Filgotinib Bests Placebo in Tx of Refractory Rheumatoid Arthritis
TUESDAY, July 23, 2019 -- Among patients with moderately to severely active rheumatoid arthritis (RA) resistant to previous therapy with biologic agents, a significantly higher clinical response rate was seen at 12 weeks for those receiving filgotinib versus placebo, according to a study published in the July 23/30 issue of the Journal of the American Medical Association.
Mark C. Genovese, M.D., from Stanford University in California, and colleagues evaluated the effects of filgotinib versus placebo in a 24-week, phase 3 trial conducted from July 2016 to June 2018 at 114 sites internationally. Researchers randomly assigned 449 adult patients (80.4 percent women) with moderately to severely active RA and inadequate response or intolerance to at least one previous biologic disease-modifying antirheumatic drug (bDMARD) to a once-daily dose of filgotinib 200 mg (148 patients), filgotinib 100 mg (153 patients), or placebo (148 patients).
The researchers found that at week 12, more patients receiving filgotinib 200 mg (66 percent) and 100 mg (57.5 percent) achieved 20 percent improvement in American College of Rheumatology criteria versus placebo (31.1 percent; difference versus placebo, 34.9 and 26.4 percent, respectively). This finding was also observed among patients with previous exposure to at least three bDMARDs (70.3, 58.8, and 17.6 percent, respectively; difference versus placebo, 52.6 percent for filgotinib 200 mg and 41.2 percent for filgotinib 100 mg). The investigators found the most common adverse events to be nasopharyngitis (10.2 percent) for filgotinib 200 mg; headache, nasopharyngitis, and upper respiratory infection (5.9 percent each) for filgotinib 100 mg; and RA (6.1 percent) for placebo. Among patients on filgotinib, four uncomplicated herpes zoster cases and one retinal vein occlusion were reported, but there were no opportunistic infections, active tuberculosis, malignancies, gastrointestinal perforations, or deaths.
"Further research is needed to assess longer-term efficacy and safety," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Gilead Sciences, which manufactures filgotinib and funded the study.
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Posted: July 2019