Fumaric acid esters for the treatment of psoriasis in Germany: characterising patients in routine care.

BACKGROUND: Fumaric acid esters (FAE) represent the most widely-used oral systemic treatment for moderate-to-severe psoriasis in Germany. Not licensed outside Germany, little is known about the demographics of patients receiving FAE. PsoBest is a large national patient registry documenting long-term treatment of psoriasis in Germany. OBJECTIVES: To evaluate FAE relative to methotrexate (MTX) in patients from the PsoBest registry. MATERIALS AND METHODS: Patient demographics, disease severity at baseline and dosing regimen were reported for patients who initiated treatment with either FAE or MTX between 2007 and 2015. RESULTS: Overall, 1,409 patients treated with FAE and 877 with MTX were analysed. At baseline, compared with the MTX cohort, patients receiving FAE were younger (45.4 vs. 50.2 years; p≤0.001) and had a lower BMI (28.0 vs. 28.3 kg/m2; p≤0.023) and less nail involvement (45.4% vs. 50.7%; p≤0.013). The MTX cohort reported a greater mean duration of illness at baseline (18.2 years vs. 14.9 years; p≤0.001). In total, 85.6% and 58.5% patients in the FAE and MTX cohorts, respectively, had not received prior systemic therapy. Cardiovascular disease was the most prevalent comorbidity (FAE: 26.7%; MTX: 31.5%; p≤0.014). Health-related quality of life was similar for both cohorts (mean DLQI: 10.8 [FAE]; 10.5 [MTX]; p≤0.079). Mean FAE dose was 165.0 mg at inclusion and 406.4 mg following up-titration. CONCLUSION: This study contributes to a better understanding of the usual practices of long-term FAE use, which may also lead to improved treatment strategies not only in Germany, but in other countries where FAE may become available in the near future.

Treatment Satisfaction in Psoriasis: Development and Use of the PsoSat Patient Questionnaire in a Cross-Sectional Study.

INTRODUCTION: Evidence supports the potential value of matching patient preferences to treatment recommendations. The aim of the study was to design and validate a questionnaire on treatment satisfaction for clinical decision-making. METHODS: We performed a comprehensive literature search identifying measurable indicators. The complete item pool was condensed to a core set by a multidisciplinary expert panel and tested in a multicentre, observational, cross-sectional study. RESULTS: The questionnaire consisted of 8 questions, rated on a 5-point Likert scale. In total, 213 dermatology centres included 2,084 patients. The mean disease duration was 19 years. A majority of patients (82.8%) was moderately to very satisfied. 108 patients (5.8%) felt to be bothered by side effects, and 32.1% ascertained that the current therapy had been conducted for too long without success. DISCUSSION: The PsoSat Questionnaire was shown to be a reliable and valid instrument for measuring therapy-related satisfaction. Further research on its implementation in clinical decision-making is necessary to finally evaluate the benefit of this tool.

Patient-relevant treatment goals in psoriasis.

Patient-oriented care requires therapeutic decisions to agree with the patients' treatment needs and goals. This study addressed the following questions: What is important to psoriasis patients starting systemic treatment? How stable are these preferences within the first year of treatment? Are treatment goals associated with age, gender, or treatment success? The importance of treatment goals was assessed for patients with moderate-to-severe psoriasis in the German Psoriasis Registry (PsoBest) at baseline (onset of a systemic treatment; n = 3066) and at a 1-year follow-up (n = 1444) using the Patient Benefit Index (PBI). Treatment success was measured with PBI global score and Psoriasis Area Severity Index (PASI). Patients with moderate-to-severe psoriasis pursued a wide range of different goals. The most general treatment goals were rated most relevant, including skin healing and quick skin improvement (94.8/94.5 % "quite" or "very" important), confidence in the therapy (93.0 %), control over the disease (92.3 %), and a clear diagnosis and therapy (89.6 %). Further important goals related to not being in fear of the disease getting worse (84.8 %), reduction in itching (83.9 %), burning (70.6 %), and pain (60.6 %) as well as attaining a normal everyday life (78.4 %) and low treatment burden (64.2-77.9 %). Goals were mostly not associated with sex and gender. Goal importance slightly increased with treatment success. In a substantial proportion of patients (30.3-54.7 %) goal importance changed within 1 year after onset of systemic treatment. We conclude that treatment goal importance should be assessed in clinical practice on a regular basis.

Comorbidity as a predictor for drug survival of biologic therapy in patients with psoriasis.

