In TERIKIDS, 109 children were randomized to receive teriflunomide and 57 were randomized to receive placebo for up to 96 weeks.
Open-label extension phase entry was possible before the end of the double-blind period for patients who experienced a relapse or demonstrated high disease activity on MRI imaging tests.
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More patients in the placebo group entered the open-label extension phase than anticipated, with 26% of patients switching from placebo to teriflunomide before 96 weeks.
After 96 weeks, there was no difference in time to first clinical relapse of multiple sclerosis with teriflunomide compared with placebo.
Teriflunomide was well tolerated—serious adverse events occurred in 11% of patients in the teriflunomide group and 11% of patients in the placebo group.
Nasal inflammation, upper-respiratory-tract infection, hair loss, tingling sensations, abdominal pain, and increased blood creatine phosphokinase were more commonly found with teriflunomide than with placebo.
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“The trial did not meet its primary endpoint—delaying time to the next clinical relapse—possibly because of more frequent switches to the open-label arm due to high MRI activity.
The study did meet several key secondary endpoints related to teriflunomide’s ability to reduce the number of new or enlarged lesions that are detected through MRI, suggesting that the medication might have beneficial effects in children with relapsing forms of multiple sclerosis,” says lead author Tanuja Chitnis, MD, director of the MGB Pediatric Multiple Sclerosis Center at MGH.
Chitnis notes that an ongoing open-label treatment extension study is continuing to evaluate the long-term effects of teriflunomide in young patients.
Source: Medindia
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