Filgotinib improves RA symptoms in patients with inadequate methotrexate response
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Filgotinib improves rheumatoid arthritis signs, symptoms and physician function, and inhibits radiographic progression, all while being well-tolerated in patients with an insufficient response to methotrexate, according to data.
“Advances in RA management have further improved patient outcomes by focusing on treat-to-target strategies, pain and inflammation reduction, and administration convenience, in addition to efficacy and safety,” Bernard Combe, MD, PhD, of CHU Montpellier, at Montpellier University, in France, and colleagues wrote in the Annals of the Rheumatic Diseases.
“Despite this focus, many patients do not achieve long-term responses with currently available therapies; in one study, only 10%-21% of patients initiating [conventional synthetic disease-modifying antirheumatic drugs] and 12% to 24% initiating TNFi therapy achieved remission within 12 months,” they added. “Potential innovations that may further improve patient outcomes in RA include new oral therapies that perform as well as, or better than, existing standard of care (SOC), particularly in patients with intolerance or inadequate response to [biological DMARDS] (bDMARD-IR).”
To assess the efficacy and safety of filgotinib (Gilead Sciences/Galapagos NV), compared with placebo or a TNF inhibitor, in patients with RA and an inadequate response to methotrexate, Combe and colleagues conducted the FINCH 1 trial. This randomized, double-blind, 52-week, placebo- and active-controlled phase 3 study enrolled 1,755 adults with active RA at 303 sites across 30 countries.
Participants were randomized 3:3:2:3 to receive once-daily filgotinib 200mg, once-daily filgotinib 100mg, biweekly subcutaneous adalimumab (Humira, AbbVie) 40mg, or placebo, all through week 24 with stable weekly background methotrexate. The primary endpoint was the proportion of patients who achieved 20% improvement in the ACR20 at week 12. The researchers examined additional efficacy measures sequentially, with safety outcomes assessed from adverse events and laboratory abnormalities.
In all, 87.4% of participants completed the study visits through the 24-week placebo-controlled period.
According to the researchers, 76.6% of participants in the filgotinib 200 mg group, as well as 69.8% of those treated with filgotinib 100 mg, achieved the ACR20 response at week 12, compared with 49.9% with placebo (P < .001). In addition, filgotinib was superior to placebo in key secondary endpoints, including RA signs and symptoms, physical function and structural damage.
The 200 mg dose of filgotinib was non-inferior to adalimumab for Disease Activity Score in 28 joints, with C-reactive protein at 3.2 or less, at week 12 (P < .001). The 100 mg dose failed to achieve non-inferiority in this regard. Adverse events and laboratory abnormalities were comparable among all treatment groups.
“In MTX-IR patients with active RA, filgotinib plus MTX reduced RA signs and symptoms, improved physical function and inhibited progression of structural joint damage,” Combe and colleagues wrote. “This study demonstrated non-inferiority of FIL200 plus MTX, but not FIL100 plus MTX, to adalimumab plus MTX, based on DAS28(CRP) low disease activity. Overall, filgotinib showed a favorable benefit-to-risk profile and both doses were well tolerated.”
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