Study: Filgotinib Effectively Treats Moderate to Severe Crohn Disease
A recent clinical trial found that filgotinib significantly increased the rate of remission in patients with active moderate-to-severe Crohn disease compared with placebo, and was associated with few adverse effects.
Researchers performed a randomized, double-blind, placebo-controlled study including 174 patients with active Crohn disease from 52 centers in 9 European countries. Filgonitib 200 mg was prescribed to 130 patients and placebo was prescribed to 44 patients. Patients took either placebo or filgotinib once day for 10 weeks. Anti-tumor necrosis factor alpha exposure, C-reactive protein concentration, and oral corticosteroid use before the start of the trial were used to stratify patients, and the primary endpoint was clinical remission at 10 weeks, defined as CDAI less than 150.
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In addition, another 10-week observational period was conducted, and patients were assigned 100 mg of filgotinib once a day, filogtinib 200 mg once a day, or placebo according to their responder status.
ANCOVA models and logistic regression models with baseline values and randomization stratification as fix effects were used to compare the placebo and filogtinib groups.
Overall, 60 of the 128 patients that took 200 mg of filgotinib achieved clinical remission at week 10 (47%), and only 10 patients of the 44 taking the placebo achieved clinical remission (23%).
Over the 20-week period, serious treatment-emergent adverse effects were reported in 14 of the 152 participants treated with filgotinib (9%) and in 3 out of 67 patients in the placebo group (4%).
“Filgotinib induced clinical remission in significantly more patients with active [Crohn] disease compared with placebo, and had an acceptable safety profile,” the researchers concluded.
—Melissa Weiss
Reference:
Vermeire S, Schreiber S, Petryka R, et al. Clinical remission in patients with moderate-to-severe Crohn’s disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial [published online December 14, 2016]. The Lancet. doi:10.1016/S0140-6736(16)32537-5.