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 end point 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 (100 mg and 200 mg) 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 100 mg or 200 mg.

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The primary end point 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 200 mg 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 200 mg + 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 100 mg or 200 mg + 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.

For more information visit Gilead.com.

This article originally appeared on MPR