JP. The first investigation on differences in the effectiveness of mycophenolate mofetil and azathioprine antimetabolites determined in Polish patients treated for non-infectious uveitis.
Objective: The first biological therapeutics have already reached their patent expiration dates and corresponding biosimilars have been approved by the EMA and FDA. The approval of products similar, but not identical to already known innovative biologics is stirring a lot of debate about safety concerns, as well as the relevance of these differences to clinical practice. Methods: A Group of 13 experts involved in various aspects of biological therapies in Poland was established. Modified Delphi method of voting was performed to achieve consensus regarding the most important aspects of biological treatment in Poland, with particular concern regarding biosimilars. Results: Ten final statements were discussed and voted upon. The statements cover general aspects of biosimilars, including expected cost-benefit ratios, extrapolation of clinical indications, interchange, switching, patient information and the requirement of patient consent. The state of post-marketing pharmacovigilance of biologicals (innovative ones as well as biosimilars) was also discussed. Conclusions: The Expert Group agreed that introduction of biosimilars is an important achievement in biological therapies, with the potential to reduce treatment costs and increase their availability. Experts also agreed that the safety of biological treatments should be monitored more carefully in Poland. There is an unmet need in Poland for the creation of a registry collecting data needed for the assessment of safety and efficacy of both biosimilars and their reference products in accordance with the experience and principles introduced in other European countries.
Background: Amoebae of the genus Acanthamoeba cause a sight-threatening infection called Acanthamoeba keratitis. It is considered a rare disease in humans but poses an increasing threat to public health worldwide, including in Poland. We present successive isolates from serious keratitis preliminary examined in terms of the identification and monitoring of, among others, the in vitro dynamics of the detected strains. Methods: Clinical and combined laboratory methods were applied; causative agents of the keratitis were identified at the cellular and molecular levels; isolates were cultivated in an axenic liquid medium and regularly monitored. Results: In a phase-contrast microscope, Acanthamoeba sp. cysts and live trophozoites from corneal samples and in vitro cultures were assessed on the cellular level. Some isolates that were tested at the molecular level were found to correspond to A. mauritanensis, A.culbertsoni, A. castellanii, genotype T4. There was variability in the amoebic strain dynamics; high viability was expressed as trofozoites’ long duration ability to intense multiply. Conclusions: Some strains from keratitis under diagnosis verification and dynamics assessment showed enough adaptive capability to grow in an axenic medium, allowing them to exhibit significant thermal tolerance. In vitro monitoring that was suitable for verifying in vivo examinations, in particular, was useful to detect the strong viability and pathogenic potential of successive Acanthamoeba strains with a long duration of high dynamics.
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