SARS-CoV-2 infection among psoriasis patients in Germany: Data from the German registries PsoBest and CoronaBest.

BACKGROUND: Limited data exist on the characteristics of SARS-CoV-2 infections in German patients with psoriasis or psoriasis arthritis (PsA). This study analyses COVID-19 prevalence and severity of symptoms in these patients. PATIENTS AND METHODS: Participants of the German registries PsoBest and CoronaBest were surveyed in February 2022. Descriptive analyses were conducted. RESULTS: 4,818 patients were included in the analysis, mean age of 56.4 years. Positive SARS-CoV-2 tests were reported by 737 (15.3%) patients. The most frequently reported acute symptoms were fatigue (67.3%), cough (58.8%), and headache (58.3%). Longer-lasting symptoms after COVID-19 were reported by 231 of 737 patients after the acute phase. For most patients (92.9%), systemic treatment for their psoriasis or PsA was not modified during the pandemic. Patients positively tested for SARS-CoV-2 were younger on average and had more often changes in the therapy of psoriasis than negatively tested patients (8.5% vs. 5.4%). CONCLUSIONS: In this cohort of patients with psoriasis or PsA undergoing systemic treatment, SARS-CoV-2 infections were common but less frequent than in the general German population. No risk signals for more severe COVID-19 or increased infection rates were observed in the patients. In addition, systemic treatments remained largely unchanged, so that no risks can be attributed to these therapies.

Perception and Impact of COVID-19 Pandemic in Psoriasis Patients: Data from the German PsoBest and the CoronaBest Registries.

Background: Limited data are available characterizing the impact of the SARS-CoV-2 pandemic on psoriasis care for patients in Germany. Objective: To analyze patient perception and impact of the pandemic on well-being and psoriasis management of German patients with moderate-to-severe psoriasis or psoriasis arthritis under systemic therapies. Methods: The CoronaBest registry captures events of SARS-CoV-2 infections and analyzes the impact of the pandemic on patients with psoriasis or psoriasis arthritis. In June 2020, and independently in February 2022, patients with psoriasis or psoriasis arthritis received a standardized questionnaire for current treatment, protective measures, well-being, and individual risks for COVID-19, among others. Results: Included were 4,194 patients in 2020 (mean age of 47.7 years and 41.8% women) and 4,818 patients in 2022 (mean age of 56.4 and 42.9% women). Treatment discontinuations were observed in 2.7% and 1.7% of patients in 2020 and 2022, respectively. In the vast majority of the cases (>92%), no additional measures were taken concerning the management of psoriasis treatments in either 2020 or 2022. Those patients with changes reported most frequently: telephone calls instead of face-to-face visits (80.2%, in 2020 vs 40.5% in 2022) or more frequent controls (27.1%, 2020 vs 22.0%, 2022). A majority (66.7%, 2020, and 70.6%, 2022) did not perceive the virus as a considerable threat. The proportion of patients feeling well informed about COVID-19 by physicians increased from 42.6% in 2020 to 51.8% in 2022. About 81.1% of patients in 2020 and 67.5% in 2022 stated that their overall personal condition was not affected due to the pandemic. Physicians attributed no special risk of contracting SARS-CoV-2 in most of the patients. Conclusion: A high rate of systemic treatment persistence and awareness of risks and protective measures indicate that health care for psoriasis largely followed current national and international recommendations during the COVID-19 pandemic.

Real-world outcomes and drug survival of brodalumab: results from the German Psoriasis Registry PsoBest.

Brodalumab, a human monoclonal antibody that targets interleukin-17 receptor A (IL-17RA), is approved in the US and EU for treatment of adults with moderate-to-severe plaque psoriasis. Although brodalumab has demonstrated efficacy and safety vs placebo in clinical trials of patients with psoriasis and psoriatic arthritis (PsA), real-world evidence is needed to evaluate long-term effectiveness and safety of brodalumab in routine care. This interim analysis of the German Psoriasis Registry PsoBest examined patient profiles, treatment outcomes, and drug survival of first-time use of brodalumab for 12 months in adult patients with moderate-to-severe plaque-type psoriasis (with and without PsA) (data cutoff: June 30, 2021). Clinician and patient-reported outcomes of the total cohort (n = 227; PsA, n = 38) indicated a rapid response to brodalumab treatment within the first 3 months, which was maintained up to 12 months. The overall one-year drug survival rate was 76.2%, the mean time to discontinuation was 8.3 months. Reasons for discontinuation were mainly loss/lack of effectiveness, followed by adverse events, contraindication and skin clearance. In sum, brodalumab demonstrated rapid and sustained effectiveness and was well-tolerated over 12 months in German patients with moderate-to-severe psoriasis and PsA in a real-world setting.

