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Background: The German S2k guideline is the first to include a checklist that captures atopic dermatitis (AD) signs and symptoms as well as the lack of treatment response to identify patients eligible for systemic therapy. Objectives: Identifying candidates for a start/switch of systemic therapy in adult AD patients in Germany by applying the S2k guideline's checklist. Methods: In this German multicentre, cross‐sectional, non‐interventional study (German Clinical Trials Register number: DRKS00023296), adult patients with mild to severe AD were enrolled at dermatological outpatient clinics and offices between April and October 2021. Demographics, clinical characteristics and quality of life were collected using questionnaires during one single visit. Eligibility for a start/switch of systemic AD therapy was evaluated according to the criteria of the German S2k guideline's checklist. Results: Atopic dermatitis patients (575) were included in the analysis. One hundred and sixty‐four patients (28.5%) received systemic (SYS) AD therapy and 411 patients (71.5%) did not (TOP). Of the TOP therapy patients, 38.7% were eligible to start systemic AD therapy, and about half of those (49.1%), were scheduled to start systemic AD therapy. The most frequent reason deciding against a systemic therapy was the patient's wish. Although 29.3% of SYS patients were eligible for a switch according to the criteria of the German S2k guideline's checklist, the majority (81.3%) did not switch AD therapy. Conclusions: This is the first study on the implementation of the German S2k guideline's checklist in everyday care of AD patients in Germany. More than one‐third of the TOP patients were identified as eligible for systemic treatment. By applying the guideline's checklist criteria, another one‐third of SYS patients may have benefited from a change of current systemic therapy. The use of the German S2k guideline's checklist in routine care represents an important tool to ensure effective patient care and identify inadequately treated patients. [ABSTRACT FROM AUTHOR]

A large cohort study conducted in Germany found that individuals who had previously been infected with COVID-19 had a 33% increased risk of developing atopic dermatitis (AD), a chronic inflammatory skin disease. The study analyzed routine healthcare data and matched 641,704 COVID-19 patients with 1,907,992 control cases. The risk of new-onset AD was significantly increased in all age groups, both sexes, and medication groups. However, the study's observational nature means that causal conclusions should be drawn with caution. Further research is needed to understand the impact of the COVID-19 pandemic on the global burden of AD. [Extracted from the article]

Background: The advent of biologics and janus kinase inhibitors has revolutionized treatment of atopic dermatitis (AD). Objective: To investigate preferences of patients with AD for attributes of currently approved systemic treatments and assess influencing factors. Methods: An online discrete choice experiment was conducted in patients with AD throughout Germany to analyze preferences for outcome (probability of (almost) clear skin at week 16, probability of significant itch improvement, time to onset of itch relief and type of side effects) and process attributes (application method and frequency of laboratory tests). Results: Participants (n=182, 75.3% female) considered side effects (Relative Importance Score (RIS): 31.2), (almost) clear skin (RIS: 24.2) and probability of itch improvement (RIS: 16.0) most important. Application method (RIS: 14.4), time to onset of itch relief (RIS: 7.4) and frequency of laboratory tests (RIS: 6.8) were less relevant. Preferences were significantly influenced by sex, age, psychiatric comorbidity, current therapy and health-related quality of life according to multivariate regression analysis. Conclusions: Participants attached great importance to safety and symptom control. However, preferences were also dependent on individual characteristics, underscoring the importance of personal counseling. Conjoined with medical considerations, patients’ preferences have fundamental impact on shared decisions for treatment of AD. [ABSTRACT FROM AUTHOR]

Introduction: Dupilumab has significantly improved the signs, symptoms and quality of life (QoL) of patients with moderate-to-severe atopic dermatitis (AD) in randomised, controlled clinical trials. However, there is a need to assess the effectiveness and safety of dupilumab in real-world clinical practice. The PROLEAD study was designed to examine the effectiveness and safety of dupilumab in moderate-to-severe AD in a real-world setting in Germany. Here, we present 12-week effectiveness and safety results with dupilumab from PROLEAD. Methods: PROLEAD is a multicentre, prospective, non-interventional study being conducted at 126 routine care sites across Germany. Adults with moderate-to-severe AD who require systemic therapy were treated with dupilumab as indicated by the Summary of Product Characteristics. Data collected included physician assessments (EASI, BSA, SCORAD, and IGA) and patient-reported outcomes (PROs [POEM, DLQI, EQ-5D-5L, Peak Pruritus NRS and MOS Sleep Scale]). Results: Of 839 patients assessed for eligibility, 828 were included. The full analysis and safety analysis sets comprised 775 and 818 patients, respectively. The number of patients receiving concomitant therapy decreased from baseline to Week 12. Mean (standard deviation [SD]) percentage change in EASI score from baseline to Week 12 was –67.5% (48.4%) and was comparable across the four body regions. The proportion of patients achieving EASI-75 was 59.4% at Week 12. Mean (SD) Peak Pruritus NRS decreased from 7.4 (2.3) at baseline to 3.4 (2.6) at Week 12. Improvements from baseline to Week 12 were reported in all PROs assessed. No new safety signals were observed. Discussion: Improvements in efficacy outcomes and adverse event rates in a real-world setting were more favourable than in phase 3 clinical trials. Conclusions: The 12-week findings of PROLEAD demonstrate that treatment with dupilumab is effective and well tolerated, with rapid onset of action in signs, symptoms and QoL in patients with moderate-to-severe AD in the real world. Trial Registration Number: DUPILL08907; NIS-Nr. 433. [ABSTRACT FROM AUTHOR]

We explored patient satisfaction with baricitinib, an oral Janus kinase inhibitor, in patients with atopic dermatitis (AD) treated in routine clinical practice. Adults with moderate-to-severe AD treated with baricitinib in clinical practice for ≥4 weeks in France, Germany, and the UK completed a one-time online survey under market research methodologies. Treatment satisfaction was assessed using a Likert scale and abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9). Patients reported demographic, disease, and treatment information. Data were analyzed descriptively. The survey was completed by 170 patients with a mean age of 39.3 years (SD = 13.5), 59% (n = 101) were female. At baricitinib initiation, 79% rated their AD as "Severe", yet 28% reported body surface area (BSA) involvement ≥10%. Most were "Satisfied" or "Very satisfied" (76%/18%) with baricitinib, with high rates reported for controlling itch (36%/56%). Itch improvements were noted by 97% of patients. Some tapered/stopped (50%/32%) topical corticosteroid use, aligned with reported improvements on the patient global assessment and BSA. Mean TSQM-9 convenience score was 78.0 (SD = 14.0). Satisfaction with itch control was particularly high, reflected in rates of improvement in itch since starting baricitinib. On the TSQM-9, the convenience score was the highest. Many patients tapered/stopped concomitant topicals, indicating baricitinib's effect in controlling AD symptoms. [ABSTRACT FROM AUTHOR]

Background: Recap of atopic eczema (RECAP) is a patient‐reported outcome measure assessing eczema control. This instrument has been developed and validated in the UK. There are self‐reported and proxy‐reported versions in English, Dutch and German. However, it is unclear whether the self‐reported version shows adequate content validity when completed by young people (8–16 years) in these languages. Objectives: To assess the content validity (comprehensibility, relevance and comprehensiveness) of the English, German and Dutch versions of the self‐reported RECAP in young people with atopic eczema and to identify the most appropriate age cutoff for self‐completion. Methods: We conducted 23 semistructured cognitive interviews with young people aged 8–16 years, using the 'think‐aloud' method. In Germany and the Netherlands, participants were recruited in dermatology clinics and in the UK through social media and existing mailing lists. Interviews were audio recorded, transcribed verbatim and analysed in the three languages, using a problem‐focused coding manual. Transcripts were coded by two independent reviewers in each country. Themes were translated into English and compared across the three countries. Results: Significant age‐related comprehensibility issues with the last three items of the questionnaire occurred with young people aged 8–11 years, causing difficulties completing RECAP without help. However, older children had only minor problems and were able to complete the questionnaire by themselves. The self‐reported version of RECAP has sufficient content validity for self‐completion in young people aged 12 years and above. However, the German version with some translational adaptations may be appropriate for children from the age of 8 years. There may be some situations where the proxy version is needed for older children too. Conclusions: The self‐reported version of RECAP is appropriate for use from the age of 12 years. The proxy version can be used in children younger than 12 years. Other measurement properties should be further investigated. What is already known about this topic?Recap of atopic eczema (RECAP) is an instrument recommended by the Harmonising Outcome Measures for Eczema initiative for the core outcome domain of long‐term control of atopic eczema.Content validity of RECAP for self‐completion by adults and of the proxy version has been assessed. What does this study add?In this study, content validity (comprehensibility, relevance and comprehensiveness) of the self‐reported version of RECAP among young people (aged 8–16 years) with atopic eczema across the UK, Germany and the Netherlands is assessed.Based on these findings, key recommendations on how to measure eczema control in young people with atopic eczema are formulated. What are the clinical implications of this work?The Dutch, English and German self‐completion versions of RECAP are recommended for use in adolescents from the age of 12 years.The proxy version could be used in children younger than 12 years or where children are cognitively or physically incapable of reporting their experience of eczema control.Caregivers should be encouraged to complete RECAP together with their child where possible. [ABSTRACT FROM AUTHOR]

