Je dlouhodobé podávání interferonů u polycythemia vera spojeno s riziky?
Keywords:
Polycytemia vera, peginterferon α2a, peginterferon α2b, ropeginterferon α2b, EudraVigilance, FAERS, nežádoucí účinky, závažnost nežádoucích účinků, ukončení (vysazení) terapie z důvodu nežádoucích účinkůAbstract
Therapy of myeloproliferative diseases with interferons is experiencing a renaissance, there are basically three reasons. Extending the effect of pegylation. Improvement of local tolerance and limitation of cytokine release by pegylation. New and encouraging evidence of efficacy with solid tolerance for pegylated interferons. Individual pegylated interferons differ from each other both from a chemical point of view and also in the three-dimensional structure of positional isomers, while one of the pegylated interferons – ropeginterferon α2b – is made up of a single molecule and has no positional isomers. Isomers of pegylated interferons appear to have different biological activity. The two largest databases of adverse effects, the American FAERS and the European Eudravigilance, show very homogeneously that there are differences in the incidence and severity of adverse effects between pegylated interferons. In addition, these differences confirm the results of controlled phase 2 and 3 clinical trials, which, among other things, monitored the incidence of premature termination of therapy due to adverse effects. Based on the analysis of adverse effects and the results of controlled clinical trials, it can be stated that ropeginterferon α2b has a significantly better tolerability in the indication of polycythemia vera compared to peginterferon α2a and peginterferon α2b, across virtually all classes of adverse effects according to the MedDRA classification. Additionally, a significantly lower proportion of patients have to discontinue ropeginterferon α2b therapy prematurely due to adverse effects compared to peginterferon α2a or peginterferon α2b therapy. Information about the safety of the therapy is important for the doctor in the same way that the information about the clinical effectiveness is important, because the set of this knowledge will help the doctor to make the optimal choice of the drug for the patient.