Key clinical point: Filgotinib 200 mg (FIL200) and 100 mg (FIL100) showed similar safety/tolerability in patients with moderate-to-severe rheumatoid arthritis (RA) with over a median of 1.6 years and maximum of 5.6 years of exposure, with FIL200 showing a lower infection rate in the long term.
Major finding: Treatment-emergent adverse events (TEAEs) were similar between FIL200 (exposure-adjusted incidence rate [EAIR], 195.4 per 100 patient-years of exposure [100 PYE]), FIL100 (176.3 per 100 PYE), and placebo (175.9 per 100 PYE) during the 12-week period. During long-term exposure, EAIR for grade ≥3 TEAEs were 6.4 and 7.6 per 100 PYE for FIL200 and FIL100, respectively, but serious infectious AEs were lower with FIL200 vs. FIL100 (EAIR, 1.6 vs. 3.1 per 100 PYE).
Study details: Data come from integrated analysis of 7 clinical trials including patients with moderate-to-severe RA who received ≥1 dose of FIL200, FIL100, or placebo.
Disclosures: This study was funded by Gilead Sciences, Inc. Some investigators including the lead author reported receiving grants, honoraria, consultancy/speaker’s fees, and being an employee of or shareholder of various sources including Gilead Sciences .
Source: Winthrop KL et al. Ann Rheum Dis. 2021 Nov 5. doi: 10.1136/annrheumdis-2021-221051 .