Patient-Oriented Eczema Measure Research Articles

Evaluation of measurement errors in the Patient-Oriented Eczema Measure (POEM) outcome.

The Patient-Oriented Eczema Measure (POEM) is the recommended core outcome instrument for atopic dermatitis (AD) symptoms. POEM is reported by recalling the presence/absence of seven symptoms in the last 7 days. To evaluate measurement errors in POEM recordings due to imperfect recall. Using data from a clinical trial of 247 AD patients aged 12-65 years, we analysed the reported POEM score (r-POEM) and the POEM derived from the corresponding daily scores for the same seven symptoms without weekly recall (d-POEM). We quantified recall error by comparing the r-POEM and d-POEM for 777 patient-weeks collected from 207 patients, and estimated two components of recall error: (1) recall bias due to systematic errors in measurements and (2) recall noise due to random errors in measurements, using a bespoke statistical model. POEM scores have a relatively low recall bias, but a high recall noise. Recall bias was estimated at 1.2 points lower for the r-POEM on average than the d-POEM, with a recall noise of 5.7 points. For example, a patient with a recall-free POEM of 11 (moderate) could report their POEM score anywhere from 5 to 14 (with 95% probability) because of recall error. Model estimates suggested that patients tend to recall itch and dryness more often than experienced (positive bias of less than 1 day), but less often for the other symptoms (bleeding, cracking, flaking, oozing/weeping and sleep disturbance; negative bias ranging 1-4 days). In this clinical trial data set, we found that patients tended to slightly underestimate their symptoms when reporting POEM, with significant variation in how well they were able to recall the frequency of their symptoms every time they reported POEM. A large recall noise should be taken into consideration when interpreting POEM scores.

Real-World Effectiveness of Dupilumab in Adult and Adolescent Patients with Atopic Dermatitis: 2-Year Interim Data from the PROSE Registry.

There is a scarcity of data beyond 1 year for the use of dupilumab to treat atopic dermatitis (AD) in a real-world setting. This study aimed to evaluate the 2-year effectiveness of dupilumab among adult and pediatric patients with moderate-to-severe AD included in a real-world, longitudinal database study. PROSE is an ongoing, prospective, observational, multi-center registry in the USA and Canada, designed to collect real-world data from patients aged ≥ 12years with moderate-to-severe AD who initiate dupilumab in accordance with country-specific prescribing information. Assessments include body surface area affected by AD (BSA), Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (P-NRS), Patient-Oriented Eczema Measure (POEM), Patient Global Assessment of Disease (PGAD) questionnaire score, and occurrence of adverse events (AEs). Of 764 patients who enrolled in PROSE, 632 (83%) remained in the study at the time of this interim analysis. Improvements were observed at the first post-baseline clinic visit (approximately 3months) in the clinician-assessed measures (mean BSA and EASI scores); improvements were sustained throughout the 2-year period covered in the present study. Consistent and sustained improvements were also observed over the 2-year period in the patient-reported measures of P-NRS, POEM, and DLQI, and in the proportion of patients reporting "very good/excellent" in answer to the question in the PGAD questionnaire: "Considering all the ways in which your eczema affects you, indicate how well you are doing". Dupilumab treatment was well tolerated, with safety findings consistent with those previously reported in studies of dupilumab for the treatment of AD. In the real-world PROSE registry, patients with moderate-to-severe AD experienced sustained improvement in disease control, symptoms, and quality of life up to 2years after initiating dupilumab treatment. Safety data were consistent with the known safety profile of dupilumab. ClinicalTrials.gov identifier: NCT03428646. Video abstract (MP4 20,717kb).

A Mobile Health App for Facilitating Disease Management in Children With Atopic Dermatitis: Feasibility and Impact Study.

Inadequate control of atopic dermatitis (AD) increases the frequency of exacerbations and reduces the quality of life. Mobile health apps provide information and communication technology and may increase treatment adherence and facilitate disease management at home. The mobile health app, Atopic App, designed for patients and their caregivers, and the associated web-based patient education program, Atopic School, provide an opportunity for improving patients' and caregivers' engagement and adherence to the management of AD. This noninterventional, observational study aimed to explore the feasibility and potential impact on the management of AD in children by caregivers using the Atopic App mobile health app. The patient-oriented eczema measure (POEM) and numerical rating scale for the grading of pruritus were used as severity scores (scale range: 0-28). The artificial intelligence model of the app was used to assess the severity of AD based on the eczema area and severity index approach. The deidentified data enabled the analysis of the severity of AD, treatment plan history, potential triggers of flare-ups, usage of available features of the app, and the impact of patient education. During a 12-month period, of the 1223 users who installed the app, 910 (74.4%) registered users were caregivers of children with AD. The web-based Atopic School course was accessed by 266 (29.2%) caregivers of children with AD, 134 (50.4%) of whom completed the course. Usage of the app was significantly more frequent among those who completed the Atopic School program than among those who did not access or did not complete the course (P<.001). Users who completed a second POEM 21 to 27 days apart exhibited a significant improvement of AD severity based on the POEM score (P<.001), with an average improvement of 3.86 (SD 6.85) points. The artificial intelligence severity score and itching score were highly correlated with the POEM score (r=0.35 and r=0.52, respectively). The Atopic App provides valuable real-world data on the epidemiology, severity dynamics, treatment patterns, and exacerbation-trigger correlations in patients with AD. The significant reduction in the POEM score among users of the Atopic App indicates a potential impact of this tool on health care engagement by caregivers of children with AD.

