News Sanofi Genzyme Presenting New Data on Lemtrada’s Beneficial Effects, Drawn from RRMS Extension Study, at AAN 2016 Sanofi Genzyme Presenting New Data on Lemtrada’s Beneficial Effects, Drawn from RRMS Extension Study, at AAN 2016 by Margarida Azevedo, MSc | April 20, 2016 Share this article: Share article via email Copy article link Sanofi GenzymeĀ is presenting promising data regarding brain volume and retinal nerve fibers in multiple sclerosis (MS) patients ā drawn from an ongoing extension study intoĀ the disease-modifying drugĀ alemtuzumab (Lemtrada) ā at the 2016 American Academy of Neurology (AAN) Annual Meeting Ā taking place in Vancouver, Canada, through April 21. The data isĀ derivedĀ from an extension study (NCT00930553)Ā thatĀ enrolled relapsing-remitting multiple sclerosis (RRMS) patients, previously treated with either alemtuzumab or the comparison agent, interferon beta-1a (Rebif), in the CARE-MS I Phase 3 clinical trialĀ (NCT00530348) and the CARE-MS II Phase 3 trial (NCT00548405). Findings indicated that trial participants whoĀ had received interferon beta-1a andĀ switched to Lemtrada in the extension study experienced a reduced rate of brain volume loss over itsĀ 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,Ā 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 previouslyĀ shownĀ 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. Ā 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 useĀ be reserved for patients who have had an inadequate response to two or more MS drugs. āThe Lemtrada data being presented at AAN from the ongoing extension study demonstrating slowed brain volume loss over three years are consistent with sustained effects seen in prior clinical, imaging and atrophy analyses,āĀ Dr. Anthony Traboulsee, associate professor of Neurology and medical director of the UBC Hospital MS Clinic of Vancouver Coastal Health, said in a Sanofi Genzyme news release. āIn addition, given the critical importance of neuroprotection in the treatment of MS, the retinal nerve fiber data are also exciting and support further investigation.ā Sanofi is discussing the trials and their findings in a number of poster presentations and discussions at the AAN, which opened on April 15, and inĀ a special session titled “Preserving Brain and Function in Multiple Sclerosis” during the Industry Therapeutics Update portion of the conference today, April 20. Print This Page About the Author Margarida Azevedo, MSc Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior TĆ©cnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies. Tags AAN 2016, alemtuzumab, brain volume loss, CARE-MS, Lemtrada, Sanofi Genzyme
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