#CMSC2018 – Gains in Functional Abilities Seen in Lemtrada-treated MS Patients Over Six Years, CARE-MS II Extension Study Shows

Patients with active relapsing-remitting multiple sclerosis (MS) continue to show improvement — lesser functional disability across a variety of measures — and often without the need for continuous treatment after taking Lemtrada for two years, according to six-year results from the CARE-MS II extension study.

These results were shared in a presentation titled “Active RRMS Patients Show Disability Improvements in Each Functional System Following Treatment With Alemtuzumab: Results From the CARE-MS II Extension” delivered by Samuel F. Hunter with the Advanced Neurosciences Institute in Franklin, Tennessee, at the 2018 CMSC Annual Meeting that ran from May 30 to June 2, in Nashville.

The CARE-MS II trial (NCT00548405) recruited patients with active relapsing-remitting MS (RRMS) who had failed to respond adequately to prior therapy.

Patients were randomized to Lemtrada (alemtuzumab), marketed by Sanofi Genzyme, which was administered as two annual courses of 12 mg/day for five days and 12 months later for three days, and their outcomes compared to those patients who randomized to treatment with Rebif (interferon beta-1a).

A previous analysis over a two-year period showed that Lemtrada-treated patients had significantly better outcomes on clinical and magnetic resonance imaging (MRI) measures compared to Rebif. Also, a significantly greater percentage of these patients achieved six-month confirmed improvement in disability scores.

Patients who completed the CARE-MS II trial were allowed to enter an open-label extension trial (NCT0090553) that offered Lemtrada treatment for up to six years. In total, 78 percent (338 patients) of the patients who enrolled in the CARE-MS II study joined the extension study and remained through its sixth year.

They could undergo a further Lemtrada course or receive another disease-modifying therapy; 50% required no additional treatments — Lemtrada or otherwise — throughout the six years, the presentation shows.

At the CMSC meeting, Hunter reported outcomes over this six-year period. He and his team analyzed changes in Expanded Disability Status Scale (EDSS) scores and the individual functional system scores of EDSS. These functional systems measure different aspects of disability, i.e., impairments in bowel/bladder, brainstem, cerebellar, cerebral, pyramidal, sensory, and visual functioning.

Researchers analyzed these score changes in two groups — the overall patient population, and a subgroup of patients with six-month confirmed disability improvement.

Results showed stable functional scores in the majority of the overall population over the six years. Interestingly, up to one third of these patients (between 24% and 29%) achieved a 1.0-point or greater improvement in their EDSS and functional system scores (1-point or greater score decreases) compared to their scores at the study’s start.

During the two-year CARE-MS II study, patients treated with Lemtrada were seen to be more than twice as likely to achieve six-month confirmed disability improvement.

Now, researchers showed that the percentage of Lemtrada-treated patients achieving this continued to improve — from 30% at year two to 43% at year six. These improvements were seen throughout the seven functional systems analyzed, with 71% of patients with six-month confirmed disability improvement also showing gains in more than one of the functional parameters.

Based on the results, Hunter concluded: “Alemtuzumab [Lemtrada] stabilized or improved all FS [functional systems] of the EDSS over 6 years in patients with RRMS who had an inadequate response to prior therapy.”

Overall, the “improvement in multiple aspects of disability indicates a broad therapeutic effect with alemtuzumab in the absence of continuous treatment,” he added.