Smartphone-Based Digital Eczema Education Program for Atopic Dermatitis in Children Aged 0 to 6 Years: Multicenter, Randomized, Parallel Controlled Clinical Study

To assess the reliability, validity and responsiveness of the Chinese version of the atopic dermatitis control tool (ADCT). After this study obtained authorization for the Chinese version of the ADCT scale. 114 patients with atopic dermatitis were enrolled from the Department of Dermatology, Peking University First Hospital using convenience sampling from October 2022. Patients were surveyed using the General Information Questionnaire, Chinese version of ADCT, patient-oriented eczema measure (POEM),peak pruritus numerical rating scale (PP-NRS),dermatology life quality index (DLQI) and the global patient self-assessment for disease severity. Mann-Whitney rank sum test and Spearman correlation analysis were used for item analysis; content validity was assessed using content validity index (CVI); exploratory factor analysis was used to assess structural validity; Cronbach' alpha coefficient was used to assess internal consistency; Spearman correlation analysis was used to assess the correlation of ADCT with other scales to assess external responsiveness. The results showed that all items were retained by item analysis. I-CVI was 0.9-1, and S-CVI/Average was 0.983; the scale extracted one common factor by factor analysis, the cumulative variance explanation rate was 77.927%; the Cronbach' alpha coefficient of the scale was 0.937; the correlation coefficients of the Chinese version of ADCT with POEM, PP-NRS, and DLQI were 0.805, 0.861, and 0.709 respectively. In conclusion, the Chinese version of the ADCT has adequate reliability, validity and responsiveness, and is suitable for measuring disease control in Chinese patients with atopic dermatitis.

33553 Real-world treatment patterns and outcomes up to 1 year among children aged <12 years with moderate-to-severe atopic dermatitis (AD) enrolled in the PEDIatric STudy in Atopic Dermatitis (PEDISTAD) observational study

Disease characteristics, comorbidities, treatment patterns and quality of life impact in children <12 years old with atopic dermatitis: Interim results from the PEDISTAD Real-World Registry

Among biological agents for the treatment of atopic dermatitis (AD), dupilumab is a front-runner. Although many studies have been conducted on the real-world use of dupilumab, the sample size is often small and data is primarily on Western people. Therefore, we investigated the efficacy and safety of dupilumab in patients with moderate-to-severe AD in Korea. All patients with moderate-to-severe AD treated with dupilumab from September 2018 to June 2019 in this institution were included and analyzed by medical records. They were evaluated using the Eczema Area and Severity Index (EASI), Numerical Rating Scale (NRS), Patient Oriented Eczema Measure (POEM), and Dermatology Quality of Life Index (DLQI), respectively on admission, after two weeks (only EASI and NRS) and after 16 weeks. Laboratory tests were measured before and 16 weeks after treatment. A total of 101 patients were included. All efficacy tools showed a significant decrease after 16 weeks; EASI 77.4%, NRS 70.0%, POEM 60.7%, and DLQI 65.0%. EASI was characterized by a marked improvement of 51.5% in just two weeks. The treatment response was not significantly different according to the interval of treatment. Elevated Lactate Dehydrogenase (LDH) at 16 weeks was associated with poor treatment response. Moreover, a high eosinophil count was related to a lower change in EASI and POEM. In the correlation analysis, EASI was not correlated to DLQI before treatment. For changes after 16 weeks, POEM showed the highest correlation with DLQI. (R = 0.66, p < 0.001) In the additional analysis for factors affecting treatment response, the female gender was associated with good treatment response. (odds ratio = 5.4, p = 0.04) Adverse events from treatment included facial erythema (9.9%) and conjunctivitis (5.0%). Overall, it was confirmed that the efficacy of dupilumab in the real-world is similar to that of the existing clinical trials. We suggest that POEM is a useful tool for identifying the quality of life. The female gender was associated with a good treatment response. Both an elevated LDH and a high eosinophil count could be a therapeutic biomarker. Further research will be needed for a long-term period.

