Real-World Data For Clinical Efficacy And Safety Analysis Of Dupilumab In The Treatment Of Moderate To Severe Atopic Dermatitis

Background Atopic dermatitis(AD)is a common chronic inflammatory skin disease.Its clinical features are mainly eczema-like manifestations,dryness,and itching.Chronic lesions include dry skin with scaly or thickened plaques,some with lichenoid changes and prurigo nodularis.Severe skin itching can cause sleep disturbance and fatigue,and even affect the patient’s mental health symptoms.The specific etiology of atopic dermatitis is still unclear,but existing studies have found that Th2 pathway immune abnormality occupies an important position in its pathogenesis.Among them,IL-4 and IL-13 secreted by Th2 cells are important to mediate the pathogenesis of atopic dermatitis.Dupilumab is a fully humanized monoclonal antibody against IL-4α subunit,which can be specific for IL-4Ra subunit shared with IL-4 and IL-13 receptor complex Combine to inhibit IL-4 and IL-13 signal transduction.The effectiveness and safety of the drug for patients with moderate to severe atopic dermatitis have been confirmed in foreign clinical trials,but there are few real-world data about the drug.Therefore,we conducted the first real-world data study on the treatment of dupilumab in adults with moderate to severe AD in China.Objectives To evaluate the effectiveness and safety of dupilumab in the clinical application of Chinese adult AD patients,and the clinical response after stopping or reducing the dose after a certain course of treatment.Methods The patient was treated with dupilumab at an initial dose of 600 mg,followed by 300 mg every two weeks,for a course of 16 weeks.Relevant clinical data were collected at the baseline location and at 4,8,12,and 16 weeks after administration.Observation index data were evaluated using the Eczema Area and Severity Index(EASI)score,the Investigator’s Global Assessment(IGA),Itch and Sleep Numerical Rating Scores(NRS),Dermatology Life Quality Index(DLQI)score,Self-Rating Anxiety Scale(SAS)and Self-Rating Depression Scale(SDS).After 16 weeks of medication,the researchers continued to track the patient’s medication and condition changes.Results A total of 39 patients were included in the study,29 of whom completed a12-week course of treatment,and 17 completed a 16-week course of treatment.In the4 th week after medication,the EASI score decreased by an average of 50.0% compared with the baseline,and decreased by 72.4% and 79.0% compared with the baseline at the12 th and 16 th weeks,respectively.At the same time,compared with the baseline,the DLQI score decreased by 54.2% and 61.3% at the 12 th week and the 16 th week,respectively,indicating that the patient’s quality of life has also been greatly improved after the medication.In the 12 th and 16 th weeks,44.8% and 76.5% of the patients reached EASI75,respectively.At the same time of treatment,the patient’s mental status such as SAS and SDS scores were also significantly improved,and we found that at the12 th week,the decrease in EASI score was positively correlated with the changes in SDS(p = 0.006),and SAS also showed similar results.And after 16 weeks of medication,after their condition was improved,they could also maintain a positive therapeutic effect by reducing the dose of medication.In terms of safety,the most common side effects are injection site reactions(3/39)and conjunctivitis(3/39),followed by herpes virus infection(2/39),upper respiratory tract infection(1/39),and erythema(1 /39).The adverse reactions observed in this study were all mild,and they were basically recoverable after symptomatic treatment.Conclusion Dupilumab has good efficacy and safety in the treatment of moderate to severe atopic dermatitis in domestic adults,and the adverse reactions that occur are basically within the acceptable range.With the improvement of the disease state,the patient’s quality of life and psychological state have also been significantly improved.