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Psoriasis: HELP
Articles from Czech Republic
Based on 93 articles published since 2008
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These are the 93 published articles about Psoriasis that originated from Czech Republic during 2008-2019.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4
1 Guideline European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. 2016

Gossec, L / Smolen, J S / Ramiro, S / de Wit, M / Cutolo, M / Dougados, M / Emery, P / Landewé, R / Oliver, S / Aletaha, D / Betteridge, N / Braun, J / Burmester, G / Cañete, J D / Damjanov, N / FitzGerald, O / Haglund, E / Helliwell, P / Kvien, T K / Lories, R / Luger, T / Maccarone, M / Marzo-Ortega, H / McGonagle, D / McInnes, I B / Olivieri, I / Pavelka, K / Schett, G / Sieper, J / van den Bosch, F / Veale, D J / Wollenhaupt, J / Zink, A / van der Heijde, D. ·Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), Paris, France Department of rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France. · Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria Second Department of Medicine, Hietzing Hospital, Vienna, Austria. · Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands. · EULAR, representing People with Arthritis/Rheumatism in Europe (PARE), London, UK. · Research Laboratory and Clinical Division of Rheumatology, Department of Internal Medicine, University of Genova, Viale Benedetto, Italy. · Medicine Faculty, Paris Descartes University, Paris, France Rheumatology B Department, APHP, Cochin Hospital, Paris, France. · Leeds NIHR Musculoskeletal Biomedical Research Unit, LTHT, Leeds, UK Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. · Department of Clinical Immunology & Rheumatology, Amsterdam Rheumatology Center, Amsterdam, The Netherlands Atrium Medical Center, Heerlen, The Netherlands. · North Devon, UK. · Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria. · Rheumazentrum Ruhrgebiet, Herne and Ruhr-Universität Bochum, Herne, Germany. · Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Germany. · Arthritis Unit, Department of Rheumatology, Hospital Clínic and IDIBAPS, Barcelona, Spain. · Belgrade University School of Medicine, Belgrade, Serbia. · Department of Rheumatology, St. Vincent's University Hospital and Conway Institute, University College Dublin, Dublin, Ireland. · Section of Rheumatology, Department of Clinical Sciences, Lund University, Lund, Sweden Sweden and School of Business, Engineering and Science, Halmstad University, Halmstad, Sweden. · Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK. · Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. · Laboratory of Tissue Homeostasis and Disease, Skeletal Biology and Engineering Research Center, KU Leuven, Belgium Division of Rheumatology, University Hospitals Leuven, Leuven, Belgium. · Department of Dermatology, University Hospital Münster, Münster, Germany. · A.DI.PSO. (Associazione per la Difesa degli Psoriasici)-PE.Pso.POF (Pan European Psoriasis Patients' Organization Forum), Rome, Italy. · Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK. · Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Potenza, Italy. · Institute and Clinic of Rheumatology Charles University Prague, Czech Republic. · Department of Internal Medicine 3, University of Erlangen-Nuremberg, Erlangen, Germany. · Department of Rheumatology, Campus Benjamin Franklin, Charité, Berlin, Germany. · Ghent University Hospital, Ghent, Belgium. · Centre for Arthritis and Rheumatic Disease, Dublin Academic Medical Centre, St. Vincent's University Hospital, Dublin, Ireland. · Schoen Klinik Hamburg, Rheumatology and Clinical Immunology, Hamburg, Germany. · Department of Rheumatology and Clinical Immunology, German Rheumatism Research Centre Berlin, Charité-University Medicine Berlin, Germany. ·Ann Rheum Dis · Pubmed #26644232.

ABSTRACT: BACKGROUND: Since the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations. METHODS: A systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated. RESULTS: The updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used. CONCLUSIONS: These recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.

2 Guideline European S3-Guidelines on the systemic treatment of psoriasis vulgaris--Update 2015--Short version--EDF in cooperation with EADV and IPC. 2015

Nast, A / Gisondi, P / Ormerod, A D / Saiag, P / Smith, C / Spuls, P I / Arenberger, P / Bachelez, H / Barker, J / Dauden, E / de Jong, E M / Feist, E / Jacobs, A / Jobling, R / Kemény, L / Maccarone, M / Mrowietz, U / Papp, K A / Paul, C / Reich, K / Rosumeck, S / Talme, T / Thio, H B / van de Kerkhof, P / Werner, R N / Yawalkar, N. ·Division of Evidence Based Medicine, Department of Dermatology, Charité - Universitätsmedizin Berlin, Berlin, Germany. · Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy. · Department of Dermatology, Aberdeen Royal Infirmary, Aberdeen, UK. · Service de Dermatologie, Hôpital Ambroise Paré Université Paris V, Boulogne, France. · Clinical Lead for Dermatology, St Johns Institute of Dermatology, St Thomas' Hospital, London, UK. · Department of Dermatology, Academic Medical Center, Amsterdam, The Netherlands. · Third Faculty of Medicine, Department of Dermatology, Charles University, Prague, Czech Republic. · Department of Dermatology, Hôpital Saint-Louis, Paris, France. · St. Johns Institute of Dermatology, St. Thomas' Hospital, London, UK. · Hospital Universitario de la Princesa, Madrid, Spain. · University Medical Center Nijmegen St Radboud, Nijmegen, The Netherlands. · Medizinische Klinik mit Schwerpunkt Rheumatologie u. klinische Immonologie, Charité - Universitätsmedizin Berlin, Berlin, Germany. · Cambridge, UK. · SZTE Borgyogyaszati Klinika, Szeged, Hungary. · Roma, Italy. · Department of Dermatology, Psoriasis-Center University Medical Center Schleswig Holstein, Kiel, Germany. · Waterloo, Canada. · Department of Dermatology, Paul Sabatier University, Toulouse, France. · Dermatologikum Hamburg, Hamburg, Germany. · Section of Dermatology and Venereology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Huddinge, Stockholm, Sweden. · Department of Dermatology, Erasmus University, Rotterdam, The Netherlands. · Department of Dermatology, University Hospital Nijmegen, Nijmegen, The Netherlands. · Department of Dermatology, Inselspital, Universitätsklinik für Dermatologie, Bern, Switzerland. ·J Eur Acad Dermatol Venereol · Pubmed #26481193.

ABSTRACT: -- No abstract --

3 Review A case of lupus-like syndrome in a patient receiving adalimumab and a brief review of the literature on drug-induced lupus erythematosus. 2017

Lomicová, I / Suchý, D / Pizinger, K / Cetkovská, P. ·Department of Dermatology and Venereology, Medical Faculty and Teaching Hospital Pilsen, Charles University, Pilsen, Czech Republic. · Department of Clinical Pharmacology, Medical Faculty and Teaching Hospital Pilsen, Charles University, Pilsen, Czech Republic. ·J Clin Pharm Ther · Pubmed #28191663.

