Effect of filgotinib vs placebo on clinical response in patients with moderate to severe rheumatoid arthritis refractory to disease-modifying antirheumatic drug therapy: The FINCH 2 randomized clinical trial
JAMA Jul 30, 2019
Genovese MC, et al. - Via a randomized clinical trial of 448 subjects with active rheumatoid arthritis (RA) who had an incomplete response or intolerance to 1 or more biologic disease-modifying antirheumatic drugs, researchers assessed the impacts of filgotinib in comparison with placebo on the signs and symptoms of RA in a treatment-refractory population. At week 12, more subjects who received filgotinib, 200 mg or 100 mg, attained American College of Rheumatology criteria response, including among subjects with previous exposure to 3 or more bDMARDs. Nasopharyngitis for filgotinib, 200 mg, headache, nasopharyngitis, and upper respiratory infection for filgotinib, 100 mg, and RA for placebo were the most prevalent adverse events. With filgotinib, 4 uncomplicated herpes zoster cases and 1 retinal vein occlusion were noted. No opportunistic infections, active tuberculosis, malignancies, gastrointestinal perforations, or deaths were noted. Hence, filgotinib, 100 mg daily or 200 mg daily, vs placebo led to a significantly bigger proportion attaining clinical response at week 12 in subjects with active RA who had an inadequate response or intolerance to 1 or more bDMARDs. Nonetheless, additional research is required to evaluate longer-term efficiency and safety.
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