Key clinical point: In patients with active rheumatoid arthritis (RA) who had limited or no prior methotrexate (MTX) exposure, filgotinib (FIL) with MTX reduced signs and symptoms of RA and improved physical function with an acceptable safety profile up to 52 weeks.
Major finding: At week 24, significantly higher proportions of patients receiving FIL200 + MTX (81%; P less than .001) and FIL100 + MTX (80%; P = .017) achieved 20% improvement in American College of Rheumatology criteria (ACR20) vs. MTX (71%). Significant improvements in Health Assessment Questionnaire-Disability Index and 28-joint Disease Activity Score with C-reactive protein less than 2.6 were seen at week 24. Adverse event rates through week 52 were comparable between all treatments.
Study details: In this 52-week phase 3 FINCH 3 trial, 1,252 patients with RA were randomly assigned in a 2:1:1:2 ratio to receive filgotinib 200 mg with MTX (FIL200 + MTX), filgotinib 100 mg with MTX (FIL100+MTX), filgotinib 200 mg monotherapy (FIL200), or MTX.
Disclosures: The study was funded by Gilead Sciences, Inc. The lead author reported receiving grant/research support from and serving as a consultant for Celltrion, Galapagos, and Gilead Sciences.
Source: Westhovens R et al. Ann Rheum Dis. 2021 Jan 15. doi: 10.1136/annrheumdis-2020-219213 .