Introduction/Background Tralokinumab is a high-affinity, fully human IgG4 monoclonal antibody that specifically targets interleukin-13, a key driver of atopic dermatitis (AD) disease progression. Clinical trials have shown that tralokinumab is efficacious in patients with moderate-to-severe AD and has a favorable safety profile, including a low frequency of adverse events such as conjunctivitis. Management of patients in routine clinical practice differs from those enrolled in clinical trials due to strict protocol criteria, and there is a lack of clinical data on tralokinumab use in the real-world setting. Objectives: TRACE is a real-world study in patients with AD, aiming to better understand the effectiveness, safety, and clinical use of tralokinumab in daily practice. Here, we describe baseline characteristics from the first patients enrolled into TRACE in Germany. Methods: TRACE is an observational, prospective, single-cohort study of adult patients with moderate-to-severe AD who are treated with tralokinumab, according to national approved labels. Eleven countries are participating in the study across Europe, North America and the Middle East. The primary objective is to assess changes in clinical signs and symptoms of AD in tralokinumab-treated patients. Secondary objectives are to investigate safety, quality of life, patient-reported outcomes and treatment adherence, among others. Results: Of the first 100 patients initiated on tralokinumab, the mean age (standard deviation [SD]) was 44.7 years (17.9) and 58% were male. Most patients had moderate-to-severe AD with a mean Investigator's Global Assessment (IGA) score of 3.5 (SD 0.7) and mean Eczema Area and Severity Index (EASI) of 22.5 (SD 12.9). Patients reported heavy symptomatic burden of disease; the mean eczema-related sleep numerical rating scale (NRS) was 5.6 (SD 2.9) and mean worst daily pruritus NRS was 6.2 (SD 2.7). Patients also reported a substantial impact on quality of life, demonstrated by a mean Dermatology Life Quality Index of 15.6 (SD 6.9). Overall, 79 patients were biologic-naïve and 19 were biologic-experienced (data missing; n=2). All biologic-experienced patients were previously treated with dupilumab, of whom most experienced one or more treatment failures. Reasons for switching from dupilumab included lack or loss of effectiveness, and adverse events, which most commonly included conjunctivitis. Conclusions: Initial findings showed that most adult patients with moderate-to-severe AD who were treated with tralokinumab were biologic-naïve, indicating tralokinumab is prescribed as firstline systemic treatment in real-world clinical practice, in line with European Dermatology Forum guidelines. The main reasons for switching from dupilumab were lack or loss of effectiveness, and adverse events, such as conjunctivitis, indicating the need for alternative biologic treatments such as tralokinumab. [ABSTRACT FROM AUTHOR]

Introduction: Dupilumab is the first biologic licensed to treat patients with moderate-to-severe atopic dermatitis (AD) who require systemic therapy. PROLEAD was designed to document the real-world effectiveness and safety of dupilumab in patients with moderate-to-severe AD. The present study aims to describe the baseline characteristics of patients treated with dupilumab in Germany. Methods: PROLEAD is a national, multicentre, prospective, non-interventional study, with a 2-year observation period. Adults with moderate-to-severe AD treated with dupilumab were included. Baseline characteristics, physician assessments, and patient-reported outcomes (PROs) were collected. Results: The study involved 126 sites throughout Germany. Of 839 patients assessed for eligibility, 828 were included, with baseline data available for 817 patients. Mean (standard deviation, SD) age of patients was 43.4 (15.8) years, with 396 (48.5%) patients being female. Overall, 66.6% of patients received their first diagnosis of AD during childhood. In total, 423 (51.8%) patients had co-existing atopic and type 2 inflammatory diseases, including allergic conjunctivitis (36.8%) and bronchial asthma (22.5%). Overall, 61.4% of patients had received systemic therapy, most commonly oral corticosteroids (49.9%). Approximately half of patients (51.3%) had received UV/phototherapy prior to baseline. Treatment with moderate-potent (Class 2) or potent (Class 3) topical corticosteroids was the most common concomitant treatment at baseline. However, 50.4% of patients had not received concomitant AD treatment with dupilumab at baseline. The most reported reason for initiating dupilumab was "Topical therapy alone was not sufficient" (95.1%). Mean (SD) physician assessments: EASI: 22.9 (14.5); SCORAD: 63.3 (16.2); IGA: 3.3 (0.7). Mean (SD) PROs: DLQI: 13.9 (7.1); peak pruritus NRS: 7.4 (2.3). Conclusions: Patients with moderate-to-severe AD present a long medical history, impaired quality of life, and high prevalence of co-existing type 2 inflammatory diseases. Dupilumab was used as a first-line systemic treatment in 38.6% of patients. [ABSTRACT FROM AUTHOR]

Background and objectives: The economic burden of atopic dermatitis (AD) is of particular interest. The present study aims to analyse the association of disease‐related characteristics, annual costs and treatment benefits in AD. Methods: Between August 2017 and June 2019, a cross‐sectional observational study in patients with AD was conducted in Germany. Cost‐of‐illness data were assessed from the societal perspective. Disease characteristics included severity, time since diagnosis and therapy, as well as atopic comorbidity and the implementation of prevention measures. Subgroup analyses of the total costs were conducted for these characteristics. A linear regression model was applied to analyse the impact of disease characteristics on the costs. Furthermore, associations of biologic treatment with outcome parameters were analysed. Results: A total of 1291 patients from 111 centres were included in the analyses. The total costs amounted on average to € 3660 ± € 6428 per patient and year. Higher costs were shown in various patient groups, for example, in patients using biologics (€ 20 983 vs. € 2470). In a regression analysis, gender, education and the number of implemented prevention measures were identified as significant predictors of costs. Patients treated with biologics showed consistently better outcome parameters and were more often satisfied with their treatment. Conclusions: Gender, education and implemented prevention measures are significant cost determinants in AD. The results confirm that treatment with biologics is the main cost driver in AD. However, incremental patient‐relevant benefits of high‐priced therapy are reflected by the significantly better clinical outcomes in the group treated with biologics. [ABSTRACT FROM AUTHOR]

Background: Parent self‐administered reports are commonly used in studies on childhood atopic dermatitis (AD) but data on its validity are sparse. We aimed to examine the agreement between parent‐ and physician‐reported measures of childhood AD throughout early life and identify the determinants. Methods: In this prospective cohort study, we used data of 449 infants and their mothers recruited in the Ulm SPATZ Health Study in Germany. Longitudinal data of parental and children's caring physicians' reports were used to assess the point and cumulative agreement of parent‐ and physician‐reported AD diagnoses, AD onset age, and trend of agreement at child ages between 1 and 6 years overall and by child and parent demographics and health conditions. A Generalized Estimating Equation model was fitted to identify factors associated with the sensitivity of parent reports. Results: The point agreement between parent‐ and physician‐reported AD was substantial at the age of 1 (kappa = 0.63, 95% CI: 0.51–0.75) but declined with age and became fair after the age of 3 (kappa < 0.40). The cumulative agreement remained moderate at the age of 6 (kappa = 0.51, 95% CI: 0.43–0.60). Parents had a bias towards delayed reporting of the AD onset age. The AD severity was the only strong determinant for the agreement of AD diagnoses and largely explained the variance of the sensitivity of parent reports. Conclusion: The disagreement between parent‐ and physician‐reported AD increases with child age, likely due to the change of AD severity. Using parent‐reported data might miss a substantial portion of mild childhood AD cases. [ABSTRACT FROM AUTHOR]

Introduction: Atopic dermatitis (AD) is a common inflammatory skin disease. Many patients are initiating a systemic therapy, if the disease is not adequately controlled with topical treatment only. Currently, there is little real-world evidence on the AD-related medical care situation in Germany. This study analyzed patient characteristics, treatment patterns, healthcare resource utilization and costs associated with systemically treated AD for the German healthcare system. Methods: In this descriptive, retrospective cohort study, aggregated anonymized German health claims data from the InGef research database were used. Within a representative sample of four million insured individuals, patients with AD and systemic drug therapy initiation (SDTI) in the index year 2017 were identified and included into the study cohort. Systemic drug therapy included dupilumab, systemic corticosteroids (SCS) and systemic immunosuppressants (SIS). Patients were observed for one year starting from the date of SDTI in 2017. Results: 9975 patients were included (57.8% female, mean age 39.6 years [SD 25.5]). In the one-year observation period, the most common systemic drug therapy was SCS (> 99.0%). Administrations of dupilumab (0.3%) or dispensations of SIS were rare (cyclosporine: 0.5%, azathioprine: 0.6%, methotrexate: 0.1%). Median treatment duration of SCS, cyclosporine and azathioprine was 27 days, 102 days, and 109 days, respectively. 2.8% of the patients received phototherapy; 41.6% used topical corticosteroids and/or topical calcineurin inhibitor. Average annual costs for medications amounted to € 1237 per patient. Outpatient services were used by 99.6% with associated mean annual costs of € 943; 25.4% had at least one hospitalization (mean annual costs: € 5836). 5.3% of adult patients received sickness benefits with associated mean annual costs of € 5026. Conclusions: Despite unfavorable risk–benefit profile, this study demonstrated a common treatment with SCS, whereas other systemic drug therapy options were rarely used. Furthermore, the results suggest a substantial economic burden for patients with AD and SDTI. [ABSTRACT FROM AUTHOR]