The prevalence of atopic dermatitis has substantially increased in recent decades, and atopic dermatitis could lead to allergic airway inflammation later in life. A previous study found that inorganic arsenic exposure was associated with allergic airway inflammation in children aged 8 to 14 years. However, the association between prenatal exposure to arsenic and other metals and the risk of atopic dermatitis among young children remains unknown. To assess the association between prenatal exposure to arsenic and other metals and the occurrence of atopic dermatitis in children at age 4 years. In total, 1152 pregnant women were enrolled in the original Taiwan Maternal and Infant Cohort Study (TMICS), a multicenter birth cohort study conducted at 9 hospitals in northern, central, southern, and eastern Taiwan from October 2012 to May 2015. Of those, 586 mothers and children aged 4 years participated in follow-up questionnaire interviews from August 2016 to January 2019. After excluding 216 participants with missing data, the final statistical analysis of follow-up data included 370 mother and child pairs from the central and eastern regions of Taiwan. Data were analyzed from February 2 to August 12, 2021. Arsenic, cadmium, lead, cobalt, copper, nickel, thallium, and zinc during pregnancy. The outcome was parent-reported atopic dermatitis history among children aged 4 years. The presence of atopic dermatitis was defined as a positive response to the question, "Has your child ever had atopic dermatitis diagnosed by a physician?" During the initial TMICS study period, concentrations of arsenic, cadmium, lead, cobalt, copper, nickel, thallium, and zinc were measured in maternal urine during the third trimester of pregnancy using an inductively coupled plasma mass spectrometer. Estimated total inorganic arsenic exposure was calculated using a model that included data on both total arsenic and arsenic species (arsenite, arsenate, monomethylarsonate, and dimethylarsenate) obtained from a previous TMICS cohort. Among 370 children included in the analysis, the mean (SD) age was 3.94 (0.59) years; 208 children (56.2%) were male, and 267 children (72.2%) were from the central region of Taiwan. A total of 110 children (29.7%) had atopic dermatitis at age 4 years. Maternal estimated total inorganic arsenic exposure during pregnancy was associated with increased odds of atopic dermatitis among children at age 4 years (odds ratio [OR], 2.42 [95% CI, 1.33-4.39] for every doubled increase of total inorganic arsenic) after adjusting for parental allergies, child's sex, geographic area, maternal educational level, and exposure to tobacco smoke. Every increased unit in the weighted quantile sum index of maternal metal exposure was significantly associated with atopic dermatitis (OR, 1.63; 95% CI, 1.28-2.07). Arsenic (40.1%) and cadmium (20.5%) accounted for most of the metal mixture index. This cohort study found that prenatal exposure to inorganic arsenic and coexposure to inorganic arsenic and cadmium were associated with a higher risk of atopic dermatitis in young children. These findings suggest that prevention of exposure to inorganic arsenic and cadmium during pregnancy may be helpful for the control of atopic dermatitis and other potential allergies in children.

