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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]

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 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: Evidence-based treatment algorithms, successfully established for asthma, are missing for atopic eczema (AE).Objectives: To investigate whether treatment according to an evidence-based algorithm is an effective and applicable concept for the management of AE.Methods: Based on a systematic literature review, we developed an evidence-based severity-score-oriented treatment algorithm for AE and compared its effectiveness to that of an individualised symptom-oriented treatment (individual therapy) in a randomised controlled trial. Sixty-three participants were randomised to algorithm (n = 32) or individual therapy (n = 31) and treated accordingly for 12 months. Study end points included difference between baseline SCORAD and mean SCORAD under treatment (primary end point), quality of life and treatment utilisation. Analysis was by intention to treat (registration: Clinical Trials.gov:NCT00148746).Results: No statistically significant differences in clinical or subjective response were observed between groups. Treatment following the algorithm and individual treatment both effectively controlled AE. Mean SCORAD reductions were 47% (95% confidence interval, CI = 38-55; algorithm) and 42% (95% CI = 29-54; individual). Clinical response was paralleled by improved quality of life in both groups. Physicians adhered to the algorithm option in 93% of their treatment decisions.Conclusion: Treatment following an evidence-based algorithm is an effective and applicable concept for the management of AE but does not show clear advantages compared to individualised treatment in a dermatological setting. [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]