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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 Even today, a substantial number of individuals with visible skin diseases still suffer from incomprehension and stigmatization. About 10 million people are affected by such diseases in Germany. The WHO strongly urges member states to take measures against stigmatization in skin diseases. Objectives Objectives are the development of an action programme to raise awareness and address stigmatization. Therefore, conception, development and testing of interventions for the destigmatization of persons with skin diseases in Germany will be carried out. Methods A series of actions addressing decision makers, politicians and the Federal Ministry of Health were initiated, all based on the World Health Assembly (WHA). Argumentation was largely based on data from health services research. Supported by the Federal Ministry of Health, a concept against stigmatization was developed by an expert consortium of researchers, dermatologists and patients. Specific strategies of structured destigmatization between those affected and those not will be developed and scientifically evaluated. Results The activities addressed to politics were - to a large extent - successfully and financially supported by a 3-year programme (2018-2020), designed to develop interventions against stigma. It was funded by the Federal Ministry of Health. The project includes conception and development, intervention and evaluation, data analyses and development of a long-term concept. Conclusions The WHO's call against stigmatization in psoriasis (resolution WHA67.9 and global report on psoriasis 2016) was taken into account and developed into a destigmatization programme supported by the German government and German politicians. This has been achieved by successful collaborations between dermatologists, researchers, patients and policymakers. Next step will be the testing of interventions in situations and surroundings, where stigmatization usually occurs. The data will be used for the implementation of a long-term concept that can be used to continue destigmatization in Germany far beyond the project's initial phase.

Background Psoriasis is a stigmatizing disease that often affects female patients more negatively than male patients. Very little systematic data on the treatment responses related to gender exists. Objectives This two-country, multi-centre, prospective, non-interventional registry study aimed to evaluate potential gender differences with respect to systemic anti-psoriatic treatment. Methods Data of patients with moderate to severe psoriasis participating in the German (PsoBest) or Swiss (SDNTT) psoriasis registry were analysed. Treatment response was defined as reaching PASI75 or PASI ≤ 3 at months 3, 6 and 12 of treatment and was supplemented by patient reported outcomes, i.e. DLQI ≤ 1 and Delta DLQI ≥ 4. Results 5,346 patients registered between 2007 and 2016 were included in the analyses (4,896 from PsoBest and 450 from SDNTT). The majority of patients received a non-biologic treatment: 67.3 % of male and 69.8 % of female patients. Overall, women showed slightly higher PASI response rates after 3, 6 and 12 months, respectively 54.8 vs. 47.2 %, p ≤ 0.001, 70.8 vs. 63.8 %, p ≤ 0.001, 72.3 vs. 66.1%, p ≤ 0.004. In line with this, we found significantly higher proportions of female patients achieving a DLQI reduction ≥ 4: 61.4 vs 54.8 % at month 3 (p ≤ 0.001), 69.6 vs. 62.4 % at month 6 (p ≤ 0.001) and 70.7 vs. 64.4 % at months 12 (p ≤ 0.002), respectively. Females on biologics showed a significantly superior treatment response in the PASI ≤ 3 at 3 (57.8 vs 48.5%) p ≤ 0.004 and 6 months (69.2 vs 60.9%) p ≤ 0.018. The non-biologics group had a significant better treatment response (PASI response, PASI 75 and PASI ≤ 3) in females over the whole treatment year. Differences found in single treatments only occurred at individual points in time and did not show a uniform trend or can be regarded as methodological artefacts. Conclusion Our data provide evidence that women experience better treatment outcome as measured by PASI to systemic anti-psoriatic therapy than men. Several factors may contribute to this observation, including adherence to treatment, weight, or different lifestyle behavior.

Psoriasis is a chronic, systemic, inflammatory skin disease with a risk of comorbidities and a potential high impact on patientsrsquo; quality of life.

Patient organisations play an important role in supporting patients with chronic diseases and allow information transfer beyond professional care structures. Until now, only few studies have investigated the benefits of a dermatological patient organisation. In this study, potential benefits of joining the German Psoriasis Association (Deutscher Psoriasis Bund e. V., DPB) were surveyed. The quasi-experimental longitudinal design included four groups of individuals suffering from psoriasis: those (1) with DPB membership of 5 years, (2) with voluntary new membership, (3) with randomly awarded membership, and (4) without membership. Participants were interviewed two times in 12 months, about quality of life, depression, participation in patient education classes, health status, and treatment benefits. 295 individuals participated (mean age 54 years; 50.3% females). At the outset of the study, participants with voluntary new membership rated their health status worse and showed higher depression scores than those with awarded membership. The proportion of participants who joined patient education classes only increased in the group of long-term members. Health status worsened in the group of non-members, and it improved in the group of those with awarded and voluntary new membership. Treatment benefit only increased in the voluntary new members group. DPB membership seems to be associated with some relief from psoriasis-related strains, particularly in the group of those who joined voluntarily. This could be due to the fact that individuals who become members out of their own volition are more likely to seek information and, therefore, benefit from their active engagement.

