Phase III FINCH clinical trial of filgotinib

Clinical Trial Phase III FINCH is investigating the efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no exposure to methotrexate (MTX). This 52-week, phase 3, multicenter, double-blind clinical trial evaluated once-daily oral filgotinib in 1,252 patients with rheumatoid arthritis, randomized 2:1:1:2 to receive filgotinib 200 mg versus methotrexate (FIL20 0+MTX), filgotinib100mg with methotrexate (FIL100+MTX), filgotinib200mg monotherapy (FIL200) or methotrexate. The primary endpoint was the proportion achieving 20% u200bu200bimprovement in American College of Rheumatology criteria (ACR20) at week 24.

81% of patients who receivedFIL200+ MTX met the primary endpoint, compared with 71% of patients who received MTX (p<0.001). At week 24, a significantly greater proportion of patients treated with FIL100 + MTX achieved an ACR20 response (80%, p=0.017) compared with MTX. Health Assessment Questionnaire-Disability Index showed significant improvement at week 24; least squares mean changes from baseline were -1.0 and -0.94 for FIL200+MTX and -0.94 for FIL100+MTX and -0.81 for MTX (p<0.001, p=0.008, respectively). At week 24, significantly more patients received FIL200+MTX (54%) and FIL100+MTX (43%) than MTX (29%) ((both p<0.001). Stratified testing was stopped at week 24 (p=0.058) to compare ACR ofFIL200 monotherapy Adverse event rates at week 52 were comparable across all treatment groups: 20 (78%) and MTX (71%).

The study results show that taking filgotinib 200 mg with methotrexate and filgotinib 100 mg with methotrexate can significantly improve the signs and symptoms and physical function of patients with active rheumatoid arthritis with limited or no history of methotrexate exposure; compared with methotrexate, filgotinib 200 mg monotherapy did not have a higher ACR20 response rate. Compared with methotrexate, filgotinib was well tolerated and had an acceptable safety profile.

The original drug filgotinib has not yet been launched in China, and therefore is not included in medical insurance. Specifications of Bangladeshi version of filgotinitine generic currently marketed overseas100mg*30 tablets The price of each box may be more than 500 yuan (the price may fluctuate due to the exchange rate), and its drug ingredients are basically the same as those of the original drug. For more drug information and specific prices, please consult Yaode Medical Consultant.