Smoking does not Alter the Therapy Response to Systemic Anti-psoriatic Therapies: A Two-country, Multi-centre, Prospective, Non-interventional Study.

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.

Biosimilars in Dermatology - theory becomes reality.

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.

Biosimilars in der Dermatologie - Theorie wird Realität.

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.

Prevalence of Obesity in Patients with Psoriasis: Results of the National Study PsoHealth3.

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.

Epidemiology and Comorbidity in Children with Psoriasis and Atopic Eczema.

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.

German psoriasis registry PsoBest: objectives, methodology and baseline data.

BACKGROUND: The German psoriasis registry PsoBest records the long-term efficacy, safety, patient benefit and treatment regimens of psoriasis. PATIENTS AND METHODS: Patients with moderate or severe psoriasis are included in PsoBest when treatment with a conventional systemic agent or biologic is started for the first time. Observation time is five years. Standardized physician and patient case report forms are obtained every three to six months. Baseline data of patients included by 31 December 2012 are presented and compared to the national health care study PsoHealth 2007 (n = 2,009). RESULTS: 602 dermatology practices and clinics have been registered and 199 have recruited n = 2,556 patients (63 % by practices, 37 % by clinics). Initially, n = 808 received biologics (316 adalimumab, 34 efalizumab, 209 etanercept, 75 infliximab, 22 golimumab, 152 ustekinumab) and n = 1,651 conventional systemic therapy (928 fumaric acid esters, 518 methotrexate, 161 cyclosporine A, 191 other drugs or UV treatment). Compared to PsoHealth, patients in PsoBest had on average a higher disease severity (PASI 14.7 vs. 10.1; DLQI 11.0 vs. 7.5; EQ-5D VAS 54.0 vs. 64.5), shorter disease duration (18.2 vs. 21.3 yrs.), lower age (47.3 vs. 51.5), higher rates of psoriatic arthritis (20.5 vs. 19.1 %) and nail psoriasis (55.0 vs. 35.6 %). On average patients receiving biologics were younger, more often male and had higher disease severity and comorbidity. CONCLUSIONS: Patients in PsoBest represent patients with a high burden of disease.

Nail psoriasis - a treatment challenge.

Nail involvement in psoriasis is common and mostly occurs with other lesions but can also occur alone. Besides psychosocial and aesthetic impairments, patients often complain about functional impairment. Nail psoriasis is a predictor for more severe psoriasis, decreased quality of life, and a higher risk for the development of psoriatic arthritis. Onychomycosis and other differential diagnoses should be excluded prior to treatment. This article presents an overview of different clinical appearances of nail psoriasis, the essential diagnostic assessment before treatment, important differential diagnoses, and published data on treatment options for nail psoriasis.

Clinical features and treatment outcomes of vitiligo from the patients' perspective: results of a national survey 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.

[Pharmacoeconomy in acne--evaluation of benefit and economics]. / Pharmakoökonomie der Akne--Bewertung von Nutzen und Wirtschaftlichkeit.

INTRODUCTION: Acne belongs to the most common skin diseases and has a prevalence in the adolescence of nearly 100% and in adults of about 4%. The quality of life indes is significantly reduced und has impact on daily activities and social life and physical and psychological well being as well. The socioeconomic relevance is based not only on its prevalence but on direct and indirect costs. For acne therapy the knowledge on therapeutic costs is of importance but the cost benefit ratio as well. GOAL: Evidence of therapeutic costs in acne and economic benefit of the therapy. METHODS: Systematic review of Cochrane data. RESULTS: Calculations reveal general costs of acne treatment in Germany over 400 Mill.Euro per year. For the treatment with topical retinoids, BPO and antibiotics as well as systemic drugs only a few studies on costeffectiveness are available. For topical treatments results are not conclusive and dependent on the different health systems. New topical combinations may have a better economic outcome, however, more studies are needed. With regard to systemic therapies of moderate to severe acne based on the international references the costbenefit ratio favours the treatment with oral isotretinoin on the longterm outcome. Superiority is based on the relationship of costs and clinical outcome and the increased quality of life as well (cost-benefit ratio). It has to be emphazised that only longterm observations over years will lead to a valid calculation of costs and benefit. FACIT: Taking the high social and quality of life impact into consideration an early, well targeted and effective therapy is prevailing. Initial higher cost are balanced by a high quality of outcome under experienced dermatological supervision. The patients benefit is ranked over the final costs because of its medical, social and ethical aspects. To sample more differentiated data on pharmacoeconomic aspects well designed new clinical studies are to be set up.