Burden of atopic dermatitis in paediatric patients: aninternational cross-sectional study.

Few large-scale international studies have broadly characterized the burden of atopic dermatitis (AD) across age groups among children and adolescents. To better characterize the AD burden in paediatric patients by disease severity. This cross-sectional, web-based survey of paediatric patients (6 months to < 18 years old) was conducted in 18 countries representing North America, Latin America, Europe, Middle East/Eurasia and East Asia. Patients with diagnosed AD were identified based on the International Study of Asthma and Allergies in Childhood criteria and self-/parent-report of ever being told by a physician that they or their child had eczema. AD severity was assessed using the Patient-Oriented Eczema Measure and Patient Global Assessment. Outcomes included measures of itch, skin pain, sleep, health-related quality of life (HRQoL), missed school days and atopic comorbidities. The survey included 1489 children aged 6 months to < 6 years; 2898 children aged 6 to < 12 years; and 3078 adolescents aged 12 to < 18 years diagnosed with AD. Although the burden of mild AD was substantial, paediatric patients with moderate or severe AD had more itch, skin pain, sleep problems and impaired HRQoL, and missed more school days relative to those with mild AD; greater burden was observed among those with severe relative to moderate AD. At least one atopic comorbidity was present in 92.5% of all respondents. These results highlight the burden of AD in paediatric patients, especially those with moderate-to-severe disease, and suggest the need for assessments that include the impact of AD on function and daily life.

Abrocitinib efficacy and safety in moderate-to-severe atopic dermatitis by race, ethnicity, and Fitzpatrick skin type

BackgroundResponse to abrocitinib treatment for moderate-to-severe atopic dermatitis (AD) has not been evaluated across racial and ethnic subpopulations. ObjectiveTo assess the efficacy and safety of abrocitinib on the basis of patient race, ethnicity, and Fitzpatrick skin type (FST). MethodsData were pooled post hoc from patients treated with abrocitinib 200 mg, 100 mg, or placebo in 3 monotherapy trials (NCT02780167, NCT03349060, and NCT03575871). Race and ethnicity were self-reported; FST was determined by study investigators. Evaluations through Week 12 include the following: (1) Investigator's Global Assessment of clear or almost-clear skin; (2) greater than or equal to 75% improvement in Eczema Area and Severity Index or SCORing AD; (3) a greater-than-or-equal-to 4-point improvement in Peak Pruritus Numerical Rating Scale score; (4) least squares mean changes in Dermatology Life Quality Index and Patient-Oriented Eczema Measure scores; and (5) treatment-emergent adverse events. ResultsThe sample comprised 628 White, 204 Asian, and 83 Black patients; 37 were Hispanic or Latino; 624 had FST I to III and 320 had FST IV to VI. Treatment with either abrocitinib dose was associated with greater proportions of patients achieving Investigator's Global Assessment of clear or almost-clear skin, ≥ 75% improvement in Eczema Area and Severity Index, ≥ 75% improvement in SCORing AD, and a ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale, or greater score changes from baseline in Dermatology Life Quality Index and Patient-Oriented Eczema Measure vs placebo regardless of race, ethnicity, or FST. Dose-response was most prominent in White patients. In Black patients, the effects of the 2 doses were similar. Treatment-emergent adverse events were more common in White and Black than in Asian patients. ConclusionAbrocitinib was more efficacious than placebo across the racial and ethnic groups and ranges of phototypes analyzed. Studies with increased representation of populations of color are warranted to elucidate potential variations in response across diverse populations. Trial RegistrationClinicaltrials.gov Identifier: NCT02780167 (phase 2b), NCT03349060 (phase 3 MONO-1), and NCT03575871 (phase 3 MONO-2).

Nocturnal Scratching and Quality of Sleep in Children with Atopic Dermatitis.

