Patient-Oriented Eczema Measure Research Articles

Impact of Atopic Dermatitis on Adult Women's Lives: A Survey of 1,009 French Women.

Atopic dermatitis (AD) is one of the most common inflammatory diseases, and has a higher prevalence among females in adulthood. The aim of this observational, cross-sectional, survey-based study was to evaluate the impact of AD on the daily lives of adult women patients. A scientific committee composed exclusively of women constructed a specific questionnaire in partnership with the French Eczema Association. Severity of AD was evaluated with the Patient-Oriented Eczema Measure (POEM). A sample of 1,009 adult women (mean age ± standard deviation: 41.8 ± 14.2 years) with AD was identified from a representative sample of the French population (82% response rate 1,230 women surveyed). According to the POEM, 50.64% (n = 511) of subjects were identified as having mild AD, 39.35% (n = 397) moderate AD, and 10.01% (n = 101) severe AD. Overall, 67.7% (n = 682) reported that their eczema involved a visible area (face, neck or hands), and 19.6% (n = 198) a sensual area (breasts/chest, genital area or buttocks). Of the 720 women with menstrual cycles, exacerbations of AD were reported to occur mostly before (50.6%) and during (48.3%) menstruation. A small proportion of women, 7.3% (n = 74), reported being afraid of becoming pregnant because of their eczema. If AD involvement was in a visible area it had a greater impact on romantic relationships, sexual relationships and occupation. If AD involvement was in a sensual area it had a greater influence on romantic relationships and sexuality. Particular attention should be given to patients with localization of AD on the face, neck or hands, as they have a higher risk of social exclusion. Moreover, these results should encourage health professionals to ask patients with AD about the possible involvement of sensual areas.

Targeted Combined Endpoint Improvement in Patient and Disease Domains in Atopic Dermatitis: A Treat-to-Target Analysis of Adults with Moderate-to-Severe Atopic Dermatitis Treated with Upadacitinib.

A treat-to-target approach was recently developed to guide systemic treatment for adults with atopic dermatitis (AD). Recommendations outlined criteria for a 3-month initial acceptable treatment target and a 6-month optimal target, evaluated using global assessment of patient-reported disease severity, as well as Eczema Area and Severity Index, itch assessed on an 11-point numerical rating scale, Dermatology Life Quality Index, or Patient-Oriented Eczema Measure. Achievement of these targets with once-daily upadacitinib (15 mg and 30 mg) monotherapy was evaluated using integrated adult data from the Measure Up 1 and 2 phase 3 studies. Among the 852 patients treated with upadacitinib 15 mg or 30 mg, the 3-month initial acceptable target was achieved by >80%, >78%, and ≥87% of patients, and the 6-month optimal target was achieved by ≥53%, >61%, and >73% of patients at weeks 2, 16, and 52, respectively. Achievement of all 6 individual criteria for each of the target goals also increased over time. These findings suggest that upadacitinib 15 mg and 30 mg may help improve standards of care in patients with moderate-to-severe AD by achieving 6-month target goals at 16weeks and as early as 2 weeks for most patients.

Drug utilization among young adults with atopic dermatitis: Influence of sex, socio-economic status and disease severity.

Atopic dermatitis (AD) affects individuals of all ages, and the first-line treatment are emollients and topical corticosteroids. There is insufficient knowledge about factors possibly affecting the drug utilization of young adults with AD. To describe the drug utilization of young adults with AD in relation to sex, socio-economic status and disease severity. A cross-sectional study based on the 24-year follow-up from the population-based BAMSE (Children, Allergy, Milieu, Stockholm, Epidemiology Survey) birth cohort linked with dispensing data from the National Drug Register (n = 2912). Self-reported AD and socio-economic status were defined from questionnaire data and disease severity was determined through the clinical examination and Patient-Oriented Eczema Measure questionnaire. The prevalence of AD in young adults was 17.7% (n = 516) and 45.5% of them were dispensed at least one drug for the treatment of AD during the study period (January 2016 to June 2019). Topical corticosteroids (TCS) were the most common drugs (32.9%) followed by emollients (21.7%). A larger proportion of men were dispensed TCS than women (39.0% vs. 29.1%: p-value = 0.020). A larger proportion of young adults with moderate-to-severe AD were dispensed TCS than those with mild AD (52.6% vs. 35.3%: p-value = 0.026). No one was dispensed the recommended amount of emollients and less than five individuals were dispensed the recommended amount of TCS for mild disease. Male sex (adj.OR 1.54, 95% CI 1.06-2.34) and moderate-to-severe AD (adj.OR 2.62, 95% CI 1.59-4.31) were associated with dispensation of TCS. A large proportion of young adults with AD was undertreated or untreated. Sex and disease severity did affect the dispensing patterns of investigated drugs.

Dermatitis Secondary to Exposure to Nickel and Fragrance at Workplace: A Case Report

Allergic contact dermatitis may be caused by exposure to chemicals. The skin usually develops type IV sensitivity where the initial sensitization may occur a few days but it may take years to develop in low grade exposure to these allergens. In the present study, the patient sustained the disorder through exposure to nickel sulfate, balsam of Peru and a fragrance mix which was confirmed by conducting a Patch test. The initial patient’s Investigator’s Global Assessment, Eczema Area and Severity Index, Dermatology Life Quality Index and Patient-oriented Eczema Measure scores were 3, 9.6, 6 and 14, respectively and improved to 1, 0.6, 1 and 1, respectively after two months of intervention. Good occupational hygiene is vital such as wearing polyvinyl chloride gloves to avoid nickel contact and effective handwashing practices to prevent nickel buildup on the hands. Avoidance of contact of fragrances in cleaning products averts contact dermatitis.

