You are here
The FINCH2 study has shown that filgotinib, an oral once daily JAK 1 inhibitor, is highly effective in rheumatoid arthritis (RA) patients who failed to respond to prior biologic therapy.
A total of 448 active RA patients were enrolled in a 24 week trial if they had an inadequate response or intolerance to 1 or more biologic disease-modifying antirheumatic drugs, were maintained on their background conventional synthetic DMARDs (csDMARDs). Patients were randomized to either daily filgotinib, 200 mg (n = 148); filgotinib, 100 mg (n = 153); or placebo (n = 148). The primary endpoint was an ACR20 response at week 12.
Week 12 outcomes showed filgotinib (FIL) to be significantly superior to placebo, with ACR20 responses:
- FIL 200 mg = 66.0%
- FIL 100 mg = 57.5%
- PBO = 31.1%; (both P < .001),
Even in patients who failed 3 or more prior biologic agents, significant ACR20 responses were achieved with FIL 200 mg (70.3%) and FIL 100 mg (58.8%) compared with PBO treated patients (17.6%).
Common adverse events (in 5-10%) included nasopharyngitis, headache, and upper respiratory infections.
There were 4 cases of herpes zoster cases, 1 retinal vein occlusion and no reports of tuberculosis, opportunistic infections, malignancies, gastrointestinal perforations, or deaths.
This is one of the pivotal drug development trials for filgotinib in RA. Gilead is partnering with Galapagos in developing filgotinib for use in RA and is planning to file for FDA approval later this year.