Itching due to atopic dermatitis causes sleep disorders in children, but its pathology is unknown. The aim of this study is to investigate nocturnal scratching as an indirect index of itching during sleep and its relationship with depth of sleep in children with atopic dermatitis. Nocturnal scratching was measured in a total of 20 children with atopic dermatitis, using a smartwatch installed with the application Itch Tracker. Depth of sleep was analysed using polysomnography. The severity of atopic dermatitis was scored using Eczema Area and Severity Index (EASI) and Patient-Oriented Eczema Measure (POEM). The number and time of nocturnal scratching measured by Itch Tracker had a significantly positive correlation with EASI scores, whereas POEM scores were not correlated with EASI scores. Mean sleep efficiency was 90.0% and scratching episodes (n = 67) started mainly during the awake stage or light sleep stages. In the scratching episodes that started during sleep stages (n = 34), the sleep stage changed to a lighter one or to the awake stage in 35.5% of episodes. Itch Tracker is applicable to measure nocturnal scratching in children. Nocturnal scratching can deteriorate quality of sleep by changing the sleep stage to a lighter one or to the awake stage.

SNG100, a novel topical treatment for moderate atopic dermatitis, in patients aged 6years or older: A randomised, double-blind, active-controlled trial.

Atopic dermatitis (AD) is one of the most common inflammatory skin diseases. It is associated with significant itch and impaired quality of life. Systemic treatments are efficient but associated with side effects. Novel topical treatments with a favourable safety profile are needed. SNG100 is a novel composition of hydrocortisone 1% in a cream base comprising sulphated polysaccharide (SPS; extracted from in-house cultivated Porphyridium Cruentum unicellular algae), a well-known hydrating, moisturising and a skin barrier repairing agent. To assess the safety, usability and efficacy of SNG100 cream in patients aged ≥6years with moderate AD. In this proof of concept phase I, double-blind, randomised trial, participants received one of three treatments for 14days: SNG100 twice daily (BID), hydrocortisone 1% BID or mometasone furoate once daily (QD). The primary endpoint was the safety and tolerability of SNG100 cream compared to hydrocortisone 1% and mometasone furoate. The secondary endpoint was the subject's usability of SNG100. Exploratory efficacy endpoints included percent change from baseline in SCOring AD (SCORAD), Eczema Area and Severity Index, Patient-Oriented Eczema Measure, Dermatology Life Quality Index, pruritus Numerical Rating Score (NRS), peak pruritus-NRS and Investigator's Global Assessment. Subjects were also followed up without any treatment for additional 14days. Overall, 66 participants were screened, and 60 patients were randomised. SNG100 demonstrated a high safety profile, similar to marketed products hydrocortisone 1% and mometasone furoate 0.1%, with no unanticipated drug safety related events. SNG100 and mometasone furoate 0.1% cream achieved almost similar and statistically significant greater percentage reductions from baseline in SCORAD as compared to hydrocortisone 1% cream. SNG100 demonstrated significant improvement in NRS as compared to hydrocortisone 1% cream. Remarkably, SNG100 led to a lasting effect with only 29.4% of subjects returning to IGA3 during the follow-up period compared to 50% and 38.9% in the hydrocortisone 1% and in mometasone furoate treatment arms, respectively. Topical SNG100 is an effective, safe, and well-tolerated innovative treatment for moderate AD. Trial registration number: NCT04615962 (Topical Cream SNG100 for Treatment in Moderate AD Subjects).

Translation and validation of patient-oriented eczema measure in the Greek language.

Translating and validating the Greek version of the Patient Oriented Eczema Measure (POEM) was our goal. A parallel backtranslation process was used to translate POEM. A total of fifty-nine adult atopic dermatitis patients were enlisted to assess validity and reliability. Through patient interviews with physicians, a questionnaire comprising demographics, POEM, and the dermatology life quality index (DLQI) was filled out. 3-7 days after the first visit, a second POEM completion was conducted. The POEM items conducted with study participants demonstrated a good level of internal consistency (Cronbach's alpha = 0.88), and no overall floor and ceiling effects were found. There was a significant correlation between the DLQI and POEM scores (Spearman rho =0.71; p<0.001). The POEM score between interviews showed an average intraclass correlation coefficient (95% confidence interval) of 0.89 (0.80, 0.94), indicating good to excellent test-retest reliability. Patient-reported outcome measures are becoming more and more common in Greece, so it's critical to have access to Greek translations of validated instruments that are frequently used in literature.

