Efficacy And Safety Study Of Real-world Dupilumab In The Treatment Of Moderate-to-severe Atopic Dermatitis In Children

BackgroundAtopic dermatitis(AD)is a chronic inflammatory skin disease characterized by recurrent episodes of eczema,intense pruritus and dry skin,typically manifesting in early childhood and seriously affecting the daily life of patients.The pathogenesis of AD is multifactorial,and the inflammatory cytokines interleukin(IL)-4 and IL-13 secreted by T helper(Th)2 play an important role in it.Dupilumab is a fully humanized IgG4 monoclonal antibody against IL-4Rαthe common receptor of IL-4 and IL-13,which can inhibit the signaling of IL-4 and IL-13,thus effectively blocking the development of AD,and has been approved for the treatment of AD in China and abroad.A large body of clinical trial data confirms that dupilumab has significant efficacy in the treatment of AD,is well tolerated in the long term,does not require laboratory monitoring,and is currently a safer alternative to systemic therapy for AD.However,data for the pediatric population are scarce,so it is particularly important to evaluate the efficacy and safety of dupilumab in the treatment of moderate-to-severe AD in children in the real world.ObjectiveTo evaluate the efficacy and safety of dupilumab in the treatment of moderate-to-severe AD in children in a domestic real-world setting and to provide clinicians with real-world study data to better understand the responsiveness of pediatric patients to dupilumab.MethodsThis is a retrospective study of the clinical efficacy and safety of dupilumab in the treatment of moderate-to-severe AD in children.The Scoring Atopic Dermatitis(SCORAD)score,the Eczema Area and Severity Index(EASI)score and the Numerical Rating Scale(NRS)were used to collect information from 15 patients who visited Shandong Dermatology Hospital from November 2020 to March 2022.Patients included in this study were children aged 1-12 years with moderate to severe AD and were treated with dupilumab.All patients were given dupilumab 300 mg subcutaneously for the first time,followed by dupilumab 300 mg every 2-4 weeks.During the treatment period,all patients were allowed to use other traditional medications for AD(e.g.,oral antihistamines,topical medications,etc.).Patients’ general condition,treatment status and standardized lesion pictures were collected by uniformly trained medical staff at viewpoint to compare the changes in SCORAD,EASI and pruritus NRS scores before and after drug treatment and to calculate the proportion of patients achieving EASI50/75/90,to compare the changes in serum immunoglobulin E(IgE)levels before and after treatment,and to observe and record possible adverse drug reactions during treatment.Result1.15 patients were included in this study,8(53.3%)females and 7(46.7%)males,with a mean age(SD)of 5.9(2.6)years.The mean duration of disease(SD)was 4.6(2.9)years,10(66.7%)patients developed the disease when they were less than 1 year old,and 5 patients(33.3%)had allergic rhinitis and/or asthma.A total of 10(66.7%)completed the 12-week follow-up and 8(53.3%)completed the 16-week follow-up.2.The median SCORAD scores for patients at weeks 0,4,12,and 16 were 60.5,33.9,21.6,and 14.5,respectively,with a decrease of 43.4%,63.3%,and 72.6%in SCORAD scores at weeks 4,12,and 16,respectively,compared to baseline;the median EASI scores for patients at weeks 0,4,12,and 16 were 13.8,6.3,4.1,and 1.2 points,respectively,and the EASI scores decreased by 52.8%,73.2%,and 86.7%,respectively,compared with baseline;the median itching NRS scores were 8.0,3.0,2.0,and 1.0 points,respectively,for patients at weeks 0,4,12,and 16,and the pruritus NRS scores decreased by 52.8%,72.2%,and 83.8%,respectively,compared with baseline.SCORAD,EASI,and itching NRS scores decreased more in the first 4 weeks of treatment,and then the decrease gradually became slower.3.The proportion of patients reaching EASI-50,EASI-75,and EASI-90 all gradually increased over time.At week 4,the proportions of patients achieving EASI-50,EASI-75,and EASI-90 were 57.1%,7.1%,and 7.1%,respectively;at week 12,the proportions of patients achieving the three indicators increased to 90%,50%,and 10%,respectively;at week 16,the proportions of patients achieving EASI-50,EASI-75,and EASI-90 reached 100%,75%,and 50%.In addition,there was a general trend of continuous decrease in total serum IgE levels in patients during the treatment period.4.In terms of treatment safety,no adverse reactions or serious adverse events were observed in all patients during the follow-up period.Conclusion1.In the domestic children population,dupilumab showed good efficacy in the treatment of AD,significantly improving clinical symptoms and signs such as disease extent,eczema area,and itching in patients,and the improvement was most pronounced in the first month.2.Dupilumab has a high safety profile in the treatment of AD in the domestic pediatric population.