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Introduction In the real-world APPRECIATE study (NCT02740218), most patients with psoriasis demonstrated notable improvements on disease severity measures and reported clinically meaningful treatment benefits with apremilast. Objective We aim to further describe patient-relevant needs and benefits and patient satisfaction with apremilast, including subgroup analyses based on patient characteristics. Methods APPRECIATE, a multinational, retrospective, cross-sectional study, enrolled patients with chronic plaque psoriasis who started apremilast according to the European label. Patient Benefit Index (PBI; range 0 (no patient-relevant benefit) to 4 (maximum patient-relevant benefit), global PBI score ≥ 1 indicating minimum patient-relevant benefit and ≥ 3 indicating high benefit) and nine-item Treatment Satisfaction Questionnaire for Medication (TSQM-9; range 0–100) were assessed 6 (± 1) months after apremilast initiation and summarized descriptively. Relationships between global PBI and TSQM-9 assessments were analyzed by Pearson correlations. Results Of 480 enrolled patients, 347 (72.3%) had remained on apremilast at 6 (± 1) months; 90.9% (300/330) achieved global PBI score ≥ 1. Mean (standard deviation) global PBI score was 2.8 (1.2). Higher achievement of global PBI score ≥ 3 was observed in patients with no prior treatments (61.1% (22/36)) or prior phototherapy (64.6% (42/65)) versus prior conventional systemic (54.4% (100/184)) or biologic (38.6% (17/44)) treatment. Strong correlations were observed between the global PBI score and the TSQM-9 global satisfaction and effectiveness subscale scores. Conclusion Patients continuing apremilast for 6 (± 1) months in APPRECIATE reported patient-relevant treatment benefits. Findings suggest that receiving apremilast earlier versus later in treatment management is consistent with greater improvements in patient-relevant treatment outcomes. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00628-3.

Background\ud APPRECIATE is a multinational, observational, retrospective, cross‐sectional study in patients treated for psoriasis with apremilast, an oral phosphodiesterase 4 inhibitor.\ud \ud Objectives\ud To describe the characteristics of patients with psoriasis treated with apremilast in the clinical setting, to evaluate real‐world outcomes of psoriasis treatment with apremilast and to better understand the perspectives of patients and physicians on treatment outcomes.\ud \ud Methods\ud In six European countries, patients with chronic plaque psoriasis treated in clinical practice who could be contacted 6 (±1) months after apremilast initiation were enrolled. Patient characteristics, Dermatology Life Quality Index (DLQI) and Psoriasis Area and Severity Index (PASI) were obtained from medical records when available. Outcomes were evaluated using patient/physician questionnaires.\ud \ud Results\ud In 480 patients at treatment initiation, mean [median; 95% confidence interval (CI)] PASI and DLQI scores were 12.5 (10.7; 11.6–13.4) and 13.4 (13.0; 11.4–14.2), respectively. At 6 (±1) months, 72.3% of patients (n = 347) continued apremilast treatment [discontinuations: lack of efficacy (13.5%), safety (11.7%), other (2.5%)]. In patients continuing treatment, 48.6% achieved a ≥75% reduction in PASI score; mean (95% CI) DLQI score was 5.7 (4.5–6.9), and mean (SD) Patient Benefit Index score was 2.8 (1.2). Physicians perceived clinical improvement in 75.6% of patients. Physicians’ perspective on overall success of apremilast in meeting expectations correlated with patients’ perception of treatment benefit (r = 0.691). Most commonly reported adverse events (>5% of patients) were diarrhoea, nausea and headache.\ud \ud Conclusions\ud Patients in APPRECIATE reported high disease burden despite more moderate skin involvement than those who enrolled in clinical trials of apremilast. Findings from APPRECIATE demonstrate the real‐world value of apremilast for psoriasis treatment, as 7 of 10 patients continued therapy and showed notable improvement in disease severity and quality of life 6 (±1) months after apremilast initiation.

Background Assessment of disease severity is an essential component of psoriasis management. Moderate-to-severe disease qualifies for systemic treatment but different definitions are used. Objectives To analyse the impact of different severity definitions for psoriasis in real-world healthcare. Methods Cross-sectional data on 3274 patients with psoriasis from more than 200 dermatology offices and clinics across Germany were analysed for disease severity based on Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). The proportions of patients having moderate-to-severe disease were determined accordingly. Results The proportion of patients meeting the European consensus criteria for moderate-to-severe psoriasis (PASI AND DLQI > 10) was 14·0%, although 45·3% attained at least PASI OR DLQI > 10. Consideration of all patients on systemic drugs as being 'moderate-to-severe' increased these proportions to 56·9% and 75·2%, respectively. When only PASI > 10 was used, moderate-to-severe disease affected 35·3% and 69·3%, respectively. Conclusions The proportion of patients with psoriasis under dermatological care considered to have moderate-to-severe disease varies considerably according to how the latter is defined, resulting in uncertainty and inequity of access to systemic therapy. We propose an international standardisation in this for the sake of more reliable treatment and healthcare planning.

