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.

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.

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.

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.

Dimensions of patient needs in dermatology: subscales of the patient benefit index.

Evaluation of patient-relevant treatment benefit gains importance for approval and reimbursement of therapeutic strategies. The 'Patient Benefit Index' (PBI) is the first questionnaire to measure patient-relevant treatment benefit in dermatology. Its global score is the average of benefits achieved after treatment, weighted by the individual importance of treatment needs. This study aimed to establish subscales of the PBI on the basis of independent and consistent treatment need dimensions. The PBI was used in a cross-sectional study involving n = 500 patients with ten distinct skin diseases, and in a longitudinal acne therapy study (n = 925). PBI dimensions were extracted by factor analysis and varimax rotation in both studies independently, using the longitudinal study data for replication. Factor analysis revealed largely similar need dimensions in both studies. The five-dimensional solution found in the cross-sectional study explained 63.0% of the variance. The need dimensions were named as reducing psychological impairments, reducing social impairments, reducing impairments due to therapy, reducing physical impairments, and building confidence into therapy. Using this factor solution, different patterns of need were found amongst the ten dermatological diseases. The PBI allows for a differential benefit assessment on five well distinguishable and interpretable subscales. The use of subscales as shown refines the interpretation of needs and benefits in dermatologic treatment.

Routine skin cancer screening in Germany: First data on the impact on health care in dermatology.

BACKGROUND: On July 1st 2008, community skin cancer screening (cSCS) was established in routine care of the German statutory health insurances (SHI). This study aimed at gathering preliminary data on the impact of community SCS on health care provision in German dermatology practices. PATIENTS AND METHODS: Standardized questionnaires were sent to about 2,000 German dermatology practices. Data were analyzed descriptively and with bivariate tests. RESULTS: In total, 693 (34.7%) questionnaires were returned. Each practice performed an average of 354 SCS per quarter, the mean payment being euro 21.50. About 78% named an increase in SCS with an average increase of 36.7%. About 54% of practices performed SCS under SHI payment combined with individual health services paid by the patients ("IGeL"), 38% only as SHI and 8% exclusively as "IGeL". In 85% of practices, the number of surgical procedures had increased since the start of community SCS. 40% had an increase in drug prescriptions related to SCS. 32% were satisfied with SCS, while 40% were unsatisfied. 29 % would prefer SCS only as covered by SHI, 29% only as IGeL, and 42% in a combined fashion. 70% regarded the quality of health care of patients with skin cancer in Germany better since the introduction of cSCS. CONCLUSIONS: Dermatologists in Germany have mainly accepted their role in providing skin cancer as standard care covered by SCS. The regulatory and economic conditions for this need further improvement.

Time needed for treatment is the major predictor of quality of life in psoriasis.

BACKGROUND: The literature on predictors of health-related quality of life in psoriasis is inconsistent. OBJECTIVE: To assess potential predictors of quality of life in psoriasis. METHODS: In a cross-sectional study involving 130 dermatological practices and outpatient clinics, data of 1,210 patients with psoriasis were collected. Quality of life was evaluated using the Dermatology Life Quality Index. Medical history, clinical and sociodemographic characteristics, therapy and health care features were used as independent variables in a backward multiple regression analysis. RESULTS: Twelve predictors were included in the model explaining 38% of variance in quality of life. The strongest predictor was daily treatment time (beta = 0.30), followed by patient-defined treatment benefit (beta = -0.18), disease severity (beta = 0.19) and treatment satisfaction (beta = -0.16). CONCLUSION: Treatment burden requires special attention when quality of life in psoriasis is to be improved. Since the larger part of variance is left unexplained, further factors predicting quality of life have yet to be detected.

Concordance of the Psoriasis Area and Severity Index (PASI) and patient-reported outcomes in psoriasis treatment.

A prospective observational study was conducted to analyze to what extent the Psoriasis Area and Severity Index (PASI) is correlated to patient reported outcomes (PRO). Data were collected on 93 outpatients with psoriasis prior to (t1) and after therapy (t2). A higher PASI score was associated with impaired Quality of Life (DLQI), however associations were only weak (R = 0.24 on t1 and R = 0.36 on t2). The average improvement in PASI score was correlated moderately highly with the change of DLQI (R = 0.50) as well as with the PBI (R = 0.45). The threshold values PASI-50 and PASI-75 were likewise positively associated with PRO, but they only incompletely reflect them: about half of the patients with PASI-50 did not see their expectations met (46.9%) or were not satisfied with the condition of the skin after treatment (56.3%). A quarter of these patients experienced no benefits from the therapy. Of the patients with PASI-75, 15.4% were not satisfied with the condition of their skin. In contrast, 36% of patients who did not attain PASI-50 specified a high level of treatment satisfaction. PASI and PRO are associated but based on different concepts. In addition to clinicial severity, patient-defined benefits should be implemented in the evaluation of psoriasis care.

