Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile at 52 Weeks in FINCH 1 and 3 Studies in Rheumatoid Arthritis - Seite 2
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) ≤3.2) and clinical remission (DAS28(CRP) <2.6) compared with adalimumab-treated patients at Week 52 (nominal p<0.05). Rates of remission based on CDAI ≤2.8 and Boolean remission criteria were also nominally significantly higher in patients receiving filgotinib 200 mg versus adalimumab at Week 52 (nominal p<0.05). Reductions in Heath Assessment Questionnaire-Disability Index from baseline to Week 52 were greater in patients receiving filgotinib 200 mg versus those receiving adalimumab (nominal p<0.05). Response rates were numerically similar between patients treated with filgotinib 100 mg versus adalimumab for these endpoints.
Filgotinib 200 mg and 100 mg demonstrated a consistent safety profile in this study of MTX-IR patients, and no new safety signals were detected through Week 52. There were five deaths, reported prior to Week 24; two patients were in the placebo group, two were in the filgotinib 200 mg group and one was in the filgotinib 100 mg group. Four deaths were reported between Weeks 24 and 52; two treated with filgotinib 200 mg, one in the adalimumab group, and one in the placebo group. Adverse events of interest including serious infections, herpes zoster, venous thromboembolism (VTE) and major adverse cardiovascular events (MACE) were infrequent and balanced across treatment groups. Herpes zoster was observed in all treatment groups, with a numeric increase in the filgotinib 200 mg group compared with the filgotinib 100 mg group.
FINCH 3 - Week 52 Data from Phase 3 Study in Methotrexate-Naïve Patients (Poster #0158)2
The FINCH 3 program evaluated filgotinib in patients naïve to methotrexate. Patients were randomized to receive filgotinib 200 mg plus methotrexate (n=416), filgotinib 100 mg plus methotrexate (n=207), filgotinib 200 mg monotherapy (n=210) and methotrexate monotherapy (n=416). 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 (p<0.001).