A five-year study demonstrated that Sanofi-Genzyme’s Lemtrada (alemtuzumab) provides long-term benefits for relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease.
Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions.
The study, “Alemtuzumab CARE-MS I 5-year follow-up,” looked at data from the CARE-MS I Phase 3 clinical trial (NCT00530348) and its extension (NCT00930553), which followed patients for up to five years.
The vast majority, 95.1 percent, of the 367 patients treated in the initial study continued in the extension trial, with 96 percent of these remaining for its entire length of five years. The results were published in the journal Neurology.
The Phase 3 Lemtrada treatment consisted of 12 mg for five consecutive days at the start of the study and three consecutive days a year later. Researchers said 68.5 percent of the patients did not require further treatment in the extension study.
Among those who needed additional treatment, 70 percent had one additional treatment course, and about one-fourth had two. Only 4.5 percent required three additional courses.
Annualized relapse rates were low. They were 0.18 in the first two years, and ranged from 0.19 to 0.14 in the next three.
Disability levels, measured by the Expanded Disability Status Scale (EDSS), remained stable over the five years in 60 percent of patients. In addition, 22.2 percent showed scores that improved one or more points. A similarly large worsening was seen in 17.8 percent, however.
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