Association of sex and systemic therapy treatment outcomes in psoriasis: a two-country, multicentre, prospective, noninterventional registry study.

BACKGROUND: Few systematic data on sex-related treatment responses exist for psoriasis. OBJECTIVES: To evaluate sex differences with respect to systemic antipsoriatic treatment. METHODS: Data from patients with moderate-to-severe psoriasis in the PsoBest or Swiss Dermatology Network of Targeted Therapies (SDNTT) registries were analysed. Treatment response was defined as achieving a ≥ 75% reduction in Psoriasis Area and Severity Index (PASI 75) or PASI ≤ 3 at treatment months 3, 6 and 12, supplemented by patient-reported outcomes [i.e. Dermatology Life Quality Index (DLQI) ≤ 1 and delta DLQI ≥ 4]. RESULTS: In total, 5346 patients registered between 2007 and 2016 were included (PsoBest, n = 4896; SDNTT, n = 450). The majority received nonbiological treatment (67·3% male, 69·8% female). Women showed slightly higher PASI response rates after 3 (54·8% vs. 47·2%; P ≤ 0·001), 6 (70·8% vs. 63·8%; P ≤ 0·001) and 12 months (72·3% vs. 66·1%; P ≤ 0·004). A significantly higher proportion of women achieved a reduction in DLQI ≥ 4 [month 3: 61·4% vs 54·8% (P ≤ 0·001); month 6: 69·6% vs. 62·4% (P ≤ 0·001); month 12: 70·7% vs. 64·4% (P ≤ 0·002)]. Regarding PASI ≤ 3, women on biologics showed a significantly superior treatment response compared with men at 3 (57·8% vs. 48·5%; P ≤ 0·004) and 6 months (69·2% vs. 60·9%; P ≤ 0·018). Women in the nonbiological treatment group had a significantly better treatment response (PASI response, PASI 75 and PASI ≤ 3) over 12 months compared with men. CONCLUSIONS: We provide evidence that women experience better treatment outcomes with systemic antipsoriatic therapy than men.

Characteristics and outcomes of patients treated with apremilast in the real world: results from the APPRECIATE study.

BACKGROUND: APPRECIATE is a multinational, observational, retrospective, cross-sectional study in patients treated for psoriasis with apremilast, an oral phosphodiesterase 4 inhibitor. OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Continued treatment with secukinumab is associated with high retention or regain of response.

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.

Reversibility of alexithymia with effective treatment of moderate-to-severe psoriasis: longitudinal data from EPIDEPSO.

BACKGROUND: Alexithymia refers to difficulty in identifying and expressing emotions. Alexithymia is associated with high burden of disease in patients with psoriasis. OBJECTIVES: To investigate whether alexithymia was reversible in patients with psoriasis following real-life therapeutic intervention. METHODS: The Epidemiological Study in Patients with Recently Diagnosed Psoriasis (EPIDEPSO; NCT01964443) was a 1-year multicentre observational study investigating the prevalence of alexithymia and other psychosocial comorbidities in patients with psoriasis with ≤ 10 years' disease duration and eligible for systemic treatment. Alexithymia was assessed using the Toronto Alexithymia Scale (TAS-20) at baseline, 6 months and 1 year. RESULTS: There was a statistically significant decrease in the prevalence of alexithymia in the follow-up cohort, from 26·7% at baseline to 21·2% at 6 months and 18·8% at 1 year. More than half of the patients (n = 77, 53·8%) who were alexithymic at baseline experienced reversion of their alexithymia. Reversion of alexithymia was higher in patients who reached a high level of disease control, defined as ≥ 75% or ≥ 90% improvement in Psoriasis Area and Severity Index. Reversion of alexithymia was associated with dramatic improvement in quality of life, anxiety and depression. Moreover, hazardous alcohol use, highly prevalent in patients with alexithymia, was reduced almost threefold at 1 year. CONCLUSIONS: Alexithymia and associated high disease burden may be reversible in patients with effective treatment of psoriasis. Proactive recognition of patients who are unable to identify and express their feelings is important.

Topology of psoriasis in routine care: results from high-resolution analysis of 2009 patients.

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 (ß = 0·147; P = 0·000), arms (ß = 0·097; P = 0·008), genitals (ß = 0·080; P = 0·010), neck (ß = -0·072; P = 0·043), scalp (ß = 0·068; P = 0·010) and nails affected (ß = 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.

Does the Dermatology Life Quality Index (DLQI) underestimate the disease-specific burden of psoriasis patients?

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.

Translating the WHA resolution in a member state: towards a German programme on 'Destigmatization' for individuals with visible chronic skin diseases.

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.

Gender and age significantly determine patient needs and treatment goals in psoriasis - a lesson for practice.

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 Swiss Dermatology Network of Targeted Therapies (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 data set includes n = 4894 patients from PsoBest and n = 449 from SDNTT with mean follow-up time of 7.5 months. RESULTS: A total of 5343 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. Analysing the patient needs on an individual level will facilitate shared decisions by patient and physician in finding the optimal personalized treatment.

