Gilead Sciences (NASDAQ:GILD) and collaboration partner Galapagos NV (NASDAQ:GLPG) announce week 52 results from two Phase 3 clinical trials, FINCH 1 and FINCH 3,
evaluating JAK1 inhibitor filgotinib in adults with moderately to
severely active rheumatoid arthritis (RA). The data are being virtually
presented at EULAR.
80.7% (n=1,417/1,755) of participants in FINCH 1
completed 52 weeks of treatment. Both doses of filgotinib showed
sustained efficacy in primary and secondary outcome measures. A greater
proportion of patients in the 200 mg filgotinib arm achieved low disease
activity and clinical remission compared to patients receiving
adalimumab [AbbVie’s (NYSE:ABBV) Humira].
78.1% (n=975/1,249) of patients in FINCH 3
completed 52 weeks of treatment. All showed sustained efficacy through
week 52 based on clinical response, physical function and radiographic
progression. Higher proportions of patients in the filgotinib 200 mg +
methotrexate, 100 mg + methotrexate and filgotinib 200 mg monotherapy
arms achieved ACR20 (20% improvement in RA symptoms), ACR50, ACR70 and
disease remission compared to methotrexate alone. Patients receiving
filgotinib showed less progression of structural damage compared to
methotrexate monotherapy.
No new safety signals were observed in either study.
Marketing applications have been filed in the U.S., Europe and Japan for the indication.
https://seekingalpha.com/news/3580332-gilead-and-galapagos-filgotinib-shows-sustained-benefit-in-ra-studies
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