Clinical observation on the efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis

To investigate the clinical efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis (AD) in China. A small sample self-controlled study before and after treatment was conducted to retrospective analysis patients with moderate to severe AD treated with dupilumab in the department of dermatology of the First Affiliated Hospital of Chongqing Medical University from July 2020 to March 2022. Dupilumab 600 mg was injected subcutaneously at week 0, and then 300 mg was injected subcutaneously every 2 weeks. The condition was evaluated by SCORAD(severity scoring of atopic dermatitis), NRS(numerical rating scale), DLQI(dermatology life quality index) and POEM(patient-oriented eczema measure). The improvement of SCORAD, NRS, DLQI and POEM was analyzed by paired t test and non-parametric paired Wilcoxon. The results showed that a total of 67 patients with moderate to severe AD received dupilumab treatment, of which 41 patients (the course of treatment was more than 6 weeks) had reduced the severity of skin lesions, improved quality of life and reduced pruritus. A total of 23 patients completed 16 weeks of treatment. At 4, 8, 12 and 16 weeks, SCORAD, NRS, DLQI and POEM decreased compared with the baseline, and the differences were statistically significant. SCORAD (50.13±15.19) at baseline, SCORAD (36.08±11.96)(t=6.049,P<0.001) at week 4,SCORAD (28.04±11.10)(t=10.471,P<0.001) at week 8, SCORAD (22.93±9.72)(t=12.428,P<0.001) at week 12, SCORAD (16.84±7.82)(t=14.609,P<0.001) at week 16, NRS 7(6,8) at baseline, NRS 4(3,5)(Z=-3.861,P<0.001) at week 4, NRS 2(1,4)(Z=-4.088,P<0.001) at week 8, NRS 1(0,2)(Z=-4.206,P<0.001) at week 12, NRS 2(0,2)(Z=-4.222,P<0.001) at week 16, DLQI (13.83±5.71) at baseline, DLQI (8.00±4.02)(t=6.325,P<0.001) at week 4, DLQI (5.61±3.50)(t=8.060,P<0.001) at week 8, DLQI (3.96±1.99)(t=8.717,P<0.001) at week 12, DLQI (2.70±1.89)(t=10.355,P<0.001) at week 16, POEM (18.04±6.41) at baseline, POEM (9.70±4.70)(t=7.031,P<0.001) at week 4, POEM (7.74±3.48)(t=8.806,P<0.001) at week 8, POEM (6.35±3.33)(t=10.474,P<0.001) at week 12, POEM (4.26±2.51)(t=11.996,P<0.001) at week 16. In the 16th week, 100%(23 patients), 91.3%(21 patients), 34.8%(8 patients) and 8.7%(2 patients) of 23 patients reached SCORAD30, SCORAD50, SCORAD70, and SCORAD90 statuses, respectively. There were 82.6%(19 patients), 95.7%(22 patients) and 95.7%(22 patients) of 23 patients with NRS, DLQI and POEM improved by≥4 points compared with baseline. Twelve patients with AD who continued to receive dupilumab after 16 weeks showed further improvement in skin lesions. The adverse events were conjunctivitis and injection site reaction. In conclusion, dupilumab is an effective and safe treatment for moderate and severe AD. However, the longer-term efficacy and safety require further studies involving larger sample sizes and a longer follow-up time.

Efficacy and safety of abrocitinib for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis: update of a living systematic review and meta-analysis.

Despite extensive research on biological therapies for atopic dermatitis (AD), recent clinical trials of the Janus kinase inhibitor 1, abrocitinib, have provided more definitive evidence regarding its efficacy and safety in treating AD. To conduct a living systematic review and meta-analysis to evaluate the efficacy and safety of abrocitinib in adolescents and adults with moderate-to-severe AD. The databases of PubMed, Embase, Cochrane Library and clinical trial registries were searched from inception of the databases to July 11, 2023. Only randomized controlled trials assessing the efficacy and safety of abrocitinib in individuals with moderate-to-severe AD were included in the meta-analysis. Twelve studies involving a total of 5,644 participants aged 12 years or older were included in the analysis. The pooled results revealed a significantly higher proportion of patients achieving Investigator Global Assessment response (RR = 3.52, 95%CI: 2.78 to 4.46), Eczema Area and Severity Index response (RR = 3.35, 95%CI:2.54 to 4.41), Peak Pruritus Numeric Rating Scale response (RR = 2.54, 95%CI: 1.95 to 3.30), and Patient-Oriented Eczema Measure response (abrocitinib 100-mg group: -4.25, 95%CrI: -5.24 to -3.27; abrocitinib 200-mg group: -7.69, 95%CrI: -8.39 to -6.99) compared to the placebo group. Additionally, there was no significant differences in adverse events between the abrocitinib and placebo groups. Abrocitinib demonstrates a favourable safety profile and robust efficacy in treating moderate-to-severe AD compared to placebo. The 200-mg dose regimen appears to be more effective than the 100-mg dose regimen for the treatment of AD.

Atopic Dermatitis in Italian Pre-School Children: Literature Review of Epidemiological Data with a Focus on Disease Prevalence and Severity.