ABSTRACT: WHAT IS KNOWN AND OBJECTIVE: Drug-induced lupus erythematosus occurs with some drugs and resolves with their withdrawal. Anti-TNF therapies have been found to be associated with a lupus-like syndrome, which is clinically distinct from classical drug-induced as well as idiopathic lupus erythematosus. CASE DESCRIPTION: We describe a case of a patient with severe psoriasis, who developed muscle pain with paraesthesia accompanied by ANA titres elevation with adalimumab treatment. The condition resolved after adalimumab cessation, and the patient was started on ustekinumab with good results. WHAT IS NEW AND CONCLUSION: Ustekinumab might be a useful treatment option for patients with a history of TNF-induced lupus-like syndrome.

4 Review Use of biologics for psoriasis in Central and Eastern European countries. 2015

Rencz, F / Kemény, L / Gajdácsi, J Z / Owczarek, W / Arenberger, P / Tiplica, G S / Stanimirović, A / Niewada, M / Petrova, G / Marinov, L T / Kazandhieva, J / Péntek, M / Brodszky, V / Gulácsi, L. ·Department of Health Economics, Corvinus University of Budapest, Budapest, Hungary. · Semmelweis University Doctoral School of Clinical Medicine, Budapest, Hungary. · Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary. · National Health Insurance Fund Administration of Hungary, Budapest, Hungary. · Department of Dermatology, Military Institute of Medicine, Warsaw, Poland. · Department of Dermatology, Charles University 3rd Medical Faculty, Prague, Czech Republic. · Dermatology Clinic 2, Colentina Clinical Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. · Department of Clinical Medicine, University of Applied Health Sciences, Zagreb, Croatia. · Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland. · Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University, Sofia, Bulgaria. ·J Eur Acad Dermatol Venereol · Pubmed #26370506.

ABSTRACT: OBJECTIVES: To evaluate the use of biological agents for the treatment of psoriasis and to explore country-specific differences within six Central and Eastern European (CEE) countries, namely Bulgaria, Croatia, the Czech Republic, Hungary, Poland and Romania. METHODS: A literature overview on the epidemiology and disease burden of psoriasis in CEE was conducted. The number of patients treated with biologics was obtained from patient registries, ministries of health, national professional societies and health insurance funds. Biological treatment rates were estimated by two different methods: (i) as a proportion of all psoriasis patients of a country (assuming a common prevalence of psoriasis 2%) and (ii) per 100,000 population. Moreover, we provide a detailed comparison of drug coverage policies and guidelines regulating the treatment with biologics in psoriasis. RESULTS: On average 0.25% of all psoriasis patients, or five psoriasis patients out of 100,000 inhabitants are treated with biologics embedding a 14.6-fold difference between the six countries. Bulgaria, Croatia and Poland lag behind the other three countries in the use of biologics. The significant differences among CEE countries cannot be explained by variations in prices of biologics, cost-effectiveness or budget impact of biologics. It seems that the time since coverage decision, the fewer number of covered biologics, the more restrictive criteria to be eligible for covered treatment in terms of baseline Psoriasis Area and Severity Index and Dermatology Life Quality Index scores, and the maximum duration of treatment allowed are responsible for the majority of the differences. CONCLUSIONS: There exists a disconnect between the European psoriasis treatment guidelines and the various CEE country-specific biologic coverage eligibilities. The cost of biologic therapy for psoriasis is not solely and directly responsible for the different use rates amongst the CEE countries. Psoriasis may not be perceived by all payers as a serious disease that can be successfully treated in a cost-effective manner.

5 Review Management of psoriasis vulgaris and multiple sclerosis with fumaric acid. 2014

Gkalpakiotis, Spyridon / Arenberger, Petr / Gkalpakioti, Petra / Meluzinova, Eva / Chandran, Devika / Arenbergerova, Monika. ·Department of Dermatovenereology, Third Faculty of Medicine, Charles University in Prague and University Hospital of Kralovske Vinohrady, Prague, Czech Republic. Electronic address: spyros@centrum.cz. · Department of Dermatovenereology, Third Faculty of Medicine, Charles University in Prague and University Hospital of Kralovske Vinohrady, Prague, Czech Republic. · Department of Neurology, Second Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic. ·J Am Acad Dermatol · Pubmed #24528918.

ABSTRACT: -- No abstract --

6 Review MicroRNAs: Emerging Regulators of Immune-Mediated Diseases. 2012

Tomankova, T / Petrek, M / Gallo, J / Kriegova, E. ·Laboratory of Immunogenomics and Immunoproteomics, Faculty of Medicine and Dentistry, Institute of Molecular and Translational Medicine, Palacky University, Olomouc, Czech RepublicDepartment of Orthopaedics, Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic. ·Scand J Immunol · Pubmed #21988491.

ABSTRACT: MicroRNAs (miRNAs) represent the most abundant class of regulators of gene expression in humans: they regulate one-third of human protein-coding genes. These small noncoding ∼22-nucleotides (nt)-long RNAs originate by multistep process from miRNA genes localized in the genomic DNA. To date, more than 1420 miRNAs have been identified in humans (miRBase v17). The main mechanism of miRNA action is the posttranscriptional regulation via RNA interference with their target mRNAs. The majority of target mRNAs (more than 80%) undergo degradation after recognition by complementary miRNA; the translational inhibition with little or no influence on mRNA levels has been also reported. Each miRNA may suppress multiple mRNA targets (average ∼200), and at the same time, one mRNA can be targeted by many miRNAs enabling to control a spectrum wide range of cellular processes. Recently, the role of miRNAs in the development of immune cells and the maintenance of immune system homeostasis gained attention, and the involvement of miRNAs in the pathogenesis of several immune system diseases has emerged. This review focuses on the role of miRNAs in autoimmune disorders (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and psoriasis), inflammatory pathologies of distinct organ (atherosclerosis, osteoarthritis and atopic eczema) and/or systemic locations such as allergy. The role of miRNAs, their predicted and known mRNA targets and description of their actions in physiological immune reactions and in the pathological processes ongoing in immune-mediated human disorders will be discussed. Finally, miRNA-based diagnostics and therapeutic potentials will be highlighted.

7 Review [Biological treatment in dermatology--psoriasis]. 2011

Ettler, K. ·Klinika nemocí kozních a pohlavních Lékarské fakulty UK a FN Hradec Králové. ettler@fnhk.cz ·Vnitr Lek · Pubmed #21957759.