Background: Atopic dermatitis (AD) is one of the most common chronic skin diseases worldwide, showing various manifestations and having a severe impact on quality of life. As previous studies demonstrated, internet search analysis can help identify public interest in diseases and possible influencing factors on search behavior. Objective: To identify AD‐related topics of interest in Germany using internet search volume. Methods: Google Ads Keyword Planner was used to identify AD‐related search terms including their search volume in Germany on a national level as well as in 16 selected cities from January 2016 to December 2019. Identified keywords were qualitatively analyzed, and temporal trends as well as the influence of seasonal and environmental factors on search volume were assessed. Results: Overall, 1222 AD‐related search terms with a search volume of 8 842 360 searches were identified. An increase from 2016 to 2019 and seasonal peaks from January to April of each year were observed. Nationwide, the search volume correlated with mean monthly temperature and sun duration. With increasing temperature and sun duration, a significant decrease in search queries was observed. The most populated cities showed the lowest number of searches per 100 000 inhabitants (Berlin, Hamburg, and Munich). In the eight categories formed (comorbidities, general, influential factors, localization, stage of life, symptoms/severity, therapy/information, and questions on AD), the highest proportion of search queries were assigned to the category "therapy/information" in most cities. In this category, a focus on the topics of "alternative medicine" and "home remedies" could be observed. Conclusion: The overall high and increasing search volume indicates a high interest in AD‐related topics, especially regarding treatment and disease education. Information provided by internet search volume analyses can optimize AD therapy and patient‐centered care by providing insight into patient needs and predicting potential climatic trigger factors. [ABSTRACT FROM AUTHOR]

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease with a multifactorial genesis including genetic predispositions and environmental risk and trigger factors. One of the latter possibly is smoking, indicated by an increased prevalence of AD in adults and children that are actively or passively exposed to cigarette smoke. Objectives: In this study, AD characteristics and its atopic comorbidities are compared in smoking and non‐smoking AD patients. Methods: TREATgermany is a non‐interventional clinical registry which includes patients with moderate to severe AD in Germany. Baseline data of patients included in TREATgermany from inception in June 2016 to April 2020 in 39 sites across Germany was analysed comparing AD disease characteristics and comorbidities in smokers vs. non‐smokers. Results: Of 921 patients, 908 (male: 58.7%) with a mean age of 41.9 ± 14.4 reported their smoking status. The objective Scoring of Atopic Dermatitis (oSCORAD) did not differ between smokers (n = 352; 38.8%) and non‐smokers, however, lesions' intensity of oozing/crusts and excoriations as well as patient global assessment scores (PGA) of AD severity were higher in smoking as opposed to non‐smoking patients. Smokers reported a lower number of weeks with well‐controlled AD and more severe pruritus than non‐smokers. Total IgE levels were more elevated in smokers and they displayed a younger age at the initial diagnosis of bronchial asthma. After adjustment for potential confounders, the increased intensity of oozing/crusts, the reduced number of weeks with well‐controlled AD and the greater pruritus remained different in smokers compared to non‐smokers. In addition, smoking patients with adult‐onset AD showed a 2.5 times higher chance of involvement of the feet. Conclusions: German registry data indicate that AD patients who smoke have a higher disease burden with a different distribution pattern of lesions in adult‐onset AD. Linked Commentary Valeria Aoki and Raquel Leão Orfali J Eur Acad Dermatol Venereol 2022; 36: 324–325. https://doi.org/10.1111/jdv.17901. [ABSTRACT FROM AUTHOR]

Background: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease worldwide and displays many atopic, but also non‐atopic comorbidities. Among the latter, mental health disorders such as depression have been extensively studied. However, data on addictions are still rare. Objectives: The aim of this study was to assess the prevalence of different kinds of addictions in adult AD patients using a single‐centre approach. Methods: This non‐interventional cross‐sectional study was performed from 03/2020 to 05/2020 at the Department of Dermatology of a large German university hospital. Participants with a diagnosis of AD confirmed by a dermatologist answered questions about disease severity (patient‐oriented eczema measure, POEM), quality of life (Dermatology Life Quality Index, DLQI) and smoking habits. They were screened for problematic alcohol consumption, drug abuse, internet addiction and pathological gambling using internationally established and validated questionnaires. Results: 157 patients (56.1% female; mean age of 49.9 ± 20.4) with an average POEM of 13.7 ± 7.5 and DLQI of 6.1 ± 5.4 were evaluated. 14.1% were identified as regular smokers, 12.1% screened positive for alcohol dependency, 6.4% for drug use disorders, 4.5% for Internet addiction and 3.2% for pathological gambling. Co‐occurrences of different addictions were observed, and a positive correlation was noted between DLQI scores and smoking. Conclusions: In summary, this study hints at elevated positive screening rates for problematic alcohol consumption, drug use disorders, Internet addiction and problem gambling compared with the general population. Screening routinely for addictions may improve patient‐centred health care of AD patients. [ABSTRACT FROM AUTHOR]

• This study included 30 950 patients diagnosed with COVID-19 • The prevalence of long-term (COVID-19-related) sick leave was 5.8% • Women and older individuals had a higher risk of long-term sick leave • Seven chronic diseases were positively associated with long-term sick leave To investigate the prevalence of, and the factors associated with, long-term sick leave in working-age patients diagnosed with COVID-19 in general practices in Germany. Patients aged 18–65 years diagnosed with COVID-19 in any of 1255 general practices in Germany between March 2020 and February 2021 were included in the study. Long-term sick leave was defined as sick leave of at least 4 weeks. The association between predefined independent variables and long-term sick leave was studied using an adjusted logistic regression model. This study included 30 950 patients diagnosed with COVID-19 (51.7% women, mean (standard deviation) age 41.5 (±13.0) years). The prevalence of long-term sick leave was 5.8%. Female sex, older age, and several conditions (noninfective enteritis and colitis; reaction to severe stress, and adjustment disorders; atopic dermatitis; mononeuropathies; reflux diseases; diabetes mellitus; and hypertension) were positively and significantly associated with long-term sick leave. Long-term sick leave was relatively rare in COVID-19 patients followed in general practices in Germany. These results should be confirmed or invalidated in other settings and countries. [ABSTRACT FROM AUTHOR]

Background Atopic diseases are among the most common chronic conditions in childhood. Causes of allergies are manifold. The aim of this paper is to evaluate risk factors for atopic diseases and unremitting wheeze and to examine if there is an association between measles, mumps and rubella (MMR) vaccination and atopic dermatitis, asthma and unremitting wheeze in Bavarian pre-schoolers. Methods Parents filled out a questionnaire on children's health and environmental and socioeconomic factors. The questionnaire was administered within the Health Monitoring Units in a cross-sectional study in Bavaria, Germany (2014/2015). Data on vaccinations were obtained via the School Entrance Examination, a mandatory examination for pre-school children in Bavaria. Rates of influential factors of atopic diseases and wheeze, MMR and DTP (diphtheria, pertussis and tetanus) vaccination were calculated for all children stratified by health outcomes. To examine if there is an association between MMR vaccination and health outcomes, a multiple logistic regression analysis was performed. Results Data were available for 3237 individuals. Symptoms and diseases were more frequent in boys. Higher parental education was associated with a higher prevalence of atopic dermatitis. There were no significant associations between any of the health outcome groups and MMR vaccination in the multiple logistic regression models with adjustment for potential confounders. Conclusions The present study is in line with the current state of research that MMR vaccination is not associated with atopic diseases. [ABSTRACT FROM AUTHOR]

Background: Progress in the management of atopic dermatitis (AD) and the recent introduction of the first biologic have raised interest in the costs of treating AD. Objectives: Since there is a lack of recent data, the objective of this study was to determine the annual costs of adults with AD from the societal perspective. Methods: A nationwide cross‐sectional study was conducted in 111 dermatological offices under routine conditions. Cost parameters were collected with a standardised questionnaire on disease‐related costs. This questionnaire allows the determination of costs for systemic and topical treatment, outpatient and inpatient visits, rehabilitation stays and travel costs. Direct costs were determined for the statutory health insurance (SHI) and for the patients (out‐of‐pocket costs). Societal costs also included the indirect costs due to incapacity to work. Costs were calculated for all severity grades and further stratified by mild and moderate‐to‐severe AD. Results: From August 2017 to June 2019, N = 1291 adult patients from all over Germany were included. The total annual costs in the group with all severity grades (n = 706) amounted to € 3616 ± € 6452 (median € 874) per patient. For patients with mild AD (n = 367), the annual costs were € 1466 ± € 3029 (median € 551) per patient, while they were € 5229 ± € 7538 (median € 1791) for patients with moderate‐to‐severe AD (n = 682). The total economic burden for treating adult patients with AD in Germany is estimated at more than € 2.2 billion. Conclusions: In total, the data from this study show that compared to for example psoriasis, AD has a moderate level of costs‐of‐illness in Germany. The approval of new therapies is expected to lead to markedly more resource utilisation in the next years. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to investigate the association between skin disorders and depression in children and adolescents in Germany.Methods: This retrospective case-control study was based on data from the Disease Analyzer database (IQVIA). The present study included children and adolescents diagnosed for the first time with depression in 185 pediatric practices between January 2017 and December 2019 (index date) and matched controls without depression. Chronic skin conditions documented within 12 months prior to the index date (i.e. date of first depression diagnosis) were included in the analyses if their prevalence was at least 0.5% in the study population. Associations between nine different skin disorders and depression (dependent variable) were analyzed in a conditional logistic regression model.Results: This study included 7,061 cases with depression and 7,061 matched controls without depression (mean age 11.3 (SD: 3.8) years; 53.4% female). Three disorders were significantly associated with depression: atopic dermatitis/eczema (OR = 1.50, 95% CI = 1.37-1.64), nail disorders (OR = 1.84, 95% CI = 1.20-2.82), and hair loss (OR = 1.84, 95% CI = 1.30-2.60). In sex-stratified regression analyses, atopic dermatitis/eczema (OR = 1.43, 95% CI = 1.26-1.61) and hair loss (OR = 2.04, 95% CI = 1.37-3.03), were significantly associated with depression in females, since only atopic dermatitis/eczema was associated with depression (OR = 1.58, 95% CI = 1.39-1.80) in males. However, strong non-significant association was additionally observed for nail disorders (OR = 2.07, 95% CI = 1.07-4.01), and pigmentation disorders (OR = 1.93, 95% CI = 1.05-3.54) in females.Conclusions: Some skin disorders are positively associated with depression in children and adolescents. Further research is needed for better understanding of the underlying mechanisms and mediating factors. [ABSTRACT FROM AUTHOR]

