Dermatitis Quality Of Life Research Articles

329 Efficacy and safety of dupilumab treatment with concomitant topical corticosteroids in children aged 6 months to 5 years with severe atopic dermatitis

Abstract There are limited approved systemic treatment options for children with atopic dermatitis (AD). Dupilumab is now approved in the United States for patients 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies. European Medicines Agency is evaluating the use of dupilumab in children aged 6 months through 5 years with severe AD only. To report the efficacy and safety of dupilumab in the subgroup of children aged 6 months to 5 years with severe AD (IGA score = 4) at baseline in the LIBERTY AD PRESCHOOL trial (NCT03346434 part B). Patients aged 6 months to 5 years with inadequately controlled moderate-to-severe AD were enrolled in LIBERTY AD PRESCHOOL (part B), a randomized, double-blind placebo-controlled phase 3 study. Patients were randomized to either dupilumab 200/300 mg every 4 weeks (200 mg if baseline weight 5 to <15 kg, 300 mg if 15 to <30 kg) or placebo for 16 weeks. All patients initiated standardized treatment with low-potency topical corticosteroids (TCS) from day –14. This analysis reports efficacy and quality-of-life endpoints including a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75), Peak-Pruritus Numerical Rating Scale (PP-NRS), Children’s Dermatology Life Quality Index (CDLQI, for children aged 4 to <6 years), and Infant’s Dermatitis Quality Of Life (IDQOL, for children <4 years) in children with severe AD. Of the total trial population of 162 patients with moderate-to-severe AD, 125 patients with severe AD at baseline were randomized: 63 to the dupilumab + TCS treatment group and 62 to the placebo + TCS treatment group. Baseline demographics were similar. Mean (SD) baseline disease characteristics were also similar between the dupilumab and placebo groups: EASI (38.8 [13.7] vs. 35.4 [12]), body surface area (63.1% [21] vs. 58.9% [21.4]), weekly average PP-NRS (7.6 [1.4] vs. 7.6 [1.6]), CDLQI (17.5 [5.5] vs. 17.8 [6.4]) and IDQOL (18.4 [5.1] vs. 17.4 [5.4]). Dupilumab treatment resulted in a rapid and significant increase in the proportion of patients achieving EASI-75 compared with placebo treatment by week 4 (27% vs. 4.8%; P = 0.0009). By week 16, this improvement was further increased compared with the placebo group (46% vs. 7%; P < 0.0001). At week 16, dupilumab-treated patients had a significantly greater percent reduction from baseline in PP-NRS compared with the placebo group (LS mean (SE)–41.8 [5.4] vs. 0.5 [5.4]; P < 0.0001). Dupilumab also resulted in significant improvement in quality-of-life outcomes compared with placebo (LS mean [SE]) change from baseline to week 16 in CDLQI (−9.1 [1.1] vs. −2.6 [1.2]; P < 0.0001); IDQOL (−9.1 [1.3] vs. −0.6 [1.1]; P < 0.0001). Treatment-emergent adverse events (TEAEs) were reported in 42 (66.7%) patients in the dupilumab group and 45 (73.8%) patients in the placebo group. Most TEAEs were mild to moderate and deemed unrelated to the study drug by the investigator. The most common TEAE was atopic dermatitis in both the dupilumab group (10 [15.9%]) and placebo group (16 [26.2%]). Additionally, TEAEs in the conjunctivitis cluster were reported by 4 (6.4%) patients in the dupilumab group and none in the placebo group. In the placebo group, 3 (4.9%) serious adverse events were reported. No dupilumab-related adverse events were serious or led to treatment discontinuation. Dupilumab significantly improved AD signs, symptoms, and quality of life in children aged 6 months to 5 years with severe AD. The safety profile was consistent with that previously seen in adults, adolescents, and children aged > 6 years of age.

The risk factors for food allergy in infants with atopic dermatitis.

There is a lack of information about which risk factors accompany food allergy (FA) in infants with atopic dermatitis (AD). We hypothesized that we would be able to predict FA through risk factors in infants with AD. This prospective descriptive cross-sectional study was performed with infants aged 1-12 months with newly diagnosed AD. The SCORing Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI), Infants` Dermatitis Quality Of Life (IDQOL), and Family Dermatological Life Quality (FDLQ) index scores were calculated at first admission. We developed a new tool, Sites of Eczema (SoE), to score sites of eczema on the body. A total of 279 infants with AD were included. FA was found in 166 (59.5%) infants with AD, of whom 112 had single and 54 had multiple FAs. The SCORAD index, EASI scores, IDQOL1, IDQOL2, and FDQL, and SoE scores were higher in the subgroup with FA compared to that without FA (p < 0.001). In the multivariate regression model, eosinophil count (odds ratio [OR]=1.00, 95% confidence interval: [CI, 1.00-1.00]; p=0.008), serum total IgE level (OR=1.02, 95% CI: [1.00-1.03]; p=0.002), pruritus score (OR=0.87, 95% CI: [0.77-0.97]; p=0.019), SCORAD index (OR=1.04, 95% CI: [1.01-1.08]; p=0.008), FDQL index (OR=1.09, 95% CI: [1.01-1.18]; p=0.014), and SoE score (OR=1.48, 95% CI: [1.00-2.19]; p=0.046) were identified as the highest risk factors for FA in infants with AD. Serum total IgE levels, eosinophil counts and ratio, SCORAD index and EASI scores, IDQOL and FDLQ index, pruritus and sleep disturbance scores, and SoE scores were identified as risk factors for FA in infants with AD in this study. The SoE score is an important risk factor for FA in infants with AD. We recommend that the risk factors for FA in patients with AD guide the management of these patients.

