Long-term Lemtrada Treatment Benefits Demonstrated in Extension Study

A five-year study demonstrated that Sanofi-Genzyme’s Lemtrada (alemtuzumab) provides long-term benefits for relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease.

Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions.

The study, “Alemtuzumab CARE-MS I 5-year follow-up,” looked at data from the CARE-MS I Phase 3 clinical trial (NCT00530348) and its extension (NCT00930553), which followed patients for up to five years.

The vast majority, 95.1 percent, of the 367 patients treated in the initial study continued in the extension trial, with 96 percent of these remaining for its entire length of five years. The results were published in the journal Neurology.

The Phase 3 Lemtrada treatment consisted of 12 mg for five consecutive days at the start of the study and three consecutive days a year later. Researchers said 68.5 percent of the patients did not require further treatment in the extension study.

Among those who needed additional treatment, 70 percent had one additional treatment course, and about one-fourth had two. Only 4.5 percent required three additional courses.

Annualized relapse rates were low. They were 0.18 in the first two years, and ranged from 0.19 to 0.14 in the next three.

Disability levels, measured by the Expanded Disability Status Scale (EDSS), remained stable over the five years in 60 percent of patients. In addition, 22.2 percent showed scores that improved one or more points. A similarly large worsening was seen in 17.8 percent, however.

Over five years, nearly 80 percent were free from six-month confirmed disability worsening, and about one-third had six-month confirmed disability improvement.

Most patients showed no disease signs over years 3–5. During this time frame, about 60 percent achieved NEDA, or No Evidence of Disease Activity. The composite measure takes into account relapses, MRI activity, and disability progression.

Patients’ brain volume loss appeared to slow down in the first two years and stabilized over the three remaining years of the study.

The report also showed that the vast majority of adverse events were either mild or moderate. No patient in the extension study quit early because of adverse effects.

There were fewer Infusion-associated reactions in the extension study than in the first study, and none of them was severe. In most patients who had a reaction, it was headache, fever, or a rash.

Infections did not become more common with accumulating Lemtrada doses. The ones that patients developed the most were colds or urinary tract infections. Five developed shingles.

Autoimmune reactions most commonly targeted the thyroid, with 40.7 percent of cases over the five years, most of which were moderate in severity.

Six patients developed cancer, amounting to 0.3 per 100 patient years. Two occurred in the CARE-MS I study and four in the extension, with no particular cancer form overrepresented.

The data demonstrated that Lemtrada remained effective over the five years, and had an acceptable safety profile.