Obesity is linked to disease severity in moderate to severe atopic dermatitis-Data from the prospective observational TREATgermany registry.

There are conflicting data on a potential association between obesity and atopic dermatitis (AD). The purpose of this study was to investigate the relationship between obesity and AD disease severity. Patients from the TREATgermany registry cohort were divided into three groups according to their body mass index (BMI). Due to low numbers, underweight patients (BMI <18.5 kg/m2) were excluded from the analysis. Physician- and patient-reported disease severity scores as well as additional phenotypic characteristics were evaluated for association with BMI. Generalized linear mixed models and multinomial logit models, respectively, were applied to investigate the association of BMI, age, sex and current systemic AD treatment with disease severity. This study encompassed 1416 patients, of which 234 (16.5%) were obese (BMI ≥30 kg/m2). Obesity was associated with lower educational background and smoking. Otherwise, obese and non-obese AD patients had similar baseline characteristics. Increased BMI was associated with higher oSCORAD (adjusted β: 1.24, 95% CI: 1.05-1.46, p = 0.013) and Patient-oriented eczema measure (POEM) (adjusted β: 1.09, 95% CI: 1.01-1.17, p = 0.038). However, the absolute difference in the overall oSCORAD was small between obese and non-obese AD patients (Δ oSCORAD = 2.5). Allergic comorbidity was comparable between all three groups, with the exception of asthma which was more pronounced in obese patients (p < 0.001). In this large and well-characterized AD patient cohort, obesity is significantly associated with physician- and patient-assessed measures of AD disease severity. However, the corresponding effect sizes were low and of questionable clinical relevance. The overall prevalence of obesity among the German AD patients was lower than in studies on other AD cohorts from different countries, which confirms previous research on the German population and suggests regional differences in the interdependence of AD and obesity prevalence.

Dupilumab provides sustained effectiveness on patient-reported outcomes and favorable safety in patients with moderate-to-severe atopic dermatitis: up to 5-year results from the daily practice BioDay Registry

BackgroundLong-term daily practice data on patient-reported benefits of dupilumab for atopic dermatitis (AD) remains limited. ObjectiveTo evaluate patient-reported outcome measures (PROMs) and the safety of dupilumab in patients with moderate-to-severe AD over a follow-up period of up to 5 years. MethodsData were extracted from the prospective, multicenter BioDay registry (October 2017 - 2022) of patients with moderate-to-severe AD treated with dupilumab in daily practice. ResultsIn total 1223 patients, 1108 adults and 115 pediatric patients, were included. After ≥1 year of treatment, mean Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), Numeric rating scale (NRS)-pruritus ranged between 7.8-8.7, 3.5-4.2, and 2.9-3.1 in adults, respectively, whilst these PROMs ranged between 8.9-10.9, 4.4-6.4, and 3.0-3.7 in pediatric patients, respectively. At follow-up, overall work impairment decreased from 40.1% to 13.3-16.3% in adults. Furthermore, class I obesity and itch-dominant patients generally had less favorable treatment response. Of all patients, 66.8% reported ≥1 adverse event, with conjunctivitis being the most common(33.7%). LimitationsThe overall percentage of missing values for selected PROMs was 26% in adults and 46% in pediatric patients. ConclusionIn addition to favorable safety, dupilumab has demonstrated sustained effectiveness across various PROMs, underscoring the treatment benefits from patients’ perspectives.

Matching-Adjusted Indirect Comparison of the Efficacy at Week32 of Tralokinumab and Dupilumab in the Treatment of Moderate-to-Severe Atopic Dermatitis.

Tralokinumab and dupilumab are biological agents licensed for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients who are candidates for systemic treatment. However, no head-to-head studies of their efficacy have been conducted. This study indirectly compared the efficacy of tralokinumab and dupilumab, both in combination with topical corticosteroids (TCS), at week32. An unanchored matching-adjusted indirect comparison was conducted using individual patient data (IPD) from the ECZTRA3 tralokinumab trial and aggregate data from the LIBERTY AD CHRONOS dupilumab trial. IPD were selected by applying inclusion criteria from LIBERTY AD CHRONOS and weighting to match summary baseline characteristics-age, sex, race, body mass index, disease duration, Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI) and SCORing Atopic Dermatitis index-of patients treated with dupilumab. Week32 outcomes of interest were 50%, 75% or 90% improvements in EASI (EASI-50, EASI-75 and EASI-90), IGA scores of 0 or 1 (IGA0/1), ≥ 4-point improvement in worst daily pruritus numerical rating scale (NRS) score, and mean improvements in DLQI and the Patient Oriented Eczema Measure (POEM). After matching, tralokinumab and dupilumab, both in combination with TCS, showed similar efficacy across clinical response endpoints at week32 (IGA0/1, tralokinumab 49.9% vs dupilumab 39.3%; EASI-50, 78.9% vs 77.5%; EASI-75, 71.5% vs 71.9%; EASI-90, 53.3% vs 56.2%). The mean change from baseline in DLQI was statistically significantly larger in the matched tralokinumab plus TCS population than in the dupilumab plus TCS arm (- 12.1 vs - 10.4, p = 0.005). Changes in POEM and worst daily pruritus NRS were similar in the two groups. The results of this analysis demonstrate that, in combination with TCS, tralokinumab and dupilumab have similar efficacy in the treatment of moderate-to-severe AD at 32weeks of therapy.

Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and MeasureUp2).

