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Relapse After First Lemtrada Course No Indication of Poor Long-Term Outcome

June 26, 2017

Researchers from the Missouri Baptist Medical Center’s Multiple Sclerosis Center for Innovations in Care presented their “Durable Efficacy of Alemtuzumab on Clinical and MRI Outcomes over 6 years in CARE-MS II Patients with Active Relapsing-Remitting Multiple Sclerosis with Relapse Between Courses 1 and 2.” According to the team, multiple sclerosis (MS) patients who experienced a relapse between their first and second rounds of Lemtrada (Alemtuzumab) had good treatment outcomes over the long run. Those who relapsed after their first round ended up with annual relapse rates similar to those who didn’t after two years. This suggested that an early relapse did not indicate a poor long-term response to Lemtrada.

The Phase 3 clinical trial consisted of 435 patients who received two doses of Lemtrada. Researchers compared the outcomes to treatment with Rebif. The first course consisted of 12 mg per day for five days and a year later, patients received an additional course for three days. 24% of the 435 patients who received Lemtrada relapsed after the first course. 83% of the patients enrolled in an extension trial, which followed patients for six years from the start of the treatment. In this group, the annual relapse rate was 1.2 relapses in the first year. The relapse rate ended up dropping to 0.5 relapses per year, and continued to drop, reaching 0.2 relapses in the last year of the extension trial. The results proved positive for Lemtrada. 63% of patients reported no six-month worsening of their disability during their sixth year. Brain images also showed that most patients had no new brain lesions and brain volume loss also decreased.

“Outcomes during year 1 of alemtuzumab do not predict longer-term response, as patients who relapsed in year 1 improved markedly over the subsequent five years.” researchers said. “These findings support administering alemtuzumab according to the approved label (two courses) to achieve optimal and durable benefits on clinical/MRI outcomes in the small population of patients experiencing relapse between courses 1 and 2.”