Phase III FINCH 1 and FINCH 3 studies of GLPG 0634 show 52-week efficacy in rheumatoid arthritis.- Gilead Sciences/Galapagos

Gilead Sciences and Galapagos announced Week 52 results from the Phase III FINCH 1 and FINCH 3 studies of GLPG 0634 (filgotinib), an investigational, oral, selective JAK1 inhibitor, in adults with moderately to severely active rheumatoid arthritis (RA). The data demonstrate sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib treatment across RA patient populations. As previously reported, the FINCH 1 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 percent 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 percent, 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) below 3.2) and clinical remission (DAS28(CRP) <2.6) compared with adalimumab-treated patients at Week 52.

As previously reported, the filgotinib 200 mg plus methotrexate group met the primary study endpoint evaluating the proportion of patients who achieved ACR20 at Week 24 versus methotrexate monotherapy. The majority of patients in FINCH 3 (78.1 percent, n=975/1,249) received study drug through Week 52. In this analysis, all treatment groups demonstrated sustained efficacy through Week 52 based on clinical response, physical function and radiographic progression. Higher proportions of patients in the filgotinib 200 mg plus methotrexate, 100 mg plus methotrexate and filgotinib 200 mg monotherapy achieved ACR20, ACR50, ACR70 response and disease remission compared with patients receiving methotrexate monotherapy at Week 52. Patients treated with filgotinib 200 mg plus methotrexate or filgotinib monotherapy experienced a significantly greater improvement in physical function (measured by reductions in Heath Assessment Questionnaire-Disability Index from baseline) compared with those receiving methotrexate alone at Week 52. 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.