Teriflunomide was well tolerated - serious adverse events occurred in 11% of patients in the teriflunomide group and 11% of patients in the placebo group. 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.Īfter 96 weeks, there was no difference in time to first clinical relapse of multiple sclerosis with teriflunomide compared with placebo. 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).
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