Atopic dermatitis is a chronic inflammatory disease characterized by increased itch, skin pain, poor sleep quality, and other symptoms that negatively affect patient quality of life. Upadacitinib, an oral selective Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 than JAK2, JAK3, or tyrosine kinase 2, is approved to treat moderate-to-severe atopic dermatitis. We aimed to evaluate the effect of upadacitinib on patient-reported outcomes over 52weeks in adults and adolescents with moderate-to-severe atopic dermatitis. Data from two phase III monotherapy trials of upadacitinib (Measure Up 1, NCT03569293; Measure Up 2, NCT03607422) were integrated. Changes in pruritus, pain, other skin symptoms, sleep, quality of life, mental health, and patient impression were evaluated. Patient-reported outcome assessments included the Worst Pruritus Numerical Rating Scale, Patient-Oriented Eczema Measure, Dermatology Life Quality Index, Atopic Dermatitis Symptom Scale, Atopic Dermatitis Impact Scale, Hospital Anxiety and Depression Scale, SCORing Atopic Dermatitis index, Patient Global Impression of Severity, Patient Global Impression of Change, and Patient Global Impression of Treatment. Minimal clinically important differences, achievement of scores representing minimal disease burden, and the change from baseline were evaluated in patients who received upadacitinib through week 52 and in patients who received placebo through week16. This analysis included 1609 patients (upadacitinib 15 mg, N=557; upadacitinib 30 mg, N=567; placebo, N=485). Baseline demographics and disease characteristics were generally similar across all arms. The proportion of patients treated with upadacitinib reporting improvements in itch increased rapidly by week 1, increased steadily through week 8, and was sustained through week 52. Patients receiving upadacitinib also experienced improvements in pain and other skin symptoms by week 1, which continued through week 16; improvements were maintained through week 52. Patient reports of improved sleep increased rapidly from baseline to week 1, increased steadily through week 32, and were sustained through week 52. Patients experienced quality-of-life improvements through week 8, which were maintained through week 52. By week 1, patients in both upadacitinib groups experienced rapid improvements in emotional state, and by week 12, patients also achieved meaningful improvements in anxiety and depression. Improvements in mental health continued steadily through week 32 and were maintained through week 52. Patients treated with upadacitinib30mg generally experienced improvements in patient-reported outcomes earlier than those treated with upadacitinib 15 mg. Through week 16, patients receiving upadacitinib experienced greater improvements versus those receiving placebo in all assessed patient-reported outcomes. Adults and adolescents with moderate-to-severe atopic dermatitis treated with once-daily upadacitinib 15 or 30 mg experienced early improvements in itch, pain, other skin symptoms, sleep, quality of life, and mental health that were sustained through week52. ClinicalTrials.gov identifiers NCT03569293 (13 August 2018) and NCT03607422 (27 July 2018).

Efficacy of Abrocitinib and Dupilumab in Patients With Moderate-to-Severe Atopic Dermatitis With Severe Itch at Baseline and in Subgroups by Baseline Thresholds of Severe Itch: A Post Hoc Analysis of the JADE COMPARE and JADE DARE Clinical Trials

Introduction: In phase 3 trials, abrocitinib provided more rapid and greater itch relief than dupilumab in patients with moderate-to-severe atopic dermatitis (AD). We examined the efficacy of abrocitinib versus dupilumab in patients with severe itch at baseline (BL) and in subgroups by BL thresholds of severe itch.Methods: Data were pooled from patients treated with abrocitinib 200 mg or dupilumab 300 mg in JADE COMPARE (NCT03720470) and JADE DARE (NCT04345367). Patients with severe itch at BL (Peak Pruritus Numerical Rating Scale [PP-NRS] ≥7), and subgroups by BL PP-NRS 7-10 were assessed for achievement of ≥4-point improvement in PP-NRS (PP-NRS4) and PP-NRS 0/1 (itch free state). Subgroups were also assessed for achievement of Patient Oriented Eczema Measure (POEM) score ≤2 (clear/almost clear AD), and Dermatology Life Quality Index (DLQI) score of 0/1 (no impact on quality of life [QoL]).Results: This analysis comprised 875 patients (abrocitinib, 453; dupilumab, 422) with severe itch at BL. Median (Q1, Q3) BL score for PP-NRS was 8.0 (7.0, 9.0) in the abrocitinib arm and 8.0 (7.0, 9.0) in the dupilumab arm; 22.0 (19.0, 26.0) and 22.0 (19.0, 27.0) for POEM; 16.0 (11.0, 20.5) and 16.0 (11.0, 20.0) for DLQI. In the overall group, PP-NRS4 responses were greater with abrocitinib versus dupilumab as early as week 2 (56% vs 32%) and sustained through week 16 (73% vs 69%). Stringent PP-NRS 0/1 responses were greater with abrocitinib versus dupilumab at weeks 2 (15% vs 3%) and 16 (35% vs 21%). Across patient subgroups by BL PP-NRS 7-10, greater proportions achieved PP-NRS4 and PP-NRS 0/1 with abrocitinib versus dupilumab at weeks 2 and 16. Greater proportions across subgroups achieved POEM ≤2 with abrocitinib compared with dupilumab at week 16 (BL PP-NRS7, 33% vs 10%; BL PP-NRS8, 29% vs 20%; BL PP-NRS9, 39% vs 16%; BL PP-NRS10, 31% vs 23%). In the overall group, greater proportions achieved DLQI 0/1 with abrocitinib versus dupilumab at weeks 2 (19% vs 6%) and 16 (38% vs 27%). Across subgroups, DLQI 0/1 responses with abrocitinib were generally greater than dupilumab at weeks 2 and 16.Conclusions: In patients with moderate-to-severe AD who had severe itch at BL, abrocitinib provided more rapid and complete/near complete itch relief and improved QoL than dupilumab as early as 2 weeks of treatment. These results were consistent across subgroups by various BL thresholds of severe itch.