Tralokinumab is a high-affinity, fully human IgG4 monoclonal antibody that specifically inhibits interleukin-13 (IL-13), a key driver of atopic dermatitis (AD) disease progression. Clinical trials have shown that tralokinumab is efficacious in patients with moderate-to-severe AD and has a favorable safety profile, including a low frequency of adverse events (AEs) such as conjunctivitis. However, management of patients in routine clinical practice differ from those enrolled in clinical trials due to strict inclusion/exclusion criteria, and there is currently a lack of clinical data on tralokinumab use in the real-world setting. TRACE is an observational cohort study of patients with AD, which aims to better understand the effectiveness, safety and clinical use of tralokinumab in the real-world setting. This study aims to describe baseline characteristics and initial insights from the first 100 patients enrolled into TRACE in Germany. TRACE is a longitudinal, prospective, new user, noncomparative, observational, single-cohort study, with primary data collection of adult patients with AD who are treated with tralokinumab, according to national approved labels. The study is taking place across countries in Europe, North America and the Middle East. The primary objective is to assess changes in clinical signs and symptoms of AD in tralokinumab-treated patients. Secondary objectives are to investigate safety, quality of life, patient-reported outcomes and adherence, among others. This analysis includes the first 100 patients enrolled from 39 sites across Germany. Of the first 100 patients in TRACE initiated on tralokinumab in Germany, the majority were males. Most patients had moderate-to-severe disease as indicated by their mean Investigator's Global Assessment score and mean Eczema Area and Severity Index. Patients reported heavy symptomatic burden of disease, as demonstrated by their mean eczema-related sleep numerical rating scale (NRS) and mean worst daily pruritus NRS. Patients also reported a substantial impact on quality of life, as demonstrated by mean Dermatology Life Quality Index. Overall, approximately 4/5 of the patients were biologic-naïve. All biologic-experienced patients were previously treated with dupilumab, of whom most experienced one or more treatment failures. Reasons for switching from dupilumab included lack or loss of efficacy, and AEs, which included mainly conjunctivitis. Initial findings from the first 100 patients from TRACE in Germany showed that the majority of adult patients with moderate-to-severe AD treated with tralokinumab were biologic-naïve, indicating that tralokinumab is prescribed as first-line systemic treatment in the real world, in line with European Dermatology Forum guidelines. Of patients who switched from dupilumab, the main reasons for switching were lack or loss of efficacy, and conjunctivitis, indicating the need for an alternative biologic treatment such as tralokinumab. [ABSTRACT FROM AUTHOR]

Background: The diagnostic significance of the atopy patch test for the management of dermatitis possibly triggered by aeroallergens is still controversial. However, sufficiently large studies with routinely tested standardized aeroallergen patch test preparations in dermatitis patients are lacking. Objective: To evaluate the reaction frequency and the reaction profiles of 10 until mid‐2015 commercially available, standardized aeroallergen patch test preparations of the 'Stallerpatch' test series (Stallergenes, Antony Cedex, France) in a large multicentre patient cohort. Methods: A retrospective data analysis of patients with suspected aeroallergen‐dependent eczematous skin lesions was performed, who were patch tested in 15 Information Network of Departments of Dermatology‐associated clinics between 2000 and 2015. Patients were stratified according to their atopic dermatitis (AD) status. Results: The study group included 3676 patients (median age 41 years, 34.8% males, 54.5% AD). The most common aeroallergens causing positive patch test reactions were Dermatophagoides pteronyssinus (19.6%), Dermatophagoides farinae (16.9%), birch (6.2%), timothy grass (6.0%), cat dander (5.4%), mugwort (4.9%) and dog dander (4.6%). Reactions to other pollen allergen preparations, that is 5 grasses (3.2%), cocksfoot (2.1%) and plantain (1.6%), were less common. Positive patch test reactions to aeroallergens were consistently more frequent in patients with AD. These patients showed proportionally less dubious, follicular, irritant and weak positive reactions. Independent of AD status, a patient history of past or present allergic rhinitis was associated with an increased chance of a positive aeroallergen patch test reaction to pollen allergens. Conclusion: The aeroallergen patch test is a useful add‐on tool in clinical routine, especially in patients with AD and/or respiratory allergy. A patch test series comprising Dermatophagoides pteronyssinus, Dermatophagoides farinae, birch, timothy grass, cat dander and mugwort seems to be suitable. Controlled studies with specific provocation and elimination procedures are required to further evaluate the diagnostic significance of the proposed screening series. [ABSTRACT FROM AUTHOR]

Summary: Background: Sodium lauryl sulfate (SLS) is the best‐studied detergent in irritant contact dermatitis. In atopic dermatitis, the two major pathophysiological abnormalities concern skin barrier function and regulation of cutaneous immune responses. The probability of atopic skin diathesis can be assessed by comprehensive analysis of patient history, as well as clinical and laboratory findings, resulting in the Erlangen Atopy Score (EAS). Objectives: To investigate the impacts of (i) atopic skin diathesis according to the EAS and (ii) the physician‐assessed diagnoses 'atopic dermatitis', 'allergic rhinitis' and 'allergic asthma' on SLS skin reactions. Methods: This is a retrospective analysis of data from 2030 consecutive patients patch tested with SLS (0·25% aqueous) from two tertiary referral centres in Germany, from 2008 to 2014. Results: Patients with a high probability of atopic skin diathesis showed no significant increase in positive SLS reactions compared with patients without atopic skin diathesis (14·2% vs. 16·8%). The grading of positive SLS skin reactions (1–4) revealed no differences in patients with or without atopic skin diathesis. Furthermore, diagnoses of atopic dermatitis, allergic rhinitis or allergic asthma had no impact on positive SLS skin reactions in multivariate logistic regression analysis. Conclusions: We found no association of increased skin irritability to SLS with atopic skin diathesis, atopic dermatitis, allergic rhinitis or allergic asthma in a large patient cohort. It therefore seems that the test of skin irritability with SLS, which is currently common practice in many centres, does not allow prediction of susceptibility to irritant eczematous inflammation in atopic vs. nonatopic individuals. What's already known about this topic? Irritant contact dermatitis and atopic skin diathesis share impaired skin barrier function as a pathophysiological pattern.Sodium lauryl sulfate (SLS) is tested at 0·25% aqueous as an irritant control in patch testing, and hence the results might be affected by atopic skin diathesis. What does this study add? Challenging a long‐standing paradigm, we found no association of increased reactivity to SLS patch tests in individuals with atopic skin diathesis, atopic dermatitis, allergic rhinitis or allergic asthma in a large patient cohort.Thus, irritant control testing with SLS, which is useful in interpreting doubtful allergen patch test results, does not depend on individual atopy status. Linked Comment: Agner and Elsner. Br J Dermatol 2020; 183:13. Plain language summary available online Respond to this article [ABSTRACT FROM AUTHOR]

