Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4

Objectives The aim of this article is to describe the safety and efficacy of filgotinib 200 mg (FIL200) or FIL 100 mg (FIL100) in Japanese patients with rheumatoid arthritis in a long-term extension (NCT03025308).Methods Patients who completed any of three parent studies (NCT02889796: inadequate response to methotrexate; NCT02873936: inadequate response to biologic disease-modifying antirheumatic drugs; NCT02886728: methotrexate-na & iuml;ve) without rescue therapy could enter the long-term extension; patients taking FIL continued their dosage, and those who received comparators were rerandomised to FIL200 or FIL100. This analysis includes Week 156 interim results.Results Among Japanese patients, 110 received FIL200, and 97 received FIL100. Mean (SD) FIL200 and FIL100 exposure was 157.0 (51.49) and 156.0 (52.45) weeks. The exposure-adjusted incidence rates (95% confidence interval) for FIL200/FIL100 were 2.7 (1.4, 5.2)/2.4 (1.2, 5.1) for herpes zoster, 0.9 (0.3, 2.8)/1.0 (0.3, 3.2) for malignancy (excluding nonmelanoma skin cancer), and 0.6 (0.2, 2.4)/0.3 (0.0, 2.4) for major adverse cardiovascular events. More patients receiving FIL200 with prior FIL200 exposure achieved clinical remission vs other groups (including Clinical Disease Activity Index remission in 40% vs <= 27% at Week 156).Conclusions FIL200 and FIL100 were generally well tolerated by Japanese patients, without new, unexpected adverse events.