According to six-year results from the CARE-MS II extension study, patients with active relapsing remitting multiple sclerosis (RRMS) who have taken Lemtrada (alemtuzumab) for two years continue to show improvement, less functional disability across a number of clinical measures and often without the need for continuous treatment.
The CARE-MS II study recruited patients with active RRMS who had failed to respond to prior therapy.
Patients were given Lemtrada at random, which was given as two annual courses of 12 mg per day for five days and then again 12 months later for three days. The outcomes of the group who received Lemtrada were compared to another group who received randomised treatment with Rebif (interferon beta-1a).
During that two year period results showed that patients treated with Lemtrada had significantly better clinical and MRI outcomes measures compared to Rebif. A significantly higher percentage of these patients achieved six-month confirmed improvement in disability scores.
Patients who completed this part of the trial were invited to take part in an open-label extension trial, which offered Lemtrada treatment for up to six years. Of those patients who decided to carry on with treatment and take part in the extension, 78% remained for the full six years. These patients could undergo further Lemtrada course, or receive another disease modifying therapy, but 50% required no further treatments with either option during those six years.
Results showed stable functional scores in the majority of the overall population over the six years. In addition, between 24% and 29% of these patients achieved a 1.0-point or greater improvement in their Expanded Disability Status Scale (EDSS) and functional system scores compared to their scores at the beginning of the study.
During the two-year CARE-MS II study, patients treated with Lemtrada were found to be more than twice as likely to achieve six-month confirmed disability improvement.
Now, this extension study has shown that the percentage of Lemtrada-treated patients achieving this continued to improve — from 30% at year two to 43% at year six. Patients made improvements across the seven functional systems analysed, with 71% with six-month confirmed disability improvement also showing better results in more than one of the functional parameters.
Dr Samuel Hunter from the Advanced Neurosciences Institute, Franklin, USA concluded: “Alemtuzumab stabilised, or improved all functional systems of the EDSS over 6 years in patients with RRMS who had an inadequate response to prior therapy.
“Improvement in multiple aspects of disability indicates a broad therapeutic effect with alemtuzumab in the absence of continuous treatment.”