ABSTRACT: Psoriasis is a chronic, relapsing skin disease affecting 1-2% of the population. Genetically-determined autoimmune inflammation is initiated by an infection (e.g. streptococcal). T-lymphocytes, producing a number ofcytokines, mainly of the Th1 profile, including TNF alpha, play a key role. The role of Th17 and its interleukin IL-23 has recently been confirmed. It contains p40 protein, also a component of IL-12. TNF alpha and p40 blockade appear to be an effective biological treatment of severe lesional psoriasis. Further research and new drug development is to assure modern individualized treatment of psoriasis as well as other skin diseases.

8 Review Phototherapy of psoriasis in the era of biologics: still in. 2011

Benáková, Nina. ·University Department of Dermatovenereology, 1st Medical Faculty, Charles University, Prague, Czech Republic. nina.benakova@email.cz ·Acta Dermatovenerol Croat · Pubmed #21933648.

ABSTRACT: This article reviews recent literature on phototherapy for psoriasis, particularly narrowband UVB. The efficacy, safety, tolerability and acceptance of phototherapy are discussed. It focuses in detail on how to improve the efficacy and safety in practice by trying to optimize the protocols, using combination therapy, monitoring the cumulative dose and providing skin cancer surveillance. Careful patient selection, individualized treatment, long-term therapy plan and complex approach to patients are the prerequisites for this. Narrowband UVB as the most widely used modality of phototherapy for psoriasis has a relatively good efficacy, cost, availability and minimal side effects. It represents a valuable treatment, which deserves more utilization and research. Although not so dynamic as in systemic drugs, research into phototherapy is ongoing. Even in the era of biologics, phototherapy remains an important therapeutic modality for psoriasis and other dermatoses and represents an essential part of modern dermatological therapy.

9 Review [Metabolic syndrome and skin diseases]. 2008

Svacina, S. ·III. interní klinika 1. LF UK a VFN, Praha. stepan.svacina@lf1.cuni.cz ·Cas Lek Cesk · Pubmed #18724527.

ABSTRACT: Skin symptoms were originally described only in some components of the metabolic syndrome (e.g. in obesity, diabetes and polycystic ovary syndrome). In the last years several skin symptoms were described also in the metabolic syndrome. These relations were mostly described between psoriasis and metabolic syndrome, where perhaps common pathogenetic mechanisms are present. Even more important is the fact that physical activity, weight loss and diet treatment can have a common positive effect on both diseases. Also some drugs can influence both diseases together.

10 Clinical Trial Multiple switches between GP2015, an etanercept biosimilar, with originator product do not impact efficacy, safety and immunogenicity in patients with chronic plaque-type psoriasis: 30-week results from the phase 3, confirmatory EGALITY study. 2018

Gerdes, S / Thaçi, D / Griffiths, C E M / Arenberger, P / Poetzl, J / Wuerth, G / Afonso, M / Woehling, H. ·Psoriasis-Center at the Department of Dermatology, Universitaetsklinikum Schleswig-Holstein, Kiel, Germany. · Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany. · Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. · Department of Dermatology, Charles University, Third Medical Faculty and Faculty Hospital Kralovske Vinohrady, Prague 10, Czech Republic. · Global Clinical Development, Biopharmaceuticals, Hexal AG, Holzkirchen, Germany. ·J Eur Acad Dermatol Venereol · Pubmed #28960486.

ABSTRACT: BACKGROUND: EGALITY was a phase III confirmatory efficacy and safety study conducted in patients with plaque-type psoriasis as a part of totality of evidence gathered during the development of GP2015, an etanercept biosimilar. OBJECTIVE: To demonstrate equivalent efficacy and comparable safety and immunogenicity of GP2015 and the etanercept originator product (ETN, Enbrel METHODS: Patients (n = 531) were randomized 1:1 to self-administer GP2015 or ETN twice-weekly subcutaneously during TP1. Patients with a ≥50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 12 were re-randomized for TP2 to continue the same treatment at once-weekly dosing or to undergo three consecutive treatment switches between GP2015 and ETN until week 30. Patients continued the last-assigned treatment during TP2, until week 52. RESULTS: Mean (standard deviation [SD]) PASI scores at baseline were similar in patients who underwent multiple switches compared to those with continued treatments during TP2. During TP2, PASI 50, PASI 75 and PASI 90 response rates, percent change from baseline in PASI scores and all other efficacy parameters were similar between the pooled switched and pooled continued treatment groups at all time points. The incidence of treatment-emergent adverse events including injection site reactions was comparable between the pooled switched (36.7%) and pooled continued (34.9%) groups. None of the patients in either treatment group were positive for binding anti-drug antibodies in TP2. CONCLUSION: Treatment efficacy, safety and immunogenicity were similar between the pooled continued and pooled switched treatments during TP2, indicating that there are no effects in the short term on clinical data of multiple switches between GP2015 and ETN.

11 Clinical Trial Quality of life aspects of patients with psoriasis using a series of herbal products. 2016

França, K / Tirant, M / Hercogovấ, J / Novotny, F / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Roccia, M G / Lotti, T. ·Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Psoriasis and Skin Clinic, Melbourne, Australia. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498669.

ABSTRACT: Psoriasis is a chronic inflammatory disease affecting 1-3% of the general population. Due to the chronic nature of the disease, patients suffer from substantial psychosocial impact and impaired quality of life. Dr Michaels® (also branded as Soratinex®), an Australian series of topical herbal products, has been showing promising results for the treatment of patients with chronic plaque psoriasis and consequent improvement in their quality of life. This study aims to access the changes in quality of life of patients with Psoriasis using an Australian series of herbal skin-care products Dr Michaels® (Soratinex®) for psoriasis. The aim of this study is to observe and analyze the impact of Dr Michaels® product family on the quality of life of patients with psoriasis, 566 patients completed the Dermatology Quality of Life Index (DQLI) questionnaire in their initial consultation and at 3 follow up consultations, over a 6 months period. At the end of the data collection, all patients’ answers were recorded and analyzed. The Psoriasis Area and Severity (PASI) Index were used to measure the severity and extent of psoriasis during the 3 consultations. The PASI for severe, moderate-severe, mild-moderate cases across time revealed a significant effect of the treatment within weeks, confirming the decreasing scores during the treatment. As well as PASI results, the final DLQI score showed a sensible reduction from mean =6.716 (at week 0) to 6.252 (at week 2), 4.015 (at week 6) and 2.407 (at week 10) signifying a 64.2% reduction of the initial score. This study demonstrates that Dr. Michaels® (Soratinex®) products, an Australian series of herbal-based skin products is effective for the treatment of psoriasis. This treatment also significantly improves patient’s quality of life.

12 Clinical Trial Efficacy and safety of Dr Michaels® (Soratinex®) product family for the topical treatment of psoriasis: a monitored status study. 2016

França, K / Novotny, F / Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Roccia, M G / Lotti, T. ·Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · PROSANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, Guglielmo Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498668.

