Key clinical point: The combination of f ilgotinib 200 mg and methotrexate showed an incremental benefit vs. methotrexate monotherapy in methotrexate-naive patients with rheumatoid arthritis (RA) and poor prognostic factors (PPF) with no new safety signals.
Major finding: Among patients with 4 PPFs, methotrexate + 200 mg filgotinib vs. methotrexate monotherapy was associated with higher rates of American College of Rheumatology (ACR) core criteria 20 (85.5% vs. 74.7%), ACR50 (70.3% vs. 48.2%), and ACR70 (54.1% vs. 28.3%) responses at week 24 and weeks 12 and 52 ( nominal P < .05 for all).
Study details: This was a post hoc analysis of the phase 3 FINCH 3 study involving 1,249 methotrexate-naive adult patients with moderate-to-severe active RA with multiple PPFs. Patients were randomly assigned to once-weekly methotrexate with once-daily oral filgotinib (200 mg or 100 mg), 200 mg filgotinib monotherapy, or oral methotrexate monotherapy for up to 52 weeks.
Disclosures: The study was funded by Gilead Sciences, Inc. The authors, including the lead author, reported receiving grants, speaker’s fees, and consultancy fees from various sources. Three authors reported being employees and shareholders of Gilead Sciences, Inc.
Source: Aletaha D et al. RMD Open. 2021 Aug 12 . doi: 10.1136/rmdopen-2021-001621 .