Abstract
According to the results of clinical trials, filgotinib is usually well tolerated and its safety is comparable to other Janus kinase (JAK) inhibitors. In the integrated analysis, the incidence of serious infections was observed in 1.0% of patients with a dose of 200 mg filgotinib and 0.9% with a dose of 100 mg filgotinib.
The risk of serious infections was similar to other JAK inhibitors. The incidence of venous thromboembolism related to exposure time was 0.2/100 patient-years for the 200 mg dose and 0.0/100 patient-years for the 100 mg dose.
The results therefore suggest a similar level of risk to patients with rheumatoid arthritis. The occurrence of malignancies was less frequent in the analysis, and the incidence related to exposure time did not increase over time.
Despite the favorable results of integrated analyzes for filgotinib, the regulatory authorities decided on a common approach to all JAK inhibitors, which should be indicated in special risk groups of patients only if there is no other treatment alternative.