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 The Dermatology Life Quality Index (DLQI) is the most frequently used health-related quality of life (HRQoL) instrument for skin diseases. According to the DLQI instructions, the responses 'not relevant' and 'my skin problem has not at all affected this aspect of life' ('not at all') have to be scored as 0 = no HRQoL impairments. Objective The aim of this study was to estimate potential bias of DLQI measurements for patients with psoriasis based on items considered to be not relevant. Methods One thousand two hundred forty-three patients with psoriasis were surveyed in a cross-sectional study. Disease severity (Psoriasis Area and Severity Index, PASI) and subjective health state (EuroQoL Visual Analogue Scale, EQ VAS) were compared per DLQI item between patients who answered the respective question 'not relevant' and those who answered 'not at all'. Results Patients who declared a DLQI item to be not relevant showed a higher disease severity and a lower health state. Conclusion Results indicate that patients who declare a DLQI item to be not relevant have a higher disease-related burden than those who do not feel affected by their psoriasis in the same aspect of life. If aspects of life are considered to be not relevant due to high disease burden, this should be reflected by a HRQoL instrument.

Background Delivery of health care to psoriasis patients plays an important role in the field of dermatology. Following the 2014 WHO resolution and the 2016 WHO global report, there has been an increase in the awareness of psoriasis among the general public. However, the perception of psoriasis by the general population remains unclear. The goal of the present study was to investigate the perception and assessment of psoriasis among the German population. Patients and methods Representative telephone survey among 2,001 adults using a standardized questionnaire. Analyses with respect to place of residence, age, gender and level of education were conducted in a descriptive manner. Results Twenty-nine percent of participants were familiar with the term "Psoriasis"; 86 %, with the German designation "Schuppenflechte". Ninety-three percent considered the disease to be a significant burden for affected individuals; 59 % stated that there were effective drugs available for psoriasis; 9 % considered the disease to be communicable. Ten percent reported that they would not want to live in the same household as an affected individual; 23 % did not want to share the same swimming pool; and 27 % did not want to be in a personal relationship with someone affected. Twelve percent stated to be familiar with the WHO resolution on psoriasis; 6 % with the World Psoriasis Day; and 3 % with the "Bitte beruhren" ("Please touch") campaign. Conclusions Although a majority of the German population is familiar with the term "Schuppenflechte", there is a significant lack of knowledge about the disease as well as prejudice toward affected individuals. Further measures are required to improve the level of information and decrease stigmatization.

HINTERGRUND Die Versorgung der Psoriasis vulgaris nimmt in der Dermatologie einen wichtigen Stellenwert ein. Im Zuge der WHO-Resolution 2014 und des WHO Global Reports 2016 hat die offentliche Aufmerksamkeit fur die Psoriasis zugenommen. Unklar ist, wie Psoriasis in der Allgemeinbevolkerung wahrgenommen wird. Ziel ist die Erfassung der Wahrnehmung und Bewertung von Psoriasis in der Bevolkerung. PATIENTEN UND METHODEN Reprasentative Telefonumfrage mit 2001 Erwachsenen mittels eines standardisierten Fragebogens. Die Auswertungen erfolgten deskriptiv nach Region, Alter, Geschlecht und Bildungsstatus. ERGEBNISSE Die Begriffe Psoriasis bzw. Schuppenflechte waren 29 % bzw. 86 % der Befragten, bekannt. 93 % schatzten die Krankheit als sehr belastend fur die Betroffenen ein, 59 % nahmen an, dass es wirksame Medikamente gegen Schuppenflechte gibt und 9 % hielten diese Erkrankung fur ansteckend. 10 % wurden nicht mit einer betroffenen Person im Haushalt leben wollen, 23 % nicht mit Betroffenen ins Schwimmbad gehen und 27 % nicht in einer Partnerschaft sein. 12 % gaben an, die WHO-Resolution zur Psoriasis zu kennen, 6 % den Weltpsoriasistag und 3 % die Kampagne "Bitte beruhren". SCHLUSSFOLGERUNGEN Wenngleich einer Mehrheit in der deutschen Bevolkerung die Schuppenflechte bekannt ist, bestehen deutliche Wissensdefizite und teilweise Vorurteile gegenuber dieser Erkrankung. Weitergehende Masnahmen zur besseren Information und zur Minderung der Stigmatisierung sind notwendig.