Atopic dermatitis (AD) is one of the most common diseases worldwide. Severe AD has a major impact on the quality of life of patients. We performed a systematic literature review on the epidemiology of AD in Italian pre-school children (age 0-5 years) and we assessed the available data on the severity of AD. In August 2022, we performed a bibliographic search using PubMed/Medline and EMBASE. We identified 10 studies with Italian data on the prevalence and/or incidence of AD in pre-school children. The period (12 months) prevalence of AD varied widely across studies, ranging between 4.0% and 42.2%, with median estimates of 14.3% among all studies and 11.8% among studies from 2010 onwards. Applied to the Italian population, this leads to a prevalence of 309,000-375,000 pre-school AD cases. Only one study computed the incidence of AD, reporting rates of 9 cases per 100 person-years in children aged 0-1 year, and 2.5 cases per 100 person-years in children aged 1-4 years. Severity data from Italy were also reviewed, across three identified three studies. A point estimate found 8.4% of cases were considered severe in one study based on the Patient-Oriented Eczema Measure (POEM), with an overall range of 7.8-11% across different Italian studies and according to various severity score types.

Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study.

Atopic dermatitis (AD) is a chronic disease that occurs mainly in children. Topical corticosteroids are the main treatment for mild to moderate AD, although they can induce side effects. The efficacy and tolerability of xyloglucan and pea protein (XG-PP) was compared with hydrocortisone in pediatric patients with AD as a steroid-sparing solution. A prospective, multicenter, comparative study enrolled 42 patients (age 0.5-12years) with mild-to-moderate AD, assigned 1:1 to XG-PP or hydrocortisone ointment. Treatments were applied twice daily for 14 consecutive days and assessed at baseline, day8, and day15. Efficacy endpoints were AD Severity Index (ADSI) score, Scoring Atopic Dermatitis (SCORAD) index, and Patient-Oriented Eczema Measure (POEM). Tolerability was assessed by the occurrence of adverse events (AEs). Both treatments significantly improved ADSI mean score from baseline to day15; in the XG-PP arm, ADSI score decreased from 10.55 to 4.15 (p = 0.00001), and in the hydrocortisone arm, from 10.65 to 4.30 (p = 0.0001). In the XG-PP arm, the mean SCORAD score decreased from 65.86 to 30.26 (p = 0.00001) and in the hydrocortisone arm from 68.84 to 31.19 (p = 0.0001) at day15. An overall decrease from moderate to mild AD for both arms (p = 0.0001) was observed with POEM. For all the three indexes evaluated, no statistical significant differences between the study arms evolution from baseline to day8 or to day15 were found. No AEs were reported. XG-PP provided a comparable efficacy to hydrocortisone ointment in managing AD, thus representing a safe and effective steroid-sparing alternative in pediatric patients with AD. Retrospectively registered on 24 November 2021 in the ISRCTN registry: 11118799.

AtopyReg®, the Prospective Italian Patient Registry for Moderate-to-Severe Atopic Dermatitis in Adults: Baseline Demographics, Disease Characteristics, Comorbidities, and Treatment History.

AtopyReg® is a multicenter, prospective, observational, non-profit cohort study on moderate-to-severe atopic dermatitis in adults promoted in 2018 by the Italian Society of Dermatology and Venereology (SIDeMaST). We aimed to describe baseline demographics, disease characteristics, comorbidities, and therapeutic data of adult patients affected by moderate-to-severe atopic dermatitis. Patients were selected based on the following inclusion criteria: age ≥ 18 years; Eczema Area and Severity Index score ≥ 16 or localization in visible or sensitive areas (face, neck, hands, or genitalia), or a Numeric Rating Scale itch score ≥ 7 or a Numeric Rating Scale sleep loss score ≥ 7, or a Dermatology Life Quality Index score ≥ 10. Demographic and clinical data at baseline were recorded and analyzed. A total of 1170 patients (male 51.1%; mean age: 44.7 years; range 18-90 years) were enrolled by 12 Italian Dermatology Units between January 2019 and November 2022. Skin lesions were eczematous in 83.2% of patients, the most involved site were the flexures (53.9%), face (50.9%), and neck (48.0%). Mean Eczema Area and Severity Index score was 22.3, mean Dermatology Life Quality Index value was 17.6, mean Patient Oriented Eczema Measure score was 13.1, and mean Numeric Rating Scale itch and sleep loss scores were 7.6 and 5.9, respectively. Previous systemic therapies were corticosteroids in 77.7% of patients, antihistamines in 50.3% of patients, and cyclosporine A in 42.6% of patients. This baseline data analysis deriving from AtopyReg® provides real-life evidence on patients with moderate-to-severe atopic dermatitis in Italy confirming the high burden of atopic dermatitis with a significant impact on patients' quality of life.

Development of SkinTracker, an integrated dermatology mobile app and web portal enabling remote clinical research studies.