ABSTRACT: The aim of the study was to investigate the efficacy and safety of Michaels® (Soratinex®) remedies in patients suffering from chronic plaque psoriasis in a Czech population. Seventy-five (34 female/41 male) patients, aged 18-72 years old (mean age: 38.5 years) with mild to severe plaque psoriasis participated in the study. The products, including cleansing gel, ointment and skin conditioner, containing fruit acid complex, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Histologic variables and various blood picture parameters, including FW, glucose, cholesterol, triacylglyceroles, bilirubin, GMT, ALT, AST, creatinine, uric acid and urea in blood were monitored, before and after therapy with Michaels® (Soratinex®) treatment. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done at time 0, and after 2, 4, 6 and 8 weeks. Patient’s improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks using Dr Michaels® (Soratinex®) treatment course, 5 patients had a moderate improvement, with the resolution of 25-50% of skin lesions; 11 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 50 patients had an outstanding improvement, with the regression of 76-100% of lesions. Only 4 patients did not achieve an improvement of psoriasis. Six patients experienced folliculitis, which resolved without cessation of treatment. Three patients worsened and discontinued treatment. Six patients dropped out because of non-compliance. The blood results and histologic findings were all normal. Our investigation shows that Dr Michaels® (Soratinex®) products can be safely and successfully used in the treatment of chronic plaque psoriasis.

13 Clinical Trial An innovative, promising topical treatment for psoriasis: a Romanian clinical study. 2016

Gianfaldoni, S / Hercogovấ, J / Fioranelli, M / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Dermatological Department University of Pisa, Pisa, Italy. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1,Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498667.

ABSTRACT: Psoriasis is a chronic inflammatory disease with negative impacts both physically and psychologically. It is a common disorder affecting 2-3% of the total world population, in some cases causing changes to the nail and joints as well as skin lesions. The cutaneous manifestations of psoriasis can vary in morphology and severity and therapy should be tailored accordingly. Even if today many therapeutic options are available for psoriasis treatment, none of them provide excellent clinical results without the risk of side effects. The authors investigate the efficacy of Dr. Michaels® (Soratinex®) natural products in the topical treatments of a group of psoriatic patients. Sixty-two patients (34 male/28 female) from Romania, aged 18-70 years (mean age: 52 years), affected by a mild to severe form of chronic plaque psoriasis were included in this study. Each patient has been treated with a triphasic application of Dr. Michaels® (Soratinex®) natural products, twice a day for six weeks. The products were applied on skin and scalp lesions, but not on the face, genital and flexures. The evaluation of the tested products was based on the PASI of each patient at time 0, 1, 2, 3, 4, 5, and 6 weeks. The tested products were ineffective in five of 57 patients. Eleven patients had a moderate improvement (PASI decrease 26-50%); 11 patients had a good improvement (PASI decrease 51-75%) and 30 patients an outstanding one (PASI decrease 76-100%). Twenty-three% of patients developed folliculitis that regressed upon discontinuation of the application. Five patients developed pruritus, which regressed spontaneously. The cosmetic effect was evaluated as indifferent by 44% of patients, as good by 40% of patients and as excellent by 16% of patients. Ninety-five% of patients stated that they would continue to use the tested products, because it was effective and with poor side effects since the products were natural. In our experimental study, the topical application of Dr. Michaels® (Soratinex®) natural products proved to be an effective natural therapeutic option for psoriasis treatment.

14 Clinical Trial Scalp psoriasis: a promising natural treatment. 2016

Wollina, U / Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498666.

ABSTRACT: Psoriasis is a lifelong chronic inflammatory disease affecting 2-3% of the worldwide population. Scalp psoriasis is a particular form of psoriasis characterized by lesions on the scalp, which may occur isolated or in association with other skin lesions. The aim of this study was to investigate the efficacy and safeness of an innovative treatment of scalp psoriasis, which is based on the topical application of natural products. Fifty adult subjects with scalp psoriasis (23 females, 27 males) from different European dermatological centres were included in the study. Forty-six patients with severely infiltrated psoriatic lesions were invited to use the products of Dr Michaels® (Soratinex®), according to a three-phase application, twice a day (morning and evening). The other 4 patients followed a different regimen: after a shampoo in the evening, they applied the conditioner in the night and washed it in the morning with the cleansing gel. The application time of Dr Michaels® (Soratinex®) products was 8 weeks. The treatment was evaluated at 0, 1, 2, 3, 4, 5, 6, 7, and 8 weeks. The evaluation was based on the Psoriasis Scalp Severity Index (PSSI) and on a photographic analysis at each of the medical evaluation points. At the end of the study, all patients showed an outstanding improvement. Five patients referred a transient pruritus, which regressed spontaneously without discontinuing the application. No other side effects have been described. We observe that Dr Michaels® (Soratinex®) natural product family can be considered as a valid therapeutic tool for scalp psoriasis when considering the exclusion criteria. The tested products provided an outstanding improvement of lesions in all the patients, without side effects.

15 Clinical Trial Dr Michaels® (Soratinex®) product for the topical treatment of psoriasis: a Hungarian/Czech and Slovak study. 2016

Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd., Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine, Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498657.

ABSTRACT: Psoriasis is a chronic inflammatory T cell-mediated skin disease, affecting about 2% of Hungarian population. Genetic predisposition as well as environmental triggering factors, and innate immune processes play a role in its etiology. Treatment of psoriasis during the initial stages and first years of disease tend to be conservative and frequently based on topical agents. The aim of this study was to investigate and to describe the efficacy and safety of Dr Michaels® (Soratinex®) skin-care products for the topical treatment of stable chronic plaque psoriasis in a Hungarian population. Two-hundred-and-eight-six (120 female/166 male) patients, aged 10-80 years old (mean age 43 years) with mild to moderate plaque psoriasis had participated in the study. The products, including cleansing gel containing a coal tar solution, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done 2 weeks before treatment, at time 0, and after 2, 4, 6 and 8 weeks. Patient’s improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks treatment course, 46 patients had a moderate improvement, with the regression of 25-50% of skin lesions; 77 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 115 patients had an outstanding improvement, with the regression of 76-98.9% of lesions. Only 13 patients did not achieve an improvement of psoriasis. Fifteen patients experienced folliculitis, which resolved after cessation of treatment. Seven patients worsened and discontinued treatment. Thirteen patients dropped out because of non-compliance. Our investigation demonstrates that Dr Michaels® (Soratinex®) products, an Australian treatment, can be used successfully in the treatment of stable chronic plaque psoriasis.