Meta-analysis of the effectiveness of psychological and pharmacological treatments for binge eating disorder.

OBJECTIVE: The aim of this study was to compute and compare mean effects of various treatments for binge eating disorder. METHOD: A total of 38 studies with 1973 participants fulfilled the defined inclusion criteria. Effect sizes, odds ratios, and simple rates were integrated in fixed and random (mixed) effects categorical models. RESULTS: From randomized controlled trials, psychotherapy and structured self-help, both based on cognitive behavioral interventions, were found to have large effects on the reduction of binge eating. Regarding pharmacotherapy, mainly comprising antidepressants, randomized controlled trials revealed medium effects for the reduction of binge eating. Uncontrolled studies on weight-loss treatments demonstrated moderate reductions of binge eating. Combination treatments did not result in higher effects compared with single-treatment regimens. Except for weight-loss treatment, none of the interventions resulted in a considerable weight reduction. DISCUSSION: Psychotherapy and structured self-help, both based on cognitive-behavioral interventions, should be recommended as the first-line treatments.

Early prediction of long-term cognitive impairment after cardiac arrest.

This prospective study evaluated the prognostic value of early neurobiochemical markers, neuron-specific enolase and astroglial protein S-100B, for long-term cognitive outcome after cardiac arrest. Six months after admission of a cohort of 80 consecutive patients, 26 survivors were able to undergo a neuropsychological test battery. Survivors showed low test performances in attention, learning/memory, and executive functioning. Neuropsychological bedside screening during the first month significantly differentiated between patients with and without long-term cognitive impairment. The neurobiochemical marker S-100B at day 3 after admission was found to predict significant proportions of variance in specific cognitive domains (learning/memory and executive functioning). The results indicate that early neuropsychological assessment might help identify patients who run at risk of long-term neuropsychological dysfunction. This study also suggests that especially the protein S-100B provides valuable information on long-term cognitive outcomes. To understand the exact relationship, results have to be replicated in larger trials.

The patient benefit index: a novel approach in patient-defined outcomes measurement for skin diseases.

Evaluation of therapeutic benefits from the patient's perspective is important in medical decision-making and reimbursement. This study aimed at developing and validating an instrument on patient-defined needs and benefits in dermatology. The questionnaire was developed according to international guidelines. The benefit assessment consists of two steps: before treatment, every patient defines his treatment needs according to a standardized list. After treatment, the patient rates the degree of benefits achieved. A "patient benefit index" (PBI) is calculated by averaging the preference-weighed results of all items. The PBI questionnaire was validated in a sample of 500 patients with ten skin diseases and in a treatment study on 906 patients with acne. The patients defined a broad spectrum of needs and treatment benefits, indicating disease-specific patterns. The PBI showed good feasibility, reliability (Cronbach's alpha >0.91) and construct validity, high responsiveness, and discrimination between subgroups. The PBI permits valid evaluation of patient-relevant benefits in dermatological treatment.

Development and validation of a new instrument for the assessment of patient-defined benefit in the treatment of acne.

BACKGROUND: Benefit assessment of drugs and medical products has become a legally established feature of medical research. A standardized assessment of benefits using scientifically sound and valid methods is essential. OBJECTIVE: Development, validation and practical evaluation of an instrument to record patient benefit in treatment of acne. PATIENTS AND METHODS: In open interviews with n = 50 patients, possible benefits of the therapy from the patients' point of view were recorded. The item pool thus generated was reviewed by a panel of dermatologists, psychologists and patients and transferred to a 23-item questionnaire. This is used prior to therapy to assess patients' desired benefits and after therapy to record the perceived benefits. The therapy goals and the resulting benefits are then used to generate a weighted 'Patient Benefit Index' (PBI). The procedure has been tested for its validity and feasibility in n = 923 patients with acne. RESULTS: Patients accepted the instrument and deemed it to be easily understandable. Additionally, the method proved itself to be internally consistent, constructively valid and sensitive to changes. CONCLUSIONS: The Patient Benefit Index (PBI) is a valid and highly accepted practical instrument for recording patient benefit. The PBI permits an individualized, patient-weighted assessment of the benefits of acne therapy.