September 2021

予後不良因子を有するMTX未治療RA患者におけるフィルゴチニブの有効性と安全性: FINCH 3試験の事後解析

RMD Open. 2021;7(2):e001621.

Post hoc analysis of the phase III FINCH study shows that filgotinib may be an alternative treatment option for patients with RA who have poor prognostic factors (PPFs), especially those not responding to standard treatment such as methotrexate (MTX).PPFs are associated with severe disease and risk for disease progression in patients with RA. Consequently, the 2019 EULAR management guidelines for RA recommend early treatment escalation for patients with PPFs who have inadequate response to first...

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February 2021

メトトレキサート無使用またはわずかな使用歴の活動性関節リウマチ患者におけるメトトレキサート併用フィルゴチニブ, フィルゴチニブ単剤, メトトレキサート: フェーズ3, 無作為化コントロール対照FINCH 3 試験

Ann Rheum Dis. 2021 Jan 15:annrheumdis-2020-219213.

Filgotinib doses in combination with MTX have shown improved signs, symptoms and physical function in patients with RA and limited or no prior MTX exposure. FIL 200mg monotherapy did not have a superior ACR20 response rate versus MTX. This 52-week, phase 3 study evaluated FIL in 1252 patients with RA. Patients were randomised to FIL 200mg + MTX or FIL 100mg + MTX, FIL 200 mg monotherapy, or MTX monotherapy. The primary endpoint was the proportion patients achieving ACR20 at week 24. Safety was e...

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メトトレキサートに効果不十分な関節リウマチ患者におけるFilgotinib 対 Placebo 対 Adalimumab: フェーズ III 無作為化臨床試験

Ann Rheum Dis. 2021 Jan 27:annrheumdis-2020-219214

Filgotinib improved RA signs and symptoms, physical function, and inhibited radiographic progression. FIL 200mg plus MTX, but not FIL 100mg plus MTX showed non-inferiority to ADA plus MTX, based on DAS28(CRP) low disease activity. FIL was also well tolerated in RA patients with inadequate response to MTX.This 52-week, phase 3 randomised clinical trial (FINCH 1) evaluated the efficacy and safety of FIL in patients with RA randomised to FIL 200 or 100mg, ADA 40mg, or placebo, all with background M...

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