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Objective:To investigate short-term efficacy and safety of subcutaneous injection of dupilumab in the treatment of moderate-to-severe childhood atopic dermatitis (AD) .Methods:A retrospective study was conducted on clinical data from children who were diagnosed with moderate-to-severe AD and subcutaneously injected with dupilumab in Department of Dermatology, Beijing Children′s Hospital, Capital Medical University from March 2021 to August 2021. Changes in the Eczema Area and Severity Index (EASI), itch Numeric Rating Scale (NRS) score, SCORing Atopic Dermatitis (SCORAD) index, and Dermatology Family quality of life Index (DFI) were analyzed before and 4 weeks after the first subcutaneous injection of dupilumab. Adverse events were collected during the first injection to the first follow-up visit at week 4 after the start of treatment. Normally distributed measurement indices were compared by using paired t test, non-normally distributed measurement indices were compared by using signed rank test, and logistic regression analysis was used to evaluate the effects of disease duration, eosinophil counts, IgE levels, personal and family history of allergic diseases on EASI50 (≥ 50% decrease in the EASI score) after dupilumab treatment. Results:A total of 39 children were enrolled in this study, including 21 males and 18 females. Twenty-one patients were aged 2 to < 6 years, 18 were aged 6 to < 18 years, and their median age ( Q1, Q3) was 65.0 (53.0, 111.0) months. Four weeks after the single-dose subcutaneous injection of dupilumab, 18 patients (84.85%) achieved ≥ 50% decrease in EASI score, 13 (60.61%) ≥ 75% decrease in EASI score; 18 (75.76%) experienced a decrease of ≥ 4 points in peak NRS, and 20 (81.82%) ≥ 3 points in peak NRS; the SCORAD score decreased by ≥ 50% in 15 (68.75%) patients, and by ≥ 75% in 7 (18.75%). Neither common adverse events such as conjunctivitis, skin infections, injection site reactions, nor serious adverse events were observed in any of the children from the first injection to the first follow-up visit at week 4. Logistic regression analysis showed no significant effect of the disease duration, eosinophil counts, IgE levels, personal or family history of allergic diseases on EASI50 (all P > 0.05) . Conclusion:A single-dose subcutaneous injection of dupilumab can markedly improve pruritus and severity of skin lesions in children with moderate-to-severe AD, and enhance the family quality of life, with favorable short-term safety.
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Objective To evaluate the effect of an emollient containing Prinsepia utilis Royle oil extracts and other extracts on clinical symptoms and disease recurrence in children aged 2-12 years with atopic dermatitis (AD) in the remission period.Methods A multicenter,randomized,parallel-group,controlled clinical trial was conducted from December 2017 to September 2018.A total of 297 children aged 2-12 years with moderate AD were enrolled from 5 hospitals in China,and randomly divided into the test group (148 cases) and control group (149 cases).In the acute stage,the two groups were both topically treated with mometasone furoate cream once a day on the skin lesions,and with an emollient containing Prinsepia utilis Royle oil extracts and other extracts twice a day throughout the whole body for 2-4 weeks.The children would be enrolled into the remission stage if their Investigator's Global Assessment (IGA) score was ≤ 1 at following visits.In the remission stage,the test group was only topically treated with the emollient twice a day throughout the whole body,while mometasone furoate cream and the emollient were both withdrawn in the control group.At weeks 4,8 and 12 in the remission stage,the recurrence of AD,eczema area and severity index (EASI),children's dermatology life quality index (CDQOL) and adverse events were evaluated.Statistical analysis was carried out with SAS 9.4 software by using t test for comparison of normally distributed continuous data between two groups,chi-square test for comparison of unordered categorical data,Kaplan-Meier method for analysis of survival rates,Cox regression analysis for evaluating the effect of different therapies on AD recurrence in children in the remission stage,and Logistic regression analysis for analysis of odds ratio (OR) of EASI or CDQOL at week 4 in the remission stage between the test group and control group.Results Of the 297 children with AD,31 breached the clinical trial protocol,and 266 were included in the per protocol set (PPS),including 132 in the test group and 134 in the control group.In the PPS,114 and 106 patients completed the follow-up in the test group and control group respectively,and the recurrence rate was significantly lower in the test group (47,41.23％) than in the control group (84,79.25％;x2 =32.96,P ＜ 0.001).The time to recurrence was significantly longer in the test group(61.99 d ± 2.80 d)than in the control group(39.17 d ± 2.54 d,t =6.03,P ＜ 0.001),and the recurrence risk was significantly lower in the test group than in the control group (Log rank test,x2 =32.02,P ＜ 0.001).After adjustment for age and gender,Cox regression analysis showed that the recurrence risk in the test group was 0.35 times that in the control group (HR =0.35,95％ CI:0.24-0.51,P ＜ 0.01).At week 4 in the remission stage,the EASI score at P50-P75 and P75-P100 in the test group were 0.42,0.25 times that in the control group respectively (95％ CI:0.20-0.86,0.12-0.54 respectively;P =0.02,＜ 0.01respectively).Moreover,the CDQOL score at P75-P100 in the test group was 0.33 times that in the control group (95％ CI:0.17-0.65,P ＜ 0.01).No significant difference in the incidence of adverse events was observed between the two groups (P ＞ 0.05).Conclusion Maintenance treatment with the emollient containing Prinsepia utilis Royle oil extracts and other extracts can markedly reduce the recurrence risk in AD children,improve clinical symptoms,and enhance the quality of life.
