Kavanaugh A, Westhovens RR, Winthrop KL, et al. - The long-term, open-label extension study DARWIN 3 demonstrated good tolerability of filgotinib with a 4-year safety profile comparable to that of the parent trials (DARWIN 1 and DARWIN 2), both in rheumatoid arthritis patients treated with combination therapy with methotrexate (MTX) or as monotherapy.

• Eligible patients who completed parent trials were given filgotinib 200 mg/day, except for 15 men who were administered filgotinib 100 mg/day.

• Exposure-adjusted incidence rate per 100 patient-years of exposure was 24.6 and 3.1 for treatment-emergent adverse events (TEAEs) and serious TEAEs, respectively, in the filgotinib + MTX group.

• These estimates were 25.8 and 4.3 in the filgotinib monotherapy group.

• American College of Rheumatology 20/50/70 responses were maintained through 4 years in 89.3%/69.6%/49.1% of the filgotinib + MTX group and 91.8%/69.4%/44.4% of the monotherapy group, respectively.