FINCH 1 Trial Filgotinib in Rheumatoid Arthritis Save
The Annals of Rheumatic Disease has published the results of a head-to-head trial showing that the Janus kinase-1 (JAK1) preferential inhibitor filgotinib was superior to a tumour necrosis factor-α inhibitor (adalimumab) in active rheumatoid arthritis (RA) on methotrexate (MTX).
This was a 52-week, placebo-controlled phase III trial where 1755 active (MTX nonresponder) RA patients were randomized to receive either filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100) daily, or adalimumab 40 mg SC biweekly, or placebo while on stable background MTX. The primary endpoint was the ACR20 at week 12.
ACR20 response rates at week 12 were significantly higher for FIL200 (76.6%) and FIL100 (69.8%) versus ADA (49.9%); and placebo (19.9%) (p<0.001). Thus filgotinib was superior to PBO, but non-inferior to adalimumab.
Filgotinib was superior to placebo in key secondary endpoints (RA signs and symptoms, physical function) and also structural damage assessed radiographically.
In this FINCH1 trial, filgotinib plus MTX reduced RA signs and symptoms, improved physical function and inhibited progression of structural joint damage. This study demonstrated filgotinib 200 mg was non-inferior to adalimumab plus MTX, based DAS28-CRP at week 12 (p<0.001); filgotinib 100 mg did not achieve non-inferiority.
Filgotinib is not being developed for use in the USA.