BACKGROUND: Psoriasis often requires lifelong therapy, and adherence to treatment is considered a marker for treatment success. Data on the drug survival of biologics in psoriasis patients with comorbidities are lacking. OBJECTIVES: This study was designed to estimate the long-term drug survival rates of different biologic agents in a cohort of psoriasis patients and to evaluate reasons and predictors for treatment adherence. METHODS: Drug survival rates and outcome parameters in psoriasis patients treated with biologic agents were analyzed. RESULTS: A total of 125 treatment periods with adalimumab (n = 37), efalizumab (n = 9), etanercept (n = 55), infliximab (n = 13), and ustekinumab (n = 11) were administered to 67 psoriasis patients. Patients with psoriatic arthritis (P = 0.010) and without comorbidity (P = 0.033) demonstrated significantly greater rates of drug survival. CONCLUSIONS: The overall efficacy of biologic agents is reduced with time. Patients with the comorbidity of metabolic syndrome demonstrate a loss of adherence to biologic treatment.

German psoriasis registry PsoBest: objectives, methodology and baseline data.

BACKGROUND: The German psoriasis registry PsoBest records the long-term efficacy, safety, patient benefit and treatment regimens of psoriasis. PATIENTS AND METHODS: Patients with moderate or severe psoriasis are included in PsoBest when treatment with a conventional systemic agent or biologic is started for the first time. Observation time is five years. Standardized physician and patient case report forms are obtained every three to six months. Baseline data of patients included by 31 December 2012 are presented and compared to the national health care study PsoHealth 2007 (n = 2,009). RESULTS: 602 dermatology practices and clinics have been registered and 199 have recruited n = 2,556 patients (63 % by practices, 37 % by clinics). Initially, n = 808 received biologics (316 adalimumab, 34 efalizumab, 209 etanercept, 75 infliximab, 22 golimumab, 152 ustekinumab) and n = 1,651 conventional systemic therapy (928 fumaric acid esters, 518 methotrexate, 161 cyclosporine A, 191 other drugs or UV treatment). Compared to PsoHealth, patients in PsoBest had on average a higher disease severity (PASI 14.7 vs. 10.1; DLQI 11.0 vs. 7.5; EQ-5D VAS 54.0 vs. 64.5), shorter disease duration (18.2 vs. 21.3 yrs.), lower age (47.3 vs. 51.5), higher rates of psoriatic arthritis (20.5 vs. 19.1 %) and nail psoriasis (55.0 vs. 35.6 %). On average patients receiving biologics were younger, more often male and had higher disease severity and comorbidity. CONCLUSIONS: Patients in PsoBest represent patients with a high burden of disease.

Cost-of-illness of leg ulcers in the community.

Leg ulcer management is complex, time-consuming and of high socio-economic importance. Data on cost-of-illness in leg ulcer care are sparse. The objective of this study was to evaluate the cost-of-illness in leg ulcer treatment in the metropolitan area of Hamburg. About 147 institutions involved in wound care participated in a cross-sectional study. Patients consecutively recruited underwent a standardised interview and clinical examination. Main economic outcomes were direct, indirect and intangible costs from a societal perspective. Five hundred and two patients with a mean age of 71 years and mean wound duration of 9 years were enrolled. Annual total costs summed up to a mean of 9060€ /patient/year (8288€ direct, 772€ indirect costs). Direct costs carried by statutory health insurances amounted to 7680€ , patients themselves paid on average 607€. Leg ulcer is associated with high costs for health insurances, patients and the society. Exploratory predictor analyses suggest that early, interprofessional disease-management could lower treatment costs.

Mapping DLQI on EQ-5D in psoriasis: transformation of skin-specific health-related quality of life into utilities.

In many countries, utility measures are required for allocation decisions. Unlike the EuroQoL-5D (EQ-5D), the dermatology life quality index (DLQI) has not been developed for the derivation of utilities. Purpose of this study was to develop and test an algorithm for the transformation of DLQI scores into utilities. Pre-existing data of two cross-sectional studies (for development, n = 1,511; for cross-validation n = 2,009) of German psoriasis patients were reanalyzed. Both EQ-5D global score and EQ-5D visual analogue scale (VAS) were used as utility measures. Correlations were computed to identify predictors of EQ-5D utilities. Linear stepwise regressions were conducted using DLQI and further possible predictors to find the optimal mapping algorithm. Using only DLQI as predictor resulted in coefficients of determination of r (2) = 0.235 (EQ-5D global score) and r (2) = 0.242 (EQ-5D VAS). In the final algorithm, seven predictors were included which correctly predicted EQ-5D VAS for 60.4 % (development database) and 60.8 % of all patients (cross-validation database) within a range of ±15 units. The algorithm explained 31.3 % of the EQ-5D variance in the development database and 26.8 % in the cross-validation database. In conclusion, mapping of DLQI on EQ-5D in psoriasis patients has severe limitations in validity and clinical relevance.

Benefit evaluation in the therapy of chronic wounds from the patients' perspective--development and validation of a new method.

