Real World SB4 (Etanercept Biosimilar) Use in Patients With Psoriasis: Data from the British Association of Dermatologists Biologic Interventions Register (BADBIR).

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

[Gastrointestinal side effects of apremilast : Characterization and management]. / Gastrointestinale Beschwerden unter Apremilast : Charakterisierung und Management.

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.

What is psoriasis? - Perception and assessment of psoriasis among the German population.

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 berühren" ("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.

Was ist Schuppenflechte? - Wahrnehmung und Bewertung der Psoriasis in der deutschen Bevölkerung.

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 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. PATIENTEN UND METHODEN: Repräsentative 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 % 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". SCHLUSSFOLGERUNGEN: 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.

Treatment Satisfaction in Psoriasis: Development and Use of the PsoSat Patient Questionnaire in a Cross-Sectional Study.

INTRODUCTION: Evidence supports the potential value of matching patient preferences to treatment recommendations. The aim of the study was to design and validate a questionnaire on treatment satisfaction for clinical decision-making. METHODS: We performed a comprehensive literature search identifying measurable indicators. The complete item pool was condensed to a core set by a multidisciplinary expert panel and tested in a multicentre, observational, cross-sectional study. RESULTS: The questionnaire consisted of 8 questions, rated on a 5-point Likert scale. In total, 213 dermatology centres included 2,084 patients. The mean disease duration was 19 years. A majority of patients (82.8%) was moderately to very satisfied. 108 patients (5.8%) felt to be bothered by side effects, and 32.1% ascertained that the current therapy had been conducted for too long without success. DISCUSSION: The PsoSat Questionnaire was shown to be a reliable and valid instrument for measuring therapy-related satisfaction. Further research on its implementation in clinical decision-making is necessary to finally evaluate the benefit of this tool.

Ustekinumab in the treatment of palmoplantar pustular psoriasis - a case series of nine patients.

BACKGROUND: Palmoplantar pustular psoriasis is a chronic inflammatory skin disease that is associated with considerable impairment in quality of life and resilience. Given the lack of approved pharmacological agents for this indication and the frequently recalcitrant disease course, therapeutic options are limited. PATIENTS AND METHODS: Following unsatisfactory therapeutic attempts with other treatment modalities, nine patients (six women; three men) were treated with ustekinumab (45 mg in individuals < 100 kg body weight, 90 mg in individuals > 100 kg) at weeks 0, 4, 12, and 24. Latent tuberculosis was ruled out prior to treatment. Regular follow-up was done at week 4 and 12, and every 12 weeks thereafter. RESULTS: Average age at the beginning of treatment was 48 years. Four patients achieved 75 % improvement in the palmoplantar Psoriasis Area Severity Index (PASI). Overall, there was an average improvement in the palmoplantar PASI of 71.6 % after 24 weeks. Two patients exhibited complete resolution after 24 weeks. Besides local injection site reactions and mild infections, no adverse effects were observed. CONCLUSIONS: This case series provides further evidence for the effectiveness and tolerability of ustekinumab in the treatment of palmoplantar pustular psoriasis. Controlled studies and observations in the context of patient registries are required to assess long-term efficacy and safety as well as the potential therapeutic benefit of intermittent therapy.

Ustekinumab in der Therapie der Pustulosis palmoplantaris - Eine Fallserie mit neun Patienten.

HINTERGRUND: Die Pustulosis palmoplantaris ist eine chronisch entzündliche Hauterkrankung, die mit bedeutenden Einschränkungen der Lebensqualität und der Belastbarkeit einhergeht. Aufgrund von Zulassungsbeschränkungen und einem häufig therapierefraktären Verlauf sind die Behandlungsmöglichkeiten 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 Körpergewicht [KG], 90 mg Ustekinumab > 100 kg KG) in Woche 0, 4, 12 und 24. Reguläre Visiten erfolgten nach 4 und 12 Wochen, im weiteren Verlauf alle 12 Wochen. ERGEBNISSE: Das Durchschnittsalter bei Therapiebeginn betrug 48 Jahre. Drei Patienten waren männlich. 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 unerwünschten Wirkungen beobachtet. SCHLUSSFOLGERUNGEN: Die Fallserie ist ein weiterer Beleg für die Wirksamkeit und Verträglichkeit 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.

