Treatment with Lemtrada (alemtuzumab) is associated with the death of patients with relapsing-remitting multiple sclerosis (RRMS) more often than previously reported and appears to be most common during the first month, according to a European review.
The study, “Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis,” was published in the journal BMC Research Notes.
Lemtrada works by inducing a marked decrease in the levels of immune T cells and B cells, which are involved in MS mechanisms, followed by a gradual recovery starting one month after treatment. Although considered safe, reports suggest that this RRMS therapy is associated with severe and possibly fatal adverse reactions resulting from complications such as the bacterial infection listeriosis and alveolar hemorrhage (bleeding into the lungs’ tiny air sacs).
Such reports prompted a team from Norway to conduct a systematic search for data on deaths following treatment with Lemtrada, marketed by Sanofi Genzyme, using the European database EudraVigilance on suspected adverse reactions linked to medicines.
The search, conducted in November 2018, included reports from clinical trials and real-world clinical practice. Immunosuppression, infection, or enhanced inflammation soon after treatment, as well as secondary autoimmunity reactions months later, were among plausible consequences of taking Lemtrada, according to its known safety profile and biological effects.
Ten fatal adverse reactions, nine among females, were identified as being most probably related to Lemtrada. Six of these cases had not been previously reported. All 10 patients were adults and died after receiving at least one treatment cycle. They ranged in age from 34 to 47 (data missing in one patient).
Nine cases were deemed probably caused by Lemtrada, with six of these patients dying within one month after receiving just one treatment infusion.
Five patients died from infection or multiple organ failure and septic shock. One patient (a woman) died from intracerebral hemorrhage after developing hypertension (high blood pressure). As it occurred soon upon treatment, and as Lemtrada has been linked with early strokes, this fatal case was also considered probably associated with the therapy.
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