The Burden of Pediatric Atopic Dermatitis: Quality of Life of Patients and Their Families.

(1) Background: Atopic dermatitis (AD) is one of the most common inflammatory skin conditions, thus having a significant impact on the quality of life (QoL) of patients and their families. We performed a survey to gather more data to help describe the burden of AD in Lithuania and to help expand the treatment plan to this important aspect of the disease. (2) Methods: A cross-sectional study was conducted involving healthy and AD pediatric patients. The assessment instruments used were the Patient-Oriented Eczema Measure (POEM), QoL, and original questionnaires (the original questionnaire was designed by the authors to determine the demographics, medical history, and treatment methods of the respondents). (3) Results: This study included 302 participants in total: 247 AD patients (51% boys) and 55 non-AD patients (51% boys). The mean age for AD patients was 6.8 ± 4.4. years, and this was 10.5 ± 3.1 years for the control patients. A significant difference was found between the QoL questionnaire scores and the Family Dermatology Life Quality Index (FDLQI) score for the atopic dermatitis group (QoL: 6.3 ± 5.6; FDLQI: 7.1 ± 6.9) and controls (QoL 0.5 ± 1.1; FDLQI 2.1 ± 5.9) (p = 0.000). The mean QoL questionnaire score for severe AD was 14.3 ± 6.2 (very large effect), that for moderate AD was 6.9 ± 4.4 (moderate effect), and that for mild AD was 4.4 ± 4.2 (small effect) (p = 0.000). (4) Conclusions: Our study revealed a moderate effect of AD on dermatology-related QoL in patients and their families. It has been shown that increased disease severity was associated with a greater impairment of QoL in both patients and patient's parents. The burden of AD in children and their parents is considerable and should be taken into account in the management of atopic dermatitis.

Cracking the code: unveiling the nexus between atopic dermatitis and addictive behavior: a cross-sectional exploration of risk factors

Atopic dermatitis (AD) stands as a prevalent chronic inflammatory skin disorder with a global reach. Beyond its cutaneous manifestations, AD is accompanied by comorbidities and psychological issues, significantly compromising the overall quality of life for individuals who suffer from AD. Previous research has evidenced a heightened prevalence of addictive disorders among dermatological patients when compared to the general population. Considering these findings, this study endeavors to examine the prevalence of addictive disorders among AD patients and, furthermore, to discern potential risk factors associated with this comorbidity. Therefore, a cross-sectional study was conducted involving patients with AD diagnosed by dermatologists within a large university hospital in Munich, South Germany, between January 2016 and December 2019. Patients received an anonymous paper-based questionnaire comprising standardized and reliable assessment tools concerning disease severity, quality of life, sexual dysfunction, well-being, and anxiety disorder as well as screening tools for various addictive disorders (compulsive internet use, drug abuse, pathological alcohol consumption, and smoking). Data were analyzed descriptively, and a multivariate logistic regression model was conducted. A total of 208 patients participated in the study, comprising 38% males and 62% females with a mean age of 44.8 ± standard deviation:17.9 years. Females showed a higher mean POEM (Patient-Oriented Eczema Measure) score compared to males (female 14.6 ± 7.8; male 12.5 ± 7.7), as well as a higher DLQI (Dermatology Life Quality Index) (female 8.5 ± 6; male 6.5 ± 6.5). Positive addictions were found in 14.9% for daily smoking, 15.4% for critical alcohol consumption, 16.8% for compulsive internet use, and 5.8% for drug abuse. Younger patients were more likely to be affected by one or multiple addictions than older patients. Patients with at least one addiction showed significantly impaired well-being and increased severe anxiety symptoms. Given the notable prevalence of addictive disorders among individuals with AD, it could be useful to implement systematic screening for such conditions as part of patient-centered care, especially focusing on young AD patients or those displaying concurrent indications of depression or anxiety.

A Qualitative Study on the Perception of Atopic Dermatitis by Malagasy Young Patients Regarding Self-Management

Atopic dermatitis (AD) is a chronic disease that usually begins in childhood and can persist at any age. It is essential for adolescents entering to adulthood to have a complete understanding of this disease, including its self-management responsibilities. This study aimed to explore Malagasy adolescents and young adults’ perceptions of atopic dermatitis regarding the concept of self-management. This is a qualitative study using semi-structured interviews with adolescent and young adult patients suffering from AD, who were followed up at the Dermatology Department of the University Hospital Joseph Raseta Befelatanana, Antananarivo, Madagascar. Interviews were recorded, transcribed verbatim, and analyzed using NVivo software version 10.2.2 (QSR International, Doncaster, Australia). Five male and seven female patients with mild to severe AD were included according to the Patient-Oriented Eczema Measure (POEM). The mean age was 19.83 years and the mean interview duration was 21.3 minutes. Despite a relatively long duration of AD, the nature of this condition, and the principles and goals of treatment are still poorly understood among young people. Consequently, many still hope for a complete cure for their AD. Our patients adhered to treatment and did not fear topical corticosteroids. This study highlights the importance of providing information about atopic dermatitis during childhood, and emphasizes the need to recommunicate this information directly to these patients during adolescence, aiming for an optimal transition process regarding disease self-management.