Early detection of comorbidity in psoriasis: recommendations of the National Conference on Healthcare in Psoriasis.

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.

Biosimilars in psoriasis: what can we expect?

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.

Influenza vaccination rate among patients with moderate to severe psoriasis.

BACKGROUND: Patients with chronic inflammatory diseases such as psoriasis vulgaris represent a risk group for developing serious complications after influenza virus infection. By vaccinating this cohort such complications might be prevented. The objective was to determine the vaccination rate among patients with moderate to severe psoriasis and to explore the surrounding circumstances. PATIENTS AND METHODS: A nationwide, non-interventional, cross-sectional study was performed in 1,229 adults with confirmed psoriasis or psoriatic arthritis. The survey consisting of 15 questions about vaccination and vaccination adherence was distributed to patients enrolled in the psoriasis patient registry "PsoBest". RESULTS: About 28 % of the patients (95 %-CI 24.0-31.6) were vaccinated. The mean age was 58 years, 40 % were females. The prevalence of psoriatic arthritis was 28 % at baseline and 39 % during the vaccination period. General practitioners vaccinated 50 % of the patients, while dermatologists suggested vaccination in 7 % of the cases. Fifty percent of the patients reported that they had been vaccinated at their own request. 91 % of the patients had been vaccinated at least once over the past ten years, receiving on average 5.9 influenza vaccinations during the decade. CONCLUSIONS: The vaccination rate in the study cohort was relatively low compared to that in the general population. Influenza vaccination had only been suggested by a small percentage of physicians.

Drug supply for children with psoriasis in Germany.

BACKGROUND: In Germany there is a lack of robust nationwide data on psoriasis therapy in children. PATIENTS AND METHODS: Secondary data from the statutory health insurance Gmnder Ersatzkasse (GEK) of the year 2009 were analyzed. Continuously insured children with psoriasis vulgaris were identified by ICD-10 codes (L 40. X). Their treatment was determined on the basis of prescriptions according to ATC code. RESULTS: 1,313 of 293,181 children and adolescents had psoriasis (0.45%). Of these, n = 651 (49.6%) received at least one medication during the observation period. Topical and systemic corticosteroids were most frequently prescribed (70.8% and 4.0% respectively). The relative frequency of prescription of systemic corticosteroids was higher in children treated by pediatricians and family physicians (by a factor of 3 and 5, respectively) than in those treated by dermatologists. Vitamin D analogs were the second most frequently prescribed drugs, used far more often by dermatologists (14.7%) than by general practitioners (1.7%) and pediatricians (0.9%). CONCLUSIONS: Drug supply for children with psoriasis in Germany appears to be inadequate. The consensus guidelines are not sufficiently considered and the use of systemic corticosteroids is still too high, even after adjustment for steroid-dependent indications. The data underline the necessity of guideline-oriented therapy and implementation of current therapeutic evidence in juvenile psoriasis.

Processes of psoriasis health care in Germany--long-term analysis of data from the statutory health insurances.

BACKGROUND: To evaluate health care provision for psoriasis patients, and to better allocate resources, precise knowledge of the health care situation is essential. The goal of this study is to analyze prescription behavior and resource utilization for psoriasis patients in Germany. METHODS: We performed a secondary analysis of routinely collected psoriasis data from 2004-2007 from members of a nationwide statutory health insurance company (Gmünder Ersatzkasse). A descriptive analysis was done on physician care, hospitalizations, and medications and related costs. RESULTS: 34,728 of the 913,145 continuously insured patients were diagnosed with psoriasis (one-year prevalence: 2.3-2.5%). At the time of the initial diagnosis, 68% of patients were treated by a dermatologist and 28% by a general practitioner (GP). Over the next 21 months, the proportion of patients seen by a dermatologist decreased to 22% and the proportion seen by a GP increased to around 70%. 15.2% of patients were absent at least once from work. 79.5% received prescriptions with an average cost of € 135 per patient per year. 97.5% of patients received topical therapy; 11% got systemic therapies. Biologics were given to about 0.1% of patients. Significant differences in prescription behavior were seen between regions and physician groups. CONCLUSION: Psoriasis is an important economic and medical issue. The majority of insured patients take prescription therapies. Dermatologists are most often the first health care provider.

