Previous studies have shown that filgotinib was generally well tolerated in previous trials and had safety similar to active comparators methotrexate and adalimumab up to 52 weeks.

This integrated analysis of safety data adds additional insights:

• The analysis includes data from seven clinical trials, and characterises both the short-term safety compared with placebo for 777 and 788 patients receiving filgotinib 200 and 100 mg, and long-term safety of filgotinib 200 and 100 mg in patients with RA exposed for 4047.7 and 2032.9 patient-years (median 1.6 and 1.3 years; maximum 5.6 and 4.7 years).
• Overall, both filgotinib 200 and 100 mg were generally well tolerated. Proportions of patients treated with filgotinib 200 and 100 mg who developed infections and serious infections were higher versus placebo. Opportunistic infections, herpes zoster infections, major adverse cardiac events, and venous thromboembolism were infrequently reported.
  
• In conclusion, over a median of 1.6 and maximum of 5.6 years of exposure, safety/tolerability of filgotinib 200 and 100 mg were similar, with a lower incidence of infections with filgotinib 200 mg among the long-term, as-treated dataset. Longer-term study of filgotinib will further elucidate this safety profile.