| Title: | Efficacy and safety of filgotinib alone and in combination with methotrexate in Japanese patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate : Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 3) |
| Authors: | Atsumi, Tatsuya Browse this author →KAKEN DB |
| Tanaka, Yoshiya Browse this author →KAKEN DB |
| Matsubara, Tsukasa Browse this author |
| Amano, Koichi Browse this author |
| Ishiguro, Naoki Browse this author |
| Sugiyama, Eiji Browse this author |
| Yamaoka, Kunihiro Browse this author |
| Westhovens, Rene Browse this author |
| Ching, Daniel W. T. Browse this author |
| Messina, Osvaldo Daniel Browse this author |
| Burmester, Gerd R. Browse this author |
| Bartok, Beatrix Browse this author |
| Pechonkina, Alena Browse this author |
| Kondo, Akira Browse this author |
| Yin, Zhaoyu Browse this author |
| Guo, Ying Browse this author |
| Tasset, Chantal Browse this author |
| Sundy, John S. Browse this author |
| Takeuchi, Tsutomu Browse this author |
| Keywords: | Filgotinib |
| Janus kinase |
| Japanese |
| phase 3 clinical trials |
| rheumatoid arthritis |
| Issue Date: | Mar-2022 |
| Publisher: | Oxford University Press |
| Journal Title: | Modern rheumatology |
| Volume: | 32 |
| Issue: | 2 |
| Start Page: | 273 |
| End Page: | 283 |
| Publisher DOI: | 10.1093/mr/roab021 |
| Abstract: | Objectives To evaluate the efficacy and safety of filgotinib for Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure. Methods Data up to 24 weeks were analysed for 71 Japanese patients from a 52-week global Phase 3 study. Patients with RA and limited or no prior MTX exposure were randomised in a 2:1:1:2 ratio to filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, or MTX. Maximum MTX dose was 15 mg/week. Primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24. Results Week 24 ACR20 rates in Japanese patients were 82.6%, 90.9%, 83.3%, and 80.0% for filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, and MTX, respectively. Greater ACR20 rates with filgotinib vs MTX occurred at Week 2. Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP Conclusions While Week 24 ACR20 rates were similar, filgotinib provided faster responses and higher remission rates vs MTX. In Japanese patients with RA and limited or no prior MTX exposure, filgotinib was generally well tolerated. |
| Type: | article |
| URI: | http://hdl.handle.net/2115/85673 |
| Appears in Collections: | 北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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