Long-term safety and efficacy of filgotinib treatment for rheumatoid arthritis in Japanese patients naïve to MTX treatment (FINCH 3)

ABSTRACT Objectives To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised-controlled trial at Week 52 and interim lon...

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Published in:Modern rheumatology 2023-07, Vol.33 (4), p.657-667
Main Authors: Atsumi, Tatsuya, Tanaka, Yoshiya, Matsubara, Tsukasa, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Westhovens, René, Ching, Daniel W T, Messina, Osvaldo Daniel, Burmester, Gerd R, Genovese, Mark, Bartok, Beatrix, Pechonkina, Alena, Kondo, Akira, Yin, Zhaoyu, Gong, Qi, Tasset, Chantal, Takeuchi, Tsutomu
Format: Article
Language:English
Subjects:
Animals
Antirheumatic Agents - adverse effects
Arthritis, Rheumatoid - drug therapy
Double-Blind Method
Drug Therapy, Combination
East Asian People
Finches
Humans
Methotrexate - adverse effects
Treatment Outcome
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Summary:ABSTRACT Objectives To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised-controlled trial at Week 52 and interim long-term extension (LTE) to Week 48 through June 2020. Methods Patients were randomised to FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, or MTX for 52 weeks. At completion, eligible patients could enrol in the LTE. Those receiving FIL continued; those receiving MTX were rerandomised (blinded) to FIL 200 or 100 mg upon discontinuation of MTX. After a 4-week washout period, MTX could be re-added. Results Adverse event rates at Week 52 and in the LTE to Week 48 were comparable across treatment groups. Week 52 American College of Rheumatology 20% improvement (ACR20) rates were 83% (19/23), 82% (9/11), 75% (9/12), and 76% (19/25) for FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, and MTX, respectively. Through LTE Week 48, ACR20 rates were maintained. Conclusions In the 56 Japanese patients treated with FIL, efficacy was maintained through Week 52 and beyond, with no increases in the incidence of adverse events.
ISSN:1439-7595
1439-7609
DOI:10.1093/mr/roac083