Study shows Lemtrada (alemtuzumab) slows brain atrophy in MS patients-Bayer/Genzyme/Sanofi

In relapsing remitting multiple sclerosis (RRMS) patients treated with Lemtrada (alemtuzumab), from Bayer Healthcare and Genzyme/Sanofi, in the Phase III pivotal studies, MRI effects observed in the two-year trials were maintained through two additional years in the extension study (years three and four). After the initial two courses of treatment in the pivotal studies, which were given at month zero and at month 12, approximately 70 percent of Lemtrada patients did not receive additional Lemtrada treatment during the following three years, through month 48.

The Phase III trials of Lemtrada were randomized, two-year pivotal studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had an inadequate response to another therapy (CARE-MS II). The rate of brain atrophy, as measured by brain parenchymal fraction (BPF), decreased progressively over four years among Lemtrada patients in CARE-MS I. In CARE-MS I and II, treatment with Lemtrada significantly reduced the risk of developing new lesions compared to interferon beta-1a. Through year four, the adverse event profile of Lemtrada was consistent with that observed during the pivotal studies. Data were presented at the 67th American Academy of Neurology (AAN) Annual Meeting.