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Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2) MODERN RHEUMATOLOGY Takeuchi, T., Matsubara, T., Atsumi, T., Amano, K., Ishiguro, N., Sugiyama, E., Yamaoka, K., Genovese, M. C., Kalunian, K., Walker, D., Gottenberg, J., de Vlam, K., Bartok, B., Pechonkina, A., Kondo, A., Gao, J., Guo, Y., Tasset, C., Sundy, J. S., Tanaka, Y. 2020: 1–16

Abstract

To evaluate efficacy and safety of filgotinib in Japanese RA patients who have failed or were intolerant to one or more biologic disease-modifying antirheumatic drugs (bDMARD) from the global FINCH 2 study (NCT02873936).This subgroup analysis was performed using the predefined statistical analyses. The FINCH 2 study is a randomized, double-blind, placebo-controlled, Phase 3 study in adult RA patients with inadequate response to bDMARDs. The randomized patients were treated with once-daily filgotinib 200?mg, filgotinib 100?mg or placebo on a background of csDMARDs for 24 weeks.Of 449 patients enrolled in the overall population, 40 patients were enrolled from Japan. In the Japanese population, the American College of Rheumatology 20% response rates at week 12 (primary endpoint) were 83.3% and 53.3% for filgotinib, 200?mg and 100?mg, respectively, vs 30.8% for placebo. Filgotinib was well tolerated, similar to the overall population.Both doses of once-daily filgotinib 200?mg and filgotinib 100?mg were effective, and generally well-tolerated in Japanese patients with active refractory RA.

View details for DOI 10.1080/14397595.2020.1859675

View details for Web of Science ID 000608504000001

View details for PubMedID 33274687