Summary: Background: Better understanding of the relationship between atopic dermatitis (AD) severity and health‐related quality of life (HRQoL) could help improve knowledge of a more effective treatment for people with AD. Objectives: To assess the relationship between AD severity and HRQoL and perception of AD symptoms in adults with moderate‐to‐severe AD in Europe and the U.S.A. Methods: Participants for this cross‐sectional, internet‐based survey were recruited from the larger population‐based National Health and Wellness Survey. AD severity was measured by Patient‐Oriented SCORing of AD. HRQoL was measured by the five‐level EuroQol‐5D, Dermatology Life Quality Index (DLQI) and Patient‐Oriented Eczema Measure (POEM). Results: Altogether, 1232 respondents were included: 1098 (89·1%) with moderate‐to‐severe AD [221 (20·1%) from France, 209 (19·0%) from Germany, 118 (10·7%) from the U.K. and 550 (50·1%) from the U.S.A.]. An additional 134 (10·9%) respondents with mild AD were included. Sociodemographic and clinical AD characteristics were similar between countries. In adults with moderate‐to‐severe AD, higher AD severity correlated with poorer HRQoL (Spearman's r = –0·38 and 0·61 for EQ‐5D and DLQI, respectively; both P < 0·001). AD severity was positively correlated with POEM (Spearman's r = 0·51; P < 0·001). People with moderate‐to‐severe vs. those with mild AD had poorer health outcomes (EQ‐5D, DLQI and POEM, P < 0·001 for all). These results were similar and consistent for the European and the U.S. populations separately. Conclusions: Higher AD severity is associated with poorer HRQoL across Europe and the U.S.A. This is a burden for patients and may provide encouragement for more effective management of AD. What's already known about this topic? Atopic dermatitis (AD) is associated with a detrimental effect on health‐related quality of life (HRQoL), including sleep disturbance, anxiety and depression.Limited data describing the relationship between different levels of AD severity and self‐reported HRQoL have been published. What does this study add? There is a positive association between increasing AD severity (Patient‐Oriented SCORing of AD) and decreasing HRQoL (EQ‐5D and Dermatology Life Quality Index) and the perception of AD symptoms (Patient‐Oriented Eczema Measure) from the patient's perspective.AD severity according to geographic locations was explored (France, Germany, the U.K., and the U.S.A.), showing that the decreasing HRQoL associated with increasing AD severity was quite consistent between the geographic locations. What are the clinical implications of this work? The results of this study showed that higher AD severity is associated with poorer HRQoL from the subject's perspective in both Europe and the US. This fact confirms that there is a burden for these patients and may provide encouragement for a more effective management of AD, especially among those with greater AD severity. Linked Comment: Rencz. Br J Dermatol 2020; 182:1083. [ABSTRACT FROM AUTHOR]

Background: Atopic eczema (AE) may be associated with several mental health problems. In Germany, existing data from selected patient cohorts may lead to misestimation of the problem. Objectives: We aimed to cross‐sectionally determine associations of AE with depression, anxiety, quality of life (QoL) and social interactions in subjects from the population‐based LIFE‐Adult‐Study. Methods: Subjects underwent standardized interviews (medical history) and answered standardized questionnaires [Centre of Epidemiologic studies‐Depression scale (CES‐D), Generalized Anxiety Disorder (GAD‐7), Lubben Social Network Scale (LSNS), Short Form Health Survey (SF‐8)]. We compared data from subjects with AE with those from subjects with selected other chronic/disabling diseases (cardiovascular, diabetes, cancer) and adjusted for selected sociodemographic parameters. Multivariate binary logistic regression was used for categorical variables, linear regression for continuous variables. Results: Out of 9104 adults included (57% female, median age 54 years), 372 (4.1%) had a history of AE. Compared with controls, subjects with AE showed higher scores for depressive symptoms (9.3% vs. 6.3%; P < 0.001) and anxiety (8.4% vs. 5.6%, P < 0.001). Odds ratio (OR) was 1.5 [CI 1.0; 2.3] (P = 0.031) for depression, which was comparable to OR in patients with a history of cancer (OR 1.6 [1–2.3], P = 0.001. OR for anxiety in AE was 1.5 [1.0; 2.2], P < 0.049, which was slightly higher than in diabetes mellitus (OR 1.2) and stroke (OR 1.4). Other than in diabetes and/or stroke, we did not find a significant association between AE and social isolation. QoL scores were lower in AE than in controls (mean 46.9 vs. 48.0, P < 0.001 for physical and 50.6 vs. 52.5, P < 0.001 for mental components). Conclusions: Subjects with AE showed higher values for depression and anxiety as well as lower QoL scores compared to controls. With regard to depression, odds in AE and cancer were hardly different. Medical care of AE patients should therefore include mental health evaluation and treatment if indicated. [ABSTRACT FROM AUTHOR]

Background: Atopic dermatitis (AD) is one of the most common chronic inflammatory diseases of the skin. Rare large‐scale data have been published on the prevalence of concomitant dermatoses. Objective: To analyse the prevalence and cutaneous comorbidity of AD in Germany. Methods: A cross‐sectional study on voluntary whole‐body skin checks by trained dermatologists in over 400 companies throughout Germany reflecting the adult working population was conducted. Prevalence ratios (PR) were calculated to compare dermatological comorbidity in employees with and without current AD. A logistic regression analysis controlling for age, sex and skin type revealed odds ratios (OR) of the occurrence of skin diseases in AD. Results: A total of N = 118 939 people were examined between 2006 and 2017 (43.2% female, mean age 43.2 ± 10.7 years, min. age 16 years, max. age 70 years). AD (point prevalence) was identified in 1.45% (men: 1.50%, women 1.39%) and decreased significantly with age. Self‐reported lifetime prevalence of AD was 4.95% (men: 3.72%, women: 6.55%). The following skin diseases were significantly more frequent in people with current AD: Contact dermatitis (PR: 3.38), hand eczema (PR: 4.62), exsiccation dermatosis (PR: 2.19), folliculitis (PR: 1.95) and port‐wine stains (PR: 1.49). Among those, folliculitis was the most frequent (prevalence in AD 16.42%). Controlled for age, sex and skin type, AD was significantly associated with – among others – hand eczema (OR: 3.96; 95% CI: 2.95–5.32), contact dermatitis (OR: 2.97; 95% CI: 1.50–5.88) and exsiccation dermatosis (OR: 1.78; 95% CI: 1.30–2.44). Psoriasis was significantly less frequent in people with AD (OR: 0.61; 95% CI: 0.39–0.94). Conclusion: In summary, cutaneous comorbidity is frequent and of great importance in people with AD, suggesting the need for comprehensive, dermatologically guided diagnostics in AD. [ABSTRACT FROM AUTHOR]

Background and purpose: There is a need for new treatment options for moderate-to-severe atopic dermatitis (AD) in adults. Dupilumab, a fully human anti-interleukin-4 receptor a monoclonal antibody, has recently been approved for this indication. Methods: A pooled analysis of a phase 2a (NCT01548404) and a phase 2b (NCT01859988) study and a subanalysis of the 2b study evaluated the efficacy and safety of subcutaneous dupilumab 300 mg once weekly (qw) and every 2 weeks (q2w) in adults with moderate-to-severe AD. Results: Dupilumab significantly improved clinical outcomes in both analyses at week 12. Itch was significantly improved in the pooled analysis as measured by peak pruritus Numerical Rating Scale, 5-dimension pruritus scale, and SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) pruritus scores (all p < .0001 vs. placebo at week 12). Sleep loss was significantly improved (SCORAD VAS sleep loss score; p < .0001 vs. placebo at week 12); similar results were shown for the q2w dose. Dupilumab had an acceptable safety profile. Conclusions: Consistent with previous studies, dupilumab qw and q2w significantly improved signs and symptoms of AD at week 12, including improvements in itch and sleep loss. Implications for practice: Subcutaneous dupilumab is an effective new treatment option for adults with moderateto- severe AD. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months. Methods: Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache. Results: Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022–12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036–10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118–6,460]; control: EUR 5,498 [5,326–5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770–1,818]; control: EUR 1,438 [1,414–1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients. Conclusion: The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group. [ABSTRACT FROM AUTHOR]

Background: After three decades of an increase in the prevalence of asthma and allergies, new findings show a plateau in the prevalence of industrialized nations. The objective of this study was to determine whether there was a change in the parent reported prevalence of asthma and allergies among Bavarian preschool children since 2004.Methods: A parent questionnaire was administered as part of the Bavarian school entrance examination in three cross-sectional studies from 2004/2005, 2006/2007 and 2012/2013. The questionnaire included items on allergy testing history, identified allergens, symptoms (e.g. wheezing, itchy eyes, rash), medically diagnosed asthma, hay fever and atopic dermatitis. Logistic regression was performed to observe time patterns and adjust for risk factors.Results: Data were available for 6350 (2004/2005), 6483 (2006/2007) and 5052 (2012/2013) individuals. Symptoms and diseases were more frequent in boys, except for allergies which affect the skin. From 2004 to 2012 the parent reported prevalence of asthma (2.6% to 2.8%), hay fever (4.7% to 4.0%) and atopic dermatitis (12.4% to 11.1%) either remained quite stable or decreased not significantly.Conclusions: Results from these three cross-sectional surveys of parent reports suggest that the parent reported prevalences of asthma and allergies are quite stable with small fluctuations since 2004 for Bavarian preschool children. Future research is needed to determine if this trend will continue. [ABSTRACT FROM AUTHOR]