Efficacy of Topical Palmitoylethanolamide (Levagen+) for the Management of Eczema Symptoms: A Double-Blind, Comparator-Controlled, Randomized Clinical Trial

Introduction: Eczema is a debilitating skin disorder clinically characterised by the development of itchy, dry, rough, and scaling skin caused by a series of rudimentary clinical phenotypes. Methods: This double-blind, randomised, comparator-controlled trial evaluated the effectiveness of topical application of a novel palmitoylethanolamide formulation (Levagen+) compared with a standard moisturiser (comparator) to reduce eczema severity and improve patient outcomes. Seventy-two participants aged over 18 years old with atopic eczema (symptoms including redness, dry skin, scaling, and/or itchiness) on their hands or arm were recruited. Participants were randomly allocated to one of two treatment groups (Levagen + or comparator). Treatment was applied to the affected area twice daily for 4 weeks. Outcome measures included Self-Assessed Eczema Area Severity Index (SA-EASI) scoring and Patient-Oriented Eczema Measure (POEM) from baseline to week 4. Results: Levagen+ was effective at alleviating symptom severity of eczema over 4 weeks. Levagen+ significantly reduced redness, dryness, and total POEM score compared to a comparator cream. Conclusion: Levagen+ can significantly reduce eczema symptom severity compared to a comparator product, supporting its use as a potential treatment for eczema. Trial registration: <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">clinicaltrials.gov</ext-link> Identifier: NCT05003453.

538 - Physician-assessed effectiveness and patient-reported outcomes in adult and adolescent patients with atopic dermatitis in the Asian subpopulation treated with dupilumab: real-world insights 1 year into the GLOBOSTAD multinational prospective observational study

Abstract Introduction In multiple randomized controlled clinical trials, dupilumab demonstrated robust efficacy in patients with moderate-to-severe atopic dermatitis (AD). Long-term effectiveness of dupilumab in real-world AD treatment is one of the main objectives of the ongoing GLOBOSTAD study. Comprehensive data on Asian patients with moderate-to-severe AD treated with dupilumab are limited. Objectives To report patient-reported outcomes and physician-assessed AD clinical measures to evaluate disease characteristics, severity, and treatment effectiveness 1 year after initiating dupilumab treatment in Asian patients. The baseline disease severity and patient demographics have been reported previously1. Methods This 5-year, multinational, multicentre, prospective, observational study (GLOBOSTAD; NCT03992417) included Asian patients ≥12 years-old with moderate-to-severe AD who initiated dupilumab treatment based on country-specific prescribing criteria. Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), Patient-Oriented Eczema Measure (POEM), Peak Pruritus Numerical Rating Scale (PP-NRS) and Dermatology Life Quality Index (DLQI) were assessed at baseline, 3 months (± 1 month), 6 months (± 2 months), and 12 months (± 2 months). Data are reported as observed in patients self-reported as Asian for enrolment/safety (N = 204; data cutoff: March 2023) and follow-up (N = 194) populations. Results During the study, EASI (&amp;gt;21 = severe; ≤7 = mild/no disease) score improved from 28.0 (12.1), mean (SD) at baseline to 7.4 (8.5) at 3 months, 5.7 (6.9) at 6 months, and was sustained until the end of observation period, 12 months, at 4.7 (7.1). Similarly, SCORAD (&amp;gt;50 = severe; &amp;lt;25 = mild/no disease) score improved from 61.5 (16.9) at baseline to 25.4 (16.6) at 3 months, 22.5(14.8) at 6 months, and further improved to 18.6 (13.3) at 12 months. During the study, patients also reported early improvements in POEM, mean (SD) from 19.1 (7.3) at baseline to 8.0 (5.8) at 3 months, 7.6 (5.5) at 6 months, and to 7.2 (5.0) at end of observation period (12 months); PP-NRS decreased from 5.7 (2.3) to 2.1 (2.2) to 1.7 (1.8), and to 1.4 (1.7) at 3 months, 6 months, and 12 months respectively; and DLQI improved from 13.2 (7.4) to 4.9 (4.6) to 4.0 (3.8), and to 4.1 (4.0) at 3 months, 6 months and 12 months respectively. Dupilumab-related adverse events were reported in 44 (21.5%) patients while 4 (2.0%) reported dupilumab-related severe adverse events. Conclusion In Asian patients, the initiation of dupilumab treatment led to early improvements in all AD outcome measures, sustained throughout the 1-year observational period. Safety and treatment effectiveness were consistent with overall population.

525 - Real-world effectiveness of upadacitinib in moderate-to-severe atopic dermatitis (AD): Results from cross-sectional analyses of the CorEvitas AD Registry

Abstract Introduction/Background Upadacitinib is an oral Janus kinase inhibitor approved to treat moderate-to-severe atopic dermatitis (AD). While clinical trials have demonstrated its efficacy in treating the signs and symptoms of AD, less is known about its effectiveness in a real-world setting. Objectives This cross-sectional study describes the real-world clinical and patient-reported outcomes of adults with AD enrolled in the CorEvitas AD Registry and treated with upadacitinib for at least four or more weeks. Methods The CorEvitas AD Registry is a prospective, non-interventional registry of adults diagnosed with AD by a dermatologist or qualified dermatology practitioner. The current analysis included participants enrolled between July 21, 2020 through August 7, 2023 who were treated with upadacitinib for at least 4 weeks at the time of evaluation by their provider. Outcome measures included assessments of: skin clearance (Validated Investigators Global Assessment Scale for Atopic Dermatitis [vIGA-AD™], Eczema Area and Severity Index [EASI]); worst itch in the past 24 hours (Peak Pruritus Numeric Rating Scale [PP-NRS]); symptom frequency (Patient-Oriented Eczema Measure [POEM]); quality of life (Dermatologic Life Quality Index [DLQI]); and disease control (Atopic Dermatitis Control Tool [ADCT]). Outcomes were cross-sectionally summarized using data collected at the latest registry visit (Overall cohort), as well as 1 to less than 5 months (1-5 months) and 5-9 months following upadacitinib initiation (Month 1-5 cohort and Month 5-9 cohort, respectively). Subgroup analyses were also conducted based on prior use of biologics indicated for AD (bio-naïve, bio-experienced). Data were analyzed as observed with no imputation. Safety events were not assessed in this ­analysis. Results A total of 335 patients (mean age 45.6 years; 51.6% female; 64.2% White) were treated with upadacitinib (15 mg: n=221 [70.8%]; 30 mg: n=91 [29.2%]; median treatment duration: 6.9 months). Some patients reported concomitant use of topical corticosteroids (28.1%) and prior use of biologics indicated for AD (dupilumab: 45.4%; tralokinumab: 6.0%). For the Overall cohort, 57.3% had clear or almost clear skin (vIGA-AD 0/1). An EASI ≤3 was observed in 74.8% of patients and 45.3% reported no/minimal itch (PP-NRS 0/1); 40.9% had both EASI ≤3 and PP-NRS 0/1. Most patients (69.3%) reported that their AD was controlled (ADCT &amp;lt;7), 36.4% reported clear or almost clear disease (POEM 0–2), and 39.8% reported no impact of AD on their quality of life (DLQI 0/1). Similar results were observed for the Month 1-5 (n=144) and Month 5-9 (n=194) cohorts; results in bio-naïve and bio-experienced patients were comparable. Conclusions More than half of patients with ≥4 weeks of upadacitinib treatment had clear or almost clear skin and greater than two-thirds reported controlled disease, with similar results observed in both bio-naïve and bio-experienced patients. Over a third reported no/minimal symptom and disease burden. These findings suggest that low levels of disease severity are observed with real-world use of upadacitinib. Future analyses will aim to report changes in disease severity and burden due to persistent upadacitinib treatment.

