Therapy Areas: Autoimmune
Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile at 52 Weeks in FINCH 1 and 3 Studies in Rheumatoid Arthritis
5 June 2020 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) and Belgium-based Galapagos NV (NASDAQ: GLPG) have released Week 52 results from the Phase 3 FINCH 1 and FINCH 3 studies of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately to severely active rheumatoid arthritis, the companies said.

The data demonstrate sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib treatment across RA patient populations.

The new data are among 15 abstracts on filgotinib in RA that will be presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.

The FINCH 1 program evaluated filgotinib versus placebo or adalimumab, on a stable background dose of methotrexate in patients with moderately to severely active RA who had prior inadequate response to methotrexate (MTX-IR).

Patients were randomised to receive filgotinib 200 mg once daily (n=475), filgotinib 100 mg once daily (n=480), adalimumab 40 mg bi-weekly (n=325) or matching placebo (n=475).

As previously reported, the filgotinib 200 mg group met the primary study endpoint evaluating the proportion of patients who achieved American College of Rheumatology Criteria of at least a 20% improvement in the number of tender and swollen joints (ACR20) at Week 12 versus placebo.

Filgotinib was superior to placebo in all secondary endpoints pertaining to signs and symptoms of RA, physical function and structural damage.

The majority of patients in FINCH 1 (80.7 %, n=1,417/1,755) completed 52 weeks of treatment with study drug. Both doses of filgotinib showed sustained efficacy in primary and secondary outcome measures at Week 52.

In addition, a greater proportion of patients treated with filgotinib 200 mg achieved low disease activity (DAS28(CRP) ≤3.2) and clinical remission (DAS28(CRP)
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