Real-World Experience of Patient-Relevant Benefits and Treatment Satisfaction with Apremilast in Patients with Psoriasis: An Analysis of the APPRECIATE Study.

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.

How do regional factors influence psoriasis patient care in Germany?

BACKGROUND: Two national surveys conducted in 2005 and 2007 indicated deficits in psoriasis care in Germany, although there has been a notable nationwide improvement within this period. It remained unclear whether regional differences in psoriasis health care have an influence on patient outcomes in Germany. AIM: Assessment of regional differences in the health care situation of patient with psoriasis in Germany. PATIENTS AND METHODS: Nation-wide cross-sectional study in 130 dermatological practices and clinics. Regional classification was based on the affiliation to the Associations of Statutory Health Insurance Physicians. A panel of experts developed eight criteria as indicators of quality of care, among them clinical characteristics and severity of psoriasis (PASI), previous treatments, quality of life and patient-relevant therapeutic benefits. RESULTS: Care indicators showed marked regional differences. The proportion of patients with preceding systemic or biologic treatment varied between regions. Those regions with high proportions had better results in patient-reported outcomes. CONCLUSIONS: Differences in economic and regulatory conditions of health care might account for the observed regional variations. Thus, further analyses of these factors are of great importance to assure consistent psoriasis health care in Germany.

Economic considerations in psoriasis management.

With a prevalence of 2% to 3%, psoriasis is a very common chronic disease worldwide and generates therapy costs and continuing cost for health insurance and patients and their families. Cost-political changes in health care and the ever increasing health-economic demands in all areas of the health system make it necessary to differentiate between the two when recording the expenses for a disease. The main characteristics of the pharmacoeconomic evaluation are the record of costs, the cost-benefit and cost-effectiveness ratio, and efficiency of various treatment forms. Numerous publications discuss the cost of individual forms of therapy in the treatment of psoriasis, but there are fewer studies on the total cost of psoriasis therapy, especially studies that take both direct and indirect costs into account. The scientific articles on pharmacoeconomy and quality of life in psoriasis have proven (without a doubt) that, despite the lack of a vital threat, psoriasis is highly important to the national economy and to those who have the disease. This justifies appropriate monetary expenditure for treatment. Studies that address the cost of therapies (especially for chronic diseases) will be necessary in the future and will create the required transparency to guarantee reasonable medical care that takes the cost-benefit ratio and the best outcome for the patient's quality of life into account.

Quality of psoriasis care in Germany: results of the national health care study "PsoHealth3".

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.

Quality of life in psoriasis patients.

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.

Patient benefit index (PBI) in the treatment of psoriasis--results of the National Care Study "PsoHealth".

BACKGROUND: Psoriasis vulgaris is a common disease that follows a chronic course. So far, few studies have addressed outcome methods which evaluate the benefits of drugs and medical devices by measuring patient preferences. OBJECTIVE: Assessment of patients' outcomes using the "Patient benefit index" (PBI), a validated goal attainment scaling tool, in the treatment of psoriasis. Data were obtained within an epidemiological study in 2,009 patients with psoriasis vulgaris and/or psoriatic arthritis. METHODS: Cross-sectional study in 133 nationwide German dermatological practices and hospital departments. The following were recorded a) in the doctors' questionnaire--previous treatments and diseases, clinical characteristics and psoriasis area and severity index (PASI), b) in the patients' questionnaire--quality of life (LQ), patient-relevant therapeutic benefits and satisfaction with care. RESULTS: On average, patients achieved a total PBI of 2.5±1.1. 86.7% of patients showed a more than minimum benefit (PBI>1). Patients treated with biologicals had a higher benefit (mean PBI 3.0) than patients in other groups (e.g. PBI 2.6 in systemics). CONCLUSION: PBI values indicate that systemic agents and biologics are of high therapeutic benefit to the vast majority of patients. The development of the PBI has enabled a decisive step to be taken in the area of scientifically-based outcome assessments.