Introduction/Background Atopic dermatitis (AD) is a chronic heterogeneous inflammatory disease characterized by recurrent eczematous lesions. Amlitelimab is a fully human, nondepleting, anti-OX40 Ligand (OX40L) monoclonal antibody that blocks upstream OX40L signaling. Here, clinical outcome assessments (COAs) from the 24-week treatment period (Part 1) and 28-week amlitelimab maintenance/withdrawal period (Part 2) of the phase 2b STREAM-AD trial in adults with moderate-to-severe AD are presented. Objectives Evaluate maintenance of COAs response, including SCORing of Atopic Dermatitis (SCORAD), Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and Atopic Dermatitis Control Tool (ADCT), in participants achieving ≥75% improvement in EASI from baseline (EASI-75) and/or an Investigator Global Assessment (IGA) score of clear/almost clear (IGA 0/1) at Week 24 in STREAM-AD. Methods STREAM-AD (NCT05131477), a randomized, double-blind, placebo-controlled, phase 2b trial, included a 24-week treatment period (Part 1), a 28-week maintenance/withdrawal period (Part 2), and a 16-week safety follow-up. In Part 1, adult participants with moderate-to-severe AD were randomized 1:1:1:1:1 to subcutaneous amlitelimab every 4 weeks (Q4W; 250 mg with 500 mg loading dose [250 mg +LD], n=77; 250 mg, n=78; 125 mg, n=77; 62.5 mg, n=79) or placebo Q4W (n=79). The primary endpoint was percent change in EASI from baseline at Week 16. Of 390 participants enrolled in Part 1, 190 entered Part 2. Participants on amlitelimab achieving EASI-75 and/or IGA 0/1 at Week 24 were rerandomized 3:1 to withdraw or continue their pre-Week 24 amlitelimab dose (250 mg +LD, n=34 [withdrawal]/n=13 [continuing]; 250 mg, n=28/n=12; 125 mg, n=33/n=12; 62.5 mg, n=35/n=7); participants achieving EASI-75 and/or IGA 0/1 on placebo continued placebo, (n=16). Participants were followed to Week 52 to evaluate maintenance of clinical responses. COAs, including SCORAD, POEM, DLQI, and ADCT, were recorded at various timepoints during the study period. ‘Responders’ for each of these COAs were defined as: SCORAD reduction from baseline ≥8.7 with baseline ≥8.7; POEM total score reduction from baseline ≥4 with baseline ≥4; DLQI reduction from baseline ≥4 with baseline ≥4; ADCT &amp;lt;7. In this post hoc responder analysis, differences between continued and withdrawn amlitelimab groups were analyzed using the Cochran-Mantel-Haenszel test stratified by baseline region and disease severity (EASI ≤21, EASI &amp;gt;21). Data collected after early treatment discontinuation due to reasons other than lack of efficacy prior to Week 24 or 52 were included for those visits. Data collected after the use of rescue/prohibited medication or treatment discontinuation due to lack of efficacy were set to missing and imputed using a worst-observation-carried-forward (WOCF) approach. Patients who discontinued treatment due to lack of efficacy or received rescue/prohibited medications were considered as non-responders. Patients with missing data were considered as non-responders. Results Of the participants who achieved EASI-75 and/or IGA 0/1 at Week 24 and were rerandomized to continue amlitelimab in Part 2 (pooled, n=44), 93.2%, 81.8%, 86.4%, and 70.5% were SCORAD, POEM, DLQI, and ADCT responders at Week 24, respectively. Of these Week 24 responders who continued on amlitelimab, 82.9%, 83.3%, 86.8%, and 77.4% maintained responses at Week 52, respectively. Of the participants who met EASI-75 and/or IGA 0/1 at Week 24 and were rerandomized to withdraw from amlitelimab in Part 2 (pooled, n=130), 84.6%, 73.8%, 71.5%, and 53.8% were SCORAD, POEM, DLQI, and ADCT responders at Week 24, respectively. Of these Week 24 responders who were withdrawn from amlitelimab, 79.1%, 71.9%, 68.8%, and 72.9% maintained responses at Week 52, respectively. Conclusions In the STREAM-AD trial, COA responses were achieved by the majority of participants who achieved EASI-75 and/or IGA 0/1 at Week 24 and were re-randomized in Part 2. High maintenance of durable responses was observed at Week 52 in patients continuing and withdrawn from amlitelimab.