531 - Physician-assessed effectiveness and patient-reported outcomes in adult and adolescent patients with atopic dermatitis treated with dupilumab: real-world insights 1 year into the GLOBOSTAD multinational prospective observational study

Abstract Introduction The GLOBOSTAD study aims to assess the extended real-world effectiveness of dupilumab in patients with atopic dermatitis (AD) receiving dupilumab as part of their normal care. Objectives To report patient-reported outcomes and physician-­assessed AD clinical measures for evaluating disease characteristics, severity, and treatment effectiveness 1 year after initiating dupilumab treatment. Methods This 5-year, multinational, prospective, observational study (NCT03992417) enrolled patients aged ≥12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. Assessments were performed at baseline, 3 months (± 1 month), 6 months (± 2 months), and 12 months (± 2 months). Data are reported as observed for enrollment/safety (N = 955; data cutoff: March 2023) and follow-up (N = 903) populations including 13 adolescent patients with AD (≥12 and &amp;lt;18 years old). Results In this study, 758/863/705 patients completed ≥1 follow-up assessment at 3 months/6 months/12 months, respectively. During the study the mean (standard deviation [SD]) Eczema Area and Severity Index (EASI; &amp;gt;21 = severe; ≤7 = mild/no disease) scores decreased from 25.1 (12.8) at baseline to 6.1 (8.0) at 3 months, 4.6 (6.4) at 6 months and sustaining throughout the observation period [12 months; 4.2 (8.4)]. Mean Patient-Oriented Eczema Measure (SD) improved from 19.7 (6.4) at baseline descending to 8.7 (6.6) at 3 months, 7.7 (6.0) at 6 months and 7.1 (5.8) at 12 months. A significant improvement was also observed in Dermatology Life Quality Index (DLQI) from 13.7 (7.1) to 5.3 (5.1) to 4.4 (4.4) to 3.9 (4.2); and children’s DLQI from 12.2 (6.2) to 2.7 (2.9) to 2.9 (3.0) to 4.8 (4.8) by the end of the 3, 6 and 12-months observational period respectively. Dupilumab-related adverse events were reported in 187 (20.8%) patients. Conclusions In a real-world scenario, the initiation of dupilumab treatment led to early and sustained improvements in AD outcome measures throughout the 1-year observational period. Safety data remained consistent with findings from previous studies.

Correlation Analysis of Clinician- and Patient-Reported Outcomes Among Japanese Adults with Atopic Dermatitis.

Atopic dermatitis (AD) is a chronic relapsing condition with high disease burden and impact on health-related quality of life (HRQoL). Correlations between clinician- and patient-reported outcomes tend to be poor, and limited data in Asian patients are available. ADDRESS-J was a prospective, non-interventional, longitudinal study that evaluated the real-world effectiveness and safety of AD treatment in Japanese adults (aged 20-59years) with moderate-to-severe AD. Three clinician-reported AD severity outcomes (Investigator's Global Assessment, Eczema Area and Severity Index, and body surface area affected), three dermatological patient-reported outcomes (Patient-Oriented Eczema Measure, Dermatology Life Quality Index, and Worst Itch Numerical Rating Scale), and two general HRQoL patient-reported outcomes (5-dimension EuroQoL questionnaire and EuroQol Visual Analog Scale) were collected at baseline and every 3months throughout the 24-month observation period. Four biomarkers were also analyzed when available (thymus and activation-regulated chemokine [TARC], lactate dehydrogenase [LDH], total immunoglobulinE [IgE], and peripheral blood eosinophil counts [PB EOS]). Spearman's correlation coefficients were calculated using all available pooled data from baseline through 24months. Correlations between the three clinician-reported outcomes were high/very high (Spearman's correlation coefficients 0.76-0.92); those between the three dermatological patient-reported outcomes were moderate (0.53-0.64), and those between the clinician-reported and dermatological patient-reported outcomes were low/moderate (0.37-0.51). Correlations between the general HRQoL patient-reported outcomes and the clinician-reported and dermatological patient-reported outcomes were negligible-moderate (0.26-0.60). Biomarker correlations with the clinician-reported and dermatological patient-reported outcomes were low/moderate for TARC and LDH (0.44-0.63), but negligible/low for PB EOS and total IgE (0.01-0.41). These results show that clinician- and patient-reported outcomes do not necessarily correlate well in Japanese adults with AD. This highlights the importance of including patient-reported outcomes when assessing disease severity/impact, planning treatment, and assessing response to treatment. UMIN Clinical Trials Registry (UMIN-CTR) Identifier UMIN000022623.

Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis

BackgroundPathogenic variants in filaggrin (FLG) are associated with an increased risk of atopic dermatitis (AD). ObjectiveTo evaluate the influence of FLG variants on the effectiveness of dupilumab treatment in AD. MethodsThis prospective observational study included adult AD patients treated with dupilumab from the BioDay Registry. FLG was analysed with smMIP targeted sequencing. Novel mutations were confirmed by Sanger sequencing. Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), Numeric Rating Scale (NRS) pruritus, Dermatology Quality of Life Index (DLQI) and Patient Oriented Eczema Measure (POEM) were assessed at baseline, week 16 and 52. ResultsGenetic analysis of 285 included patients showed bi-allelic pathogenic variants (FLG-/-) in n=41 (14%), mono-allelic pathogenic variants (FLG-/+) in n=64 (23%) and wild-type alleles (FLG+/+) in n=180 (63%). Three novel pathogenic variants were found. We observed no clinically relevant differences in EASI, IGA, NRS pruritus, DLQI and total POEM scores for patients with and without pathogenic FLG variants at all time points. The FLG-/- group showed significantly higher POEM flaking and dryness scores at week 16 (p<0.001 and p=0.002, respectively) and 52 (p<0.001 and p=0.016, respectively) compared to FLG+/+, and also significant differences compared with FLG-/+, while differences in delta scores were non-significant. ConclusionThis study suggests that the effectiveness of dupilumab treatment in AD patients was not influenced by pathogenic FLG variants. However, patients with bi-allelic pathogenic FLG variants tended to have a drier skin before and during dupilumab treatment compared to patients with mono-allelic pathogenic variants or wild-type alleles.

Health literacy in adult patients with atopic dermatitis: A cross-sectional study

BackgroundHealth literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand health information and services needed to make appropriate health decisions. Patients with limited health literacy are less likely to manage chronic diseases appropriately. ObjectiveTo assess the prevalence of limited health literacy in patients with atopic dermatitis (AD), and its association with other patient-reported outcomes. MethodsA cross-sectional questionnaire-based study was conducted at a tertiary referral centre for AD. Patients diagnosed with AD by a dermatologist between 2019 and 2021 were identified from medical records. Perception-based health literacy was assessed by the European Health Literacy Survey Questionnaire 16 (HLS-EU-Q16) and performance-based health literacy by the Newest Vital Sign (NVS). Patients completed the Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and Atopic Dermatitis Control Tool (ADCT) to measure AD severity, quality of life and AD disease control, respectively. ResultsIn total, 322 patients were included (response rate 48.3%). Based on the HLS-EU-Q16, 32.4% had limited health literacy (8.4% inadequate and 24.0% problematic) which was associated with impaired quality of life. According to the NVS, 20.3% had inadequate health literacy which was associated with older age. ConclusionUp to one-third of the patients with AD showed signs of limited health literacy, which was associated with impaired health related quality of life and older age. Further research should evaluate the influence of inadequate health literacy on health outcomes and focus on strategies to improve organizational health literacy to eventually enhance patient-centered care.

Patients with Atopic Dermatitis Not on Systemic Therapy have High Rates of Severe, Uncontrolled Disease, and Considerable Impact on Quality of Life