BACKGROUND Though patient needs are key drivers of treatment decisions, they are rarely systematically investigated in routine care. OBJECTIVE This study aimed at analysing needs and expectations from the patient perspective in the German and Swiss psoriasis registries PsoBest and SDNTT with respect to treatment choice, age and gender. METHODS The German and Swiss psoriasis registries observe patients recruited at first-time use of systemic drugs. Within 10 years, clinical (Psoriasis Area Severity Index (PASI), Body Surface Area (BSA)) and patient-reported outcomes are documented, including the Dermatology Quality of Life Index (DLQI) and the Patient Benefit Index (PBI), characterizing patient needs for treatment. The analysis dataset includes n=4,894 patients from PsoBest and n=449 from SDNTT with mean follow-up time of 7.5 months. RESULTS 5,343 patients registered between 2008 and 2016 were included in the analyses (at baseline: 59.6% male, mean age 47.6 years±14.5, PASI 14.2±9.7, BSA 22.7±19.7, DLQI 11.3±7.2).The most important patient needs were to "get better skin quickly" and to "be healed of all skin defects". Subgroup analyses by age revealed significant differences in needs, especially higher needs regarding social impairments in patients younger than 65 years. Patients 65 years or older attributed more importance to sleep quality, less dependency on medical visits, fewer side effects and confidence in the therapy. Out of 25 items reflecting patient needs, 20 items were rated significantly more important by women than men, with the greatest differences regarding feeling of depression, sleep quality and everyday productivity. Divided by treatment, needs were rated differently, recommending individualized and targeted choice of therapy. CONCLUSION Age and gender stratify patient needs. Women showed higher expectations and rated specific needs in psoriasis treatment higher than men. Analyzing the patient needs on an individual level will facilitate shared decisions by patient and physician in finding the optimal personalized treatment. This article is protected by copyright. All rights reserved.

Psoriasis can involve the skin, joints, nails and cardiovascular system and result in a significant impairment in quality of life. Studies have shown a lower response rate to systemic anti-psoriatic therapies in smokers, and smoking is a trigger factor for psoriasis. The aim of this study was therefore to analyse the response to systemic therapies for psoriasis, with a focus on smoking. Prospectively collected data from patients with moderate to severe psoriasis included in the national psoriasis registries for Germany and Switzerland (PsoBest and SDNTT) were analysed. Therapy response was defined as reaching a Psoriasis Area and Severity Index (PASI) reduction of 75%, PASI ≤ 3 or Dermatology Life Quality Index (DLQI) ≤ 1. Out of 5,346 patients included in these registries, 1,264 met the inclusion criteria for this study. In the smoking group, 715 (60.6%) reached therapy response at month 3, compared with 358 (63.7%) in the non-smoking group (p ≤ 0.269), 659 (74.1%) vs. 330 (77%) reached therapy response at month 6 (p ≤ 0.097), and 504 (76.6%) vs. 272 (79.0%) at month 12 (p ≤ 0.611). Therefore, these data do not show that smoking affects the response rate of anti-psoriatic therapy after 3, 6 and 12 months.

In 2005, the first national psoriasis survey in Germany revealed large deficits in health care particularly in patients with moderate to severe disease. The consecutive goal was to improve health care for psoriasis countrywide. For this, a large-scale national program was initiated starting with a comprehensive analysis of structures and processes of care for psoriasis. Patient burden, economic impact and barriers to care were systematically analyzed. In order to optimize routine care, a S3 guideline, a set of outcomes measures and treatment goals, were developed. Implementation was enforced by the German Psoriasis Networks (PsoNet) connecting the most dedicated dermatologists. The annual National Conference on Health Care in Psoriasis established in 2009 consented National Health Care Goals in Psoriasis 2010-2015 and defined a set of quality indicators, which are monitored on a regular basis. Currently 28 regional networks including more than 800 dermatologists are active. Between 2005 and 2014 7 out of 8 quality indicators have markedly improved, and regional disparities were resolved. e.g., mean PASI (Psoriasis Area Severity Index) dropped from 11.4 to 8.1 and DLQI (Dermatology Life Quality Index) from 8.6 to 5.9. A decade of experience indicates that a coordinated nationwide psoriasis program based on goal orientation can contribute to better quality of care and optimized outcomes.

