6,3.9±0.6 vs.1.9±0.8,6.9±2.1 vs.1.7±1.8,5.1±2.7 vs.1.0±1.5,P<0.001)。达到EASI-75的患者比例71.2%,其中躯干皮损改善明显优于头颈部和四肢;血清总IgE水平较基线明显下降(1170 IU/mL vs.425 IU/mL,P<0.001)。女性达到EASI-75的概率是男性的11.2倍(95%CI:1.3~97.3,P=0.028)。治疗期间15例(28.8%)报告治疗相关不良事件,以结膜炎(11.5%)、注射部位反应(9.6%)最常见,均未导致停药。结论度普利尤单抗治疗6~17岁中重度AD具有良好的疗效及安全性。

Objective To evaluate efficacy and safety of dupilumab in treatment of moderate-to-severe atopic dermatitis(AD)among children aged 6-17 years.Methods An open-label prospective study was designed.Moderate-to-severe AD patients aged 6-17 years were enrolled,who were prescribed dupilumab in Children’s Hospital of Chongqing Medical University from August 2021 to March 2022.Doses of dupilumab administered subcutaneously were determined basing on baseline body weight as below:baseline body weight≥15 kg to<60 kg:loading dose 600 mg,followed by 300 mg q4w;≥60 kg:loading dose 600 mg,followed by 300 mg q2w.The scoring atopic dermatitis(SCORAD),eczema area and severity index(EASI)score,investigator global assessment(IGA)score,pruritus/sleep numerical rating scale(NRS)score and laboratory indexes were evaluated before and after treactment.Results A total of 52 patients with moderate-to-severe atopic dermatitis who finished 16 weeks treatment were enrolled.The mean age was(9.9±2.8)years-old.The SCORAD,EASI,IGA,pruritus and sleep NRS scores all decreased significantly,compared with baseline scores(52.8±15.3 vs.18.3±6.6,22.7±9.9 vs.6.0±5.6,3.9±0.6 vs.1.9±0.8,6.9±2.1 vs.1.7±1.8,5.1±2.7 vs.1.0±1.5 respectively,P<0.001).71.2%of patients achieved EASI-75.Cutaneous lesion on trunk improved more markedly,compared with head,neck,and extremities.The serum total IgE level of post-treatment was significantly lower than baseline level(1170 IU/mL vs.425 IU/mL,P<0.001).The ratio of achievement of EASI-75 among female was 11.2 times higher than that of male(95%CI:1.3-97.3,P=0.028).Treatment-related adverse events were reported by 15(28.8%)patients during treatment,of which conjunctivitis was the most common(11.5%)adverse events,followed by injection site reaction(9.6%).None resulted in drug withdrawal.Conclusion Dupilumab is effective and safe for treatment of moderate-to-severe AD children aged 6-17 years.