The study, “Alemtuzumab improves preexisting disability in active relapsing-remitting MS patients,” published in the journal Neurology, supports the idea that treatment with Lemtrada should be considered earlier in disease management, particularly since its benefits seem likely outnumber its side effects.
“While many MS drugs slow the progress of disability, there have been little data about the ability of treatments to help restore function previously lost due to MS,” Gavin Giovannoni, the study’s first author and a professor at the Blizard Institute, Queen Mary University of London, said in a news release.
“We saw improvements in many of our participants who received alemtuzumab treatment, including their mobility, coordination, bladder function and thinking skills,” he said.
The Phase 3 CARE-MS II trial (NCT00548405) compared Lemtrada and Rebif (interferon beta-1a) in patients who previously had continuing relapses while being treated with other drugs. In total, 426 patients were treated with Lemtrada, and 202 with Rebif. Patients received treatment every three months, and functional tests were performed at the same intervals. Lab tests were done on a monthly basis.
Researchers evaluated patients’ performance in a series of functional tests, comparing abilities at the beginning and end of the study, which ran for two years.
Lemtrada-treated patients were found to be more likely to improve their Expanded Disability Status Scale (EDSS) scores, and at the end of the study, nearly 28 percent had improved by at least one point on the disability scale. The proportion of patients who improved while receiving Rebif, in comparison, was 15 percent.
Those receiving Lemtrada were also 2.5 times more likely to improve their cognitive skills, and had more than two times a greater likelihood of reduced ataxia (lack of voluntary coordination of muscle movements) compared to Rebif-treated patients.
Giovannoni, however, underscored that the treatment was only able to reverse disability in patients who were in a relatively early stage in the disease course. Other studies are needed to determine if the same is true for people in more advanced MS stages.
“These benefits have to be weighed against the drug’s risks, which include serious, and rarely, life-threatening, autoimmune problems, as well as infusion reactions and infections,” Giovannoni said.
Lemtrada was approved as a disease-modifying therapy for relapsing MS patients by the U.S. Food and Drug Administration in November 2014. Because of its potential side effects, however, the FDA recommended that its use “should generally be reserved for people who have had an inadequate response to two or more MS therapies,” according to a release by Sanofi Genzyme, the drug’s manufacturer.