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Objective To evaluate the efficacy and safety of desonide 0.05％ cream in the treatment of mild to moderate infantile atopic dermatitis (AD).Methods A multicenter,randomized,openlabeled,active-controlled clinical trial was conducted.A total of 120 infants with AD were enrolled from Department of Dermatology,Beijing Children's Hospital,Capital Medical University,Children's Hospital of Chongqing Medical University and Children's Hospital of Fudan University between December 2016 and November 2017.These patients were randomly divided into 2 groups to be topically treated with desonide 0.05％ cream (test group,n =61) and hydrocortisone butyrate 0.1％ cream (control group,n =59),respectively.After the treatment for 1,2 and 3 weeks,the response rate,improvement of eczema area and severity index (EASI) and infants' dermatitis quality of life (IDQOL) were evaluated,and adverse events and reactions were recorded.Statistical analysis was carried out with SAS 9.4 software using confidence interval method and non-inferiority test for the comparison of response rates between the test group and control group,two-sample t test for the comparison of quantitative data between two groups,paired t test for comparing pre-and post-treatment EASI scores and IDQOL scores.If the data were not normally distributed or there was heterogeneity of variance,Wilcoxon rank sum test was used for the comparisons of pre-and posttreatment EASI scores and IDQOL scores before and after the treatment,and chi-square test was used for the comparison of unordered categorical data between the test group and control group.Results At weeks 1,2and 3 after the initial treatment,analysis of the full analysis set (FAS) showed that 46 (86.79％),49(92.45％) and 51 (96.23％) patients in the test group received improvement respectively,and 36 (83.72％),35 (81.40％) and 41 (95.35％) in the control group received improvement respectively.The non-inferiority test showed that the response rate in the test group was non-inferior to that in the control group (non-inferiority boundary value was-0.15).At the baseline,1,2 and 3 weeks,the EASI scores in the test group were 4.57 ± 3.19,0.72 ± 0.89,0.45 ± 0.87 and 0.18 ± 0.40 respectively,and the EASI scores in control group were 4.50 ± 3.29,1.03 ± 1.81,0.62 ± 0.85 and 0.28 ± 0.82 respectively.Paired Wilcoxon rank sum test showed that the EASI scores in the test group and control group significantly decreased after the treatment for 1,2 and 3 weeks compared with those at the baseline (the test group:T =-715.5,-9.4,-715.5,respectively,all P ＜ 0.001;the control group:T =-437.5,-473.0,-472.0,respectively,all P ＜0.001).However,Wilcoxon rank sum test revealed that there was no significant difference in the EASI scores between the two groups at any of the above time points (P ＞ 0.05).Paired Wilcoxon rank sum test showed that IDQOL scores in the test group significantly decreased at the above time points after the treatment compared with those at the baseline (all P ＜ 0.001),while Wilcoxon rank sum test revealed that there was no significant difference in the IDQOL score between the test group and control group (all P ＞0.05).Adverse reactions were observed in 12 (19.7％) patients in the test group,and 10 (16.9％) in the control group,and there was no significant difference in the adverse reactions between the two groups (x2 =0.029,P ＞ 0.05).Conclusion The efficacy of desonide 0.05％ cream in the treatment of mild to moderate infantile AD is equivalent to that of hydrocortisone butyrate 0.1％ cream,so desonide 0.05％ cream can be a treatment option for mild to moderate infantile AD.
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Objective To evaluate the efficacy and safety of Chushizhiyang ointment for the treatment of mild atopic dermatitis in infants.Methods A multicenter,randomized,open,active-controlled clinical trial was conducted.A total of 204 infants with atopic dermatitis were enrolled and randomly divided into 2 groups to be topically treated with Chushizhiyang ointment (test group,n =103) and hydrocortisone butyrate cream (control group,n =101),respectively,for 2 weeks.The improvement of eczema area and severity index (EASI) scores and quality of life was evaluated at 7 days and 14 days after the treatment,so was the incidence of adverse events and adverse reactions.Results Ninety-eight infants in the test group and 101 in the control group were included in the full analysis set,which revealed that the disease severity significantly decreased after the treatment in both groups.The EASI scores at the baseline and on days 7 and 14 were 2.47 ± 4.04,0.92 ± 1.25 and 0.39 ± 1.04 respectively in the test group,as well as 2.13 ± 2.01,0.85 ± 1.58 and 0.45 ± 1.65 respectively in the control group.Furthermore,the test group and control group both showed that EASI scores on days 7 and 14 significantly decreased compared with those at the baseline (the test group:T =-1 666,-1 793,respectively,both P ＜ 0.001;the control group:T =-1 951,-1 941,respectively,both P ＜ 0.001).No significant differences in EASI scores at the baseline or on days 7 and 14 were observed between the test group and control group (all P ＞ 0.05).The response rates in the test group and control group were 47.96％ (47/98) and 55.44％ (56/101) respectively on day 7,as well as 79.59％ (78/98) and 84.16％ (85/101) respectively on day 14,and there were also no significant differences between the two groups (both P ＞ 0.05).The adverse reactions mainly manifested as erythema,itching and scaling in the test group,as well as hypopigmentation,telangiectasia,scaling and hyperpigmentation in the control group.No significant difference in the incidence of adverse events was found between the test group (2.9％,3/103) and control group (6.9％,7/101).Conclusion Chushizhiyang ointment shows definite efficacy for mild atopic dermatitis in infants with good safety and tolerability,and can be a teatment option for mild atopic dermatitis in infants.