Treatment Patterns and Healthcare Resource Utilization Among Patients with Atopic Dermatitis: A Retrospective Cohort Study Using German Health Claims Data.

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.

Disease burden and treatment needs of patients with psoriasis in sexually-sensitive and visible body areas: results from a large-scale survey in routine care.

Psoriasis may cause considerable disease burden. The involvement of sexually-sensitive/visible body areas has been associated with decreased quality of life (QoL), more depressive symptoms and stigmatisation experiences. To characterise the topical distribution of psoriasis in sexually-sensitive and visible areas, to examine its impact on QoL and to determine which specific patient needs should be addressed in routine care. Patients with psoriasis vulgaris were recruited within a cross-sectional nationwide survey, involving 157 randomly assigned German dermatology practices/clinics. The main outcome measures were the EuroQoL visual analogue scale (EQ VAS), the Dermatology Life Quality Index (DLQI), the Patient Needs Questionnaire (PNQ) and a grid scheme for topical distribution of psoriasis. The sample included 2,009 patients (43.7% female; 21.8% ≥ 65 years; 64.2% with lesions in sexually-sensitive areas and 86.2% with lesions in visible areas). Patients with concomitant involvement of sexually-sensitive and visible areas presented increased DLQI impairments relative to patients with no involvement of sexually-sensitive or visible areas (F(3, 1723) = 4.091, p = 0.007). Significant differences were also found for patient needs dimensions (PNQ) depending on the body areas affected (F(15, 4602) = 2.936, p < 0.001). Significant effects of gender and age group were also observed. Increased disease severity, lesions in both sexually-sensitive/visible or only visible areas, and increased QoL impairment were associated with specific patient needs. These results highlight the need for proactive evaluation of difficult-to-communicate impairments and the requirements for patient-centred routine care.

Validation of Dermaphot(®) for the assessment of steroid-induced skin atrophy.

Currently, there are no accurate and simple methods available to measure this risk of atrophy in patients treated with topical glucocorticosteroids. In the present clinical trial, we validated a new score (Dermaphot(®) score) to assess the atrophogenic potential of glucocorticosteroids. 36 healthy adult volunteers were included in an investigator-initiated, blinded, randomized, intra-individual comparison, vehicle controlled multi-centre study. Subjects were treated in a randomized manner for 3 weeks with pimecrolimus cream 1 %, mometasone furoate (1 mg/g), clobetasol propionate 0.05 % and vehicle. In addition, ultrasound examination for skin thickness was performed. Data demonstrated a direct correlation of the achieved Dermaphot(®) score and the ultrasound thickness measurements. Our study shows that the Dermaphot(®) score can be used as a simple method to evaluate the atrophogenic potential of glucocorticosteroids. Respectively, we showed that the new score is an easy, valid and sensitive new tool for early detecting and quantifying even subclinical glucocorticosteroid-induced skin damage. We demonstrated that the score is able to differentiate the extent of skin atrophy (damage) after 3 weeks of topical glucocorticosteroid application with different levels of skin transparency and levels of telangiectasia.

International multicenter psoriasis and psoriatic arthritis reliability trial for the assessment of skin, joints, nails, and dactylitis.

OBJECTIVE: Clinical trials in psoriasis and psoriatic arthritis (PsA) involve assessment of the skin and joints. This study aimed to determine whether assessment of the skin and joints in patients with PsA by rheumatologists and dermatologists is reproducible. METHODS: Ten rheumatologists and 9 dermatologists from 7 countries met for a combined physical examination exercise to assess 20 PsA patients (11 men, mean age 51 years, mean PsA duration 11 years). Each physician assessed 10 patients according to a modified Latin square design that enabled the assessment of patient, assessor, and order effect. Tender joint count (TJC), swollen joint count (SJC), dactylitis, physician's global assessment (PGA) of PsA disease activity (PGA-PsA), psoriasis body surface area (BSA), Psoriasis Area and Severity Index (PASI), Lattice System Physician's Global Assessment of psoriasis (LS-PGA), National Psoriasis Foundation Psoriasis Score (NPF-PS), modified Nail Psoriasis Severity Index (mNAPSI), number of fingernails with nail changes (NN), and PGA of psoriasis activity (PGA-Ps) were assessed. Variance components analyses were carried out to estimate the intraclass correlation coefficient (ICC), adjusted for the order of measurements. RESULTS: There is excellent agreement (ICC >/=0.80) on the mNAPSI, substantial agreement (0.6 >/= ICC < 0.80) on the TJC, PASI, and NN, moderate agreement (0.4 >/= ICC < 0.60) on the PGA-Ps, LS-PGA, NPF-PS, and BSA, and fair agreement (0.2 >/= ICC < 0.40) on the SJC, dactylitis, and PGA-PsA. The only measure that showed a significant difference between dermatologists and rheumatologists was dactylitis (P = 0.0005). CONCLUSION: There is substantial to excellent agreement on the TJC, PASI, NN, and mNAPSI among rheumatologists and dermatologists.

[The role of biologics into the management of psoriasis: a consensus paper by the Psoriasis Study Group, Arbeitsgemeinschaft Dermatologische Forschung]. / Stellenwert von Biologics in der Psoriasis-Therapie: Ein Konsensus-Papier der Arbeitsgruppe Psoriasis, Arbeitsgemeinschaft dermatologische Forschung.

About 20% of all psoriasis patients require photo- and/or systemic therapy because of the severity of their disease. Side effects, contraindications, insufficient clinical responses, and lack of long-term efficacy underline the need for novel and improved anti-psoriatic therapies. In recent years, the technology has been established to generate therapeutic molecules from living cells capable of inhibiting disease-relevant mediators or cell-cell interactions. Several of these so-called biologics interfering with key steps in the immunopathogenesis of psoriasis have the potential to meet this need with regard to treating moderate to severe psoriasis. Here, the Psoriasis Study Group of the Arbeitsgemeinschaft Dermatologische Forschung (ADF) analyses the established anti-psoriatic treatment modalities. With the shortcomings of these options in mind, biologics with an immediate relevance for clinical application in the treatment of psoriasis are discussed. The focus is on their potential medical advantages along with safety aspects. Moreover, legal and economical aspects with an impact on the use of biologics are addressed.