Characterization of patients with psoriatic arthritis in dermatologic and rheumatologic care: analysis of two registries.

BACKGROUND AND OBJECTIVE: Psoriatic arthritis (PsA) is a chronic systemic inflammatory disease affecting the musculoskeletal system, skin and nails. The aim is to characterize sociodemographic and clinical patient profiles documented in dermatologic and rheumatologic care. PATIENTS AND METHODS: Data of 704 patients with PsA from the dermatological Psoriasis Registry PsoBest (PB) and 1066 patients from the rheumatological disease registry RABBIT-SpA (RS) were analyzed. Comparable anamnestic and clinical variables were identified and descriptively analyzed. RESULTS: The mean age was 51.7 years in PB and 51.9 in RS. Disease duration of psoriasis was longer, mean cutaneous severity was higher in PB. However, more patients in RS vs. PB had tender joints and swollen joints. Mean Dermatology Life Quality Index was higher in PB and mean Health Assessment Questionnaire in RS. Patient reported global disease activity and pain were lower in PB. IL-23 inhibitors were used more frequently in PB, and TNF inhibitors in RS. CONCLUSIONS: Clinical specialization was associated with different clinical and treatment patterns of PsA. This may indicate a selection by dominant manifestation of psoriatic disease and potentially by effects of health care access. Psoriatic arthritis should be treated in a multidisciplinary approach considering all facets of this complex disease.

Which PASI Outcome Is Most Relevant to the Patients in Real-World Care?

In psoriasis treatment, there is a high need to define meaningful endpoints and differences from the patient perspective to analyze patient-relevant differences of frequently used outcome methods for psoriasis under real-world conditions. A sample of 3116 patients from the German Psoriasis-Registry PsoBest was analyzed for clinical as well as patient-reported outcomes (PRO) after 3- and 6-month treatment. The parameters PASI, DLQI, and PBI were intercorrelated and related to two anchoring variables: (1) patient satisfaction with treatment and (2) perceived complete clearance. Baseline data were as follows: PASI 10.5 ± 9.1, DLQI 12.4 ± 3.4, and PBI 2.7 ± 0.3. There was an almost linear relationship between "complete patient satisfaction" and the relative differences in PASI in the range from PASI 25 to PASI 90. However, there was no additional benefit between PASI 90 and PASI 100. The same finding resulted from the anchoring variable "perception of complete healing". When related to DLQI outcomes, relative PASI changes as well as absolute changes and PASI at 3 and 6 months showed relevant differences between the PASI classes 25 to 90 but not between PASI 90 and PASI 100. Under real-world conditions, changes in PASI and DLQI reflect patient-relevant benefits.

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.

Efficacy and Survival of Systemic Psoriasis Treatments: An Analysis of the Swiss Registry SDNTT.

BACKGROUND: The Swiss psoriasis registry SDNTT (Swiss Dermatology Network for Targeted Therapies) records the long-term safety and effectiveness of systemic treatment regimens for psoriasis. PATIENTS AND METHODS: Patients with moderate to severe psoriasis are included in the SDNTT when treatment with a conventional systemic agent or biologic is initiated that was not previously used by the respective patient. Patients are followed over a 5-year period. Clinical data are obtained every 3-6 months using standardized case report forms. Here, baseline data and follow-up data for 1 year of patients included from October 2011 until December 2014 were analyzed. RESULTS: Within 39 months, 323 patients from 7 tertiary dermatology centers in Switzerland were recruited in the SDNTT; 165 patients received biologics and 158 conventional systemic therapies. Patients treated with biologics had a significantly higher severity (PASI 11.3 vs. 9.2, BSA 15.6 vs.11.9, psoriatic arthritis 36.4 vs. 10.8%; p ≤ 0.005, p ≤ 0.013, p ≤ 0.001) and a longer duration of illness (19.2 vs. 14.4 years, p ≤ 0.003) compared to patients starting a conventional systemic treatment. PASI reduction was satisfying in both treatment groups, with 60.6% of patients treated with biologics achieving PASI75 after 1 year compared to 54.2% of patients receiving conventional systemic drugs (nonsignificant). On average, the drug survival in patients receiving a biologic therapy was significantly longer than those receiving conventional systemic treatments (30.5 vs. 19.2 months, p ≤ 0.001). CONCLUSIONS: In the real-world setting of a prospective national therapy registry, the application of current therapeutic guidelines for patients with moderate to severe psoriasis resulted in a PASI reduction of approximately 70% within the first year of treatment, but current therapeutic targets of PASI75 and PASI90 were reached in only 58 and 36% of patients, respectively, at 1 year, highlighting a gap in efficacy between selective clinical trials and the real-world setting.