Introduction: Tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) is a non-steroidal, topical aryl hydrocarbon receptor agonist approved for the treatment of plaque psoriasis in adults with no restrictions on location, extent, or duration of use. In the phase 3 PSOARING trial program, tapinarof cream 1% once daily (QD) for the treatment of plaque psoriasis was efficacious and well tolerated. Plaque psoriasis affecting the head and neck region occurs commonly, with a high impact on patients’ health-related quality of life, through pruritus and psychological distress. Patients may consider topicals unacceptable for scalp/facial use due to poor cosmetic properties (e.g., greasiness), leading to low medication adherence. There is a need for efficacious, cosmetically elegant, non-steroidal topicals that can be used without restrictions.Objective: To assess patient-reported outcomes (PROs) with tapinarof cream for adults with mild to severe plaque psoriasis in the head and neck region, including the scalp, in a phase 4, open-label trial.Methods: Adults with head and neck region target lesion Physician Global Assessment (tPGA) score of 2 (mild), 3 (moderate), or 4 (severe) received tapinarof for 12 weeks. PROs included Peak Pruritus Numerical Rating Scale (PP-NRS) score for the head and neck region; achievement of ≥4-point reduction in PP-NRS score; Dermatology Life Quality Index (DLQI) score by visit; and responses to a Patient Satisfaction Questionnaire© (PSQ) at Week 12.Results: 31 patients received tapinarof; 58.1% (18/31) had the target lesion on the scalp. Baseline mean PP-NRS (head and neck region) and total DLQI scores were 5.8 and 9.7, respectively, demonstrating significant pruritus and disease impact. Improvement in mean PP-NRS score was demonstrated at Week 1 (–1.6), the earliest assessment, surpassing the minimal clinically important ≥4-point improvement by Week 12 (−4.2). At Week 12, 70.0% (n=14/20) achieved ≥4-point reduction in PP-NRS score. Mean DLQI minimal clinically important difference of −4.0 was demonstrated as early as Week 1 (−4.0), improving to −7.2 at Week 12. Most patients strongly agreed or agreed with PSQ questions assessing satisfaction with cosmetic elegance (93.3%), quick absorption (96.7%), application ease (86.7%), efficacy (83.3%), and confidence in tapinarof (83.3%). Compared with topicals used previously for plaque psoriasis, most strongly agreed or agreed that tapinarof was more effective (76.9%) and easier to use (76.9%).Conclusions: In patients with plaque psoriasis affecting the head and neck region, tapinarof cream 1% QD demonstrated rapid and clinically meaningful improvements in patient-reported pruritus and disease impact as early as Week 1, the first assessment, with continued improvement through Week 12. Patients reported high rates of satisfaction and positive perceptions of tapinarof.Funding Support: Dermavant Sciences, Inc.

Atopic dermatitis is a widespread problem, and its treatment is a complicated problem for clinicians. The efficacy, safety, cost and complexity of therapeutic measures are the Key components for treatment compliance and ultimately define the success of treatment. The article presents the results of a prospective open-label study of the clinical efficacy of the application of mometasone furoate (Elocom) for atopic dermatitis in children with the exudative and erythematous squamous forms with initial signs of lichenification and its effect on the IDLQI (Infant's Dermatological Life Quality Index). It was established that the application of Elocom vs. the hydrocortisone cream and ointment (in case of the exudative form) contributed to the faster reduction of the intensity of clinical manifestations of atopic dermatitis.

Atopic dermatitis is a chronic inflammatory skin disease significantly affecting patients' and their parents' lives. Mothers are mostly responsible for the long-term treatment and their wellbeing is essential. The major objective of this cross-sectional study was to investigate the relationship between atopic dermatitis in children, especially concomitant itch, and the quality of life, stress, sleep quality, anxiety, and depression of their mothers. The study included 88 mothers of children with atopic dermatitis and 52 mothers of children without atopic dermatitis. All mothers completed sociodemographic questionnaire, the Perceived Stress Scale, the Athens Insomnia Scale and the Hospital Anxiety and Depression Scale. Additionally, mothers of children with atopic dermatitis filled in the Family Dermatology Life Quality Index. The severity of atopic dermatitis and pruritus intensity were evaluated by the Scoring Atopic Dermatitis Index and the Numerical Rating Scale, respectively. The severity of atopic dermatitis and itch significantly correlated with the quality of life, insomnia, and perceived stress of the mothers. Mothers whose children had had atopic dermatitis for more than 6 months had significantly higher scores of anxiety and depression. The results highlight the importance of screening mothers for functional impairment to provide adequate support. More attention should be directed to the standardization of stepped care interventions addressing factors resulting in the impaired functioning of mothers.

