Clinical Efficacy And Safety Analysis Of Dupilumab In The Treatment Of Moderate-to-severe Atopic Dermatitis

Objective:To analyze a series of clinical indicators and adverse reactions of patients with moderate to severe atopic dermatitis（AD）during the treatment with dupilumab.To systematically evaluate the clinical efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis.Methods:This study is mainly a prospective study on the clinical efficacy and safety of Dupilumab in the treatment of moderate to severe atopic dermatitis for 16 weeks.55 patients with moderate to severe atopic dermatitis were collected from November 2020 to November 2021.The treatment plan was to inject 600 mg of dupilumab subcutaneously in week 0（the first time）,and 300 mg subcutaneously in week 2,4,6,8,10,12,14 and 16 respectively.The treatment course was 16 weeks.The basic information,clinical features,medical history,drug allergy history,family history of the patients were collected.At the 0th,4th,8th,12 th and 16 th week of treatment,the photos of patients’ skin lesions were collected,and the AD score（SCORAD）,ADCT score,dermatology life quality index（DLQI）,numeric rating scale（NRS）,EASI score,IGA and incidence of adverse events（conjunctivitis,injection site reaction,drug allergy,upper respiratory infection）.Results:In this study,54 patients（1 case stopped using）who had completed 16 weeks of treatment were analyzed for symptoms such as skin lesions and itching at the 0th,4th,8th,12 th and 16 th weeks of treatment,and the scores of EASI,IGA,SCORAD,POEM,NRS and DLQI were recorded.The clinical efficacy was mainly expressed by EASI50,EASI75,EASI90 and IGA0/1,that is,the skin lesions of patients were cleared by 50%.The scores of EASI,IGA,SCORAD,NRS,POEM and DLQI at week 0（initial treatment）were 26.95,3.65,52.13,7.96,14.41 and 13.89,respectively,and the disease severity was moderate to severe.At the 4th week of treatment,the percentage of patients who reached EASI50,EASI75,EASI90 and IGA0/1 were 53.7%,7.4%,1.9%and 18.5% respectively.At the 8th week of treatment,the patients who reached EASI50,EASI75,EASI90 and IGA0/1 were 75.9%,20.4%,3.7% and 35.2% respectively.At the 12 th week of treatment,90.7%,40.7%,16.7% and 48.1% of patients reached EASI50,EASI75,EASI90 and IGA0/1 respectively.At the 16 th week of treatment,the patients who reached EASI50,EASI75,EASI90 and IGA0/1 were 98.1%,70.4%,33.3%and 61.1% respectively.At the 16 th week,SCORAD,NRS,POEM and DLQI were improved by 72.4%,78.8%,63.3% and 74.2% respectively compared with the baseline level.The difference is statistically significant.Of the 55 patients included in this study,12 patients（21.8%）had adverse reactions of different severity during the treatment,mainly manifested as injection site reactions such as redness,pain and itching,conjunctivitis,upper respiratory tract infection and so on.Adverse reactions are generally mild,which can be relieved by themselves,and usually do not lead to termination of treatment.Only one patient stopped taking the drug due to drug allergy,and improved after stopping taking the drug through antiallergic treatment.Conclusions:（1）This study shows that the treatment of moderate and severe atopic dermatitis with dupilumab can obviously relieve itching symptoms,reduce the area of skin lesions,and improve the quality of life,which proves its effectiveness.（2）The common adverse reactions of dupilumab in the treatment of moderate to severe atopic dermatitis are injection site adverse reactions such as swelling and pain,itching,conjunctivitis,upper respiratory tract infection,and most of them are mild to moderate,and will not cause drug discontinuation.（3）The patients in this study have different previous treatment schemes,small sample size and short follow-up time,so more studies on long-term efficacy and safety are needed.