Patients with atopic dermatitis not on systemic therapy have high rates of severe, uncontrolled disease and considerable impact on quality of life&#x0D; Eric Simpson1, Christian Fenske2, Alvin Li3, Zach Dawson2, Yolanda Muñoz Maldonado3, Kaylee Ho3, Kayla Callahan3, Linda Stein Gold4, Seemal Desai5, Alexandra Golant6, Douglas DiRuggiero7, Jonathan I Silverberg8&#x0D; 1Oregon Health &amp; Science University, Portland, Oregon, USA; 2Eli Lilly and Company, Indianapolis, USA; 3CorEvitas LLC, Waltham, Massachusetts, USA; 4Henry Ford Health System, Michigan, USA; 5Innovative Dermatology, PA, Texas, USA; 5The University of Texas Southwestern Medical, Dallas, Texas, USA; 6Icahn School of Medicine at Mount Sinai, New York, USA; 7Skin Cancer and Cosmetic Dermatology Center, Rome, Georgia, USA; 8George Washington University School of Medicine and Health Sciences, Washington, DC, USA&#x0D; Background: Decision to initiate a new systemic therapy (ST) among patients with atopic dermatitis (AD) is complex. This cross-sectional study explored overall disease burden, sociodemographic and clinical characteristics, and disease activity among patients with moderate-to-severe AD.&#x0D; Methods: Adult patients with AD who had a vIGA-ADTM score ≥3 and Eczema Area Severity Index (EASI) score ≥12 at enrollment were identified from the prospective, longitudinal CorEvitas AD Registry between 07/21/2020 and 12/31/2022. Included patients were newly prescribed an eligible ST (ST group) or not prescribed an eligible ST (non-ST group) at enrollment. Patients on ST before enrollment were excluded. Sociodemographic characteristics, disease features, severity measures (vIGA-ADTM [0–4]; body surface area (BSA) [0–100%]; EASI [0–72]), and patient-reported outcomes (PROs) were assessed. PROs included Dermatology Life Quality Index (DLQI) [0-30], Itch/Pruritus Numeric Rating Scale [0-10], Patient-Oriented Eczema Measure (POEM) [0-26], and AD Control Tool (ADCT) [&lt;7 controlled, &gt;7 not controlled]. Differences in means or proportions of characteristics among ST and non-ST groups were summarized using effect sizes (ES).&#x0D; Results: The study included 673 (mean age=50.7 years, 55.6% female) patients who were newly prescribed ST and 229 (47.8 years, 51.3%) who were not prescribed ST. The overall distribution of race (Whites 70.4% vs. 60.5%, Asians 8.6% vs. 17.5%, Black 13.7% vs. 8.3%, Other 7.3% vs. 13.6%; ES=0.17) and geographic region (West 8.5% vs. 28.4%, South 32.1% vs. 15.7%; ES=0.27) had small differences between the ST and non-ST groups. More patients (n=402 [59.7%]) in the ST group had severe AD (vIGA-ADTM=4), whereas moderate AD (vIGA-ADTM=3) was more common (n=137 [59.8%]) in the non-ST group. Higher disease severity was reported in the ST group versus non-ST group: BSA (mean [SD]: 41.6% [17.1] vs. 31.5% [16.0]; ES=0.61) and EASI (24.3 [10.1] vs. 19.8 [8.6]; ES=0.47). Mean [SD] PRO measures were also higher in the ST group compared to non-ST group: DLQI (11.7 [7.5] vs. 10.4 [7.9]; ES=0.17), mean peak pruritus in the past 24 hours (6.8 [2.9] vs. 6.1 [3.1]; ES=0.25), POEM (17.8 [7.1] vs. 16.6 [7.5]; ES=0.17), and ADCT (14.4 [6.1] vs. 13.0 [6.7]; ES=0.21).&#x0D; Conclusion: Patients not initiating ST have high rates of severe, uncontrolled AD, and considerable burden from their disease, indicating potential delayed or undertreatment. Understanding the factors that influence the decision to escalate therapy in systemic-eligible patients is important for improving care of AD.&#x0D;  &#x0D; Disclosures&#x0D; Eric Simpson: Dr. Simpson reports personal fees from Advances in Cosmetic Medical Derm Hawaii LLC, AbbVie, Amgen, AOBiome LLC, Arcutis Biotherapeutics, Arena Pharmaceuticals, Aslan Pharma, Boehringer-Ingelheim USA, Inc., Boston Consulting Group, Bristol Myers Squibb – BMS, Collective Acumen LLC (CA), CorEvitas, Dermira, Eli Lilly, Evelo Biosciences, Evidera, ExcerptaMedica, FIDE, Forte Bio RX, Galderma, GlaxoSmithKline, Incyte, Janssen, Johnson &amp; Johnson, Kyowa Kirin Pharmaceutical Development, Leo Pharma, Medscape LLC, Merck, MauiDerm, MLG Operating, MJH holding, Pfizer, Physicians World LLC, PRImE, Regeneron, Revolutionizing Atopic Dermatitis Inc., Roivant, Sanofi-Genzyme, Trevi therapeutics, Valeant, Vindico Medical education, WebMD.  Dr. Simpson reports grants (or serves as Principal investigator role) from AbbVie, Acrotech Biopharma Inc., Amgen, Arcutis, Aslan, Castle Biosciences, CorEvitas, Dermavant, Dermira, Eli Lilly, Incyte, Kymab, Kyowa Kirin, National Jewish Health, Leo, Pfizer, Regeneron, Sanofi, and Target RWE. These potential conflicts of interest have been reviewed and managed by OHSU.&#x0D; Christian Fenske: Employment and stockholder, Eli Lilly and Company.&#x0D; Alvin Li: Employee of CorEvitas, LLC and stockholder, Eli Lilly and Company.&#x0D; Zach Dawson: Employment and stockholder, Eli Lilly and Company.&#x0D; Yolanda Muñoz Maldonado: Employee of CorEvitas, LLC.&#x0D; Kaylee Ho: Employee of CorEvitas, LLC.&#x0D; Kayla Callahan: Employee of CorEvitas, LLC and stockholder, Eli Lilly and Company.&#x0D; Linda Stein Gold: Investigator, advisor and/or speaker for Lilly, BMS, UCB, Pfizer, Sanofi, Regeneron, Dermavant, Arcutis, Sun, Incyte, Leo, Aslan.&#x0D; Seemal Desai: Dr. Desai is currently performing paid consulting services. He has previously been an advisor for Lilly and also performed consulting and/or clinical for multiple organizations.&#x0D; Alexandra Golant: Dr. Golant has received consulting or speaker fees from: Regeneron, Sanofi, AbbVie, Incyte, Dermavant, Lilly, Leo Pharma, Arcutis, Janssen, Amgen, Pfizer.&#x0D; Douglas DiRuggiero: Industry speaker bureau and advisory boards: AbbVie, Amgen, Arcutis, BMS, Incyte, Janssen, Lilly, Novartis, Sanofi/Regeneron, UCB.&#x0D; Jonathan I. Silverberg: Jonathan Silverberg has received honoraria as a consultant and/or advisory board member for AbbVie, AOBiome, Arcutis, Alamar, Amgen, Arena, Asana, Aslan, BioMX, Biosion, Bodewell, Boehringer-Ingelheim, Cara, Castle Biosciences, Celgene, Connect Biopharma, Dermavant, Dermira, Dermtech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo Pharma, Menlo, Novartis, Optum, Pfizer, RAPT, Regeneron, Sanofi-Genzyme, Shaperon, Union; speaker for AbbVie, Eli Lilly, Leo Pharma, Pfizer, Regeneron, Sanofi-Genzyme; institution received grants from Galderma, Pfizer.