16 Clinical Trial Clinical evaluation of the effectiveness of “Dr Michaels®” (also branded as Soratinex®) products in the topical treatment of patients with plaque psoriasis. 2016

Fioranelli, M / Hercogovấ, J / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Department of Nuclear Physics, Sub-nuclear and Radiation, Guglielmo Marconi University, Rome, Italy. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”- Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine - Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa. Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498655.

ABSTRACT: Psoriasis is generally considered as an autoimmune inflammatory cutaneous-systemic disease, with chronic course and high rate of recurrence, while its high risk of comorbidities affect the patients’ quality of life significantly. Despite the good therapeutic response, most of the available options show tendency for poor tolerance and high rate of occurrence of side effects. Therefore, the interest of patients and doctors to investigate the possibility of treating psoriasis with natural substances is not surprising. The aim of this study was to investigate the efficacy and safety of the herbal skin-care product Dr Michaels® (Soratinex®) for the management of chronic plaque psoriasis, within a 6 to 8 week treatment course. Thirty patients of both sexes, aged between 24 and 70 years with mild to moderate psoriasis vulgaris were included in this study. The products of Dr Michaels® (Soratinex®) were applied in sequence: cleansing gel, ointment after 3-4 minutes and tonic care (for the fire-smeared ointment) 2 times per day for restorative care and cleansing gel for psoriasis within scalp 3 times a week. The study lasted six weeks. The severity and extent of the lesions were evaluated by PASI score (Psoriasis Area and Severity Index). Based on the obtained result, the products of “Dr Michaels® (Soratinex®)” have proved to be effective in the treatment of mild and moderate psoriasis vulgaris. In the study group, no improvement was observed in 10% of patients, a slight improvement in 20%, good in 40% and very good in 16.6% of patients.

17 Clinical Trial A clinical examination of the efficacy of preparation of Dr Michaels® (also branded as Soratinex®) products in the treatment of psoriasis. 2016

Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Wollina, U / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”-Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd, Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine - Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa. Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498653.

ABSTRACT: Psoriasis is a chronic inflammatory disease with negative impacts both physically and psychologically. It is a common disorder affecting 2-3% of the total world population, in some cases causing changes to the nail and joints as well as skin lesions. The cutaneous manifestations of psoriasis can vary in morphology and severity and therapy should be tailored accordingly. The aim of the study was to investigate the efficacy of Dr Michaels® (Soratinex®) product line in the treatment of psoriatic patients with different age and disease severity. A total number of 270 patients with verified psoriasis, aged 9-60 years old participated in the studies, including 128 children: 23 girls and 105 boys, (all of them selected from the Department of Dermato-allergology of the Russian Pediatric Hospital Clinic, Moscow, and of the 4th Department of Dermatology of the 52nd Moscow City Hospital Clinic). The patients were separated into 3 groups according to the severity of the disease (based on the PASI-index). All the patients have been treated with Dr Michaels® (Soratinex®) products twice daily, as three different forms were available for application: a cleansing gel, an ointment and a conditioner. The severity of the disease and the efficacy of the treatment have been defined with the evaluation of the PASI index of each patient. The obtained results were recorded in a graphic form showing the changes of the PASI-index on days 3, 7, 14, and 21 counted from the start of the trial. Clinical remission was achieved in 147 patients, a significant improvement in 73, partial improvement in 32, while no effect was seen in 12 patients and deterioration in 6. This open trial demonstrated the clinical efficacy of topical application of Dr Michaels® (Soratinex®) preparation. We observed clinical remissions of psoriasis in adults and in children.

18 Clinical Trial A multi-centred open trial of “Dr Michaels®” (also branded as Soratinex®) topical product family in psoriasis. 2016

Wollina, U / Hercogovấ, J / Fioranelli, M / Gianfaldoni, S / Chokoeva, A A / Tchernev, G / Tirant, M / Novotny, F / Roccia, M G / Maximov, G K / França, K / Lotti, T. ·Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany. · 2nd Medical Faculty, Charles University, Bulovka Hospital, Institute of Clinical and Experimental Medicine, Prague, Czech Republic. · Department of Nuclear Physics, Sub-nuclear and Radiation, G. Marconi University, Rome, Italy. · Dermatological Department University of Pisa, Pisa, Italy. · ”Onkoderma”- Policlinic for dermatology and dermatologic surgery, Sofia, Bulgaria; Department of Dermatology and Venereology, Medical University of Plovdiv, Medical faculty, Plovdiv, Bulgaria. · Medical Institute of Ministry of Interior (MVR), Department of Dermatology, Venereology and Dermatologic Surgery, Sofia, Bulgaria. · Psoriasis and Skin Clinic, Melbourne, Australia. · PRO SANUM Ltd., Sanatorium of Prof. Novotný, Štěpánská Prague 1, Czech Republic. · University B.I.S. Group of Institutions, Punjab Technical University, Punjab, India. · Department “Medicinal Information and Non-interventional studies”, Bulgarian Drug Agency, Sofia, Bulgaria. · Department of Dermatology and Cutaneous Surgery, Department of Psychiatry and Behavioral Sciences, Institute for Bioethics and Health Policy, University of Miami, Miller School of Medicine - Miami, FL, USA; Centro Studi per la Ricerca Multidisciplinare e Rigenerativa. Università Degli Studi "G. Marconi", Rome, Italy. · Chair of Dermatology, University of Rome “G. Marconi” Rome, Italy. ·J Biol Regul Homeost Agents · Pubmed #27498651.

ABSTRACT: Psoriasis is a chronic, recurring skin disease affecting 2-4% of the population. Genetic predisposition and precipitating factors play a role in its etiology. The disease can occur in any age or gender group. The most frequently affected areas of the body include scalp, extensor surfaces of the extremities, skin folds and nails. While a number of therapies exist for the treatment of psoriasis with a total resolution of the skin, achieving remission in a high percentage of sufferers, a treatment that results in the maintenance of remission and is free of side effects is still a desirable goal. The aim of the study was to investigate the efficacy and tolerability of Dr Michaels® (Soratinex®) topical product family in psoriasis, in terms of decreasing parakeratosis, inflammation, infiltration and involved area. Seven-hundred-and-twenty-two subjects, mean age 42.3 years (range: 18-68 years) with mild to moderately severe psoriasis, with no other current anti-psoriatic therapy, consisting of 382 males and 340 females, above 18 years of age were included and the observations were subjected to statistical analysis. Triphasic application of Dr Michaels® (Soratinex®) products was employed for 8 weeks, using Cleansing Gel, Scalp and Body Ointment and Skin Conditioner. The treatment proved to be ineffective for 22 patients (3.1%) out of 722. 84 patients (11.6%) had moderate improvement with 26-50% of cleared skin lesions; 102 patients (14.1%) had good improvement with 51-75% of cleared skin lesions; 484 patients (67.0%) experienced outstanding improvement with 76-100% of the cleared skin lesions, with 52% of them achieving total resolution. Twelve patients worsened and discontinued treatment; 18 patients discontinued because of non-compliance; 33 patients developed folliculitis as a side effect. Based on the results of this study, the Dr Michaels® (Soratinex®) product family can be successfully applied in mild to moderately severe psoriasis when considering the exclusion criteria.

