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Pivotal Phase III Data Published on Lemtrada (Alemtuzumab) in Multiple Sclerosis

Drug was more effective than Rebif in reducing relapse rates (Nov. 1)

Results from the CARE-MS I and CARE-MS II pivotal studies of Lemtrada (alemtuzumab, Sanofi/Genzyme) in patients with relapsing-remitting multiple sclerosis (MS) have been published in the November 1 online issue of The Lancet.

In both trials, Lemtrada was significantly more effective at reducing annualized relapse rates than was the active comparator, Rebif (high-dose subcutaneous interferon beta-1a, EMD Serono/Pfizer), and more patients treated with Lemtrada were relapse-free at 2 years. In addition, in CARE-MS II, the accumulation of disability was significantly slowed in patients given Lemtrada versus those given Rebif. Further, patients treated with Lemtrada were significantly more likely to experience improvement in disability scores than were those treated with Rebif, suggesting a reversal of disability in some patients.

CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis) are randomized phase III studies comparing the investigational treatment alemtuzumab with a standard-of-care MS treatment, Rebif, in patients with relapsing-remitting MS who were naïve to prior treatment or who had relapsed while on prior therapy, respectively.

In both studies, Lemtrada was significantly superior to Rebif in reducing relapses. In CARE-MS I, 78% of patients treated with Lemtrada remained relapse-free for 2 years, compared with 59% of the Rebif group (P < 0.0001). In the CARE-MS II trial, 65% of patients treated with Lemtrada were relapse-free at 2 years, compared with 47% of those given Rebif (P < 0.0001). In addition, in CARE-MS II, Lemtrada reduced relapse rate to a greater extent than did Rebif in all subgroups defined by previous therapy, including those with or without interferon therapy, and those previously treated with Rebif or Copaxone (glatiramer acetate injection, Teva Pharmaceuticals).

Data from the CARES II study also showed that Lemtrada reduced the risk of sustained accumulation of disability by 42% compared with Rebif (P = 0.008). The mean disability score for patients treated with Lemtrada decreased over a 2-year period, indicating an improvement in their physical disability, while the mean score for patients given Rebif increased, indicating a worsening of disability (P < 0.0001).

Source: Sanofi, October 31, 2012.

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