Biosimilars sind biologische Medikamente, bei denen es sich um Nachbildungen eines spezifischen Referenzprodukts handelt. Biosimilars der Tumornekrosefaktor-alpha-Inhibitoren Infliximab und Etanercept sind bereits zugelassen und stehen für dermatologische Indikationen zur Verfügung. Die Aufsichtsbehörden verlangen eine eingehende Analyse der physikochemischen und funktionellen Eigenschaften dieser hochkomplexen Moleküle sowie klinische Daten hinsichtlich ihrer gleichwertigen Wirksamkeit und Sicherheit anhand mindestens einer klinischen Studie mit einer sensitiven und homogenen Population. Für die Zulassung in einem regulierten Arzneimittelmarkt muss daher nachgewiesen werden, dass die Biosimilars praktisch gleichwertig mit dem jeweiligen Originalpräparat sind. Demzufolge werden diese Daten von einem Molekül (dem Originator) auf das andere (das Biosimilar) extrapoliert und die resultierende Zulassung umfasst die gleichen Indikationen wie beim Originalpräparat. Die Extrapolation ist zwar gut akzeptiert und reguliert, es fehlen jedoch klare Empfehlungen hinsichtlich der Austauschbarkeit von Originator und Biosimilar ebenso wie Daten über mehrmalige aufeinanderfolgende Umstellungen. Die aktuellen wissenschaftlichen Erkenntnisse stehen einer Anwendung von Biosimilars bei dermatologischen Indikationen nicht entgegen. Eine mehrmalige Umstellung der Biosimilars sollte jedoch sorgfältig überdacht werden. Um das Vertrauen in Biosimilars zu festigen und ihre Evidenz zu verbessern, ist es essentiell das spezifische Produkt, das jeder Patient erhält, möglichst genau und möglichst im Rahmen von Patientenregister zu dokumentieren.

Biosimilars are biological medicines that are analogues of a specific reference product. Biosimilars of the tumor necrosis factor alpha inhibitors infliximab and etanercept are already approved and available for dermatological indications. Regulatory agencies require in-depth analysis of physicochemical and functional properties of these highly complex molecules as well as clinical data on their similarity regarding efficacy and safety in at least one clinical trial in a sensitive and homogeneous population. Thus, it must be shown that biosimilars are essentially the same as the originator product if they are to be licensed in regulated drug markets. As a consequence, these data are extrapolated from one molecule (the originator) to another (biosimilar) resulting in an approval that includes the same indications as the originator product. While extrapolation is well accepted and regulated, clear recommendations regarding the interchangeability of originators and biosimilars as well as data on multiple consecutive switching are missing. Current scientific knowledge does not argue against the use of biosimilars for dermatological indications, but sequential switching of biosimilars should be considered carefully. To increase confidence and enhance evidence for biosimilars, accurate documentation of the specific products given to each patient is essential and should preferably be included in patient registries.

The field of dermatological comorbidity in psoriasis is only passively explored with contradictory results. Objective of this study was to further investigate the complex field of psoriasis and associated skin diseases by identifying skin comorbidity patterns in an extensive cohort of employees in Germany. Retrospective analysis of data deriving from occupational skin cancer screenings was conducted. From 2001 to 2014 German employees between 16 and 70 years from different branches underwent single whole-body screenings by trained dermatologists in their companies. All dermatological findings and need for treatment were documented. Point prevalence rates and their 95% confidence intervals were computed. Logistic regression analysis was performed to calculate odds ratios (OR) of single dermatological diseases to occur together with psoriasis controlled for age and sex. Data from 138,930 persons (56.5% male, mean age 43.2) were evaluated. Psoriasis point prevalence was 2.0%. Of those 20.6% had unmet treatment needs of their disease. Onychomycosis was the most frequent dermatological comorbidity with a prevalence of 7.8%. Regression analysis found rosacea (OR = 1.40, 95% CI 1.13-1.72) and telangiectasia (OR = 1.25, 95% CI 1.10-1.41) to be significantly associated with psoriasis. 17.2% of psoriasis patients had at least one further finding requiring treatment. The highest treatment needs were found for onychomycosis (3.4%), tinea pedis (3.1%), and verruca plantaris (1.0%). It can be concluded that persons with psoriasis are at increased risk to suffer from comorbid skin diseases, which should be considered in treatment regimens. Particular attention should be paid to fungal diseases of the feet.