Fumaric acid esters for the treatment of psoriasis in Germany: characterising patients in routine care.

BACKGROUND: Fumaric acid esters (FAE) represent the most widely-used oral systemic treatment for moderate-to-severe psoriasis in Germany. Not licensed outside Germany, little is known about the demographics of patients receiving FAE. PsoBest is a large national patient registry documenting long-term treatment of psoriasis in Germany. OBJECTIVES: To evaluate FAE relative to methotrexate (MTX) in patients from the PsoBest registry. MATERIALS AND METHODS: Patient demographics, disease severity at baseline and dosing regimen were reported for patients who initiated treatment with either FAE or MTX between 2007 and 2015. RESULTS: Overall, 1,409 patients treated with FAE and 877 with MTX were analysed. At baseline, compared with the MTX cohort, patients receiving FAE were younger (45.4 vs. 50.2 years; p≤0.001) and had a lower BMI (28.0 vs. 28.3 kg/m2; p≤0.023) and less nail involvement (45.4% vs. 50.7%; p≤0.013). The MTX cohort reported a greater mean duration of illness at baseline (18.2 years vs. 14.9 years; p≤0.001). In total, 85.6% and 58.5% patients in the FAE and MTX cohorts, respectively, had not received prior systemic therapy. Cardiovascular disease was the most prevalent comorbidity (FAE: 26.7%; MTX: 31.5%; p≤0.014). Health-related quality of life was similar for both cohorts (mean DLQI: 10.8 [FAE]; 10.5 [MTX]; p≤0.079). Mean FAE dose was 165.0 mg at inclusion and 406.4 mg following up-titration. CONCLUSION: This study contributes to a better understanding of the usual practices of long-term FAE use, which may also lead to improved treatment strategies not only in Germany, but in other countries where FAE may become available in the near future.

Benefits of a membership in a psoriasis patient organisation: a quasi-experimental longitudinal study.

BACKGROUND AND OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Quality of Life in Patients with Atopic Dermatitis: Disease Burden, Measurement, and Treatment Benefit.

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-relevant treatment goals in psoriasis.

Patient-oriented care requires therapeutic decisions to agree with the patients' treatment needs and goals. This study addressed the following questions: What is important to psoriasis patients starting systemic treatment? How stable are these preferences within the first year of treatment? Are treatment goals associated with age, gender, or treatment success? The importance of treatment goals was assessed for patients with moderate-to-severe psoriasis in the German Psoriasis Registry (PsoBest) at baseline (onset of a systemic treatment; n = 3066) and at a 1-year follow-up (n = 1444) using the Patient Benefit Index (PBI). Treatment success was measured with PBI global score and Psoriasis Area Severity Index (PASI). Patients with moderate-to-severe psoriasis pursued a wide range of different goals. The most general treatment goals were rated most relevant, including skin healing and quick skin improvement (94.8/94.5 % "quite" or "very" important), confidence in the therapy (93.0 %), control over the disease (92.3 %), and a clear diagnosis and therapy (89.6 %). Further important goals related to not being in fear of the disease getting worse (84.8 %), reduction in itching (83.9 %), burning (70.6 %), and pain (60.6 %) as well as attaining a normal everyday life (78.4 %) and low treatment burden (64.2-77.9 %). Goals were mostly not associated with sex and gender. Goal importance slightly increased with treatment success. In a substantial proportion of patients (30.3-54.7 %) goal importance changed within 1 year after onset of systemic treatment. We conclude that treatment goal importance should be assessed in clinical practice on a regular basis.

