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

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

Documentation of psoriasis in routine care - expert consensus on a German data set.

BACKGROUND AND OBJECTIVES: Documenting patient data in psoriasis clinical practice can improve care, but standardized and transparent documentation is rare. The current project aimed to develop a data set for the documentation of psoriasis in daily practice. MATERIAL AND METHODS: In four online Delphi rounds and one in-person meeting, 27 psoriasis experts allocated variables to a standard, an optimal and an optional data set. Most of the questions were standardized. Open questions were included to allow for the provision of reasons and to enlarge the data sets. Furthermore, in the in-person meeting we considered a) patients' attitudes and b) dermatologists' information on the current usage and acceptability in Germany. RESULTS: The consensus approach resulted in a data set with 69 variables. The standard data set includes 20, the optimal data set 31 and the optional data set 18 variables. In summary, the data set can mainly be grouped into master data, general status and medical history data, medical history of psoriasis, status of psoriasis, diagnostics and comorbidity, therapies and patient-reported outcomes. CONCLUSIONS: The consensus recommendation of a standard, an optimal and an optional data set for routine care of psoriasis intends to be a decision-making aid and an orientation for both daily practice and further development of documentation systems.

Dupilumab Demonstrates Rapid Onset of Action in Improving Signs, Symptoms and Quality of Life in Adults with Atopic Dermatitis.

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.