Assessing therapeutic benefit of any drug and medical device is essential in registration and cost reimbursement decisions in Germany and in many nations. In this study, a method for the assessment of patient-relevant benefits in wound therapy was developed and validated. A total of 83 items on treatment benefit from the patients' perspective were collected in an open survey, including n = 50 patients with chronic wounds. The item pool was compiled to a list of 22 items by an interdisciplinary panel of experts including patients. The item list is presented prior to therapy to assess patient-relevant treatment needs and during or after therapy to establish if benefits have been attained. A weighed patient benefit index (PBI) is calculated from the items of both questionnaires. The instrument was examined for practical feasibility, reliability, and validity in a prospective study involving n = 172 patients with acute or chronic wounds treated by vacuum-assisted therapy. Validation criteria were: change in generic and disease-specific quality of life; judgment of efficacy by patients and physicians; treatment satisfaction; patients' willingness to recommend the therapy to others. Construct validity was given for all criteria applied. Cronbach's alpha was 0.88. The instrument was well-accepted by patients and rated relevant for the assessment of benefit in wound treatment.

Quality of life evaluation in wounds: validation of the Freiburg Life Quality Assessment-wound module, a disease-specific instrument.

Many patients with chronic wounds suffer not only directly from their wounds but also from high financial, social and psychological impairments, significantly reducing their quality of life. In order to provide an instrument both applicable to different patient populations and sensitive to areas of impact specific to certain skin diseases, the modular instrument 'Freiburg Life Quality Assessment' has been developed. Each disease-specific version of the instrument consists of a core module of generic items and items specific for a distinct skin disease. Objective of the study was to assess reliability, sensitivity to change, and validity of the module for chronic ulcers. The instrument was implemented in a longitudinal observational study on vacuum-seal therapy (n = 175), in a cross-sectional observational study involving patients with chronic leg ulcers (n = 384) and in a randomised clinical trial on keratinocyte transplantation (n = 198). The instrument showed good internal consistency (Cronbach's alpha ≥0·85). There were minor floor effects ≤4·3%, but no ceiling effects. Retest-reliability and convergent validity with the EuroQol quality of life questionnaire (EQ-5D) (visual analogue scale) were satisfactory. Change scores correlated with change in other quality-of-life instruments (r = 0·59-0·61), but not with change in wound status.

Cost-of-illness of chronic leg ulcers in Germany.

Chronic wounds are important because of their frequency, their chronicity and high costs of treatment. However, there are few primary data on the cost-of-illness in Germany. The aim was to determine the cost-of-illness of venous leg ulcers (VLU) in Germany. Prospective cost-of-illness study was performed in 23 specialised wound centres throughout Germany. Direct, medical, non medical and indirect costs to the patient, statutory health insurers and society were documented. Thereover, health-related quality of life (QoL) was recorded as intangible costs using the Freiburg quality of life assessment for wounds (FLQA-w, Augustin). A total of 218 patients (62.1% female) were recruited consecutively. Mean age was 69.8 +/- 12.0 years. The mean total cost of the ulcer per year and patient was 9569 euros, [8658.10 euros (92%) direct and 911.20 euros (8%) indirect costs]. Of the direct costs, 7630.70 euros was accounted for by the statutory health insurance and 1027.40 euros by the patient. Major cost factors were inpatient costs, outpatient care and non drug treatments. QoL was strikingly reduced in most patients. In Germany, VLU are associated with high direct and indirect costs. As a consequence, there is a need for early and qualified disease management. Deeper-going cost-of-illness-studies and cost-benefit analyses are necessary if management of chronic wounds is to be improved.

How do regional factors influence psoriasis patient care in Germany?

BACKGROUND: Two national surveys conducted in 2005 and 2007 indicated deficits in psoriasis care in Germany, although there has been a notable nationwide improvement within this period. It remained unclear whether regional differences in psoriasis health care have an influence on patient outcomes in Germany. AIM: Assessment of regional differences in the health care situation of patient with psoriasis in Germany. PATIENTS AND METHODS: Nation-wide cross-sectional study in 130 dermatological practices and clinics. Regional classification was based on the affiliation to the Associations of Statutory Health Insurance Physicians. A panel of experts developed eight criteria as indicators of quality of care, among them clinical characteristics and severity of psoriasis (PASI), previous treatments, quality of life and patient-relevant therapeutic benefits. RESULTS: Care indicators showed marked regional differences. The proportion of patients with preceding systemic or biologic treatment varied between regions. Those regions with high proportions had better results in patient-reported outcomes. CONCLUSIONS: Differences in economic and regulatory conditions of health care might account for the observed regional variations. Thus, further analyses of these factors are of great importance to assure consistent psoriasis health care in Germany.