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

Atsumi, Tatsuya; Tanaka, Yoshiya; Matsubara, Tsukasa; Amano, Koichi; Ishiguro, Naoki; Sugiyama, Eiji; Yamaoka, Kunihiro; Westhovens, Rene; Ching, Daniel WT; Messina, Osvaldo Daniel; Burmester, Gerd R; Genovese, Mark; Bartok, Beatrix; Pechonkina, Alena; Kondo, Akira; Yin, Zhaoyu; Gong, Qi; Tasset, Chantal; Takeuchi, Tsutomu

doi:10.1093/mr/roac083

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

Author:

Atsumi, Tatsuya

Tanaka, Yoshiya ; Matsubara, Tsukasa ; Amano, Koichi ; Ishiguro, Naoki ; Sugiyama, Eiji ; Yamaoka, Kunihiro ; Westhovens, Rene ; Ching, Daniel WT ; Messina, Osvaldo Daniel ; Burmester, Gerd R ; Genovese, Mark ; Bartok, Beatrix ; Pechonkina, Alena ; Kondo, Akira ; Yin, Zhaoyu ; Gong, Qi ; Tasset, Chantal ; Takeuchi, Tsutomu

Keywords:

Science & Technology, Life Sciences & Biomedicine, Rheumatology, Filgotinib, Janus kinase, Japanese, Phase 3 clinical trials, rheumatoid arthritis, METHOTREXATE SUBPOPULATION ANALYSES, GLOBAL PHASE-3, HERPES-ZOSTER, 24-WEEK DATA, COMBINATION, GLPG0634/GS-6034, INHIBITOR, Animals, Humans, Antirheumatic Agents, Arthritis, Rheumatoid, Double-Blind Method, Drug Therapy, Combination, East Asian People, Methotrexate, Treatment Outcome, filgotinib, 1103 Clinical Sciences, Arthritis & Rheumatology, 3202 Clinical sciences

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.