Gilead Sciences and Galapagos NV announced that filgotinib met the primary and major secondary endpoints in the phase 3 ‘FINCH 1’ rheumatoid arthritis, as well as the primary endpoint in the phase 3 ‘FINCH 3’ study in methotrexate (MTX)-naive rheumatoid arthritis patients. Filgotinib is an investigational oral, selective JAK1 inhibitor.
FINCH 1 (N=1759) is an ongoing, randomized, double-blind, placebo- and active-controlled study that is investigating filgotinib (100mg and 200mg) vs adalimumab or placebo, in addition to a stable dose of methotrexate, in adults with moderately-to-severely active rheumatoid arthritis. At week 24, patients in the placebo arm who did not discontinue the study drug were reassigned to either filgotinib 100mg or 200mg.
The primary endpoint was the proportion of patients achieving an American College of Rheumatology 20% response (ACR20) compared to placebo at Week 12. ACR20 response was seen in 69.8% of the filgotinib 100mg group and 76.6% of the filgotinib 200mg group (both P<.001), vs 70.8% of the adalimumab 40mg group and 49.9% of the placebo group.
Also, a greater proportion of filgotinib-treated patients achieved ACR50 and ACR70 responses compared with placebo at week 12 for both doses (P<.001) and a statistically significant reduction in the Health Assessment Questionnaire Disability Index (HAQ-DI) at week 12 was seen with filgotinib vs placebo. Rate of clinical remission (DAS28 [CRP] <2.6) and low disease activity (DAS28 [CRP] ≤3.2) at week 12 were significantly higher for patients in both filgotinib arms vs placebo.
FINCH 3 (N=1252) is an ongoing, randomized, double-blind, and active-controlled study examining filgotinib monotherapy or in combination with MTX, in adults with moderately-to-severely active rheumatoid arthritis who are MTX-naive.
The primary endpoint was the proportion of patients achieving ACR20 response at week 24. ACR20 response was seen in 78.1% of the filgotinib monotherapy group, 80.2% of the filgotinib 100mg + MTX group (P<.05), and 81.0% of the filgotinib 200mg + MTX group (P<.001), compared with 71.4% of the MTX alone group. There was a significantly higher proportion of patients achieving ACR50, ACR70, and clinical remission at week 24 in the filgotinib 100mg or 200mg + MTX groups compared with patients receiving MTX alone. Also, filgotinib was associated with a greater reduction in HAQ-DI vs MTX alone at week 24.
Additional findings from FINCH 1 and 3 will be submitted for presentation at a future scientific conference.
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