ZusammenfassungHintergrund Die Pustulosis palmoplantaris ist eine chronisch entzundliche Hauterkrankung, die mit bedeutenden Einschrankungen der Lebensqualitat und der Belastbarkeit einhergeht. Aufgrund von Zulassungsbeschrankungen und einem haufig therapierefraktaren Verlauf sind die Behandlungsmoglichkeiten limitiert. Patienten und Methodik Nach zuvor frustranen Therapien erhielten 9 Patienten mit Pustulosis palmoplantaris nach Ausschluss einer latenten Tuberkulose Ustekinumab (45 mg Ustekinumab bei 100 kg KG) in Woche 0, 4, 12 und 24. Regulare Visiten erfolgten nach 4 und 12 Wochen, im weiteren Verlauf alle 12 Wochen. Ergebnisse Das Durchschnittsalter bei Therapiebeginn betrug 48 Jahre. Drei Patienten waren mannlich. Bei n = 4 Patienten (44,4 %) wurde eine Verbesserung um 75 % des Palmoplantar-Psoriasis-Area-Severity-Index (PPPASI) erreicht. Insgesamt verbesserte sich der PPPASI nach 24 Wochen durchschnittlich um 71,6 %. Eine komplette Abheilung zeigte sich bei n = 2 Patienten nach 24 Wochen. Bis auf lokale Injektionsreaktionen und leichte Infekte wurden keine unerwunschten Wirkungen beobachtet. Schlussfolgerungen Die Fallserie ist ein weiterer Beleg fur die Wirksamkeit und Vertraglichkeit von Ustekinumab in der Therapie der Pustulosis palmoplantaris. Zur Beurteilung der Langzeitwirkung und -sicherheit sowie der Wirksamkeit einer intermittierenden Therapie sind kontrollierte Studiendaten sowie Beobachtungen im Rahmen von Patientenregistern notwendig.

BACKGROUND Conventional analyses present aggregate data, masking late responders and efficacy reductions. Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, shows sustained efficacy in moderate-to-severe psoriasis. OBJECTIVES To determine stability of response to secukinumab, changes in efficacy were assessed in individual patients. METHODS This is a post hoc analysis of two phase III randomized controlled trials, FIXTURE (trial registration: NCT01358578) and CLEAR (trial registration: NCT02074982). Patients received secukinumab 300 mg (FIXTURE and CLEAR), etanercept 50 mg (FIXTURE) or ustekinumab 45 or 90 mg (CLEAR) over 52 weeks. Mutually exclusive response categories were defined: ≥ 90% improvement in the Psoriasis Area and Severity Index (PASI 90) ('excellent'), ≥ 75% improvement in PASI (PASI 75) and < PASI 90 ('good') and < PASI 75 ('insufficient'). Reductions in efficacy were defined as shifts from higher to lower response categories between two consecutive visits maintained for a third consecutive visit. Loss of efficacy was defined as a reduction of efficacy resulting in 'insufficient' response. All comparisons are descriptive. RESULTS At 52 weeks, in CLEAR, 90·2% (303/336) of patients on secukinumab achieved stable efficacy without loss and 77·7% (261/336) showed stable efficacy without any reduction of response [74·3% (252/339) and 59·9% (203/339) of patients for ustekinumab]. In FIXTURE, 83·5% (273/327) and 66·4% (217/327) of patients on secukinumab had stable efficacy without loss or reduction of response [58·3% (190/326) and 42·6% (139/326) for etanercept]. Response was regained by continuing secukinumab treatment in 50% (8/16) of patients in CLEAR and 26% (9/34) in FIXTURE. Similar patterns were observed for other response definitions. CONCLUSIONS Efficacy with secukinumab was stable over 52 weeks of treatment in most patients. Continued treatment with secukinumab resulted in regain of efficacy in some patients. Persistent loss of response was uncommon. What's already known about this topic? Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, shows significant and sustained efficacy in the treatment of moderate-to-severe psoriasis. Secondary loss of response may be experienced by a minority of patients treated with secukinumab, as with other biologics, but the extent of this and the potential for regain of efficacy with continued treatment is not well understood. What does this study add? To determine stability of response to secukinumab and inform clinical practice, changes in efficacy were assessed at individual patient level using response categories. Efficacy with secukinumab was stable over 52 weeks of treatment in most patients, and continued treatment with secukinumab resulted in efficacy regain after loss in some patients. Persistent loss of response was uncommon. Patient factors such as body weight may affect the likelihood of loss of efficacy.

