Genzyme's Lemtrada Reports Positive Results After 4 Years

The second year of the extension study of Lemtrada (alemtuzumab) for multiple sclerosis (MS) reported positive interim results, according to a data released on September 11 by Genzyme at the 2014 ACTRIMS-ECTRIMS Joint Meeting in Boston, Massachusetts.

Relapse rates and sustained accumulation of disability remained low during years 3 and 4 among patients who previously received Lemtrada in the Phase III CARE-MS I and CARE-MS II studies.

More than 90% of the patients treated with Lemtrada in these studies enrolled in the extension study, where they were eligible to receive additional treatment if they experienced at least 1 relapse or at least 2 new or enlarging brain or spinal cord lesions.

Approximately 70% of these patients did not receive a third course through the second year of the extension study.

“These extension study results provide further evidence of the prolonged efficacy of Lemtrada on both relapses and disability,” said Alasdair Coles, MD, senior lecturer for the Department of Clinical Neurosciences at the University of Cambridge in the United Kingdom, said in a statement. “The majority of patients continued to experience reduced disease activity even though their last Lemtrada treatment was 3 years earlier.”

Patients in the CARE-MS studies received the drug as 2 annual courses, once at the start of the study and again 12 months later. The trials were randomized, 2-year studies comparing Lemtrada to high-dose interferon beta-1a in patients with relapsing-remitting MS. The patients had active disease and were either new to treatment (CARE-MS I) or had relapsed on prior therapy (CARE-MS II).

In the second year of the extension study — 4 years after initial treatment — the annualized relapse rates were 0.14 and 0.23 for patients receiving Lemtrada in CARE-MS I and CARE-MS II, respectively. Approximately three-quarters (74%) of patients in CARE-MS I and two-thirds of patients (66%) of patients in CARE-MS II showed improved or stable disability as measured by the Expanded Disability Status Scale.

Lastly, more than three-quarters of patients in both trials who received Lemtrada did not experience a worsening of their disability that persisted for 6 continuous months during the 4 years of observation.

No new risks were identified, though there were 2 deaths previously reported during the extension study: one from sepsis and the second from a presumed accident deemed unrelated to the study.

Approximately 2% of patients developed immune thrombocytopenia during the 4 years, but all responded to treatment.

The most common side effects of Lemtrada are infections of the upper respiratory tract and urinary tract, thyroid disorders, and reactions such as headache, rash, nausea, insomnia, dizziness, and flushing.