Biosimilar versus originator etanercept: a real-life clinical study.

BACKGROUND: Over the last few years, novel therapeutic approaches based on the use of monoclonal antibodies against cytokines, or their cognate receptors, involved in psoriasis progression have shown remarkable results, being capable to reduce disease progression and increase patient's quality of life. Among these is etanercept (Enbrel®, Pfizer, Sandwich, UK) and its biosimilar compound SB4 (Benepali®, Samsung Bioepis, Delft, The Netherlands), both approved for the treatment of moderate to severe psoriasis. Aim of the present study was to evaluate in a less controlled environment, such as real-life, the actual bioequivalence between the etanercept (ETN) and the SB4 in term of safety, efficacy and patient's quality of life. METHODS: For this purpose, we analyzed a case study consisting of 65 patients affected by plaque psoriasis, with or without psoriatic arthritis at our dermatological outpatient center of Sant'Andrea Hospital in Rome, all of them under treatment with either ETN or the biosimilar SB4 drug for at least 3 months. The indicators used to evaluate the effectiveness of the therapies were the Psoriasis Area and Severity Index, the Visual Analogue Scale (VAS) for itch, the VAS for pain, and the Dermatology Life Quality Index. RESULTS: The results showed no significant differences among the two drugs in all the analyzed parameters confirming the equivalence between the ETN and its biosimilar SB4. CONCLUSIONS: Overall, we can confirm the overlapping clinical efficacy between ETN and its biosimilar SB4 drug and that even in an uncontrolled environment such as real-life, the biosimilar drugs are an excellent opportunity to reduce health costs allowing to expand the audience of patients who can benefit from these innovative treatments.

Hydroxytyrosol: A natural compound with promising pharmacological activities.

Hydroxytyrosol is a phenolic phytochemical with antioxidant properties in vitro. It is a natural compound that can be found in olive leaves and oil. The main dietary source of hydroxytyrosol is extra virgin olive oil. Due to its bioavailability, chemical properties and easy formulation along with its lack of toxicity, hydroxytyrosol is considered an excellent food supplement by the nutraceutical and food industries. The purpose of this review is to discuss the potential therapeutic effects of hydroxytyrosol in vivo. To do so, we conducted an electronic search in PubMed and other literature databases using "hydroxytyrosol", "beneficial effect/s", "pharmacology" as key-words. From this search, we found that hydroxytyrosol has anti-inflammatory, anti-tumor, antiviral, antibacterial and antifungal properties. Hydroxytyrosol also improves endothelial dysfunction, decreases oxidative stress, and is neuro- and cardio-protective. Due to all these biological properties, hydroxytyrosol is currently the most actively investigated natural phenol. The evidence presented in this review suggests that hydroxytyrosol has great pharmacological potential.

Genetics and pharmacogenetics in the diagnosis and therapy of cardiovascular diseases.

Cardiovascular diseases are the main cause of death worldwide. The ability to accurately define individual susceptibility to these disorders is therefore of strategic importance. Linkage analysis and genome-wide association studies have been useful for the identification of genes related to cardiovascular diseases. The identification of variants predisposing to cardiovascular diseases contributes to the risk profile and the possibility of tailored preventive or therapeutic strategies. Molecular genetics and pharmacogenetics are playing an increasingly important role in the correct clinical management of patients. For instance, genetic testing can identify variants that influence how patients metabolize medications, making it possible to prescribe personalized, safer and more efficient treatments, reducing medical costs and improving clinical outcomes. In the near future we can expect a great increment in information and genetic testing, which should be acknowledged as a true branch of diagnostics in cardiology, like hemodynamics and electrophysiology. In this review we summarize the genetics and pharmacogenetics of the main cardiovascular diseases, showing the role played by genetic information in the identification of cardiovascular risk factors and in the diagnosis and therapy of these conditions.

Hereditary thrombophilia.

Thrombophilia is a group of disorders in which blood has an increased tendency to clot. It may be caused by inherited or acquired conditions. Thrombophilia is associated with risk of deep venous thrombosis and/or venous thromboembolism. Factor V Leiden thrombophilia is the most common inherited form of thrombophilia and prothrombin-related thrombophilia is the second most common genetic form of thrombophilia, occurring in about 1.7-3% of the European and US general populations (3). Thrombophilia may have autosomal dominant, autosomal recessive or X-linked inheritance. Genetic testing is useful for confirming diagnosis and for differential diagnosis, recurrence risk evaluation and asymptomatic diagnosis in families with a known mutation.

Monogenic hyperlipidemias.

Monogenic hyperlipidemias are a group of inherited disorders characterized by elevated plasma concentrations of lipids and lipoproteins. High plasma concentrations of lipids are the most frequent risk factor for cardiovascular disease. Monogenic hyperlipidemias are a minor cause with respect to multifactorial hyperlipidemias. Diagnosis is based on clinical findings and lipid panel measurements. Genetic testing is useful for confirming diagnosis and for differential diagnosis, recurrence risk calculation and prenatal diagnosis in families with a known mutation. Monogenic hyperlipidemias can have either autosomal dominant or recessive inheritance.