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Thursday, April 28, 2016

Sanofi Genzyme Presenting New Data on Lemtrada’s Beneficial Effects, Drawn from RRMS Extension Study, at AAN 2016


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Sanofi Genzyme is presenting promising data regarding brain volume and retinal nerve fibers in multiple sclerosis (MS) patients — drawn from an ongoing extension study into the disease-modifying drug alemtuzumab (Lemtrada) — at the 2016 American Academy of Neurology (AAN) Annual Meeting  taking place in Vancouver, Canada, through April 21.
The data is derived from an extension study (NCT00930553) that enrolled relapsing-remitting multiple sclerosis (RRMS) patients, previously treated with either alemtuzumabor the comparison agent, interferon beta-1a (Rebif), in the CARE-MS I Phase 3 clinical trial (NCT00530348) and the CARE-MS II Phase 3 trial (NCT00548405).
Findings indicated that trial participants who had received interferon beta-1a and switched to Lemtrada in the extension study experienced a reduced rate of brain volume loss over its three years of treatment. Previous findings in both CARE-MS studies had shown that median yearly brain volume loss was, in year two, -0.50% for CARE-MS I and -0.33% for CARE-MS II. In the extension study, the median brain volume loss was reduced in year one (CARE-MS I: -0.07%, and CARE-MS II: 0.02%), year two (CARE-MS I: -0.13% and CARE-MS II: -0.05%), and year three (CARE-MS I: -0.09% and CARE-MS II: -0.14%).
Moreover, researchers reported an improvement in retinal nerve fiber layer (RNFL) thickness in 26 Lemtrada-treated RRMS patients. Over the two years of treatment, the change in average RNFL thickness for all eyes was +1.5 micrometers, which might indicate a protection of retinal axons in these patients.
Lemtrada was previously shown to be significantly more effective than interferon beta-1a at reducing annualized relapse rates and slowing accumulation of disability, and is an approved treatment for RRMS.  However, it has been associated with serious side effects in clinical trials, including autoimmune disorders such as thyroid disease and nephropathies, infections and pneumonitis, and the U.S. Food and Drug Administration (FDA) recommends that its use be reserved for patients who have had an inadequate response to two or more MS drugs.

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