Медицинский совет (Dec 2015)
Tyrosine kinase inhibitor Tofacitinib. Safety issues
Abstract
Tofacitinib (TOFA) was the first synthetic small molecule drug which was comparable with genetically engineered biological agents (GIBA) in terms of its therapeutic effect in rheumatoid arthritis (RA). Results of treatment of over 4 thousand RA patients showed that the most common adverse events were nasopharyngitis, upper respiratory infections and urinary tract infections, herpes, diarrhea, nausea, gastritis. Serious side effects were registered in 15.4% of patients, and serious infections in 4.5%. Opportunistic infections occurred in 0.6% of patients, half of which were cases of tuberculosis. Anemia, hemocytopenia, increased lipidemia, a mild temporary decrease in glomerular filtration rate and increased creatinemia were also recorded. There were no anaphylactic or other immediate reactions. TOFA administration results were not different from those after treatment with GIBA in terms of mortality, incidence of infections and cancer.
Keywords