Treatment with Sanofi Genzyme’s Lemtrada (alemtuzumab) for up to two years lowers the levels of serum neurofilament light chain (sNfL), a proposed biomarker of nerve damage, in relapsing-remitting multiple sclerosis (RRMS) patients to levels comparable to those seen in healthy people, data from the CARE-MS I study shows.
These results were shared in the presentation “Alemtuzumab Treatment Reduces Serum Neurofilament to Levels Comparable With Healthy Controls More Effectively Than SC IFNb-1a: CARE-MS I” at the recent 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in Seattle, Washington.
In the CARE-MS I (NCT00530348) trial, RRMS patients with highly active disease, 18 to 53 years old, were randomized to begin treatment with either 12 mg of Lemtrada, infused for three or five consecutive days in two annual courses, or with subcutaneous (under-the-skin) injections of Rebif given three times weekly for two years. The safety and efficacy of the two treatments were compared at the study’s end in 2011.
Data showed that Lemtrada reduced disease activity over two years significantly more than did Rebif.
Now researchers assessed the effects of Lemtrada against Rebif based on blood levels of sNfL, a proposed biomarker of nerve cell damage and disease activity, in CARE-MS I trial participants.
Their sNfL levels were compared to those of healthy controls, after being adjusted for participants’ age.
Results showed that the median levels of sNfL in healthy controls ranged from 12.0 pg/mL at 18 years old to 27.1 pg/mL at age 53.
At the beginning of the trial, the median sNfL levels were similar between both groups of RRMS patients, those who received Lemtrada (31.7 pg/mL) and Rebif (31.4 pg/mL).
Median sNfL levels at the trial’s start were similar between both groups of RRMS patients, those given Lemtrada (31.7 pg/mL) and those given Rebif (31.4 pg/mL).
After six months of treatment, however, sNfL levels were significantly lower in the Lemtrada-treated group compared to Rebif — 17.2 pg/mL vs. 21.4 pg/mL, respectively. This difference remained significant through to two years of treatment, with Lemtrada-treated patients (354 people) showing lower sNfL levels (13.2 pg/mL) compared to the Rebif group (18.7 pg/mL; 157 people).
At each six-month analysis of CARE-MS I participants, taken up to two years post-treatment, the number of patients with sNfL levels higher than those of age-matched healthy controls was significantly higher in the Rebif group than in the Lemtrada group — 65% and 46%a at six months and 53% and 28% at two years, respectively.
The odds of having sNfL at levels comparable or lower than healthy controls was also significantly higher in Lemtrada-treated patients compared to the Rebif group: more than doubled at month six and maintained at month 24.
These results suggest that Lemtrada is better than Rebif “in reducing sNfL levels in treatment-naive early RRMS patients to levels comparable with healthy controls,” the researchers wrote.
“Clinical implications of this finding are yet to be further elucidated,” they added.
This work into sNfL levels in CARE-MS I patients was supported by Sanofi Genzyme and Bayer HealthCare Pharmaceuticals.
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