#ACTRIMS2018 – Third Course of Lemtrada Improves Relapse, Disability in MS Patients, CARE-MS II Trial Shows

Multiple sclerosis (MS) patients who experience a relapse after two courses of Lemtrada (alemtuzumab) treatment showed improvements in relapse rate and disability after a third Lemtrada course, according to results of the CARE-MS II trial extension.

The poster reporting the findings, titled “Efficacy of Alemtuzumab Retreatment in Patients Who Experienced Disease Activity after the Initial Two Courses: Results from the CARE-MS II Extension,” was presented at the third annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018, held in San Diego, California.

In the CARE-MS II trial (NCT00548405), patients with active relapsing-remitting MS who failed to respond adequately to prior therapy showed significantly greater improvements on clinical and magnetic resonance imaging (MRI) outcomes when treated with Lemtrada compared to Rebif (interferon beta-1a) over a two-year period.

In the trial, Lemtrada, marketed by Sanofi Genzyme, was administered as two courses of 12 mg/day for five days and 12 months later for three days.

In an extension trial (NCT0090553) for three more years, Lemtrada-treated patients who relapsed after the two short courses in the initial two-year period of CARE-MS II could undergo another Lemtrada course or receive another disease-modifying therapy. Most of the patients in the trial, however, didn’t require additional treatment and continued to show sustained improvements in the follow-up period.

Now, researchers reported the outcomes of patients who needed re-treatment with Lemtrada due to disease relapse or MRI activity during the extension trial.

Specifically, the team analyzed patients treated with at least one additional Lemtrada course and compared Lemtrada’s efficacy outcomes one year before and one year after the third (or more) treatment course.

Researchers analyzed several parameters to assess efficacy, including the annualized relapse rate, improvement or stability in the Expanded Disability Status Scale (EDSS) score compared to the score at baseline, and six-month confirmed disability improvement.

Patients treated with another type of disease-modifying therapy rather than Lemtrada were excluded from the analysis.

A total of 88 percent of the patients who enrolled in the CARE-MS II study (344 patients out of 393) joined the extension study and remained until the study’s completion in the sixth year. Forty-five percent (178 out of 393 patients) received at least one additional course of Lemtrada and no other disease-modifying therapy.

Comparing the annualized relapse rate in these patients one year before and after the third course of Lemtrada, researchers saw a significant decrease following treatment, from 0.85 to 0.20, respectively. Moreover, this low rate remained stable for up to three more years (around 0.27), and 68 percent of the patients either maintained or improved their disability scores after Lemtrada’s third course.

Also, Lemtrada’s third treatment course led to a higher percentage of patients with improvements in six-month confirmed disability measured after one year of administration compared to one year before, at 14.4 percent versus 4.4 percent, respectively.

Overall, “these data support that in the CARE MS II extension, patients who experienced MRI activity or relapse after Course 2 benefitted from retreatment with a third alemtuzumab course, which can reduce relapses and improve disability,” the team concluded.