Apremilast is an oral inhibitor of phosphodiesterase-4 (PDE4) that is licensed for the second-line treatment of psoriasis and psoriatic arthritis. Data from several phase III clinical trials and real-world studies showed a good benefit-risk profile, with diarrhea and nausea as the most common adverse events. Diarrhea and nausea most frequently occurred during the first month of treatment. In most cases, they were mild or moderate in severity and tended to resolve over time with continued dosing and without intervention. In this review we summarize available data on gastrointestinal side effects of apremilast in patients with psoriasis and psoriasis arthritis and provide practical strategies for managing these symptoms.

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.

Background Most data suggesting an association between psoriasis and cardiovascular disease (CVD) have come from specialized populations at either low or high risk of CVD. Atopic dermatitis (AD) has been associated with a number of modifiable risk factors, particularly obesity. There has been a recent controversy on the suggestion that associations with comorbidities in psoriasis may be due to overreporting or biased by disease severity and therefore not necessarily representative of the general psoriasis population. Objectives To evaluate the prevalence of AD and psoriasis and to compare the prevalence rates of comorbidities based on a large sample of health insurance data. Methods Data were collected from a database of non-selected individuals from a German statutory health insurance organization that covers all geographic regions. Individuals identified by International Classification of Diseases (ICD)-10 codes applied to all outpatient and inpatient visits in the year 2009. Comorbidities were evaluated by ICD-10 diagnoses. Results The database consisted of 1 642 852 members of a German statutory health insurance. Of 1 349 671 data sets analyzed, 37 456 patients ≥18 years were diagnosed with psoriasis (prevalence 2.78%), and 48 140 patients ≥18 years of age were diagnosed with AD, equivalent to a prevalence of 3.67%. Patients with psoriasis showed increased rates of comorbidities in all age groups. Comorbidities related to the metabolic syndrome including arterial hypertension [prevalence ratio (PR), 1.94; 95% confidence interval (CI), 1.90–1.98], hyperlipidaemia (PR, 1.77; 95% CI, 1.73–1.81), obesity (PR, 1.74; 95% CI, 1.69–1.79) and diabetes mellitus (PR, 1.88; 95% CI, 1.83–1.94) were significantly more common among patients with psoriasis compared to AD. Conclusions Diseases forming part of the metabolic syndrome showed significant lower prevalence rates in patients with AD than in patients with psoriasis. Within the limitations of secondary healthcare data, our study disproves the suggestion that associations with comorbidities in psoriasis may be biased by a higher degree of severity or overreporting.

Background Psoriasis is associated with significant patient burden. Few studies have specifically measured patient preferences and benefits. Objectives Outcomes assessment using the Patient Benefit Index (PBI) in nationwide psoriasis surveys comparing health care in 2007 and 2014. Methods This was a non-interventional, cross-sectional survey conducted in 2007 and 2014 in randomly selected dermatological practices and clinics recording by a) physicians: comorbidity, clinical severity (PASI, GCA), and b) patients: quality of life (DLQI, EQ-5D), patient-relevant therapeutic benefits (PBI) and previous and curent treatments. Results In 2014, a total of n = 1265 patients (43.4% female, mean age 51.9 ± 14.3 years.; mean disease duration 21.6 ± 15.4 years.) were included. Overall PBI was 2.8 ± 1.1. A total of 91.6% of patients showed a more than minimum clinically relevant benefit (PBI>1). Patients treated with biologics and biologics combined with conventional systemics showed the highest benefit compared to patients with conventional systemic treatment and patients treated with topical steroids. In comparison with the 2007 survey (n = 2009), there was an increase in PBI from 2.5 ± 1.1 to 2.8 ± 1.1 and a gain of patients with high benefits (PBI ≥3) by 30% (38.5% vs. 49.4%). Conclusion In German routine care, psoriasis patients have shown increased therapeutic benefits over time with highest benefits deriving from biologics combined with systemics.