In-person dermatology clinical research studies often face recruitment and participation challenges due to travel-, time-, and cost-associated barriers. Studies incorporating virtual/asynchronous formats can potentially enhance research subject participation and satisfaction, but few mobile health tools are available to enable remote study conduct. We developed SkinTracker, a patient-facing mobile app and researcher-facing web platform, that enables longitudinal collection of skin photos, patient reported outcomes, and biometric health and environmental data. Eight design thinking sessions including dermatologists, clinical research staff, software engineers, and graphic designers were held to create the components of SkinTracker. Following iterative prototyping, SkinTracker was piloted across six adult and four pediatric subjects with atopic dermatitis (AD) of varying severity levels to test and provide feedback on SkinTracker for six months. The SkinTracker app enables collection of informed consent for study participation, baseline medical history, standardized skin photographs, patient-reported outcomes (e.g., Patient Oriented Eczema Measure (POEM), Pruritus Numerical Rating Scale (NRS), Dermatology Life Quality Index (DLQI)), medication use, adverse events, voice diary to document qualitative experiences, chat function for communication with research team, environmental and biometric data such as exercise and sleep metrics through integration with an Apple Watch. The researcher web portal allows for management and visualization of subject enrollment, skin photographs for examination and severity scoring, survey completion, and other patient modules. The pilot study requested that subjects complete surveys and photographs on a weekly to monthly basis via the SkinTracker app. Afterwards, participants rated their experience in a 7-item user experience survey covering app function, design, and desire for participation in future studies using SkinTracker. Almost all subjects agreed or strongly agreed that SkinTracker enabled more convenient participation in skin research studies compared to an in-person format. To our knowledge, SkinTracker is one of the first integrated app- and web-based platforms allowing collection and management of data commonly obtained in clinical research studies. SkinTracker enables detailed, frequent capture of data that may better reflect the fluctuating course of conditions such as AD, and can be modularly customized for different skin conditions to improve dermatologic research participation and patient access.

Interpreting the Relationship Among Itch, Sleep, and Work Productivity in Patients with Moderate-to-Severe Atopic Dermatitis: A PostHoc Analysis of JADE MONO-2.

Abrocitinib, an oral, once-daily Janus kinase 1-selective inhibitor, improved itch severity, sleep, and work productivity versus placebo in patients with moderate-to-severe atopic dermatitis. The aim of this study was to investigate relationships among itch, sleep, and work productivity in the phase III JADE MONO-2 clinical trial. A repeated-measures longitudinal model was used to examine relationships between itch (using the Peak Pruritus Numerical Rating Scale [PP-NRS] or Nighttime Itch Scale [NTIS]) and sleep disturbance/loss (using the Patient-Oriented Eczema Measure sleep item and SCORing AD Sleep Loss Visual Analog Scale) and, separately, between itch and work productivity (using theWork Productivity and Activity Impairment-Atopic Dermatitis Version 2.0 questionnaire). Mediation modelling was used to investigate the effect of treatment (abrocitinib vs placebo) on work impairment via improvements in itch and sleep. The relationships between itch/sleep and itch/work productivity were approximately linear. PP-NRS scores of 0, 4-6, and 10 were associated with 0 days, 3-4 days, and 7 days per week of disturbed sleep, respectively. PP-NRS or NTIS scores of 0-1, 4-5, and 10 were associated with 0-10%, 20-30%, and >50% overall work impairment, respectively. Seventy-five percent of the effect of abrocitinib on reducing work impairment was indirectly mediated by improvement in itch, followed by sleep. These results quantitatively demonstrate that reducing itch severity is associated with improvements in sleep and work productivity. Empirical evidence for the mechanism of action of abrocitinib showed that itch severity is improved, which reduces sleep loss/sleep disruption and, in turn, improves work productivity. NCT03575871.

The disease burden of pediatric patients with atopic dermatitis in Japan.

Atopic dermatitis (AD) is a chronic skin condition that is associated with significant patient burden and decreased health-related quality of life (HRQoL). We report results of the real-world Epidemiology of Children with Atopic Dermatitis Reporting on their Experience study in Japanese pediatric patients, focusing on the impact of AD severity on disease burden. Children and adolescents aged 6 months to 17 years (or their caregivers/parents) completed an online survey between September 26, 2018, and March 5, 2019. Patients with diagnosed AD (i.e., met International Study of Asthma and Allergies in Childhood criteria and had a self-reported AD diagnosis) were evaluated for disease severity using the Patient-Oriented Eczema Measure (POEM). Impact of AD severity on AD symptoms (itching, pain, and sleep disturbance), disease flares, atopic comorbidities, healthcare resource utilization, school days missed, and HRQoL were assessed. Of 5702 Japanese pediatric patients, 547 had diagnosed AD and were included in this analysis. Based on POEM scores, AD severity was clear/mild in 346 patients (63.3%), moderate in 177 (32.5%), and severe in 24 (4.4%). Across all age groups (i.e., less than 6, 6-11, and 12-17 years), increased AD severity was associated with increased AD symptom severity, number of flares, atopic comorbidities, healthcare resource utilization, and school absences, as well as worsened HRQoL. This population-based study of Japanese children and adolescents showed that greater AD severity had a high impact on disease burden.