Recommendations for detection of individual risk for comorbidities in patients with psoriasis.

Since the pathogenesis of psoriasis vulgaris is now understood as a T cell mediated systemic auto-immune disease, the awareness for the potential systemic implications of the chronic active inflammation has grown. By evaluation of patient registries and study data, several complexes of comorbidities could be identified in recent years, albeit not all of them being clinically relevant. Comorbidity in this context will be defined as two or more diagnostically distinguished medical conditions existing simultaneously, but without a causal link. Nevertheless, there is some strong indication for pathogenetic link between some specified comorbidities and psoriasis at molecular and immunological level. The need for an interdisciplinary assessment of the potential interrelation is obvious. In order to detect the individual risk for comorbidities in patients with moderate to severe psoriasis and to recommend the course of action, a checklist has been developed at an interdisciplinary level that is reduced to the quintessential points for the use in daily practice.

Quality of psoriasis care from the patients' perspective--results of the national health care study PsoReal.

BACKGROUND: Two national surveys conducted in 2005 and 2007 indicated deficits in psoriasis care in Germany, although a significant improvement could be observed. When assessing health care provision it is crucial to take the patient's perspective into consideration. Therefore different approaches may be necessary. OBJECTIVES: (1) To survey reliable data on the health care situation of psoriasis vulgaris from the perspective of patient organisation members. (2) To compare the health care of patient organisation members 2008 with patients surveyed in dermatological centres 2005 and 2007. METHODS: A nationwide, non-interventional, cross-sectional study: 2,449 patient members of the "Psoriasis-Bund e.V.", the largest patient organization for psoriasis in Germany, were interviewed. DATA COLLECTED: sociodemographics; medical history; therapies; health-related quality of life; patient-defined treatment benefit. RESULTS: Quality of life was found to be considerably impaired (DLQI>10) in 23.6% of patients (compared to 34.1%/28.2% in 2005/2007). 49.1% had received systemic therapeutics (vs. 33.0%/47.3% in 2005/2007). On average, the participants had been absent from work for 8 days in the previous year because of their psoriasis (vs. 3.9/4.0 days in 2005/2007). CONCLUSION: Using the same indicators, the members of the patient organisation participating in 2008 rated their health care situation better than patients surveyed in 2005 and 2007. This may be attributed to the fact that members of patient organisations are better informed, which can lead to a more differentiated perception of burden of disease and better access to health care facilities.

Nail psoriasis as a severity indicator: results from the PsoReal study.

BACKGROUND: Although nail psoriasis affects a substantial proportion of psoriasis patients and causes significant psychologic distress, few epidemiologic data characterizing patients with nail involvement are available. The aim of this research was to elucidate differences between patients with nail psoriasis and those without any nail involvement, taking quality indicators of health care from the patient's perspective into account. METHODS: In total, 2449 patient members of the Deutscher Psoriasis Bund, the largest patient organization for psoriasis in Germany, were interviewed in this nationwide, noninterventional, cross-sectional study. Patients with nail psoriasis were compared with patients without any nail involvement with regard to gender, age, disease duration, affected body surface area, health-related quality of life (Dermatology Life Quality Index [DLQI] ED-5D), patient-defined treatment benefit, amount of inpatient treatments, disease duration, and numbers of work days lost. RESULTS: Data from 2449 patients with psoriasis were analyzed. Overall, 44.8% (1078) of patients were female, mean age was 57.0 ± 11.7 years, and 72.8% had nail involvement and showed higher values for affected body surface area than those without nail involvement (8.3% versus 5.6%, respectively; P < 0.004). Health-related quality of life was significantly lower in patients with nail psoriasis (DLQI 7.2 versus 5.3; ED-5D 60.1 versus 67.3), who had more days off work (9.8 versus 3.3). CONCLUSION: Nail involvement is an important symptom of psoriasis and is associated with greater disease severity and quality of life impairment. Accordingly, management of psoriasis should include a special focus on nail involvement.

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

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