Two national surveys conducted in 2005 and 2007 indicated deficits in psoriasis care and induced the composition of the ‘‘National Goals for Health Care in Psoriasis 2010–2015’’. The aim of this work was to (1) evaluate the quality of care for patients with psoriasis in Germany, (2) compare this with prior psoriasis studies PsoHealth1 (2005) and PsoHealth2 (2007), and (3) review the implementation of national treatment goals. By means of a cross sectional study the following indicators of health care quality were collected: psoriasis severity (Psoriasis Area Severity Index (PASI) and proportion of PASI >20), quality of life (Dermatology Life Quality Index (DLQI) were corporated: proportion of DLQI >10), previous systemic treatment, inpatient treatment, and days absent from work due to psoriasis. Between January 2013 and March 2014, 1265 patients from 82 dermatological centres were included (mean age of 52 years). 9.2 % had a PASI >20 (2007: 11.6 %; 2005: 17.8 %). 21.3 % reported strong quality of life restrictions (DLQI >10) (2007: 28.2 %; 2005: 34.0 %). 59.5 % had received a systemic treatment at least once within the last 5 years (2007: 47.3 %; 2005: 32.9 %). 20.1 % were treated inpatient within the last 5 years (2007: 20.1 %; 2005: 26.9 %). The current data indicate a better health care situation for psoriasis in Germany. The implementation of the S3-Guideline and the ‘‘National Goals for Health Care in Psoriasis 2010–2015’’ could have been contributing factors.

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.

Health-related quality of life (HRQoL) is often markedly impaired in both adults and children with atopic dermatitis. The quality of life of the parents of infants or children with this chronic disease is also affected owing to problems such as itch-induced sleeping problems and treatment effort. As HRQoL is only partly associated with disease severity, both parameters should be evaluated in research and clinical practice. For the measurement of HRQoL, both skin- and disease-specific questionnaires are available in addition to generic instruments. In randomized controlled trials on atopic dermatitis, HRQoL is most commonly evaluated with the Dermatology Life Quality Index for use in adults and related questionnaires for children and families, such as the Children's Dermatology Life Quality Index. There is evidence that different treatment modalities may be effective in improving HRQoL in adults, children, and parents, which is supported by the patients' own evaluation of treatment benefit in an observational study.

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.

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.

Zusammenfassung Hintergrund Psoriasis ist mit einer erhohten Rate an Komorbiditat assoziiert, deren fruhzeitige Erkennung in die Nationalen Versorgungsziele aufgenommen worden ist. Bislang fehlte eine konsentierte Empfehlung zur Fruherkennung innerhalb einer dermatologischen Routineversorgung. Ziel der vorliegenden Arbeit war die interdisziplinare Entwicklung von Algorithmen zur Fruherkennung. Methodik Die Entwicklung des Konsensuspapiers beruht auf einem dreistufigen Vorgehen: In der ersten Stufe erfolgte in einer nationalen Versorgungskonferenz zur Psoriasis im Auftrag der Deutschen Dermatologischen Gesellschaft (DDG) und des Berufsverbandes der Deutschen Dermatologen (BVDD) eine Definition von Bedarfen, Einsatzbereichen, Konzeption und Methodik eines Tools zur Fruherkennung. Im zweiten Schritt wurde durch einzelne Arbeitsgruppen auf Basis einer Literaturrecherche die Evidenz fur den Einsatz von Screening-Parametern zusammengetragen. Im dritten Schritt erfolgte von einer interdisziplinaren Arbeitsgruppe die Verabschiedung der Algorithmen mittels Delphi-Befragung. Ergebnisse In den Literaturrecherchen der assoziierten Arbeitsgruppen wurden fur 15 Gruppen von Komorbiditat uber 2 000 Publikationen gesichtet. Fur die nachfolgenden zwolf Indikationen wurde ein Screening-Algorithmus konsentiert: Arterielle Hypertonie, Dyslipidamie, Adipositas, Diabetes, metabolisches Syndrom, nicht-alkoholische Steatohepatitis, Depression, Nikotinabusus, Alkoholabusus, chronische entzundliche Darmerkrankungen, Psoriasisarthritis, maligne Lymphome. Es wurde dabei auf die Belange in der dermatologischen Versorgung eingegangen. Schlussfolgerung Es stehen fur das Screening auf Komorbiditat bei Psoriasis vereinheitlichte und im Expertenkonsens verabschiedete Schemata zur Verfugung, die bundesweit im Rahmen von „PsoNet –Regionale Psoriasisnetze in Deutschland“ umgesetzt werden konnen.

Summary Background Psoriasis is associated with an increased rate of comorbidities, whose early detection has been adopted into the national healthcare goals. To date, agreed recommendations on early detection in the context of routine dermatological care are missing. The objective of this study was the interdisciplinary development of screening algorithms. Methods The development of the consensus paper was based on a three-step process. First, the National Conference on Healthcare in Psoriasis, convening on behalf of the German Society of Dermatology (DDG) and the Professional Association of German Dermatologists (BVDD), developed a definition of the requirements, areas of application, conception, and methodology of a screening tool. Secondly, based on a literature search, individual working groups compiled evidence for the use of screening parameters. In a third step, an interdisciplinary working group adopted the algorithms in a Delphi consensus process. Results The associated working groups evaluated more than 2,000 publications on 15 different comorbidities. A screening algorithm was agreed on for the following twelve indications: arterial hypertension, dyslipidemia, obesity, diabetes mellitus, metabolic syndrome, nonalcoholic steatohepatitis, depression, nicotine abuse, alcohol abuse, chronic inflammatory bowel disease, psoriasis arthritis, and malignant lymphoma. In this context, the requirements of everyday dermatological care were addressed in particular. Conclusions With respect to screening for comorbidities in psoriasis, standardized and consented algorithms are available, which – on national level – may be implemented as a screening tool within the framework of PsoNet – German Psoriasis Networks.