19 Clinical Trial Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis. 2016

Constantin, Tamas / Foeldvari, Ivan / Vojinovic, Jelena / Horneff, Gerd / Burgos-Vargas, Ruben / Nikishina, Irina / Akikusa, Jonathan D / Avcin, Tadej / Chaitow, Jeffrey / Koskova, Elena / Lauwerys, Bernard R / Calvo Penades, Inmaculada / Flato, Berit / Gamir, Maria Luz / Huppertz, Hans-Iko / Jaller Raad, Juan Jose / Jarosova, Katerina / Anton, Jordi / Macku, Marie / Otero Escalante, William J / Rutkowska-Sak, Lidia / Trauzeddel, Ralf / Velez-Sanchez, Patricia J / Wouters, Carine / Wajdula, Joseph / Zang, Chuanbo / Bukowski, Jack / Woodworth, Deborah / Vlahos, Bonnie / Martini, Alberto / Ruperto, Nicolino / Anonymous1410860. ·From the Paediatric Rheumatology International Trials Organisation (PRINTO), Istituto G. Gaslini, Pediatria II-Reumatologia, PRINTO, Genoa, Italy.T. Constantin, MD, PhD, 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary; I. Foeldvari, MD, Hamburg Centre for Child and Adolescent Rheumatology, Hamburg, Germany; J. Vojinovic, MD, PhD, Clinic of Pediatrics, Clinical Centre, Faculty of Medicine, University of Nis, Serbia; G. Horneff, MD, Asklepios Clinic, Sankt Augustin, Germany; R. Burgos-Vargas, MD, Hospital General de Mexico, Mexico City, Mexico; I. Nikishina, MD, V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; J.D. Akikusa, MD, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia; T. Avcin, MD, PhD, University Medical Centre Ljubljana, Pediatric Clinic, Ljubljana, Slovenia; J. Chaitow, MD, The Sydney Children's Hospital Network, Westmead, Sydney, Australia; E. Koskova, MD, PhD, National Institute of Rheumatic Diseases, Piestany, Slovakia; B.R. Lauwerys, MD, PhD, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain and Department of Rheumatology, Cliniques Universitaires Saint-Luc, Brussels, Belgium; I. Calvo Penades, MD, PhD, Hospital Universitario y Politécnico La Fe, Pediatric Rheumatology Unit, Valencia, Spain; B. Flato, MD, PhD, Oslo University Hospital, Department of Rheumatology, Oslo, Norway; M.L. Gamir, MD, Hospital Ramon y Cajal Unidad de Reumatologia Pediatrica, Madrid, Spain; H.I. Huppertz, MD, Klinikum Bremen-Mitte, Prof. Hess-Kinderklinik, Bremen, Germany; J.J. Raad, MD, Centro de Reumatologia y Ortopedia, Barranquilla, Atlantico, Colombia; K. Jarosova, MD, Revmatologicky Ustav, Prague, Czech Republic; J. Anton, MD, PhD, Pediatric Rheumatology Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Espluges (Barcelona), Spain; M. Macku, MD, Fakultni nemocnice Brno, Bohunice, Detska Nemocnice, Ambulance detske revmatologie detske kliniky, Brno, Czech Republic; W.J. O ·J Rheumatol · Pubmed #26932344.

ABSTRACT: OBJECTIVE: The main objective was to determine the 2-year clinical benefit and safety of etanercept (ETN) in children with the juvenile idiopathic arthritis (JIA) categories of extended oligoarthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA). METHODS: CLIPPER was a 96-week, phase IIIb, open-label, multicenter study. Patients with eoJIA, ERA, or PsA received ETN 0.8 mg/kg once weekly (50 mg max) for up to 96 weeks. The proportions of patients reaching the JIA American College of Rheumatology (ACR) 30/50/70/90/100 and inactive disease responses at Week 96 were calculated. Adverse events (AE) were collected throughout the study (intention-to-treat sample). RESULTS: There were 127 patients (eoJIA n = 60, ERA n = 38, PsA n = 29) who received ≥ 1 dose of ETN. The mean disease duration was 31.6 (eoJIA), 23.0 (ERA), and 21.8 (PsA) months. At Week 96, JIA ACR 30/50/70/90/100/inactive disease responses (95% CI) were achieved by 84.3% (76.7, 90.1), 83.5% (75.8, 89.5), 78.7% (70.6, 85.5), 55.1% (46.0, 63.9), 45.7% (36.8, 54.7), and 27.6% (20.0, 36.2) of patients, respectively. The most common AE (no. events, events per 100 patient-yrs) overall were headache (23, 10.7), pyrexia (12, 5.6), and diarrhea (10, 4.6). The most common infections were upper respiratory tract infection (83, 38.6), pharyngitis (50, 23.2), gastroenteritis (22, 10.2), bronchitis (19, 8.8), and rhinitis (17, 7.9). No cases of malignancy, active tuberculosis, demyelinating disorders, or death were reported. CONCLUSION: Over 96 weeks of therapy, ETN demonstrated sustained efficacy at treating the clinical symptoms of all 3 JIA categories, with no major safety issues.

20 Clinical Trial Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial. 2014

Vaclavkova, Andrea / Chimenti, Sergio / Arenberger, Petr / Holló, Peter / Sator, Paul-Gunther / Burcklen, Michel / Stefani, Mylène / D'Ambrosio, Daniele. ·Actelion Pharmaceuticals Ltd, Allschwil, Switzerland. · Department of Dermatology, University of Rome "Tor Vergata", PTV-Policlinico di Tor Vergata, Rome, Italy. · Department of Dermatology, Charles University, Third Faculty of Medicine, Prague, Czech Republic. · Department of Dermatovenerology and Oncodermatology, Semmelweis University, Budapest, Hungary. · Department of Dermatology, Municipal Hospital Hietzing, Vienna, Austria. · Actelion Pharmaceuticals Ltd, Allschwil, Switzerland. Electronic address: daniele.dambrosio@actelion.com. ·Lancet · Pubmed #25127208.