Background: Data from early-stage studies suggested that interleukin (IL)-4 and IL-13 are requisite drivers of atopic dermatitis, evidenced by marked improvement after treatment with dupilumab, a fully-human monoclonal antibody that blocks both pathways. We aimed to assess the efficacy and safety of several dose regimens of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments.Methods: In this randomised, placebo-controlled, double-blind study, we enrolled patients aged 18 years or older who had an Eczema Area and Severity Index (EASI) score of 12 or higher at screening (≥16 at baseline) and inadequate response to topical treatments from 91 study centres, including hospitals, clinics, and academic institutions, in Canada, Czech Republic, Germany, Hungary, Japan, Poland, and the USA. Patients were randomly assigned (1:1:1:1:1:1), stratified by severity (moderate or severe, as assessed by Investigator's Global Assessment) and region (Japan vs rest of world) to receive subcutaneous dupilumab: 300 mg once a week, 300 mg every 2 weeks, 200 mg every 2 weeks, 300 mg every 4 weeks, 100 mg every 4 weeks, or placebo once a week for 16 weeks. We used a central randomisation scheme, provided by an interactive voice response system. Drug kits were coded, providing masking to treatment assignment, and allocation was concealed. Patients on treatment every 2 weeks and every 4 weeks received volume-matched placebo every week when dupilumab was not given to ensure double blinding. The primary outcome was efficacy of dupilumab dose regimens based on EASI score least-squares mean percentage change (SE) from baseline to week 16. Analyses included all randomly assigned patients who received one or more doses of study drug. This trial is registered with ClinicalTrials.gov, number NCT01859988.Findings: Between May 15, 2013, and Jan 27, 2014, 452 patients were assessed for eligibility, and 380 patients were randomly assigned. 379 patients received one or more doses of study drug (300 mg once a week [n=63], 300 mg every 2 weeks [n=64], 200 mg every 2 weeks [n=61], 300 mg every 4 weeks [n=65], 100 mg every 4 weeks [n=65]; placebo [n=61]). EASI score improvements favoured all dupilumab regimens versus placebo (p<0·0001): 300 mg once a week (-74% [SE 5·16]), 300 mg every 2 weeks (-68% [5·12]), 200 mg every 2 weeks (-65% [5·19]), 300 mg every 4 weeks (-64% [4·94]), 100 mg every 4 weeks (-45% [4·99]); placebo (-18% [5·20]). 258 (81%) of 318 patients given dupilumab and 49 (80%) of 61 patients given placebo reported treatment-emergent adverse events; nasopharyngitis was the most frequent (28% and 26%, respectively).Interpretation: Dupilumab improved clinical responses in adults with moderate-to-severe atopic dermatitis in a dose-dependent manner, without significant safety concerns. Our findings show that IL-4 and IL-13 are key drivers of atopic dermatitis.Funding: Sanofi and Regeneron Pharmaceuticals. INSET: Panel: Research in context.. [ABSTRACT FROM AUTHOR]

Background The successful treatment of atopic eczema ( AE) should result in the improvement of both physical symptoms and patient′s quality of life (QoL). This study was conducted using a sample of dermatologists throughout Germany. This is due to dermatologists being the main health care providers of AE. Objectives Obtaining reliable data on quality of care of AE from both the patient's and the physician's perspective. Methods This cross-sectional study assessed: the individual clinical history; dermatology-specific QoL ( DLQI); state of health ( EQ-5d- VAS); treatments; burden caused by disease and treatment; patient-defined treatment benefit ( PBI). Results Data from 1678 adult patients (60.5% female, mean age: 38.4 ± 15.9) were analysed. The most frequently used treatments during the last five years were emollients (90.4%) and topical corticosteroids (85.5%). In this study, 75.8% of the patients felt only moderately or not at all impaired by their treatment. The mean DLQI (0 = minimum-30 = maximum QoL impairment) was 8.5 ± 6.5. The EQ-5d- VAS (100 = best possible) was 63.6 ± 22.0 on average. 26.6% reported suffering 'often' or 'every night' from sleeplessness due to severe itching. Mean PBI was 2.4 ± 1.1 (4 = maximum benefit). Conclusions This study provides first data on the health care of adults with AE in Germany at a national level and reveals the need for a more effective care. Whereas most patients consider their treatment-related burden as low, the daily burden of the disease seems to be high: one third reports sleeplessness due to itching which indicates insufficient therapeutic regimes in these cases. A better implementation of the German national guideline for AE and a systematic analysis of the difficulties causing its limited effects is needed. [ABSTRACT FROM AUTHOR]

Background There is little knowledge about the costs of occupational hand eczema. Objectives To estimate the societal costs of patients with occupational hand eczema in Germany. Methods Resource use during the past year, disease severity and quality of life [Dermatology Life Quality Index (DLQI)] were gathered for patients with occupational hand eczema before they entered a special rehabilitation programme. Costs were calculated from the societal perspective. The analysis focused on all patients and the severity groups no signs/mild (group A) and moderate to severe (group B). Results One hundred and fifty-one patients were analysed, with a mean age of 44.9~years and a mean DLQI score of 10.9; 64.9% were male. Sickness absence was recorded for 62.9% of all patients (76.4~days on average in the last 12~months). Annual societal costs were €8799 per patient. Indirect costs represented 70% of total costs. Quality of life (DLQI) was statistically different across both severity groups (group A, 7.9; group B, 12.9), but direct treatment costs were not (€2705 versus €2610, respectively). There was a trend towards higher indirect costs in patients in severity group B (group A, €5120; group B, €6796). Conclusion The annual societal costs of patients with occupational hand eczema in this study are high, and similar to those for severe psoriasis and atopic dermatitis. [ABSTRACT FROM AUTHOR]

To cite this article: Mertens J, Stock S, Lüngen M, Berg AV, Krämer U, Filipiak-Pittroff B, Heinrich J, Koletzko S, Grübl A, Wichmann H-E, Bauer C-P, Reinhardt D, Berdel D, Gerber A. Is Prevention of Atopic Eczema with Hydrolyzed Formulas Cost-Effective? A Health Economic Evaluation from Germany. Pediatr Allergy Immunol 2012: 23: 597-604. Abstract Objective: The German Infant Nutritional Intervention (GINI) trial, a prospective, randomized, double-blind intervention, enrolled children with a hereditary risk for atopy. When fed with certain hydrolyzed formulas for the first 4 months of life, the risk was reduced by 26-45% in PP and 8-29% in intention-to-treat (ITT) analyses compared with children fed with regular cow's milk at age 6. The objective was to assess the cost-effectiveness of feeding hydrolyzed formulas. Patients and Methods: Cost-effectiveness was assessed with a decision tree model programmed in TreeAge. Costs and effects over a 6-yr period were analyzed from the perspective of the German statutory health insurance (SHI) and a societal perspective at a 3% effective discount rate followed by sensitivity analyses. Results: The extensively hydrolyzed casein formula would be the most cost-saving strategy with savings of 478 € per child treated in the ITT analysis (CI95%: 12 €; 852 €) and 979 € in the PP analysis (95%CI: 355 €; 1455 €) from a societal perspective. If prevented cases are considered, the partially whey hydrolyzed formula is cost-saving (ITT -5404 €, PP -6358 €). From an SHI perspective, the partially whey hydrolyzed formula is cost-effective, but may also be cost-saving depending on the scenario. An extensively hydrolyzed whey formula also included into the analysis was dominated in all analyses. Conclusions: For the prevention of AE, two formulas can be cost-effective or even cost-saving. We recommend that SHI should reimburse formula feeding or at least the difference between costs for cow's milk formula and the most cost-effective formula. [ABSTRACT FROM AUTHOR]

Resumen [ABSTRACT FROM AUTHOR]

Atopic dermatitis is a chronic, relapsing form of inflammatory skin disorder that is affected by genetic and environmental factors. We performed a genome-wide association study of atopic dermatitis in a Chinese Han population using 1,012 affected individuals (cases) and 1,362 controls followed by a replication study in an additional 3,624 cases and 12,197 controls of Chinese Han ethnicity, as well as 1,806 cases and 3,256 controls from Germany. We identified previously undescribed susceptibility loci at 5q22.1 (TMEM232 and SLC25A46, rs7701890, Pcombined = 3.15 × 10?9, odds ratio (OR) = 1.24) and 20q13.33 (TNFRSF6B and ZGPAT, rs6010620, Pcombined = 3.0 × 10?8, OR = 1.17) and replicated another previously reported locus at 1q21.3 (FLG, rs3126085, Pcombined = 5.90 × 10?12, OR = 0.82) in the Chinese sample. The 20q13.33 locus also showed evidence for association in the German sample (rs6010620, P = 2.87 × 10?5, OR = 1.25). Our study identifies new genetic susceptibility factors and suggests previously unidentified biological pathways in atopic dermatitis. [ABSTRACT FROM AUTHOR]

Background: SOLAR II is the 2nd follow-up of a population-based cohort study that follows the participants of ISAAC Phase Two recruited in Munich and Dresden in 1995/6. A first follow-up study was conducted 2002 and 2003 (SOLAR I). The aims of SOLAR II were to investigate the course of atopic diseases over puberty taking environmental and occupational risk factors into account. This paper describes the methods of the 2nd follow-up carried out from 2007 to 2009 and the challenges we faced while studying a population-based cohort of young adults. Methods: Wherever possible, the same questionnaire instruments were used throughout the studies. They included questions on respiratory and allergic diseases, domestic and occupational exposure and work related stress. Furthermore, clinical examinations including skin prick tests, spirometry and bronchial challenge with methacholine, exhaled nitric oxide (FeNO) and blood samples were employed at baseline and 2nd follow-up. As information from three studies was available, multiple imputation could be used to handle missing data. Results: Of the 3053 SOLAR I study participants who had agreed to be contacted again, about 50% had moved in the meantime and had to be traced using phone directories and the German population registries. Overall, 2904 of these participants could be contacted on average five years after the first follow-up. From this group, 2051 subjects (71%) completed the questionnaire they received via mail. Of these, 57% participated at least in some parts of the clinical examinations. Challenges faced included the high mobility of this age group. Time constraints and limited interest in the study were substantial. Analysing the results, selection bias had to be considered as questionnaire responders (54%) and those participating in the clinical part of the study (63%) were more likely to have a high parental level of education compared to non-participants (42%). Similarly, a higher prevalence of parental atopy (e. g. allergic rhinitis) at baseline was found for participants in the questionnaire part (22%) and those participating in the clinical part of the study (27%) compared to non-participants (11%). Conclusions: In conclusion, a 12-year follow-up from childhood to adulthood is feasible resulting in a response of 32% of the baseline population. However, our experience shows that researchers need to allocate more time to the field work when studying young adults compared to other populations. [ABSTRACT FROM AUTHOR]

