Filgotinib Trial Shows Efficacy for Ankylosing Spondylitis

The oral therapy filgotinib could be a more effective treatment for patients with active ankylosing spondylitis who fail treatment with NSAIDs, according to the results of a study presented at the Clinical Congress of Rheumatology West in San Diego last month.

The study, which was also published Dec. 1, 2018 in the Lancet, included 116 patients with ankylosing spondylitis who all had an inadequate response or intolerance to two or more NSAIDs. Led by Desiree van deer Heijde, M.D., Ph.D., of Leiden University Medical Center, Netherlands, researchers conducted a 12-week, randomized, placebo-controlled, double-blind trial that compared a 200 mg dose of filgotinib treatment in 55 patients to 52 who received the placebo.

"Filgotinib is efficacious and safe for the treatment of patients with active ankylosing spondylitis who have not responded to first-line pharmacological therapy with NSAIDs. Further investigation of filgotinib for ankylosing spondylitis is warranted," the authors wrote in the Lancet.

The primary endpoint was the change from baseline in ankylosing spondylitis disease activity score (ASDAS) at week 12. The mean ASDAS change from baseline to week 12 was -1·47 (SD 1·04) in the filgotinib group and -0·57 (0·82) in the placebo group, with a least squares mean difference between groups of -0·85 (95% CI -1·17 to -0·53; p<0·0001).

REFERENCE

Van der Heijde D, Baraliakos X, Gensler LS, et. al., Efficacy and safety of filgotinib, a selective Janus Kinase 1-inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomized, placebo-controlled, phase 2 trial, Lancet (2018). doi: 10.10.16/S01240-6736(18)32463.2.