ABSTRACT: BACKGROUND: We assessed the efficacy, safety, and tolerability of ponesimod, an oral, selective, reversible modulator of sphingosine 1-phosphate receptor 1, in patients with moderate to severe chronic plaque psoriasis. METHODS: Between Sept 22, 2010, and Oct 24, 2012, patients with psoriasis area and severity index (PASI) scores higher than 10 were enrolled into this multicentre double-blind, phase 2 study. They received 20 mg or 40 mg ponesimod or placebo once daily for 16 weeks. Those with at least 50% reduction in PASI score at 16 weeks and who were receiving ponesimod were rerandomised to receive maintenance ponesimod therapy or placebo until week 28. The primary endpoint was reduction in PASI score from baseline of at least 75% (PASI75) at week 16. This study is registered with ClinicalTrials.gov, number NCT01208090. FINDINGS: Of 326 patients initially randomised (20 mg ponesimod n=126, 40 mg ponesimod n=133, and placebo n=67) PASI75 was achieved at week 16 in 58 (46·0%), 64 (48·1%), and nine (13·4%), respectively. The treatment effect was significant for the two ponesimod doses (both p<0·0001). Of 219 patients who entered the maintenance period, PASI75 was achieved by week 28 in 35 (71·4%) of 49 who continued on 20 mg ponesimod and 41 (77·4%) of 53 on 40 mg ponesimod, and in 19 (42·2%) of 45 who swapped from 20 mg to placebo and 19 (40·4%) of 47 from 40 mg to placebo. Ponesimod was associated with dyspnoea, raised liver enzyme concentrations, and dizziness. INTERPRETATION: Significant clinical benefit was seen at week 16 that increased with maintenance therapy. FUNDING: Actelion Pharmaceuticals.

21 Article Serum Levels of Aryl Hydrocarbon Receptor, Cytochromes P450 1A1 and 1B1 in Patients with Exacerbated Psoriasis Vulgaris. 2018

Beránek, M / Fiala, Z / Kremláček, J / Andrýs, C / Krejsek, J / Hamáková, K / Palička, V / Borská, L. ·Institute of Clinical Biochemistry and Diagnostics, University Hospital Hradec Králové and Faculty of Medicine in Hradec Králové, Charles University, Czech Republic. · Department of Biochemical Sciences, Faculty of Pharmacy in Hradec Králové, Charles University, Czech Republic. · Institute of Hygiene and Preventive Medicine, Faculty of Medicine in Hradec Králové, Charles University, Czech Republic. · Institute of Pathological Physiology, Faculty of Medicine in Hradec Králové, Charles University, Czech Republic. · Institute of Clinical Immunology and Allergology, Faculty of Medicine in Hradec Králové, Charles University, Czech Republic. · Clinic of Dermal and Venereal Diseases, University Hospital Hradec Králové, Czech Republic. ·Folia Biol (Praha) · Pubmed #30394267.

ABSTRACT: The aryl hydrocarbon receptor (AhR) is highly expressed in psoriasis skin lesions. The aim of this study was to investigate serum concentrations of AhR, cytochromes P450 (CYP) 1A1 and 1B1 in patients with exacerbated psoriasis vulgaris treated with combined therapy of ultraviolet radiation (UVR) and crude coal tar. The analyses were performed by using enzyme-linked immunosorbent assays. Before the treatment, the patients had significantly higher serum levels of AhR and CYP1A1 than healthy controls. AhR median noticeably decreased after the therapy; nevertheless, it remained significantly higher compared to the controls. CYP1A1 levels measured before and after the therapy did not differ significantly. Serum CYP1A1 positively correlated with AhR values before and after the treatment. The serum values of CYP1B1 were very low and we did not see any differences between the study group and the control group. The study demonstrated that serum levels of AhR and CYP1A1 could indicate their immunopathological and metabolic roles in exacerbated psoriasis.

22 Article Entheseal involvement in patients with systemic lupus erythematosus: an ultrasound study. 2018

Di Matteo, Andrea / Filippucci, Emilio / Cipolletta, Edoardo / Satulu, Iulia / Hurnakova, Jana / Lato, Valentina / De Angelis, Rossella / Horvath, Rudolf / Pavelka, Karel / Salaffi, Fausto / Grassi, Walter. ·Department of Clinical and Molecular Sciences, Rheumatology Unit, Carlo Urbani Hospital, Polytechnic University of Marche, Jesi, Ancona, Italy. · Rheumatology Department, Internal Medicine Clinic, Kalmar County Hospital, Kalmar, Sweden. · Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic. · Department of Pediatric and Adult Rheumatology, Motol University Hospital, Prague, Czech Republic. ·Rheumatology (Oxford) · Pubmed #29982722.

ABSTRACT: Objectives: The main objective of this study is to explore the prevalence and distribution of entheseal US changes in a cohort of SLE patients, taking as controls a group including both PsA patients and healthy subjects. The secondary objective is to investigate the correlation between the US findings and the clinical and serological data in SLE patients. Methods: Clinical and US assessment of quadriceps, patellar and Achilles tendons, and plantar fascia entheses were performed by independent rheumatologists on 65 patients with SLE, 50 patients with PsA and 50 healthy subjects. US findings were identified according to the OMERACT definitions. In SLE patients, the correlation between the US changes and the clinical and laboratory findings was evaluated. Results: US revealed one or more abnormalities in at least one enthesis in 44 out of 65 SLE patients (67.7%), 47 out of 50 PsA patients (94.0%) and 22 out of 50 healthy subjects (44.0%). In SLE patients, US findings indicating active inflammation were significantly more frequently detected than in healthy subjects (P < 0.001). The distal enthesis of the patellar tendon was the most commonly involved. The presence of power Doppler signal at the enthesis was an independent predictor of SLE disease activity (SLEDAI-2k P < 0.001, β = 0.52; musculoskeletal-BILAG P < 0.001, β = 0.56). Conclusion: The burden of entheseal sonographic changes was significantly higher in SLE patients than in healthy subjects, especially as regards active inflammation. The presence of power Doppler signal at the enthesis may represent a potential biomarker of SLE disease activity.

23 Article Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). 2018

Nash, Peter / Mease, Philip J / McInnes, Iain B / Rahman, Proton / Ritchlin, Christopher T / Blanco, Ricardo / Dokoupilova, Eva / Andersson, Mats / Kajekar, Radhika / Mpofu, Shephard / Pricop, Luminita / Anonymous1051124. ·Department of Medicine, University of Queensland, Brisbane, Australia. drpnash@tpg.com.au. · Swedish Medical Centre and University of Washington, Seattle, WA, USA. · University of Glasgow, Glasgow, UK. · Memorial University of Newfoundland, St. John's, NL, Canada. · Allergy/Immunology and Rheumatology Division, University of Rochester, Rochester, NY, USA. · Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain. · Medical Plus, s.r.o., Uherské Hradiště, and University of Veterinary and Pharmaceutical Sciences, Faculty of Pharmacy, Brno, Czech Republic. · Novartis Pharma AG, Basel, Switzerland. · Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. ·Arthritis Res Ther · Pubmed #29544534.