Impact of wearing Comfiknit Atopic Eczema® T‐shirts on patients with atopic dermatitis: An open‐label pilot study

AbstractObjectivesAtopic dermatitis (AD) is aggravated by various factors, including perspiration and heat. Thus, it is recommended that AD patients wear breathable clothing to maintain disease remission. Japan has four seasons, so the ideal clothing for individuals with AD may differ throughout the year. The aim of this study was to evaluate the impact of wearing a newly developed performance fabric, named the Comfiknit Atopic Eczema® T‐shirt, which absorbs excess perspiration from the skin surface and retains moisture within the fabric. We evaluated the effects of the T‐shirts on the clinical characteristics of AD and compared the effects in summer and winter.MethodsTen adult outpatients with AD took part in an open‐label pilot study for 4 weeks during the summer and for 4 weeks during the winter. The Eczema Area and Severity Index (EASI), the Patient‐Oriented Eczema Measure (POEM), the itch Visual Analogue Scale (VAS), the stratum corneum water content (SCWC), skin pH, and skin bacterial cultures were evaluated. A Treatment Satisfaction Questionnaire for Medication‐9 (TSQM‐9) was filled out only after the intervention.ResultsThe mean EASI, POEM, and itch VAS scores in both summer and winter fell after wearing the Comfiknit Atopic Eczema® T‐shirts, whereas the SCWC increased. There was no significant difference in the skin surface pH or bacterial cultures before and after the intervention.ConclusionsWearing Comfiknit Atopic Eczema® T‐shirts helped to prevent exacerbation of AD in summer and winter. Thus, wearing T‐shirts made from performance fabric may help to maintain skin homeostasis.

Abrocitinib effect on patient-reported outcomes in patients with moderate-to-severe atopic dermatitis: Results from phase 3 studies, including the long-term extension JADE EXTEND study.

Abrocitinib improved signs and symptoms of moderate-to-severe atopic dermatitis (AD) at Weeks 12 and 16 in phase 3 studies, with a manageable safety profile. Patient-reported outcomes with long-term abrocitinib treatment were not reported. To evaluate patient-reported outcomes with long-term abrocitinib treatment in patients with moderate-to-severe AD. JADE EXTEND (NCT03422822) is an ongoing, phase 3, long-term extension study that enrolled patients from previous abrocitinib AD trials. This analysis includes patients from the phase 3 trials JADE MONO-1 (NCT03349060), JADE MONO-2 (NCT03575871) and JADE COMPARE (NCT03720470) who completed the full treatment period of placebo or abrocitinib (200 or 100 mg once daily) and subsequently entered JADE EXTEND and were randomised to receive once-daily abrocitinib 200 or 100 mg. Patient-reported endpoints to Week 48 included the proportion of patients who achieved Dermatology Life Quality Index (DLQI) scores of 0/1 (no effect of AD on quality of life [QoL]) and a ≥4-point improvement in Patient-Oriented Eczema Measure (POEM) score (clinically meaningful improvement). Data cut-off: April 22, 2020. Baseline DLQI mean scores were 15.4 and 15.3 in the abrocitinib 200- and 100-mg groups, respectively, which corresponded to a 'very large effect' on QoL; at Week 48, mean DLQI scores were lower with abrocitinib 200 mg (4.6; 'small effect' on QoL) and abrocitinib 100 mg (5.9; 'moderate effect' on QoL). Baseline POEM mean scores were 20.4 and 20.5 in the abrocitinib 200- and 100-mg groups, respectively; at Week 48, mean POEM scores were 8.2 and 11.0. Week 48 patient-reported responses with abrocitinib 200 mg and abrocitinib 100 mg were 44% and 34% for DLQI 0/1, and 90% and 77% for a ≥4-point reduction in POEM score. In patients with moderate-to-severe AD, long-term abrocitinib treatment resulted in clinically meaningful improvement in patient-reported symptoms of AD, including QoL.

