Key clinical point: Treatment with filgotinib and methotrexate (MTX) reduced signs and symptoms of rheumatoid arthritis (RA) in patients with moderate-to-severe active RA and inadequate response to MTX.
Major finding: Proportion of patients achieving 20% improvement in American College of Rheumatology criteria at week 12 was significantly higher with filgotinib 200 mg (76.6%) and 100 mg (69.8%) vs. placebo (49.9%; P for all less than .001). Overall, both filgotinib doses were well tolerated.
Study details: Findings are from FINCH I phase 3 study including 1,755 patients with moderate-to-severe active RA and inadequate response to MTX. Patients were randomly assigned to once-daily oral filgotinib 200 mg or filgotinib 100 mg, subcutaneous adalimumab 40 mg biweekly, or placebo, all with stable background MTX.
Disclosures: The study was funded by Gilead Sciences. Study investigators including the lead author reported ties with various pharmaceutical companies, including Gilead Sciences. MC Genovese, F Matzkies, B Bartok, L Ye, and Y Guo declared being employees and shareholders of Gilead Sciences. JS Sundy, A Jahreis, and N Mozaffarian declared being former employees of Gilead Sciences and may hold shares. C Tasset declared being an employee and shareholder of Galapagos NV. JA Simon, U Kumar U, and S-C Bae report no disclosures.
Source: Combe B et al. Ann Rheum Dis. 2021 Jan 27. doi: 10.1136/annrheumdis-2020-219214.