ABSTRACT: BACKGROUND: The study aimed to assess 52-week efficacy and safety of secukinumab self-administration by autoinjector in patients with active psoriatic arthritis (PsA) in the FUTURE 3 study ( ClinicalTrials.gov NCT01989468). METHODS: Patients (≥ 18 years of age; N = 414) with active PsA were randomized 1:1:1 to subcutaneous (s.c.) secukinumab 300 mg, 150 mg, or placebo at baseline, weeks 1, 2, 3, and 4, and every 4 weeks thereafter. Per clinical response, placebo-treated patients were re-randomized to s.c. secukinumab 300 or 150 mg at week 16 (nonresponders) or week 24 (responders) and stratified at randomization by prior anti-tumor necrosis factor (TNF) therapy (anti-TNF-naïve, 68.1%; intolerant/inadequate response (anti-TNF-IR), 31.9%). The primary endpoint was the proportion of patients achieving at least 20% improvement in American College of Rheumatology response criteria (ACR20) at week 24. Autoinjector usability was evaluated by Self-Injection Assessment Questionnaire (SIAQ). RESULTS: Overall, 92.1% (300 mg), 91.3% (150 mg), and 93.4% (placebo) of patients completed 24 weeks, and 84.9% (300 mg) and 79.7% (150 mg) completed 52 weeks. In the overall population (combined anti-TNF-naïve and anti-TNF-IR), ACR20 response rate at week 24 was significantly higher in secukinumab groups (300 mg, 48.2% (p < 0.0001); 150 mg, 42% (p < 0.0001); placebo, 16.1%) and was sustained through 52 weeks. SIAQ results showed that more than 93% of patients were satisfied/very satisfied with autoinjector usage. Secukinumab was well tolerated with no new or unexpected safety signals reported. CONCLUSIONS: Secukinumab provided sustained improvements in signs and symptoms in active PsA patients through 52 weeks. High acceptability of autoinjector was observed. The safety profile was consistent with that reported previously. TRIAL REGISTRATION: ClinicalTrials.gov NCT01989468 . Registered 21 November 2013. EudraCT 2013-004002-25 . Registered 17 December 2013.

24 Article Psoriasis treatment with adalimumab in clinical practice: long-term experience in a center for biological therapy in the Czech Republic. 2018

Adenubiova, Elizabeth / Arenberger, Petr / Gkalpakioti, Petra / Arenbergerova, Monika / Jircikova, Jitka / Dolezal, Tomas / Gkalpakiotis, Spyridon. ·a Department of Dermatovenereology, Third Faculty of Medicine , Charles University and Faculty Hospital of Kralovske Vinohrady , Prague , Czech Republic. · b Value outcomes s.r.o , Prague , Czech Republic. ·J Dermatolog Treat · Pubmed #29307245.

ABSTRACT: BACKGROUND: Adalimumab therapy has an established record of high efficacy in psoriasis treatment. However, only a limited number of studies have investigated long-term results in clinical practice. OBJECTIVES: To evaluate the effectiveness and safety of adalimumab in a center for biological therapy in the Czech Republic. METHODS: Retrospectively, we analyzed 90 patients with moderate to severe psoriasis who were treated with adalimumab between 2008 and 2016. The proportion of patients achieving PASI75, 90, and 100 after 3, 6, 12, 18, 24, 30, and 36 months was determined. RESULTS: The mean period of treatment was 4.4 years (maximum duration reached was 8.6 years). PASI75 was observed in 85.6% of patients after 3 months, PASI90 in 50%, and PASI100 in 23.3%. Throughout the 3-year analysis, PASI90 was persistent in 91.4% and PASI100 in 51.7%. The majority of patients who reached PASI100 showed a trend to maintain the response in the long-term follow-up. No safety issues were identified. CONCLUSIONS: Adalimumab is effective and safe in the long-term treatment of psoriatic patients in daily clinical practice. Once patients achieved PASI100, they tended to remain stable in treatment.

25 Article Mapping Quality of Life (EQ-5D) from DAPsA, Clinical DAPsA and HAQ in Psoriatic Arthritis. 2018

Mlcoch, Tomas / Tuzil, Jan / Sedova, Liliana / Stolfa, Jiri / Urbanova, Monika / Suchy, David / Smrzova, Andrea / Jircikova, Jitka / Hrnciarova, Tereza / Pavelka, Karel / Dolezal, Tomas. ·Institute of Health Economics and Technology Assessment, Vaclavska 316/12, 12000, Prague 2, Czech Republic. mlcoch@iheta.org. · Institute of Health Economics and Technology Assessment, Vaclavska 316/12, 12000, Prague 2, Czech Republic. · Institute of Rheumatology, Prague, Czech Republic. · Clinic of Rheumatology, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic. · Department of Clinical Pharmacology, Rheumatology, University Hospital Plzen, Plzen, Czech Republic. · Third Internal Clinic, University Hospital Olomouc, Olomouc, Czech Republic. ·Patient · Pubmed #29164493.

ABSTRACT: BACKGROUND: Clinical trials and observational studies lacking measures of health-related quality of life (QoL) are often inapplicable when conducting cost-effectiveness analyses using quality-adjusted life-years (QALYs). The only solution is to map QoL ex post from additionally collected clinical outcomes and generic QoL instruments. Nonetheless, mapping studies are absent in psoriatic arthritis (PsA). METHODS: In this 2-year, prospective, multicentre, non-interventional study of PsA patients, EQ-5D and key clinical parameters such as Disease Activity in PsA (DAPsA), clinical DAPsA (cDAPsA; DAPsA without C-reactive protein [CRP]), and Health Assessment Questionnaire disability index (HAQ) were collected. We employed a linear mixed-effect regression model (ME) of the longitudinal dataset to explore the best predictors of QoL. RESULTS: A total of 228 patients were followed over 873 appointments/observations. DAPsA, cDAPsA and HAQ were stable and highly significant predictors of EQ-5D utilities in both cross-sectional and longitudinal analyses. The best prediction was provided using a linear ME with HAQ and cDAPsA or DAPsA. A HAQ increase of 1 point represented a decrease in EQ-5D by -0.204 or -0.203 (p < 0.0001); a one-point increase in cDAPsA or DAPsA dropped EQ-5D equally by -0.005 (p < 0.0001). The ME revealed steeper and more accurate association compared with cross-sectional regressions or non-linear models/transformations. CONCLUSIONS: This is the first mapping study conducted in PsA and we hope that our study will encourage further mapping studies in PsA. The results showed that in cases where CRP is absent, cDAPsA provides similar results to DAPsA in predicting QoL.

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