MRI Data Indicate Slowing of Brain Atrophy with Lemtrada
The clinical program consisted of randomized, two-year pivotal studies comparing Lemtrada to high-dose Rebif (interferon beta-1a) in patients with relapsing remitting multiple sclerosis (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 decreased progressively over four years among Lemtrada patients in CARE-MS I. Among CARE-MS II Lemtrada patients, the rate of brain atrophy decreased progressively over three years and remained low in year four. In both studies, the median yearly brain volume loss was less than -0.20% in years three and four, which was lower than what was observed during the two-year pivotal studies. In CARE-MS I and II, treatment with Lemtrada significantly reduced the risk of developing new lesions compared to interferon beta-1a. In the extension study, most of the Lemtrada-treated patients from CARE-MS I and II were free of new lesions and MRI activity in years three and four (approximately 70%).
In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
Lemtrada, a monoclonal antibody that targets CD52 is already indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).
For more information call (617) 745-4447 or visit Genzyme.com.