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.

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.

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.

Influenza vaccination rate among patients with moderate to severe psoriasis.

BACKGROUND: Patients with chronic inflammatory diseases such as psoriasis vulgaris represent a risk group for developing serious complications after influenza virus infection. By vaccinating this cohort such complications might be prevented. The objective was to determine the vaccination rate among patients with moderate to severe psoriasis and to explore the surrounding circumstances. PATIENTS AND METHODS: A nationwide, non-interventional, cross-sectional study was performed in 1,229 adults with confirmed psoriasis or psoriatic arthritis. The survey consisting of 15 questions about vaccination and vaccination adherence was distributed to patients enrolled in the psoriasis patient registry "PsoBest". RESULTS: About 28 % of the patients (95 %-CI 24.0-31.6) were vaccinated. The mean age was 58 years, 40 % were females. The prevalence of psoriatic arthritis was 28 % at baseline and 39 % during the vaccination period. General practitioners vaccinated 50 % of the patients, while dermatologists suggested vaccination in 7 % of the cases. Fifty percent of the patients reported that they had been vaccinated at their own request. 91 % of the patients had been vaccinated at least once over the past ten years, receiving on average 5.9 influenza vaccinations during the decade. CONCLUSIONS: The vaccination rate in the study cohort was relatively low compared to that in the general population. Influenza vaccination had only been suggested by a small percentage of physicians.

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.

Processes of psoriasis health care in Germany--long-term analysis of data from the statutory health insurances.

BACKGROUND: To evaluate health care provision for psoriasis patients, and to better allocate resources, precise knowledge of the health care situation is essential. The goal of this study is to analyze prescription behavior and resource utilization for psoriasis patients in Germany. METHODS: We performed a secondary analysis of routinely collected psoriasis data from 2004-2007 from members of a nationwide statutory health insurance company (Gmünder Ersatzkasse). A descriptive analysis was done on physician care, hospitalizations, and medications and related costs. RESULTS: 34,728 of the 913,145 continuously insured patients were diagnosed with psoriasis (one-year prevalence: 2.3-2.5%). At the time of the initial diagnosis, 68% of patients were treated by a dermatologist and 28% by a general practitioner (GP). Over the next 21 months, the proportion of patients seen by a dermatologist decreased to 22% and the proportion seen by a GP increased to around 70%. 15.2% of patients were absent at least once from work. 79.5% received prescriptions with an average cost of € 135 per patient per year. 97.5% of patients received topical therapy; 11% got systemic therapies. Biologics were given to about 0.1% of patients. Significant differences in prescription behavior were seen between regions and physician groups. CONCLUSION: Psoriasis is an important economic and medical issue. The majority of insured patients take prescription therapies. Dermatologists are most often the first health care provider.

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 care in chronic leg ulcer in the community: introduction of quality indicators and a scoring system.

BACKGROUND: Treatment of chronic wounds is complex, particularly as a standard for the assessment and evaluation of quality of care is missing. OBJECTIVES: To develop indicators for quality of care in chronic wounds in general, and to evaluate the quality of care in leg ulcers in Hamburg, Germany, in particular. METHODS: Twenty indicators were derived from a national Delphi expert consensus to compute a single index of quality of care. This index was applied in a cross-sectional study involving a large spectrum of care providers and leg ulcer patients in the community. Trained wound experts interviewed and examined the patients, who had to complete standardized questionnaires. RESULTS: On average, 64% of the quality criteria were met in the consecutive sample of 502 patients with chronic leg ulcers of any origin; 75% of the patients were satisfied with their wound care. Predictors of quality of care are presented. CONCLUSIONS: This instrument is feasible, valid and ready for comparisons of patient groups, regions and care systems, and for optimization processes in wound care.