Emerging treatments for moderate-to-severe atopic dermatitis (AD) may provide greater and faster improvement in AD signs and symptoms than current therapies. To examine JADE COMPARE (NCT03720470) data using stringent efficacy end points. Adults with moderate-to-severe AD were randomly assigned 2:2:2:1 to receive oral abrocitinib 200 or 100 mg once daily, subcutaneous dupilumab 300 mg every 2 weeks (600-mg loading dose), or placebo, with medicated topical therapy for 16 weeks. Stringent response thresholds were applied for Eczema Area and Severity Index (EASI), Investigator's Global Assessment, Dermatology Life Quality Index, Peak Pruritus Numerical Rating Scale, and Night Time Itch Scale severity. At week 16, 48.9%, 38.0%, and 38.8% of the abrocitinib 200-mg, 100-mg, and dupilumab groups, respectively, achieved greater than or equal to 90% improvement from baseline in EASI versus 11.3% placebo; 14.9%, 12.6%, and 6.5% achieved Investigator's Global Assessment 0 (clear) versus 4.8% placebo; 29.7%, 21.6%, and 24.0% achieved Dermatology Life Quality Index 0/1 (no/minimal impact on quality of life) versus 10.6% placebo; and 57.1%, 44.5%, and 46.1% achieved Night Time Itch Scale severity 0/1 (no/minimal night-time itch) versus 31.9% placebo. Kaplan-Meier median time to greater than or equal to 90% improvement from baseline in EASI was 59, 113, and 114 days in the abrocitinib 200-mg, 100-mg, and dupilumab groups, respectively, and was not evaluable for placebo; median time to Peak Pruritus Numerical Rating Scale 0/1 (no/very minimal itch) was 86 and 116 days for abrocitinib 200-mg and dupilumab groups, respectively, and was not evaluable for abrocitinib 100-mg and placebo groups. A greater proportion of patients treated with abrocitinib than placebo had almost complete control of AD signs and symptoms.

The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set for atopic dermatitis (AD) clinical trials, including four core outcome domains: clinician-reported signs, patient-reported symptoms, eczema control and quality of life. For eczema control, the Atopic Dermatitis Control Tool (ADCT) and the Recap of Atopic Eczema (RECAP) were chosen through consensus methods as equivalent instruments. This study aimed to develop equations to map scores between ADCT and RECAP to facilitate inter-measurement comparison and data synthesis. Patients with AD completed the HOME core outcome set of instruments, including ADCT, RECAP, Dermatology Life Quality Index series, Peak Pruritus Numerical Rating Scale and Patient-Oriented Eczema Measure, during routine clinic visits. Clinicians assessed disease severity using the Investigator Global Assessment x Body Surface Area measure. Among 50 participants, ADCT and RECAP were strongly correlated (Pearson's correlation coefficient, r = 0.970). Four mapping models were evaluated: simple linear regression (SLR), SLR without intercept, square root transformation (SRT) and SRT without intercept. While the SRT no intercept model had the lowest root mean square error, it produced nonlinear confidence intervals and risked overfitting. The SLR no intercept model, with high predictive accuracy (R2 = 0.971) and interpretability, was selected as the primary approach. Two equations were derived to convert scores between ADCT and RECAP, enabling standardized comparisons. This study provides two equations for mapping between ADCT and RECAP, strengthening the HOME outcome measurement set and synthesizing the two measures for clinical and research purposes. Validation with larger, independent cohorts is warranted to confirm these findings.

Childhood atopic dermatitis (AD) is a chronic inflammatory disease associated with pruritus and sleep loss. It is important to evaluate quality-of-life (QoL) impairment objectively in atopic diseases in children. To investigate the utility of the Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) in children with eczema. PADQLQ, Patient-Oriented Eczema Measure (POEM, a short-term subjective symptom score), Nottingham Eczema Severity Score (NESS, a long-term subjective symptom score) and Children's Dermatology Life Quality Index (CDLQI, a short-term subjective symptom score) were compared and correlations evaluated. PADQLQ, POEM, NESS and CDLQI correlated well with each other (n = 132 sets; Spearman correlations: rho = 0·48-0·70, P < 0·001). A Bland-Altman plot showed a reasonably good agreement between CDLQI and PADQLQ. PADQLQ showed that symptoms of asthma, allergic conjunctivitis and allergic rhinitis were present in 20-30%, 45-71% and 58-67% of children with AD, respectively. Nevertheless, there was no association of eczema symptomatology by POEM or NESS with the severity of other allergic diseases. PADQLQ correlates well with AD-specific severity and QoL scores and reflects all allergic symptoms that holistically influence QoL in children with AD. PADQLQ is hence a composite severity score in terms of clinical symptomatology and QoL impairment for AD.

