Integrated safety analysis of filgotinib in Japanese patients with moderately to severely active rheumatoid arthritis...

To evaluate the long-term safety of filgotinib as a treatment for moderately to severely active rheumatoid arthritis for up to 5 years in Japanese patients.

Safety was assessed in Japanese patients receiving filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100) in three Phase 3 multinational trials (NCT02889796, NCT02873936, and NCT02886728) and a long-term extension trial (NCT03025308) through May 2022.

The pooled Japanese population included 124 patients receiving FIL200 and 107 receiving FIL100, with 413.6 and 352.9 patient-years of exposure [median (maximum) of 3.9 (5.0) and 3.7 (5.1) years], respectively. Overall, 97% of patients experienced treatment-emergent adverse events [EAIR 29.1 (95% confidence interval: 25.5-33.2)], and 73% experienced treatment-related adverse events [21.8 (18.7-25.4)]; rates were similar between FIL200 and FIL100. In the FIL200 and FIL100 groups, EAIRs (95% confidence intervals) were 2.7 (1.5-4.8) and 2.0 (0.9-4.2) for serious infections and 3.1 (1.8-5.4) and 2.6 (1.3-4.9) for herpes zoster. No venous or arterial systemic thromboembolism occurred. There were 0 and 2 incidents of all-cause mortality in the FIL200 and FIL100 groups, respectively.

Long-term filgotinib treatment was well tolerated at 200 and 100 mg in Japanese patients with rheumatoid arthritis over a period of up to 5 years, confirming previous global analyses.