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The drug is well-tolerated in methotrexate inadequate response patients with rheumatoid arthritis.
Bernard Combe, MD, PhD
Filgotinib 100 mg and 200 mg show sustained efficacy based on clinical and patient-reported outcomes.
The findings were published as part of the European E-Congress of Rheumatology 2020 (EULAR 2020) due to the cancellation of the in-person annual meeting.
Bernard Combe, MD, PhD, from the University of Montpellier, and a team of US and international-based investigators, presented results from the 52-week FINCH 1 study. The study assessed the efficacy and safety of filgotinib in patients with rheumatoid arthritis who had an inadequate response to methotrexate.
In the global, phase 3, double-blind, active- and placebo-controlled study, the investigators randomized patients with inadequate response to methotrexate who had active rheumatoid arthritis on a background of stable methotrexate to oral filgotinib 200 mg or 100 mg once daily, subcutaneous adalimumab 40 mg every 2 weeks, or placebo up to week 52. Patients who received placebo were then rerandomized to either filgotinib 200 mg or 100 mg.
The investigators assessed efficacy from clinical, radiographic, and patient-reported outcomes. They did not adjust week 52 comparisons for multiplicity.
There were a total of 1755 patients treated and 1417 received the study drug through week 52. A majority of the patients were female (81.8%). The mean duration of rheumatoid arthritis was 7.8 years and the baseline mean of Disease Activity Score-28(CRP) was 5.7. Overall, 475 patients were randomized to filgotinib 200 mg once daily, 480 patients received filgotinib 100 mg once daily, 325 patients received adalimumab 40 mg bi-weekly, and 475 patients had a matching placebo.
The team found filgotinib efficacy was sustained through week 52. Of the patients who received filgotinib 200 mg, 100 mg, and adalimumab, 54%, 43%, and 46% had week 52 DAS28(CRP) <2.6 (nominal P for filgotinib 200 vs adalimumab=.024). The safety profile of the drug through week 52 was consistent with week 24 data. The filgotinib 200 mg group met the primary endpoint evaluating the proportion of patients who achieved American College of Rheumatology criteria of at least 20% improvement in the number of tender and swollen joints at week 12 versus placebo.
Adverse events were infrequent and balanced among treatments. Such events included serious adverse events, infection, and serious infection. Herpes zoster occurred in few patients. Some patients (4.7%) discontinued treatment due to adverse events.
Before week 24, there were 5 reported deaths—2 patients in the placebo group, 2 from the filgotinib 200 mg group, and 1 from the filgotinib 100 mg group. Between weeks 24 and 52, there were 4 deaths—2 patients were treated with filgotinib 200 mg, 1 was from the adalimumab group, and 1 was from the placebo arm.
Filgotinib 200 mg and 100 mg both showed sustained efficacy through week 52 based on clinical and patient-reported outcomes and radiographic progression. The drug was well-tolerated in methotrexate inadequate response patients with rheumatoid arthritis, with faster onset and greater efficacy for 200 mg versus 100 mg.
The study, “Efficacy and Safety of Filgotinib For Patients With Rheumatoid Arthritis With Inadequate Response to Methotrexate: FINCH 1 52-Week Results,” was published on the EULAR 2020 website.