Background Atopic eczema (AE) is a common dermatological condition that causes significant problems in everyday life and high levels of illness-related stress in substantial proportions of patients. The extent to which adult AE is associated with clinically relevant psychiatric morbidity is unclear. Objectives To investigate the association between adult AE and major psychiatric/psychosomatic disorders. Methods Case–control study utilizing the GKV database Saxony, an interdisciplinary administrative outpatient database from Germany. All patients documented as having AE at least twice within the study period (2003–2004) ( n = 3769, mean age 44 years) were individually matched by age and sex to 3769 controls without AE. Logistic regression models were fitted to investigate the relationship of AE with affective, stress-related, behaviour and schizophrenic disorders, considering sociodemographic characteristics, consulting behaviour and allergic comorbidities as potential confounding factors. Results Eczema was independently associated with affective [adjusted odds ratio (OR) 1·42, 95% confidence interval (CI) 1·13–1·79], stress-related (OR 1·55, 95% CI 1·35–1·77), behaviour (OR 1·52, 95% CI 1·03–2·23) and schizophrenic disorders (OR 2·12, 95% CI 1·22–3·71). For each psychiatric condition the likelihood of being affected significantly increased with each physician visit due to AE, suggesting that the risk of psychiatric comorbidity increases with the severity of AE. Conclusions This study indicates psychiatric comorbidity of adults with AE. Collaboration between dermatologists and mental health specialists may optimize medical care for a significant subgroup of patients with AE. [ABSTRACT FROM AUTHOR]

Background Allergic diseases have been increasing during the last decades. Previous studies suggest an impact of a variety of risk factors on the prevalence of food hypersensitivity. Objective Data of a cross-sectional population-based survey were analysed to study the prevalence of food hypersensitivity in females and males adjusted for age and education. Methods A population aged 18–79 years from a representative, randomly sampled survey studying 13 300 inhabitants from Germany (Berlin) was analysed. The Berlin study data were weighted with regard to age, sex, education and allergic diseases such as atopic dermatitis, rhinoconjunctivitis and asthma. Instruments for evaluation included mailed questionnaires, structured telephone interviews, physical examinations, detection of total IgE, skin prick tests and double-blind, placebo-controlled food challenge tests (DBPCFC). Results Three thousand two hundred and twenty-seven questionnaires were evaluated. The data show a significantly higher risk of self-reported symptoms in the female group, among persons with higher education and in the age group of 18–39 years. Among individuals with clinical symptoms, females were at lower risk of having positive skin prick tests [aOR=0.32; 95% CI (0.21–0.50); P<0.01] and having a raised total IgE [aOR=0.37; 95% CI (0.24–0.56); P<0.01], but showed a higher risk of non-IgE and IgE-mediated food hypersensitivity [aOR=2.27; 95% CI (1.31–3.93); P<0.01] than males. Based on weighted data, the point prevalence of adverse reactions to food resulted in 3.3% [95% CI (2.4–4.5%)] for women and 1.8% [95% CI (1.2–2.7%)] for men after DBPCFC. Conclusion From a general population survey conducted in Germany, we determined that women are at greater risk of having symptoms of food allergy and also at greater risk of having DBPCFC-confirmed symptomatic food allergy. However, among individuals with symptoms of food allergy, men have a higher prevalence of food-specific IgE-sensitization and of raised total IgE than women. [ABSTRACT FROM AUTHOR]

Background Prevalence studies of atopic diseases such as atopic dermatitis (AD), hay fever and allergic asthma have mostly been performed in children. Studies in the adult population are still rare. Objectives We estimated the lifetime prevalence of different atopic diseases in an elderly population in Saarland, Germany. Additionally we investigated the association between atopic diseases and sociodemographic factors including age, gender, duration of school education (as a proxy measure of socioeconomic status), family history, and size of place of residence. Methods This study was conducted between June 2000 and December 2002 in the State of Saarland, Germany. Participants aged 50–75 years ( n = 9961) were recruited by their general practitioner in the context of a general health screening examination. All filled out a standardized questionnaire and reported whether a physician had ever diagnosed an atopic disease (hay fever, AD or asthma). Results Overall, 9949 subjects (mean age 62 years, 45% men) were included in this analysis. The lifetime prevalence of reported AD, hay fever and asthma was 4·3%, 8·3% and 5·5%, respectively. Lifetime prevalence of AD and asthma among women, and lifetime prevalence of hay fever among both genders, strongly decreased with age. Duration of school education (≤ 9 years, 10–11 years, > 11 years) was strongly associated with AD (3·7%, 5·7%, 6·8%; P trend < 0·0001) and hay fever (7·2%, 11·2%, 12·8%; P trend < 0·0001), but only tentatively with asthma. Conclusions The lifetime prevalence of AD is considerably lower in the elderly compared with the prevalence reported among younger adults in recent studies. Adults with a longer duration of school education appeared to have a higher risk for atopic diseases. [ABSTRACT FROM AUTHOR]

Introduction: Infection with varicella-zoster virus (VZV) is known to facilitate secondary bacterial infection, which is cause for particular concern in children with atopic dermatitis. This 2-year study assessed the safety, reactogenicity, and immunogenicity of a live attenuated Oka strain varicella vaccine (Varilrix, GlaxoSmithKline Biologicals) in 160 children aged 1-9 years with atopic dermatitis randomized to vaccination at the start of either the 1st or 2nd study year (VAR-1Y and VAR-2Y, respectively). Mean SCORing Atopic Dermatitis (SCORAD) scores at baseline were 19.3+/-11.1 and 26.0+/-10.4 in the two groups, respectively.Results: Varicella vaccination did not adversely affect the severity of atopic dermatitis, with analysis of variance (ANOVA) confirming equivalence for the change in SCORAD index from baseline to week 8 between vaccinated and unvaccinated subjects. Within-group comparison of post-vaccination changes in SCORAD index from baseline to week 8 and month 12 in the VAR-2Y group showed a greater reduction in mean SCORAD scores following vaccination in year 2 than in year 1 when subjects were unvaccinated. Overall, SCORAD indices fell by approximately 10 points in both study groups over the 2 years of follow-up. Varicella vaccination was well tolerated, with no children withdrawn due to adverse events. Injection site redness was the most frequent solicited adverse event, occurring in 17.1% of subjects. Seroconversion rates were 94.3% at week 8 and 88.9% at month 12. In all, 43.6% of vaccinees reported at least one varicella contact during the course of the study. However, none developed varicella infection after vaccination over the 2 years of follow-up.Conclusion: In summary, vaccination with a live attenuated varicella vaccine appears safe and effective in children with atopic dermatitis. [ABSTRACT FROM AUTHOR]

Many factors may aggravate atopic dermatitis. The aim of this study was to determine the frequency of atopic dermatitis in an unselected population sample and to evaluate the role of food allergy. Patients with atopic dermatitis were recruited from the population in Berlin, Germany, using a postal questionnaire. Skin prick tests for allergens were performed, followed by food challenges. A total of 1739 questionnaires was returned. In all, 23.5% of patients stated that they had atopic dermatitis, and 146 persons (8.4%) fulfilled our atopic dermatitis criteria after a detailed telephone interview. Of these, 111 were examined, and 28 (1.6%) were identified as currently suffering from atopic dermatitis. Twenty-seven patients were further evaluated: 9127 were found to be skin prick test negative, 19/27 were skin prick test positive either to pollen and/or food allergens. Nine of 27 were challenged with the suspected food allergen: 119 showed a worsening of the eczema, 319 had oral symptoms, and 519 were negative. In conclusion, only 20% of adults with a positive history of atopic dermatitis show active eczema lesions at a given time point. The data indicate that most individuals with atopic dermatitis were sensitized against pollen allergens and according to that, pollen-associated food allergens. A non-selected AD patient cohort does not frequently suffer from clinically relevant pollen-associated food allergy. [ABSTRACT FROM AUTHOR]

A polymorphism in the promoter region of the CD14 gene, C-159T, has been shown to be associated with increased levels of soluble CD14 (sCD14) and decreased serum immunoglobulin E (IgE) and the expression of a more severe atopic phenotype in previous studies. To test if these associations are consistently found in different populations and different age groups, we genotyped 2048 children of different age groups as well as 888 adults from different regions of Germany for the CD14 C-159T polymorphism. While an association between this promoter polymorphism and levels of sCD14 could be confirmed in our study population (CC: 1017 ng/ml vs TT: 1370 ng/ml, P = 0.03), no association between CD14 C-159T genotypes and IgE levels or the prevalence of atopic diseases was seen. The lack of association between CD14 genotypes and IgE as well as atopic outcomes in this large German study population seems to indicate that CD14 genotypes may not directly be involved in the development of allergies during childhood. [ABSTRACT FROM AUTHOR]

