MS medication can slow down disease progression.
Two short courses of Lemtrada (alemtuzumab) prevented multiple sclerosis from becoming active and progressing for five years, a study reported.
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.
Among the 376 patients who required more treatment, 30 percent had one additional Lemtrada course, 10.4 percent had two, and 1.6 percent had three. A small proportion of patients also received other disease-modifying treatments.
The most common reason for additional treatment was relapse. Nevertheless, Lemtrada reduced annualized relapse rates to only 0.18 of patients by the fifth year. In addition, during the five years, 75 percent of patients experienced no worsening of their disability over six-month cycles. And 49 percent of patients’ disability improved.
Researchers also tracked patients’ scores on the NEDA — or No Evidence of Disease Activity — index. The composite measure takes into account relapses, disease activity detected in MRI scans, and disability progression. In year five, 58 percent of patients achieved NEDA, slightly more than the 53 percent in year three.
Read full article: MS Progression Halted Over Five Years by Lemtrada, Study Reports
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