Abstract Objective To evaluate long-term safety of filgotinib as treatment of moderately to severely active rheumatoid arthritis (RA) for up to 5 years in Japanese patients. Methods Safety was assessed in Japanese patients receiving filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100) in three Phase 3, multinational trials (NCT02889796, NCT02873936, NCT02886728) and a long-term extension trial (NCT03025308) through May 2022. Results 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% experienced treatment-emergent adverse events (EAIR 29.1 95% CI 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% CIs) 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. Conclusions Long-term filgotinib treatment was well tolerated at 200 mg and 100 mg in Japanese patients with RA over up to 5 years, confirming previous global analyses.
Tanaka et al. (Tue,) studied this question.
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