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 alemtuzumab or 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.
“The 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,” 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. “In addition, given the critical importance of neuroprotection in the treatment of MS, the retinal nerve fiber data are also exciting and support further investigation.”
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 in a special session titled “Preserving Brain and Function in Multiple Sclerosis” during the Industry Therapeutics Update portion of the conference today, April 20.