Guarded Optimism for Experimental MS Drug
Alemtuzumab Appears to Repair Damage to Brain in Patients With MS
Once-a-Year Treatment continued...
Between December 2002 and July 2004, 334 patients in Europe and the United States were enrolled in the study.
About a third of the patients were treated with the first-line therapy interferon beta-1a, given by injection three times a week. The remaining patients were treated with alemtuzumab, given by infusion in once-a-year cycles.
The initial cycle involved four-hour infusions given daily for five days. Twelve months later, most patients got a second, three-day course of the drug.
Three years after the trial was initiated, treatment with the experimental drug was associated with dramatic reductions in clinical relapses and a reduction in inflammatory activity (as seen on brain MRI scans) compared to the interferon treatment.
But Cole says the fact that the experimental treatment actually appeared to reverse damage to brain tissue caused by MS is the most exciting finding from the study.
"That is unprecedented and very big news," he says. "Another important part of the strategy involves treating patients very early in the course of the disease with the most effective agents we have."
The study was funded by the drug companies Genzyme and Bayer Schering Pharma AG, which own the marketing rights to alemtuzumab.
In a Wednesday morning news conference, Genzyme Medical Director Susan Moran, MD, addressed the death that occurred during the study.
The patient died from an autoimmune-mediated blood condition known as idiopathic thrombocytopenic purpura (ITP). Moran said the death could have been avoided if ITP had been recognized as an adverse effect of the treatment.
"Unfortunately, the patient had symptoms of ITP but did not seek medical attention prior to diagnosis because this was not recognized as an adverse event," she says.
Once the risk was known, patients in the study were monitored closely for ITP. Five additional cases were identified, and all were managed with treatment.
Close Monitoring Essential
Moran says all the patients enrolled in the phase III trial and all patients who end up taking the drug if it is approved for MS will have to be monitored closely for this adverse effect.