No difference seen between teriflunomide and placebo groups for primary end point of time to first confirmed clinical relapse
TUESDAY, Dec. 14, 2021 (HealthDay News) — Teriflunomide did not differ from placebo for time to first confirmed clinical relapse, but it might have some beneficial effects for children with relapsing multiple sclerosis, according to a study published in the December issue of The Lancet Neurology.
Tanuja Chitnis, M.D., from the Massachusetts General Hospital for Children in Boston, and colleagues conducted a phase 3 trial involving children aged 10 to 17 years diagnosed with relapsing multiple sclerosis. Patients were randomly assigned to oral teriflunomide or matching placebo in a 2:1 ratio (109 and 57 patients, respectively) for up to 96 weeks. Patients with confirmed clinical relapse or high magnetic resonance imaging (MRI) activity were able to enter into a subsequent 96-week open-label extension phase before the end of the double-blind period.
The researchers found that switches to the extension phase due to high MRI activity occurred more frequently than anticipated in the placebo group (26 percent versus 13 percent for the teriflunomide group), reducing the power of the study. After 96 weeks, no difference was seen in time to first confirmed clinical relapse with teriflunomide versus placebo (hazard ratio, 0.66; 95 percent confidence interval, 0.39 to 1.11; P = 0.11). There was a reduction seen in the number of new or enlarged T2 lesions with teriflunomide versus placebo (relative risk, 0.45; 95 percent confidence interval, 0.29 to 0.71; P = 0.00061) and in the number of gadolinium-enhancing lesions (relative risk, 0.25; 95 percent confidence interval, 0.13 to 0.51; P < 0.001).
“The study did meet several key secondary end points related to teriflunomide’s ability to reduce the number of new or enlarged lesions that are detected through MRI,” Chitnis said in a statement.
Several authors disclosed financial ties to biopharmaceutical companies, including Sanofi, which manufactures teriflunomide and funded the study.
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