[Psoriasis therapy in pregnancy : Consultation of pregnant patients]. / Systemische Psoriasistherapie während der Schwangerschaft : Individuelle Beratung von schwangeren Patientinnen.

Systemic therapy of pregnant patients with psoriasis requires special attention and has to be adapted to disease activity throughout the pregnancy. With the approval of the first tumor necrosis factor alpha inhibitors for the treatment of these patients, a new range of options has to be discussed with the women. If the inflammatory presentation of the psoriasis demands systemic therapy, the decision for treatment should be made as early as possible, preferably before the onset of pregnancy.

Definition of psoriasis severity in routine clinical care: current guidelines fail to capture the complexity of long-term psoriasis management.

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.

Cost-of-illness of psoriasis - results of a German cross-sectional study.

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 standardized 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 1158 patients in 132 centres. Annual average costs for patients with psoriasis: total costs € 5543 ± € 8044, systemic treatment costs (paid by the statutory health insurances [SHI]) € 3733 ± € 7322, out-of-pocket costs € 224 ± € 406, total SHI costs € 4940 ± € 7533, direct costs € 5164 ± € 7581 and indirect costs € 379 ± € 2087. 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.

Synchrotron radiation micro X-ray fluorescence spectroscopy of thin structures in bone samples: comparison of confocal and color X-ray camera setups.

In the quest for finding the ideal synchrotron-radiation-induced imaging method for the investigation of trace element distributions in human bone samples, experiments were performed using both a scanning confocal synchrotron radiation micro X-ray fluorescence (SR-µXRF) (FLUO beamline at ANKA) setup and a full-field color X-ray camera (BAMline at BESSY-II) setup. As zinc is a trace element of special interest in bone, the setups were optimized for its detection. The setups were compared with respect to count rate, required measurement time and spatial resolution. It was demonstrated that the ideal method depends on the element of interest. Although for Ca (a major constituent of the bone with a low energy of 3.69 keV for its Kα XRF line) the color X-ray camera provided a higher resolution in the plane, for Zn (a trace element in bone) only the confocal SR-µXRF setup was able to sufficiently image the distribution.

Prevalence of alexithymia in patients with psoriasis and its association with disease burden: a multicentre observational study.

BACKGROUND: Single-centre studies show that alexithymia, defined as difficulty in recognizing and describing emotions, is more prevalent among patients with psoriasis than in the general population. However, its prevalence and the consequences of the association between alexithymia and psoriasis are unclear. OBJECTIVES: The primary objective of this study was to determine the prevalence of alexithymia, as defined by a score ≥ 61 in the 20-item Toronto Alexithymia Scale, in a large sample of patients who had plaque psoriasis for ≤ 10 years and were eligible for phototherapy or systemic treatment. The secondary objectives were to investigate the relationship between alexithymia and the clinical and psychological aspects of psoriasis. METHODS: Data were collected in the framework of an observational, multicentre, international study, the EPidemiological Study In Patients With Recently DiagnosEd PSOriasis (EPIDEPSO), aiming at investigating the prevalence of alexithymia and other psychosocial comorbidities in patients with psoriasis of ≤ 10 years' disease duration. RESULTS: The prevalence of alexithymia within a cohort of 670 patients was 24·8% (95% confidence interval 21·7-28·2). Patients with alexithymia had a higher burden of psoriasis, including significant impairment of quality of life, higher levels of anxiety and depression, a higher risk of alcohol dependency and impairment of work productivity, compared with patients without alexithymia. CONCLUSIONS: It is important to identify alexithymic patients with psoriasis in clinical practice as they experience a higher disease burden and have a lower ability to express their feelings.

Prevalence and comorbidities in adults with psoriasis compared to atopic eczema.

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.

A setup for synchrotron-radiation-induced total reflection X-ray fluorescence and X-ray absorption near-edge structure recently commissioned at BESSY II BAMline.

An automatic sample changer chamber for total reflection X-ray fluorescence (TXRF) and X-ray absorption near-edge structure (XANES) analysis in TXRF geometry was successfully set up at the BAMline at BESSY II. TXRF and TXRF-XANES are valuable tools for elemental determination and speciation, especially where sample amounts are limited (<1 mg) and concentrations are low (ng ml(-1) to µg ml(-1)). TXRF requires a well defined geometry regarding the reflecting surface of a sample carrier and the synchrotron beam. The newly installed chamber allows for reliable sample positioning, remote sample changing and evacuation of the fluorescence beam path. The chamber was successfully used showing accurate determination of elemental amounts in the certified reference material NIST water 1640. Low limits of detection of less than 100 fg absolute (10 pg ml(-1)) for Ni were found. TXRF-XANES on different Re species was applied. An unknown species of Re was found to be Re in the +7 oxidation state.

Classical group theory adapted to the mechanism of Pt3Ni nanoparticle growth: the role of W(CO)6 as the "shape-controlling" agent.