Health utility estimation in children and adolescents: a review of health technology assessments

Objective: Health utility estimates for children and adolescents are critical for cost–utility analyses informing health technology assessment (HTA) authorities’ decisions governing access to pediatric treatments. However, in a recent review, only 29% of published pediatric cost–utility models used a utility measure validated for children. We examined utility estimates used in pediatric HTAs.Methods: A targeted review of pediatric HTAs was performed, focusing on agencies reporting utility estimate sources and methods.Results: Searches identified 11 HTAs in pediatric indications and five in mixed populations with separate analyses for adults and children. Among 13 appraisals reporting methodological detail, five used pediatric utility estimates (based on the Health Utilities Index [HUI], n = 3; Atopic Dermatitis Quality of Life [ADQoL], n = 1; or mapping, n = 1). Issues were identified with mapping, use of adult data for some health states, and assumptions about ADQoL responses. In the remaining eight appraisals, adult utility estimates were applied. Caregiver utility was included in two of 16 appraisals.Conclusions: Only 38% of pediatric HTAs reviewed used pediatric utility estimates, and HTA authorities raised concerns about these data in many cases; only 12% of HTAs included caregiver utility. Although several preference-based utility measures are available for pediatric populations, limited data and guidance on selection of measures are available. When estimating pediatric utility weights, alternative measures should be reviewed for suitability given the model population and health condition. Pediatric and adult utility estimates should be applied appropriately as patients age over time, and caregiver and/or family member utility should be included, where relevant. Gaps exist in utility measures for children aged <4 years and caregivers.

The role of thymus and activation-regulated chemokine as a marker of severity of atopic dermatitis

The role of thymus and activation-regulated chemokine as a marker of severity of atopic dermatitis

Validity and reliability of Persian version of infants’ dermatitis quality of life index (IDQOL) questionnaire

Background: Atopic dermatitis is the most common inflammatory skin disease in children. Severe itching may lead to an impaired quality of life in the patients. In this study, we evaluated the validity and reliability of Persian version of a questionnaire regarding the infants’ dermatitis quality of life in children suffering from atopic dermatitis.Methods: When the original authors approved of the Persian version of the questionnaire, the parents completed the questionnaire for their 98 children with atopic dermatitis aged less than four years. We analyzed the data by SPSS 16. Cronbach’s alpha and inter-item and calculated the correlations to evaluate the reliability and validity via Kaiser criterion and scree plot.Results: The calculated mean score of questionnaire was 9.65±5.41. The first (itching and scratching) and eight questions (treatment problems) obtained the highest and lowest scores, respectively. There was a strong, positive correlation between the severity of the disease and the quality of life score in the patients. Cronbach’s alpha was calculated as 0.88 which is a sign of good internal consistency of the items. The inter-item correlative coefficients varied between -0.004 to 0.87. We used Kaiser’s criterion and scree plot to evaluate the validity and achieve a two-factor solution.Conclusion: Persian version of infants’ dermatitis quality of life index questionnaire was valid and reliable.

地奈德乳膏与丁酸氢化可的松乳膏治疗婴幼儿特应性皮炎的多中心、随机、平行对照临床研究

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, open-labeled, 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 post-treatment 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, 2 and 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 0.05) . 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 0.05) . 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 (χ2= 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. Key words: Dermatitis, atopic; Desonide; Hydrocortisone; Multicenter study; Randomized controlled trial; Infant

Gender differences in health‐related and family quality of life in young children with atopic dermatitis

Atopic dermatitis (AD) has an established impact on health-related quality of life (HRQoL) and family QoL. This study was designed to investigate gender differences in health-related and family QoL in children with AD. Cohorts of 25 girls and 25 boys with AD aged <4years were selected from 102 children with AD. Children in the girls' and boys' groups were individually matched across groups for age and severity of AD according to their scores on the SCORAD Index (SCORing of Atopic Dermatitis). The children's parents filled in the Infants' Dermatitis Quality of Life (IDQoL) Index and the Dermatitis Family Impact (DFI) questionnaires. The impact of AD on QoL (P<0.05) and family QoL (P<0.05) was more severe in girls. The severity of AD as assessed by the parents was equal in both groups. More parents of girls reported that AD impacted on the "child's mood" (P<0.05) and "enjoying family activity" (P<0.05). "Child's mood" and "sleep disturbance" were highly scored by parents of girls (P=0.01 and P<0.05, respectively). Severity of AD as assessed by parents and IDQoL Index scores correlated with SCORAD scores in both groups. Scores on the DFI correlated with patient age in boys. The child's age correlated with the emotional distress of parents in both groups and had an impact on "relationships in the family" in girls only. Several DFI items and overall family QoL correlated with patient age in boys. The impact of AD on QoL and family QoL was more severe for girls. Relationships between parents progressively worsen with patient age in girls. Reported gender differences should be further investigated and may influence educational programs and advice given to parents of children with AD.