Background: There are controversial data as to interdependencies of exposure to furred pets in infancy and the prevalence of asthma and hay fever in children. Does the timing, intensity and type of pet exposure matter? Methods: Cross-sectional questionnaire data on 8216 German schoolchildren aged 5–7 years not living on a farm in ten rural districts in Bavaria in 1997 were analysed. The diagnosis of asthma and hay fever was ascertained with the International Study of Asthma and Allergies in Childhood (ISAAC) core questions. Wheeze and asthma were classified as ‘atopic’ in children who also had hay fever or atopic dermatitis. Prevalence and intensity of exposure to pets in the first year of life and at present were assessed via questionnaire. Results: Although the study was of considerable size we found no convincing association between atopic disease and pet exposure in general. Exposure to cats from the first year of life to school entry, however, was associated with a reduced prevalence of atopic asthma, if cats were allowed to be in the child's bedroom: no case of atopic asthma in 296 children exposed and an aOR 0.11 (95% CI:0.01–0.52) for atopic wheeze in the last 12 months. Conclusions: Allowing cats to be in the child's bedroom from the first year of life onwards may be an indicator of intensive exposure to cats and appears to prevent the development of childhood asthma. [ABSTRACT FROM AUTHOR]

The aim of the study was to evaluate the psychometric properties of the German translation of the Child Health Questionnaire (CHQ). Parents of two clinical samples were asked to rate the quality of life of their children using the German version of the CHQ. Item internal consistency (item-scale correlation) and internal consistency of scales were tested; quartiles and factor analysis were conducted. The results of the German clinical samples were compared with US clinical samples (t-test). The two clinical German sub-groups were compared using multivariate analysis (MANOVA). The psychometric testing of the CHQ showed good results. Internal consistency of the hypothesized scales were all higher than 0.70. The results of the factor analysis confirmed the results of the US norm sample: As expected, the subscales loaded on two factors explaining 57.4% of the total variance. The group comparison supported the discriminative properties of the CHQ. Preliminary psychometric findings support use of the German version of the CHQ. The next step will be the testing of healthy German samples and development of norm scores. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the association between keeping pets in early childhood and the occurrence of atopic dermatitis in an ongoing birth cohort followed up to the age of 2 years. We analyzed data of 4578 children in the intervention and observation part of an ongoing cohort study. The children were recruited at birth in the two study regions Wesel and Munich between January 1996 and June 1998. Information on atopic diseases and pet ownership was obtained by questionnaire at the child's first and second birthday. The logistic regression model showed a negative association between ‘keeping any pet’ and in particular ‘keeping dogs’ in the 1st year of life and the development of atopic dermatitis in the 1st and the 2nd years of life. The protective effects remained statistically significant after adjusting for several possible confounding variables (1st yearany pet OR 0.71, 95% CI [0.55;0.92], 1st yeardog OR 0.62, 95% CI [0.39;0.98], 2nd yearany pet OR 0.74, 95% CI [0.57;0.97], 2nd yeardog OR 0.63, 95% CI [0.40;0.98]). Ownership of small furred pets (hamster, rabbit and guinea pig) also showed a borderline protective effect for the 1st year. We assume an association between keeping pets and undefined environmental factor(s) that contribute protectively to the development of atopic dermatitis in early life, presumably by effects on the maturation of the immune system. [ABSTRACT FROM AUTHOR]

Background Atopic dermatitis (AD) is a common skin disease in childhood. Micro- and macroenvironmental factors have not yet been studied simultaneously in a large cohort of the same area in detail. Objectives The incidence of AD was investigated in 97% of all school entrants (n = 4219) in the city of Hannover, Germany, with regard to the influence of individual and environmental factors. Methods A standardized questionnaire based on the criteria of Hanifin and Rajka that has the sensitivity and specificity of 97% compared with the clinical diagnosis of a dermatologist and a logistic regression model were used. Multiple local-based environmental factors were analysed for all 49 city quarters. Results Of all children studied, 10.5% suffered from AD at some time in their lives. The frequency of AD was significantly increasing with more privileged socio-economic status (P < 0.01). Independent factors that were associated with a higher frequency of AD were German nationality (12.4% AD compared with 2.1% in non-German), higher paternal socio-economic status (i.e. father's profession), higher daily duration of the fathers' professional work and the lack of paternal shift work. In contrast, there was no significant association between the frequency of AD and local environmental factors such as the biological effective level of air pollution and urbanization. Conclusions In conclusion, we confirm an association between a privileged life-style and a higher incidence of AD in a large number of investigated children between 5 and 9 years of age (97·6% of children were 6 or 7 years old) for the German city of Hannover. We propose the socio-economic status as a marker for different life-styles and social micro-environments in further studies as there were multiple significant correlations between individual social and environmental factors. The macro-environment seems to be less important for the disease outcome in this context. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a clinically characteristic, chronic inflammatory skin disease of unknown origin. IgE-mediated uptake and antigen focusing of environmental allergens by dendritic cells (DCs) is assumed to be a central immunopathogenetic event. A so-called intrinsic type of AD (IAD) has been delineated from the more common extrinsic AD (EAD) by normal serum IgE levels, negative RAST tests and negative immediate-type skin reactions towards environmental allergens. The recently characterized human autoantigen Hom S 1 has been proposed to play a part in the pathogenesis of IAD. Objectives To compare clinical and laboratory data between patients with IAD and EAD, and to investigate potential differences in the inflammatory micromilieu of the epidermal compartment in IAD and EAD lesions. Methods Epidermal DC phenotyping, a recently validated technique based on the three-colour flow cytometric analysis of Langerhans cells and the so-called inflammatory dendritic epidermal cells from epidermal single-cell suspensions, was performed on samples from 69 patients with AD (seven with IAD and 62 with EAD) and 94 controls. Results Patients with EAD tended to have an earlier onset of disease but similar disease duration and family history of atopic diseases. Quantitative analysis of CD36 expression on DCs as a marker of inflammation, as well as the percentage of inflammatory dendritic epidermal cells in the CD1a+ epidermal DC pool, indicated a comparable disease activity in IAD and EAD. EAD was characterized by a significantly higher FcεRI expression on the CD1a+ epidermal DCs than IAD. Using the FcεRI/FcγRII expression ratio as a disease marker for AD, values for IAD fell below the diagnostic cut-off level of 1·5 for this ratio. Conclusions While IAD is clinically similar to EAD, the inflammatory microenvironment in this condition seems different from classical EAD and can be distinguished by phenotyping of epidermal DCs. [ABSTRACT FROM AUTHOR]

Examines whether atopic disorders were related to social class in a pediatric population in Germany. Lifetime prevalence rates of atopic disease; Rates of allergic sensitization; Level of occurrence by social class.

Evaluates the capacity of early atopic dermatitis to predict aeroallergen sensitization and the manifestation of respiratory atopic disorders at five years of age. Participation of children of a German prospective birth cohort study; Indication of atopic dermatitis in the first three months as a risk factor for aeroallergen sensitization at five years.

Background. Eczema herpeticum (EH) is a potentially serious, systemic complication in subjects with atopic dermatitis (AD) caused by herpes simplex virus (HSV). The innate immune dysregulation that predisposes these subjects to cutaneous viral infections is not well understood. We tested the hypothesis that defects in mannan-binding lectin (MBL) may be associated with an increased risk of EH. Methods. We evaluated serum MBL levels and functional activity in 13AD subjects with a history of EH (EH+) and 21AD subjects with no history of EH (EH-). MBL levels were detected by enzyme immunoassay. MBL pathway functional activity was evaluated by determining MBL C4b deposition capacity. Results.We found no statistical difference in MBL serum levels or function between EH+ and EH- groups. Conclusion. Considering the limitations of this study (e.g., small samples size) our findings suggest that MBL defects do not play a role in EH. [ABSTRACT FROM AUTHOR]

Current clinical research in eczema (atopic dermatitis) is hampered by a profusion of outcome measures, most of which have not been developed or tested adequately. The first Harmonising Outcome Measures for Eczema meeting (HOME 1) was an exploratory meeting to determine whether there was sufficient interest and enthusiasm in the international scientific community to form a collaborative group to define a minimum set of core outcomes for future eczema (atopic dermatitis) research. The meeting was open to all participants of the 6th Georg Rajka Symposium/International Symposium on Atopic Dermatitis/New Trends in Allergy VII meeting in Munich, 22-24 July 2010. Approximately 40 individuals attended. Prior to the meeting, an international Delphi exercise was performed to develop consensus-based sets of core outcome domains for eczema for 'controlled trials' and 'clinical recordkeeping'. The results of this Delphi exercise were presented at the meeting and critically discussed by the attendees. The constructive group discussion identified several important issues for future eczema outcomes research such as the degree to which patients and carers can be involved and the importance of involving colleagues from countries not represented at the meeting. In summary, this exploratory meeting indicated a genuine interest in the academic eczema community to form an international multiprofessional group dedicated to harmonizing outcomes research in eczema. The group decided to continue collaboratively with the HOME initiative. [ABSTRACT FROM AUTHOR]