Classical group theory was applied to prove the Pt3Ni crystallographic transformation from Platonic cubic to Archimedean cuboctahedral structures and the formation of Pt3Ni polypods. The role of W(CO)6 as a shape-controlling agent is discussed with respect to the crystallographic features of the clusters and superstructures generated as control samples.

Barriers to guideline-compliant psoriasis care: analyses and concepts.

Despite the availability of effective therapeutics and evidence-based treatment guidelines, a substantial proportion of patients with moderate-to-severe psoriasis does not receive appropriate care. This under-provision of health care may cause further worsening of health, remarkable limitations of the patient's quality of life, and indirect costs for the health care system. In order to provide guideline-compliant care for every psoriasis patient, it is important to identify barriers obstructing optimal care. Studies have identified various barriers on the physician's and on the patient's side; however, respective studies approached only single barriers, and not all of them in the context of psoriasis. Other publications that describe barriers systematically did not focus on psoriasis either. The objective of this literature review was to identify barriers and facilitators, based on studies analysing quality of care and single barriers, resulting in a comprehensive model of causal factors. Our analyses revealed three categories of barriers - patient-related, physician-related and external factors: On the patient side, we found non-adherence to therapies to be an important barrier, often in close association with psychiatric factors. Barriers on the physician's side predominantly are incomplete knowledge of the guidelines as well as the complexity of psoriasis comorbidity. In some countries, payment for patients with complex disease status is poor and inconsistent reimbursement regulations potentially interfere with optimal care. The current analysis indicates that most barriers are interdependent. Thus, measures approaching related barriers simultaneously are required. To improve care for psoriasis patients, further studies systematically addressing all potentially relevant barriers in conjoint are needed.

Patient benefits in the treatment of psoriasis: long-term outcomes in German routine care 2007-2014.

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.

Psoriasis registries worldwide: systematic overview on registry publications.

BACKGROUND: Safety and efficacy of new treatments are analyzed in clinical trials but their capacity to show potential effects of long-term treatment and more than short latency of onset is limited. To meet this challenge, patient registries (of treatments or diseases) collect prospective data of real-world patients in daily practice without tight selection of patients. OBJECTIVE: The aim of this article was to identify existing psoriasis patient registries by published articles and evaluation of monitored treatment classes, patients, research questions addressed, and measurement instruments implemented. MATERIALS & METHODS: A systematic review of Medline (PubMed) and Embase (Ovid) databases for publications on psoriasis patient registries, including cross-validation was conducted October 2015. RESULTS: 14 patient registries for long-term observation of psoriasis patients in real-world care were identified. Registries were established since 2005, the majority is located in Europe. The number of published studies from single registries ranged from 1 to 10. Most registries include patients treated by conventional systemics as well as biologics. The number of patients analyzed ranged from 35 to >12 000 patients. The publications mostly addressed safety issues or treatment outcomes, followed by baseline description, drug survival, predictor analyses, and treatment patterns. CONCLUSION: A variety of local, national, and international patient registries collect longitudinal data on (systemic) psoriasis treatment. The number of publications reflect the main registry objectives of safety and effectiveness, with additional therapy-related investigations being addressed as well. Based on the information from publications, the combination of data from these registries will involve many methodological challenges. To gain comparability and combinability of cohorts and data across registries, further harmonization of data collection is demanded.

[Malignancies of the skin and immunomodulatory antirheumatic therapy]. / Hautmalignome und immunmodulierende Antirheumatikatherapie.

For the clinical practice there is uncertainty as to what degree the therapeutic immunomodulation of rheumatoid arthritis (RA) is associated with a weakening of protective tumor immunity. Neoplasms of the skin in particular are known to exhibit increased incidence rates in association with therapeutic immunosuppression in transplantation medicine; however, the immunosuppression required for the prevention of allogenic graft rejection is much more intensive and thus not directly transferable to the potential risks for an onset or relapse of melanoma or non-melanoma skin cancers (NMSC), e. g. spinocellular and basal cell carcinomas in association with the antirheumatic treatment of RA. This review covers the association of RA and its pharmacotherapy with conventional synthetic (cs) and biologic disease-modifying antirheumatic drugs (DMARD) on the basis of a systematic literature search. The incidence rates of NMSC are twice as high in biologic-naive RA patients compared to the general population, whereas the respective incidence rates for melanoma do not differ. A biologic treatment with tumor necrosis factor (TNF) blockers compared with administration of csDMARD only has a minor, if any effect on the increase of NMSC risk but is associated with a trend towards an elevated incidence rate of new onset melanoma although significance level was not reached in all of the reviewed studies. The data on non-TNF blocking biologics is sparse. Accordingly, it is inappropriate to draw any strong conclusions on potentially associated skin cancer risks from the present lack of safety signals. The consideration of individual risk factors, recommendations on sufficient UV protection and regular skin monitoring may serve to improve the safety of DMARD therapy in RA.