Background Different phenotypes have been described in psoriasis. Few details are known about the topology of patients in routine care. Objectives To characterize the frequency and distribution of body sites affected by psoriasis in Germany. Methods Data from a national cross-sectional study (PsoHealth2) were analysed. Each practice consecutively recruited 20 patients independently of treatment. Topical distribution was identified with a detailed grid scheme of 1424 squares filled by the patient. Psoriasis history, clinical findings, comorbidity and patient-reported outcomes were obtained. Results In total, 2009 patients with psoriasis were observed. Nineteen per cent of patients had psoriatic arthritis, 65·4% had scalp involvement and 35·6% had nail involvement; in 40·5% of patients, their first-degree relatives also had psoriasis. In total, 1927 (95·9%) provided complete grid data. The mean number of grids marked was 152·4 ± 193·2, corresponding to 10·7% of body surface area. The most frequently affected body areas were the elbows, knees, lower legs and scalp (65-78%). In a linear regression analysis (corrected R² = 0·093), the strongest predictors of reductions in health-related quality of life (HRQoL), measured by the Dermatology Life Quality Index, were having the hands (β = 0·147; P = 0·000), arms (β = 0·097; P = 0·008), genitals (β = 0·080; P = 0·010), neck (β = -0·072; P = 0·043), scalp (β = 0·068; P = 0·010) and nails affected (β = 0·064; P = 0·005). Conclusions Typical psoriatic lesions are found in real-world care. However, smaller areas are important determinants of reductions in HRQoL.

The German Psoriasis Registry PsoBest was conducted in 2008 in order to investigate the long-term outcomes and safety of systemic treatments for moderate-to-severe psoriasis. Safety analysis of antipsoriatic drugs with special focus on serious adverse events (SAE) for infections, malignancies and major cardiac events (MACE) was done. Nationwide non-interventional patient treatment registry conducted in 251 active dermatology centers. Until June 2012, n = 2444 patients [40 % female; mean age 47.3 (SD 14.1) years; mean duration of disease 18.2 (SD 14.7) years] were recruited, including n = 1791 patients (3842 patient years) with conventional systemic drugs and n = 908 (3442 patient years) with biological drugs. Mean PASI (Psoriasis Area and Severity Index) at inclusion was 14.7, mean DLQI (Dermatology Life Quality Index) 11.1, mean BMI (Body Mass Index) 28.2. The overall rate of SAE per 100 patient years were 1.3 (SD 0.9) per 100 patient years in conventional systemic and 1.5 (SD 1.2) in biologics (p > 0.5, no significant difference). The rates per 100 patient years for single severe adverse events were as follows (systemic/biologics): serious infections, 0.33/0.65 [CI (confidence interval) 0.13–0.54/0.35–0.98]; MACE, 0.56/0.77 (CI 0.29–0.97/0.41–1.31); malignancies (except non-melanoma skin cancer), 0.46/0.49 (CI 0.22–0.84/0.21–0.97). There were no significant differences between single drugs in any of the safety parameters. The conventional systemic and biologic drugs for psoriasis show satisfying safety under routine psoriasis care in Germany with respect to infections, MACE and malignancies.

Background: First studies have shown that juvenile psoriasis is associated with an increased prevalence of comorbidity. Objectives: We carried out a data analysis to characterise the profiles of comorbidity in children with psoriasis and atopic eczema. Methods: Prevalence data were derived from the database of a German statutory health insurance company according to ICD-10 codes L40 (psoriasis) and L20 (atopic eczema) of children up to 18 years insured in 2009. Results: Data sets included 1.64 million persons and 293,181 children. 1,313 children = 0.45% (0.42-0.47) had a diagnosis of psoriasis and 30,354 = 10.35% (10.24-10.47) had a diagnosis of atopic eczema. Obesity, hyperlipidaemia, arterial hypertension and diabetes were more often diagnosed in children with psoriasis in comparison to all children without psoriasis and to those with atopic eczema. Conclusion: Children with psoriasis and atopic eczema show different and specific patterns of comorbidity which should be detected early and treated adequately.

