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The FINCH study included three Phase III trials, all of which achieved their primary endpoints. Compared with placebo or MTX, Filgotinib can achieve the remission index of ACR20/50/70 well, and all individual ACR components show improvement. The results showed that compared with placebo or MTX, Filgotinib treatment consistently achieved the ACR20/50/70 remission index and improved on all ACR criteria.
Compared with placebo or MTX, the proportion of patients receiving 200mg Filgotinib combined with MTX or other conventional synthetic anti rheumatic drugs who achieved lower disease activity and/or remission (DAS28-CRP ≤ 3.2 and DAS28-CRP<2.6) was significantly increased at weeks 12 and 24. In patients with poor response to MTX, the combination of Filgotinib and MTX significantly inhibited the progression of structural joint injury compared to placebo+MTX at week 24.
from FDA，2023.07
