Winthrop KL, Tanaka Y, Takeuchi T, et al. - Similar safety/tolerability profiles were displayed by filgotinib (Janus kinase-1 preferential inhibitor) 200 and 100 mg over a median of 1.6 and maximum of 5.6 years of exposure, with a lower incidence of infections with filgotinib 200 mg among the long-term, as-treated dataset.

• Combining data from seven clinical trials, experts assessed short-term safety relative to placebo (PBO) for 777 and 788 patients taking filgotinib 200 and 100 mg as well as long-term safety of filgotinib 200 and 100 mg in rheumatoid arthritis cases exposed for 4,047.7 and 2,032.9 patient-years (median 1.6 and 1.3 years; maximum 5.6 and 4.7 years).

• Comparable rates of treatment-emergent adverse events (TEAEs) (including grade ≥3) were reported with filgotinib or PBO during PBO-controlled period; long-term exposure-adjusted incidence rates of TEAEs grade ≥3 were 6.4 and 7.6/100patient-years exposure for filgotinib 200 and 100 mg.

• Overall, a generally good tolerability of both filgotinib 200 and 100 mg was evident.

• Infections and serious infections occurred in higher proportions of patients treated with filgotinib 200 and 100 mg vs those treated with PBO.

• Infrequent occurrence of opportunistic infections, herpes zoster infections, major adverse cardiac events, and venous thromboembolism was observed.

• Longer-term testing of filgotinib will further elucidate this safety profile.