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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]

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]

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]