Lemtrada’s maker, Sanofi-Genzyme, said the study covered the two-year CARE-MS II Phase 3 clinical trial (NCT00548405) and a long-term extension (NCT00930553) trial of people with relapsing-remitting MS.
In addition to demonstrating Lemtrada’s effectiveness, the study showed that it was safe, researchers said.
Their article, “Alemtuzumab CARE-MS II 5-year follow-up, Efficacy and safety findings,” was published in the journal Neurology.
The Phase 3 trial participants had had an active disease, with at least two relapses in the two years before the study and an inadequate response to earlier treatment. The trial compared Lemtrada’s effectiveness with that of Rebif (interferon beta-1a).
The Lemtrada group received 12-mg doses for five consecutive days at the start of the study and three consecutive days a year later.
Ninety-three percent of the 435 patients who completed the trial enrolled in the extension, which followed patients for another three years.
Remarkably, 60 percent of patients required no additional treatment after the two years of the Phase 3 study.
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