PA26 Paediatric atopic dermatitis: correlation between Eczema Area Severity Index, quality of life and visual analogue scale severity scores reported by children and their parents, and in different age groups

Abstract Atopic dermatitis (AD) often has a significant impact on the quality of life (QoL) of those affected and their families. Validated QoL and visual analogue scales (VAS) are widely used in dermatology to measure the impact of this common disease. As part of a larger prospective study, we subanalysed data to look at the correlation between Eczema Area and Severity Index (EASI) score, three different QoL scores and parental/child VAS scores for overall severity, itch and sleep disturbance. Data were analysed from 68 paediatric patients with AD (42 males, 26 females), aged 4–16 years (mean 10 years, 0 months). Patient age groups were subdivided into 4–8 years (n = 17), 8–12 years (n = 25) and 12–16 years (n = 26). Scores for EASI, Children’s Dermatology Life Quality Index (CDLQI), Patient Oriented Eczema Measure (POEM) and Dermatitis Family Impact questionnaire (DFI) were measured, and VAS scores (0–10) were assessed for overall severity, itch and sleep loss. The mean EASI score for the cohort was 18.3, and comparable for all age groups: 4–8 years (17.6), 8–12 years (18.1) and 12–16 years (19.0). The CDLQI correlated with DFI (r = 0.72), POEM (r = 0.66) and overall VAS severity scores (r = 0.61). Further analysis by age group showed CDLQI correlated with POEM and DFI most strongly in younger age groups (4–8 years: POEM r = 0.86; DFI r = 0.77; 8–12 years: POEM r = 0.72; DFI r = 0.81) compared with older children aged (12–16 years: POEM r = 0.41; DFI r = 0.53). The CDLQI and VAS overall severity scores correlated consistently across age groups (4–8 years, r = 0.59; 8–12 years, r = 0.67; 12–16 years, r = 0.66). By comparing EASI with CDLQI scores, moderate correlation was found between the age groups (4–8 years, r = 0.39; 8–12 years, r = 0.53; 12–16 years, r = 0.46). Comparing EASI with the three VAS severity scores, we found poor correlation between EASI score and overall severity score (r = 0.24). This was most marked in the 4–8 years group (n = 17, r = 0.04) vs. the 8–12 years group (n = 25, r = 0.27) and 12–16 years group (n = 22, r = 0.33). Similarly, there was poor correlation between EASI and sleep loss score (r = 0.21) and itch score (r = 0.35) across all age groups. In our study, all of the existing validated QoL scores above correlated well with each other and across different age groups. The CDLQI and VAS severity scores also correlated consistently at all ages. There was poor correlation between EASI and VAS severity scores. This was more apparent in younger age groups, implying a high degree of caregiver distress due to eczema in younger children. This may indicate that as children mature their own perception of eczema may diverge from the perceived parental disease severity/impact on the family.

P40 Dupilumab treatment restores skin barrier function in lesional and nonlesional skin of patients with atopic dermatitis and improves patient-reported outcomes

Abstract The objective of this analysis is to report the effect of dupilumab treatment on skin barrier function and patient-reported outcomes (PROs) in adults and adolescents with moderate-to-severe atopic dermatitis (AD). BALISTAD (NCT04447417) was an open-label trial in which transepidermal water loss (TEWL) was assessed repeatedly before and after skin tape stripping (STS) samples were taken from lesional and nonlesional skin of 26 patients with AD treated with dupilumab, and from normal skin of 26 matched healthy volunteers aged 12–65 years over a period of 16 weeks. PROs assessed included Patient-Oriented Eczema Measure (POEM), Peak Pruritus Numerical Rating Scale (PP-NRS) and Dermatological Life Quality Index [DLQI; for patients &amp;gt; 17 years old; Children’s DLQI (CDLQI) for patients aged &amp;gt; 12 to &amp;lt; 17 years]. At baseline, the median TEWL after five STS was statistically significantly higher in the lesional and nonlesional skin of patients with AD compared with healthy skin (P &amp;lt; 0.001 and P &amp;lt; 0.01, respectively) and statistically significantly decreased following dupilumab initiation as early as week 2 (P &amp;lt; 0.001 and P &amp;lt; 0.05, respectively). After 16 weeks of dupilumab treatment, there was no statistically significant difference in adjusted mean TEWL in AD lesional and nonlesional skin compared with matched healthy skin (P = 0.225 and P = 0.163, respectively). Significant improvement from baseline [mean (SD) change from baseline] was seen as early as week 2 in mean POEM [−8.4 (5.1)], DLQI [−5.3 (4.7)], CDLQI [−6.2 (4.7)] and PP-NRS [−2.2 (1.8); P &amp;lt; 0.001 and P &amp;lt; 0.05)] for CDLQI. Improvement was sustained through to week 16 [mean (SD) change from baseline; P &amp;lt; 0.001] for POEM [−13.6 (8.5)], DLQI [−8.6 (7.4)] and PP-NRS [−4.2 (2.6)] and with a P-value of &amp;lt; 0.01 for CDLQI [−9.2 (5.0)]. Dupilumab treatment normalizes epidermal barrier function in lesional and nonlesional skin in patients with moderate-to-severe AD, as measured with TEWL, and improves PROs. Funding sources: research sponsored by Sanofi and Regeneron Pharmaceuticals Inc.