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.

Background: Psoriasis is frequently associated with obesity which possibly contributes to reduced treatment response. Objectives: Assessment of the prevalence of obesity in patients with psoriasis in Germany 2013/2014. Patients and Methods: The frequency of overweight and obesity was assessed by the body mass index (BMI) and evaluated according to the severity of psoriasis [Psoriasis Area and Severity Index (PASI)]. Results: This national, cross-sectional survey involved 83 dermatological practices and outpatient clinics, including 1,265 patients (mean age 52 years; 43.4% female). The BMI of patients with psoriasis in 2013/2014 was found to be 28.0 and therefore was significantly higher compared to that of patients with psoriasis in 2007 with a BMI of 26.9 as well as compared to the normal population in 2013 with an overall BMI of 25.9. Conclusions: The prevalence of obesity in patients with psoriasis is higher than in the normal population. The trend towards a higher BMI in patients with psoriasis continues over time.

The treatment goal algorithm for psoriasis, first originated in 2007, has ever since been adopted into treatment guidelines. It remained unclear how many patients have experienced the use of treatment goals in routine care and how these are perceived. The aim of the pilot study was to get first insight in the use and impact of therapeutic goals in a large cohort of patients with psoriasis in routine care. This study is a multicenter, non-interventional, cross-sectional health care study in n = 213 dermatology centers across Germany. A standardized physician and patient questionnaire was used, including demographics, disease and treatment characteristics. To evaluate patient treatment perception and satisfaction, a questionnaire (PsoSat) addressing 8 specific items was designed. Consistency and validity of the questionnaire were controlled by factor analyses and reliability tests. In total n = 1,883 patients were included for analysis (54.2 % male). Mean age was 52 years, mean disease duration 19 years. In total 45.5 % (n = 856) stated an improvement of psoriatic symptoms in the last 4 weeks. In patients including treatment goals, the course of psoriasis in the last 4 weeks was rated significantly better and predicted significantly higher patient satisfaction. Patients reporting periodic outcomes measurement of psoriasis treatment, also had significantly better course of disease, higher satisfaction and a lower psoriasis severity. A majority of patients experienced the use of treatment goals in practice. The association of using treatment goals with clinical outcomes and treatment satisfaction was markedly positive. These findings indicate that the use of treatment goals and outcome measurements in fact improve psoriasis management.

Die Versorgung der Psoriasis vulgaris nimmt in der Dermatologie einen wichtigen Stellenwert ein. Im Zuge der WHO-Resolution 2014 und des WHO Global Reports 2016 hat die öffentliche Aufmerksamkeit für die Psoriasis zugenommen. Unklar ist, wie Psoriasis in der Allgemeinbevölkerung wahrgenommen wird. Ziel ist die Erfassung der Wahrnehmung und Bewertung von Psoriasis in der Bevölkerung.Repräsentative Telefonumfrage mit 2001 Erwachsenen mittels eines standardisierten Fragebogens. Die Auswertungen erfolgten deskriptiv nach Region, Alter, Geschlecht und Bildungsstatus.Die Begriffe Psoriasis bzw. Schuppenflechte waren 29 % bzw. 86 % der Befragten, bekannt. 93 % schätzten die Krankheit als sehr belastend für die Betroffenen ein, 59 % nahmen an, dass es wirksame Medikamente gegen Schuppenflechte gibt und 9 % hielten diese Erkrankung für ansteckend. 10 % würden nicht mit einer betroffenen Person im Haushalt leben wollen, 23 % nicht mit Betroffenen ins Schwimmbad gehen und 27 % nicht in einer Partnerschaft sein. 12 % gaben an, die WHO-Resolution zur Psoriasis zu kennen, 6 % den Weltpsoriasistag und 3 % die Kampagne "Bitte berühren".Wenngleich einer Mehrheit in der deutschen Bevölkerung die Schuppenflechte bekannt ist, bestehen deutliche Wissensdefizite und teilweise Vorurteile gegenüber dieser Erkrankung. Weitergehende Maßnahmen zur besseren Information und zur Minderung der Stigmatisierung sind notwendig.

