Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2)

Tsutomu Takeuchi, Tsukasa Matsubara, Tatsuya Atsumi, Koichi Amano, Naoki Ishiguro, Eiji Sugiyama, Kunihiro Yamaoka, Mark C. Genovese, Kenneth Kalunian, David Walker, Jacques Eric Gottenberg, Kurt de Vlam, Beatrix Bartok, Alena Pechonkina, Akira Kondo, Jie Gao, Ying Guo, Chantal Tasset, John S. Sundy, Yoshiya Tanaka

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: 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) Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
JournalModern rheumatology
DOIs
Publication statusAccepted/In press - 2020

Keywords

  • Filgotinib
  • Janus kinase
  • Japanese
  • phase 3 clinical trials
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology

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