Teriflunomide may temper lesion growth in children with multiple sclerosis: Lancet
There are few treatment options for children with multiple sclerosis -- a condition in which the immune system attacks the protective covering of nerves in the brain and spinal cord -- and most therapies for the disease have not been tested in children.
An international team of investigators, including researchers at Massachusetts General Hospital (MGH), has conducted a phase 3, randomized, double-blind clinical trial to examine the safety and efficacy of teriflunomide, an oral immunomodulatory drug approved in more than 80 countries for the treatment of adults with relapsing forms of multiple sclerosis. Based on the trial's results, which appear in Lancet Neurology, teriflunomide was recently approved by the European Commission for children aged 10-17 years with a diagnosis of relapsing remitting multiple sclerosis.
In the trial, called TERIKIDS, 109 children were randomized to receive teriflunomide and 57 were randomized to receive placebo for up to 96 weeks (nearly two years). Early entry in an open-label extension phase (where patients were guaranteed to receive teriflunomide) 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.Importantly, more patients in the placebo group entered the open-label extension phase (because of high MRI activity) than anticipated, with 26% of patients switching from placebo to teriflunomide before 96 weeks.
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