FDA-Approved Medications: New Data on Previously Approved Medications: Infused Medications
Company: Sanofi Genzyme
- Intravenous infusion over four hours for two treatment courses:
- First course: 12 mg/day on five consecutive days;
- Second course: At one year, 12 mg/day on three consecutive days;
- Approved in 2014 for relapsing forms of MS
Lemtrada (alemtuzumab) is a monoclonal antibody formulated to slow or prevent the immune system’s destruction of the neuroprotective myelin sheath by killing white blood (immune) cells. The United States’ prescribing information for the medication describes the risk of serious and potentially fatal adverse events with use of the medication, including stroke, autoimmune conditions, infusion reactions, and certain cancers.35
The EMA made the recommendations after its drug-safety monitoring committee received reports of cardiovascular issues – including heart attacks and strokes – as well as immune complications in people with MS taking Lemtrada.36 Because of the potential toxicity associated with Lemtrada, the manufacturer advises using the agent only in “patients who have had an inadequate response to two or more [DMTs].”35
Meanwhile, findings from a recent long-term analysis suggest that people receiving Lemtrada for relapsing-remitting MS may retain function nearly a decade after starting treatment.
Over the course of four years, Lemtrada significantly improved clinical and imaging outcomes in the CARE-MS I clinical trial and a subsequent extension study. An additional five-year extension trial, TOPAZ, assessed participants’ continuing function and disease progression. Patients could receive Lemtrada or another disease-modifying therapy as needed at the investigators’ discretion. Among Lemtrada-treated patients in the original CARE-MS I study, 75% stayed in the study through the entire five-year extension phase, and 55% required no additional treatment with Lemtrada or another disease-modifying therapy.
After the full nine-year study period:
- 68% of patients showed no signs of confirmed disability progression over a given six-month period, and 41% showed improvement after confirmed six-month disability progression.
- The mean increase Expanded Disability Status Score (EDSS) was 0.10, suggesting overall minimal disability progression. Also, 77% of patients had improved or stable EDSS scores.
- 89% of patients showed no gadolinium-enhanced lesions, and 68% were free of new or enlarging T2 lesions. Also, 68% showed no disease activity after magnetic resonance imaging.
- Median cumulative brain volume loss (BVL) was 1.97%. Also, median annual BVL was 0.22% or less in Years 3 through 9.
Lemtrada also maintained a consistent safety profile throughout the extended nine-year period. The cumulative incidence of thyroid-related adverse events was 46%, and the incidence of immune thrombocytopenia (an uncommon disorder marked by reduced platelet counts) was 2%. Overall, the incidence of drug-related adverse events and infections declined over the nine-year period.37