Efficacy And Safety Of Dupilumab In The Treatment Of Adults With Moderate To Severe Atopic Dermatitis

Objective To evaluate the efficacy and safety of dupilumab in adult patients with moderate-to-severe AD.Methods Between January 2019 and December 2019,patients were randomized to receive a 600 mg loading dose of dupilumab or placebo,then 300 mg of dupilumab or placebo once every 2 weeks for 16 weeks,and then were followed up for 12 weeks.The primary efficacy endpoint was the proportion of patients with both Investigator’s Global Assessment(IGA)score of 0 to 1 and a reduction from baseline of≥2 points at week 16.The secondary efficacy end point was that the proportion of patients with Eczema Area and Severity Index(EASI)score decreased by≥ 50%,75%and≥90%at week 16,the percentage change of EASI score and the percentage of Body Surface Area(BSA)were changed;and the changes of EASI score and BSA were evaluated before treatment and after treatment 2,4,8,12 and 16 weeks.Results A total of 14 patients(mean age 28.9 years;13 men and one woman),seven were treated with dupilumab,and seven were treated with placebo.At week 16,one patient in the dupilumab group and one in the placebo group reached the primary endpoint,14.29%in both groups.At week 16,6 patients in the dupilumab group(85.71%)and 1 patient in the placebo group(14.29%)achieved≥75%reduction in the EASI score.7 patients in the dupilumab group(100%)and 2 patient in the placebo group(28.57%)achieved≥50%reduction in the EASI score.2 patients in the dupilumab group(28.57%)and 1 patient in the placebo group(14.29%)achieved≥90%reduction in the EASI score.The average percentage change of EASI score in dupilumab group was 81.63%,45.68%in the placebo group;the average percentage change of BSA in dupilumab group was 64.46%,86%in the placebo group.After 2,4,8,12 and 16 weeks of treatment,the difference of EASI score between the two groups was statistically significant,which proved that the efficacy of dupilumab was better than that of placebo;after 2,4,8,12 and 16 weeks of treatment,the difference of BSA between the two groups was not statistically significant,which could not prove that the efficacy of dupilumab was better than that of placebo,considering the small sample size.One patient in the dupilumab group developed an upper respiratory tract infection,and one in the placebo group discontinued the study drug because the disease worsened.Conclusions dupilumab is effective and safe in the treatment of adults with moderate to severe atopic dermatitis.