medwireNews: Findings from the phase III FINCH 1 trial suggest that use of the selective Janus kinase (JAK)1 inhibitor filgotinib may be beneficial for patients with rheumatoid arthritis (RA) and a previous inadequate response to methotrexate.
As reported by Bernard Combe (CHU Montpellier, France) at the EULAR 2019 congress in Madrid, Spain, participants were randomly assigned to receive filgotinib at a dose of 200 or 100 mg/day, the active comparator adalimumab at a dose of 40 mg every 2 weeks, or placebo. All treatments were given alongside a stable dose of methotrexate throughout the study, and the majority of patients in all groups (96–98%) were biologic-naïve.
The investigators found that the 475 patients receiving filgotinib 200 mg and the 480 given filgotinib 100 mg were significantly more likely to achieve the primary endpoint of an ACR20 response at week 12 than the 475 patients in the placebo group, at rates of 76.6% and 69.8% versus 49.9%.
Combe reported that that the ACR20 response rate at week 12 was 70.8% for the 325 participants given adalimumab, which was “close to that for 100 mg filgotinib.”
He also pointed out that “the onset of action was quite fast,” with participants in the filgotinib 200 mg and 100 mg groups having significantly higher ACR20 response rates than those given placebo at week 2, and results remained consistent at the 24-week follow-up.
In accordance with these findings, ACR50 and ACR70 response rates were significantly higher among patients treated with filgotinib versus placebo at most of the timepoints studied, and radiographic progression measured by change in mTSS score from baseline to week 24 was significantly lower in the filgotinib 200 mg and 100 mg groups versus the placebo group (0.13 and 0.17 vs 0.38 points, respectively).
Combe reported that 49.7% of patients given filgotinib 200 mg, 38.8% of those given the 100 mg dose, 43.4% of those given adalimumab, and 23.4% of the placebo group achieved low disease activity according to a DAS28-CRP score of 3.2 points or less at 12 weeks, demonstrating noninferior efficacy of the 200 mg dose of filgotinib versus adalimumab.
The presenter said that a similar proportion of patients in the four treatment arms experienced adverse events, with 4.4%, 5.0%, 4.3%, and 4.2% of participants in the filgotinib 200 mg, filgotinib 100 mg, adalimumab, and placebo groups, respectively, experiencing serious treatment-emergent adverse events. The corresponding rates of serious infections were 1.7%, 1.7%, 2.5%, and 0.8%.
He pointed out that “there was no signal for herpes zoster, major adverse cardiovascular events, venous thrombotic events, malignancies, or deaths,” but noted that there was “a slight increase” in rates of neutropenia and lymphopenia among patients treated with filgotinib versus placebo.
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Ann Rheum Dis 2019; 78: 77–78 (abstract)
European Congress of Rheumatology 2019; Madrid, Spain: 12–15 June
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