IntroductionAllergic comorbidities are common in patients with atopic dermatitis (AD). Individual trials with abrocitinib or dupilumab demonstrated efficacy and safety in patients with moderate-to-severe AD and allergic comorbidities. This post hoc analysis of the phase 3 JADE COMPARE and DARE trials compared efficacy, safety, and quality of life following abrocitinib and dupilumab treatment in adults with moderate-to-severe AD, with or without comorbid asthma, allergic rhinitis, or food allergy.MethodsData were pooled from patients who received abrocitinib (200 mg/day) or dupilumab (300 mg/every 2 weeks) for 16 weeks with concomitant topical therapy. Assessments by self-reported asthma, allergic rhinitis, or food allergy included the proportion of patients achieving Investigator’s Global Assessment of clear or almost clear (IGA 0/1), ≥ 75% improvement in Eczema Area and Severity Index (EASI-75), ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4), least squares mean change from baseline in Dermatology Life Quality Index (DLQI) and SCORing Atopic Dermatitis (SCORAD), and safety.ResultsOf 1195 patients (abrocitinib, n = 588; dupilumab, n = 607), 377 (32%), 225 (19%), and 211 (18%) patients self-reported comorbid asthma, food allergy, or allergic rhinitis, respectively. Week 16 IGA 0/1 responses were comparable between patients with/without comorbidity with abrocitinib (52%/54% [with/without asthma], 50%/54% [with/without allergic rhinitis], and 53%/53% [with/without food allergy]) or dupilumab (42%/42%, 37%/43%, and 47%/41%). EASI-75 and PP-NRS4 responses and DLQI and SCORAD improvements were also comparable between patients with/without comorbidity in each treatment arm. Treatment-emergent adverse events were more common in patients with comorbidities in the abrocitinib (76%/67% [with/without asthma], 80%/67% [with/without allergic rhinitis], and 78%/67% [with/without food allergy]) and dupilumab (71%/53%, 71%/57%, and 62%/59%) arms.ConclusionAbrocitinib and dupilumab improved AD signs and symptoms with a manageable safety profile in patients with moderate-to-severe AD, regardless of asthma, allergic rhinitis, or food allergy.Graphical available for this article.Trial RegistrationClinicalTrials.gov identifier, NCT03720470 (JADE COMPARE) and NCT04345367 (DARE).Graphical Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-025-01516-w.

Effect of Living Close to Major Roadways on the Development of Asthma and Atopic Dermatitis in Children: Longitudinal Analyses of the Childrenʼs Health and Environmental Research (CHEER)

The prevalence of atopic dermatitis (AD) in children has steadily increased over time, yet it remains largely unknown how maternal factors during pregnancy are associated with child AD. Few studies have specifically assessed the relationship between prenatal stress and child AD, with inconsistent findings. In this prospective cohort study following 426 mother-child dyads from pregnancy to middle childhood, women reported stressful life events (SLEs) experienced during the 12 months before delivery and AD outcomes in children aged approximately 4–6 years, including current, location-specific, and ever AD. We used Poisson regression to estimate risk ratios (RRs) and corresponding 95% confidence intervals (CIs) associated with a 1-unit increase in prenatal SLEs, adjusting for potential confounders. We also assessed whether the association between prenatal SLEs and child AD was modified by child sex, history of maternal atopy, or prenatal maternal resilient coping. The mean (standard deviation) of prenatal SLEs reported in the overall sample was 1.4 (1.6), with 37.1% of women reporting none. A 1-unit increase in prenatal SLEs was not significantly associated with current AD (RR: 1.08, 95% CI: 0.89, 1.31), location-specific AD (RR: 1.09, 95% CI: 0.78, 1.52), or ever AD (RR: 0.97, 95% CI: 0.87, 1.09). We did not find evidence of effect modification. Findings from this study suggest no association between prenatal SLEs and AD in middle childhood, although larger longitudinal studies with enhanced case definition and higher variability of SLE experience may more fully inform this question.