Investigational JAK1 Inhibitor Looks Promising in Phase 3 RA Study
Top-line data from the FINCH 2 trial showed that treatment with filgotinib (Gilead and Galapagos), an investigational, selective JAK1 inhibitor, led to a significantly higher proportion of rheumatoid arthritis (RA) patients achieving American College of Rheumatology 20% (ACR20) response, compared with placebo.
The 24-week Phase 3 trial randomized patients with moderate-to-severely active RA and prior inadequate response/intolerance to biologic agents to receive once-daily filgotinib 100mg, 200mg, or placebo; patients were on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
Results showed that at week 12, 57.5%, 66.0%, and 31.0% of the filgotinib 100mg group (N=153), 200mg group (N=147), and placebo group achieved ACR20, respectively (P<.001), while at week 24, the responses were similar with 54.9%, 69.4% and 34.5% of the filgotinib 100mg group, 200mg group, and placebo group achieving ACR20 (P<.001).
The proportion of patients who achieved clinical remission (DAS28[CRP]<2.6) was also significantly higher in the filgotinib groups. At week 12, 25.5% of the 100mg group and 22.4% of the 200mg group achieved clinical remission, compared with 8.1% of the placebo group, while at week 24, 26.1%, 30.6%, and 12.2% achieved clinical remission in the filgotinib 100mg, 200mg, and placebo arms, respectively.
Filgotinib, which is currently being investigated in 2 other trials, FINCH 1 and 3, was found to be generally well-tolerated; serious adverse events occurred in 3.4%, 5.2%, and 4.1% of patients in the placebo, filgotinib 100mg, and filgotinib 200mg groups, respectively.
Full results from FINCH 2 will be presented at a future scientific conference.