Delivery of health care to psoriasis patients plays an important role in the field of dermatology. Following the 2014 WHO resolution and the 2016 WHO global report, there has been an increase in the awareness of psoriasis among the general public. However, the perception of psoriasis by the general population remains unclear. The goal of the present study was to investigate the perception and assessment of psoriasis among the German population.Representative telephone survey among 2,001 adults using a standardized questionnaire. Analyses with respect to place of residence, age, gender and level of education were conducted in a descriptive manner.Twenty-nine percent of participants were familiar with the term "Psoriasis"; 86 %, with the German designation "Schuppenflechte". Ninety-three percent considered the disease to be a significant burden for affected individuals; 59 % stated that there were effective drugs available for psoriasis; 9 % considered the disease to be communicable. Ten percent reported that they would not want to live in the same household as an affected individual; 23 % did not want to share the same swimming pool; and 27 % did not want to be in a personal relationship with someone affected. Twelve percent stated to be familiar with the WHO resolution on psoriasis; 6 % with the World Psoriasis Day; and 3 % with the "Bitte berühren" ("Please touch") campaign.Although a majority of the German population is familiar with the term "Schuppenflechte", there is a significant lack of knowledge about the disease as well as prejudice toward affected individuals. Further measures are required to improve the level of information and decrease stigmatization.

Background Though psoriasis poses a substantial chronic socio-economic burden, few studies have addressed the economic impact in Germany. Objectives The objective was to evaluate the annual costs of psoriasis in Germany from the societal perspective. Methods A cross-sectional study was performed in randomly selected German dermatology practices and clinics in 2013/2014 using standardised questionnaires of illness-related costs. Costs were grouped by perspective and category as well as analysed by sex and age. Group differences were tested by non-parametric tests. Results Complete data were obtained from 1,158 patients in 132 centres. Annual average costs for patients with psoriasis: Total costs € 5,543 ± € 8,044, systemic treatment costs (paid by the statutory health insurances (SHI)) € 3,733 ± € 7,322, out-of-pocket costs € 224 ± € 406, total SHI costs € 4,940 ± € 7,533, direct costs € 5,164 ± € 7,581 and indirect costs € 379 ± € 2,087. Significant higher costs in male and significant lower costs in 65+-year-old patients were found. Conclusions Psoriasis induces a considerable economic burden. Between 2003 and 2014, costs have markedly shifted from hospital, out-of-pocket and indirect costs towards systemic drug costs. This article is protected by copyright. All rights reserved.

Patient-reported outcomes are major components of decision making in clinical research, reimbursement, health policy and health care for psoriasis. The most important construct in patient-reported outcomes is health-related quality of life (HRQoL) which encompasses the individual's well-being with respect to health. HRQoL cannot directly be measured but is assessed in single dimensions, especially physical, emotional, social and functional aspects. For this, disease- and condition-specific instruments are used. Psoriasis is a chronic inflammatory disease affecting the skin as well as other tissues and organ systems. Patients suffer from a large scale of impairments, for example, physical symptoms, stigmatization and embarrassment, psychological strain and disabilities in profession. Improvement of HRQoL is a major objective of disease management. Current knowledge on determinants of HRQoL and the treatments available increase QoL in clinical care.

Summary Biosimilars are biotechnologically processed drugs whose amino acid sequence is identical to the original biopharmaceutical. They are of considerable clinical, economical, and health care interest. As patents for biologicals used to treat psoriasis expire, biosimilars will become more and more important within the field of dermatology. The patents for the two top-selling drugs (adalimumab and etanercept) will terminate in the next few years. Applications for biosimilars will presumably be submitted to the EMA and the FDA for all patent-free biologicals. Both regulatory bodies have issued guidelines on the assessment of bioequivalence, as well as the benefits and risks of biosimilars. While the preclinical requirements of the FDA and EMA are largely comparable, the formal requirements for clinical bioequivalence, including clinical efficacy and safety, differ markedly. Therefore, from a medical and health care perspective before biosimilars enter the market, specific evidence-based regulatory conditions need to be created and fulfilled. Only then biosimilars can be a less expensive option for a large number of patients, providing them with substances of the same value. Adequate, unequivocal proof of their bioequivalence, quality, and related patient safety should have priority over any ostensible economic benefits.

The German psoriasis registry PsoBest records the long-term efficacy, safety, patient benefit and treatment regimens of psoriasis.