Five year data of Lemtrada (alemtuzumab) in CARE-MS 1 and CARE-MS 2 studies in MS- Sanofi

Sanofi and its subsidiary Genzyme announced positive new five-year investigational data from the extension study of Lemtrada (alemtuzumab) for patients with relapsing remitting multiple sclerosis (RRMS). These results will be presented on 9 October 2015 at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

In RRMS patients treated with alemtuzumab in the Phase III pivotal studies, the effects described below observed in the two-year trials were maintained through three additional years in the extension study (years 3, 4 and 5). After the initial two courses of treatment in the pivotal studies, which were given at month 0 and at month 12, 68% of alemtuzumab patients from CARE-MS I and 60% from CARE-MS II did not receive additional alemtuzumab treatment during the following four years, up to month 60.

The low annualised relapse rates observed in patients who received alemtuzumab in CARE-MS I (0.18) and CARE-MS II (0.27) were maintained from year 3 (0.19 and 0.22) to year 5 (0.15 and 0.18). Up to year 5, 80% and 76% of patients who received alemtuzumab in CARE-MS I and CARE-MS II, respectively, did not experience worsening of disability progression confirmed over 6 months as measured by the Expanded Disability Status Scale (EDSS). Up to year 5, 33% and 43% of patients who had some disability before receiving alemtuzumab in CARE-MS I and CARE-MS II, respectively, had improvement in EDSS score confirmed over at least 6 months as compared with pre-treatment baseline. Up to year 5, patients who received alemtuzumab in CARE-MS I and II experienced a slowing of brain volume loss as measured by brain parenchymal fraction on magnetic resonance imaging (MRI). In years 3, 4 and 5, the median yearly brain volume loss was -0.20% or less, which was lower than that observed during the 2 year pivotal studies. In each of years 3, 4 and 5, most patients had no evidence of MRI disease activity (70–72%, CARE-MS I; 68–70%, CARE-MS II). Up to year 5, the incidence of most adverse events during the extension study was comparable or reduced compared with the pivotal studies. The frequency of thyroid adverse events was highest in year 3 and declined thereafter.

Comment: In the extension of CARE-MS 1 and CARE-MS 2 studies, 68% and 60% respectively of alemtuzumab patients needed no additional infusions in the four prior years – i.e. 'stable remission'. The data may help alemtuzumab move from a third line treatment to a position earlier in the treatment pathway. Some patients needed two short courses of treatment at month 0 and month 12 and then nothing else, which may have cost-saving implications.