Patient-reported outcomes (PROs) have gained substantial importance in medical research and care. One of the major areas of PROs is health-related quality of life (HRQoL), which reflects the personal health condition of an individual in physical, social, emotional, and functional dimensions. Other concepts of PROs include a patient’s psychological condition, satisfaction, and preferences. In a general sense, PROs summarize all facts of a medical observation or intervention reported by the patient. In most cases, these outcomes cannot be recorded by other techniques and can only poorly be measured by professionals or relatives (via proxies). This article summarizes the concepts, methodology of measurement, and interpretation of results of PROs in dermatology, with a particular focus on HRQoL. The review is based on a November 2011 literature search and additional scientific exploration by the authors. An updated systematic review on the research terms patient reported outcomes, quality of life, patient preferences, willingness to pay, and PROs was performed. The resulting series of publications were checked for accuracy, topical match, and content. In terms of specific outcomes tools in dermatology, 105 instruments for assessing QoL of dermatology with validated data were identified. With respect to guidelines on QoL measurement in dermatology, three specific guides were found. PROs, in particular QoL and patient preferences, are indispensable constructs in the assessment of the patient perspective in clinical care, clinical research, health services research, and clinical routine. The use of validated methodologies is recommended, and, in most cases, validated instruments are available. Any instrument used should be checked for validity, scientific pureness, and feasibility.

Epidemiological studies indicate an increased risk of co-morbidities and an association with other inflammatory diseases in psoriasis. However, most analyses have been performed on small samples of patients. The aim of this study was to evaluate the prevalence of co-morbidities in psoriasis based on a large set of health insurance data. The database of 1.3 million patients in a German nationwide statutory health insurance scheme was analysed. Data-sets of patients with confirmed psoriasis were extracted and analysed for co-morbidities. Of 1,344,071 subjects, 33,981 had a diagnosis of psoriasis (prevalence 2.5%). Metabolic syndrome was 2.9-fold more frequent among these patients. The most common diagnoses were arterial hypertension (35.6% in psoriasis vs. 20.6% in controls) and hyperlipidaemia (29.9% vs. 17.1%). The frequencies of rheumatoid arthritis (prevalence ratio (PR) 3.8), Crohn's disease (PR 2.1) and ulcerative colitis (PR 2.0) were also increased among patients with psoriasis. In conclusion, psoriasis is associated with significant co-morbidities that imply an elevated risk of severe complications.

insurance funds and other parties involved in the health care sector have realized the need to obtain specific data on health services provision. The task of health services research is to investigate the reality of health services provision under everyday conditions (German Medical Association 2005). Health services research has established itself as the third pillar of health research – along with biomedical basic research and clinical research. In order to provide a picture of the state of health services provision in Germany, it is necessary to obtain sufficient upto-date national data on the German health care system. Though the development of effective health services research is now regarded as essential, our knowledge of the state of health services provision in Germany is, in some cases, still only rudimentary, even in the case of some of the most common diseases. This is especially true for skin diseases.

Summary 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.

Background: Vitiligo causes substantial disease burden and patient needs still remain underestimated. Objective: To assess the clinical features, treatment outcomes and satisfaction in patients with vitiligo. Methods: A nationwide, cross-sectional German postal survey was conducted. Clinical features and treatment outcomes of vitiligo (affected body surface, comorbidities, treatments applied, patient benefit index [PBI]) were evaluated using a standardized patient questionnaire. Results: 1,023 patients (71.4% women, mean age 44.4 years) completed the questionnaire. The average onset of disease was at 24.1 years, and the mean disease duration was 20.3 years. The mean number of body sites affected was 6.9, and the mean affected body surface area was 14.9%. On average, 3.7 therapies had been applied previously, with a total PBI of 1.03 ± 1.12. Only 38.7% experienced a PBI >1, which indicates a minimal patient benefit. Conclusions: Most therapeutic options are considered to be of low patient benefit. There is a need for more beneficial treatments and improved care in patients with vitiligo.

Summary Background: Many different forms of treatment are available for psoriasis. The German standard is the national AWMF S3 guideline. A national survey on psoriasis care in 2005 indicated deficits in psoriasis care in Germany. Aim: Assessment of the health care situation of patients with psoriasis in Germany. Methods: Nation-wide cross-sectional study, in 142 dermatological practices and clinics. The following data were documented: a) Doctor Questionnaire: Treatment, illnesses, clinical characteristics and severity (PASI). b) Patient Questionnaire: Quality of life (QoL), patient relevant therapeutic benefits and satisfaction with the quality of the care. A panel of experts developed and analyzed 8 criteria as indicators of the quality of care. Results: Of the 2009 evaluated patients, 11.6% suffered from severe psoriasis (PASI > 20) and 27.4% from moderate psoriasis (PASI 10–20). The average PASI value was 10.1, and the DLQI 7.5. 32.2% of patients had a serious reduction in their QoL (DLQI > 10). The share of patients with preceding systemic therapy was 47.3%, in severe psoriasis 62.1%, while 20.1% of the patients had received inpatient treatment. The average number of days absent from work was 3.4. Compared to 2005, all 8 indicators improved. Conclusion: Significant numbers of psoriasis patients show serious quality of life reductions and high grades of clinical severity. In comparison to 2005, there has been a notable, nation-wide improvement in psoriasis care.