FINCH 3 Results: Filgotinib with Methotrexate Outperforms Methotrexate Alone

Data from the FINCH 3 study of filgotinib in patients with rheumatoid arthritis showed that combination therapy with methotrexate led to significant improvements over methotrexate monotherapy. Study participants were all naïve to methotrexate therapy.

The study results through week 24 were presented at the European Congress of Rheumatology (EULAR 2019) in Madrid, Spain, by Rene Westhovens, MD, PhD, University Hospitals, Leuven, Belgium.

“These data reinforce our belief that filgotinib has the potential to make a meaningful difference for patients with rheumatoid arthritis, both early and also late in the course of treatment when other treatments have failed,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences, in a release.

The double-blind, active-controlled study randomized 1252 patients, included 1249 patients who received the assigned drug, and 1130 patients who completed week 24 of the 52-week study. Participants had moderately to severely active rheumatoid arthritis and were naïve to treatment with methotrexate.

Participants were randomized 2:1:1:2 to 1 of 4 groups: filgotinib 200mg + methotrexate (n = 416), filgotinib 100mg + methotrexate (n = 207), filgotinib 200mg (+placebo; n = 210), or methotrexate (+placebo; n = 416). Most of the participants were female (76.9%). The mean time since diagnosis with rheumatoid arthritis was 2.2 years and the median was 0.4 years.

The primary endpoint was the proportion of participants who achieved an American College of Rheumatology 20% disease activity reduction (ACR20) at week 24.

Meeting the primary endpoint, significantly more patients receiving filgotinib 200 mg plus methotrexate (81.0%; P <.001) and filgotinib 100 mg plus methotrexate (80.2%; P <.05) reached ACR20 than patients receiving methotrexate monotherapy (71.4%).

Patients in the filgotinib 200 mg and filgotinib 100 mg combination groups were also significantly more likely to achieve ACR50 (61.5%, P <.001; 57.0%, P <.01, respectively) and ACR70 (43.8%, P <.001; 40.1%, P <.001) than those in the methotrexate monotherapy group (ACR50, 45.7%; ACR70, 26.0%).

The Disease Activity Score, based on C-reative protein in 28 joints, was <2.6 in 54.1% and 42.5% of patients in the filgotinib 200 mg and 100 mg combination groups, respectively, compared to 29.1% of those in the methotrexate monotherapy group (P <.001 for both comparisons).

The safety profile was comparable to previous studies. Serious adverse events and serious infections occurred in the filgotinib 200mg + methotrexate (4.1%; 1.0%, respectively), filgotinib 100mg + methotrexate (2.4%; 1.0%), filgotinib 200mg (4.8%; 1.4%), and methotrexate (2.9%; 1.0%) groups. One death occurred during the study in the filgotinib 200 mg plus methotrexate group, which was due to lupus myocardiopathy.

The abstract, “Efficacy And Safety Of Filgotinib For Patients With Rheumatoid Arthritis Naïve To Methotrexate Therapy: Finch 3 Primary Outcome Results,” was presented on Saturday June 15 at EULAR 2019.