Global prevalence of psoriasis is ranging from 0.91 % to 8.5 % [1]. Exact numbers are missing for Slovakia. 1-5% range is the most probable while 2 % is also mentioned as an average prevalence for the European population. There is approximately 110 thousand patients suffering from psoriasis when extrapolating from total population of 5.5 million [2]. Extracutaneous manifestation is observed in 11–30 % of patients after years of solely skin symptoms presentation [3, 4, 5, 6].Objective: To estimate prevalence of psoriatic arthritis among psoriatic patients population visiting dermatology out-patient irrelevant of the disease duration and the treatment regimen. To compare the sensitivity of both tests (ToPAS and PASE) used, evaluate possible PsA risk factors.Methods: This was a prospective, non-interventional, epidemiological, observational study conducted using a survey administered to psoriatic patients by their dermatologists. 10–20 consequent outpatients with psoriasis in each center in 43 regional dermatology officies were screened for the presence of extra-cutaneous symptoms (i.e. joint pain, enthesitis, dactylitis, nail involvement) using questionnaire, developed specificaly for this study, and by the PASE and ToPAS questionnaires. Patients without personal history of PsA and „positivity“ of PASE and/or ToPAS were sent to the center for confirmation / exclusion of the diagnosis by applying CASPAR criteria. Outcomes were statistically processed.Results: 177 (21.8 %) of total of 831 psoriatic patients had PsA. 9 of 177 (5.35 %) has been newly diagnosed. There was almost equal number of men (50.5 %) and women (49.5 %).Plaque psoriasis has been most frequent type – 76.9 %. 43.2 % of PsA patients reported the onset of the disease after 40 years of life. Time interval between onset of psoriasis and PsA has been less than 10 years in 20.2 %, 10–20 years in 20.8 % and more than 20 years in 16.1 %. Most frequent co-morbidity in the study population was hypertension 23.2 %, asthma 3 % and diabetes 2.4 %. Average value of BSA and PASI was higher in PsA vs. non-PsA group: 24 vs. 20 and 10 vs 9, respectively. The sensitivity (72.6 % vs 58.9 %, P=0.01) and specificity (81.3 % vs 80.5 %) of ToPAS was higher compared to PASE.Conclusion: 21.8 % PsA prevalence in psoriatic population in Slovakia is within the range observed in other studies. ToPAS test showed comparable results in terms of specificity, but significantly better results in terms of sensitivity and its early application should be of major importance because of the diagnostic process acceleration. The effect of an early diagnosis on the total patient outcome should be an objective of further research. This project was supported from educational grant of Pfizer Inc.

Introduction: Biology therapies in a various medical specializations and for a broad spectrum of indications were launched during last two decades. As a new in class the therapies were obliged to provide additional data re gar ding efficacy and safety after their real medical practice integration. Patient registries, databases collecting various patient data, were introduced to grant data on the treatment effectiveness, safety, and long-term on treatment survival. Satisfactory treatment effect and acceptable safety profile were confirmed after couple of years of careful observation. However, the benefits were usually offered at much higher treatment costs compared to the standard therapies. Biologically similar drugs, so-called biosimilars (B.S), are being launched after original molecule patent protection expiry during recent years. They were expected as an ideal solution to avoid distinct impact on the medical budget: comparable effect for less money. The unsubstantiated doubts about biosimilar efficacy and safety were the reason of the late launch in many markets. Since biosimilars are considered as new therapy entities, the cautiousness to certain extent should be required. Information gained from post-marketing observations and patient registries over several years, confirmed the biosimilar product comparable quality. Healthcare budget savings could secure easier therapy access for more new patients.

A b s t r a c tThe introduction of new pharmacotherapy entities in the last decade accentuate the necessity to set up treatment guidelines based on real life evidence. Randomized controlled trials remain golden standard of a research. Data derived from studies aiming on daily clinical practice should bring needed, added value. Disease prevalence growth, due to increased life expectancy, better diagnostic procedures and earlier medical intervention, as well as ever growing demand for highly priced, sophistically produced drugs put stress on healthcare budgets even in developed countries. Large databases commonly called -therapy registries are implemented to collect data on therapy effectivity in terms of effectiveness, safety and patient long-term on therapy survival. Registries importance rose together with biological therapies introduction. New in class molecules entered the market conditionally being obliged to provide additional e.g. safety data. Such procedures require involvement of many different professionals, e.g. physicians, professional medical bodies, IT experts, database administrators, statisticians and government institutions. Paper based, followed by computer based forms were distributed among physicians to collect these data. eHealth technologies provide physicians with centralized, more intuitive applications. The particularities of different diagnosis caused great variations within each specific registry launched. Important information was missing since they were pointed out as optional and many were redundant causing frustration among physicians due to inadequate administrative workload. The main objective of this work was to set up the therapy registry standards and procedures. Methodology of "ideal" moderate to severe plaque psoriasis biology therapy registry development, introduction, administration and evaluation was prepared to assist any government institution or professional body when planning registry deployment. Electronic application based on widely used MS Excel platform was developed and installed in the biological therapy centers as a standalone application for the pilot use.