Study co-author Alasdair Coles, PhD, tells WebMD that phase III trials will soon be underway to determine if the benefits outweigh the risks of alemtuzumab in patients with early relapsing-remitting multiple sclerosis.Hauser is the head of neurology at the University of California, San Francisco Medical Center.
Once the risk was known, patients in the study were monitored for ITP. Five other cases were identified, and all were managed with treatment. Careful monitoring is essential
In a long editorial in the study, MS neurologist and researcher Stephen L. Hauser, MD, writes that it is not yet clear whether alemtuzumab will prove to be an acceptable first-line treatment for early MS.
Surprisingly, some patients who received the experimental drug had less disability associated with the disease three years after the start of the study when entering, leaving hope that the treatment could stop the disease in the bud, before it proceeds to its paralyzing stage. 1 dead alemtuzumab
The study was funded by the pharmaceutical companies Genzyme and Bayer Schering Pharma AG, which owns the marketing rights to alemtuzumab.
According to the National MS Society, relapsing-remitting MS accounts for 85percent of people who are first diagnosed with MS.
Unfortunately, the patient had symptoms of ITP but did not seek medical advice prior to diagnosis because it was not recognized as an adverse event, he said.
Moran said that all the patients included in the Phase III study, and all patients who end up taking the drug if it is approved for MS should be closely monitored for this adverse effect.
Approximately one third of patients were treated with first-line therapy of interferon beta-1a, administered by injection three times a week. The other patients were treated with alemtuzumab, given by infusion in a single year cycles.
Taken together, the toxic effects associated with alemtuzumab considerably curb the enthusiasm for its routine use in patients with multiple sclerosis until more is known about its long-term safety and sustained efficacy, he writes.
But nearly one in four patients treated with alemtuzumab developed complications related to thyroid treatment.
John Richert, MD, of the National Multiple Sclerosis Society (NMSS), WebMD is clear that aggressive treatment early in the disease is a better strategy than waiting for MS progresses.
Cambridge researchers first tried the drug in patients with multiple sclerosis, with little success.
The new Phase II study, reported only included patients with early relapsing-remitting multiple sclerosis who had not been treated with other Member States.
Richert is vice president of clinical programs and research for the SMN.
It is appropriate that the role of alemtuzumab in MS remains to be determined.
Patients with early relapsing-remitting multiple sclerosis treated with the drug alemtuzumab had far less impact and evidence of progression of multiple sclerosis compared with patients treated with the approved treatment, interferon beta-1a.
The initial course included four hours a day by infusion for five days. Twelve months later, most patients received a second course of three days of medication. Answer unprecedented
The study appears in the October 23 issue of the New England Journal of Medicine.
This medication may be the turning point that we are looking for, but we know that the Phase III study is done, he said.
Even more troubling, 3percent of patients developed a potentially fatal autoimmune, which resulted in the death of a patient.
An experimental drug has been shown to be much more effective for the treatment of MS prompt intervention widely used in a study, but the efficiency has a price.
Three years after the trial was initiated, treatment with the investigational drug has been associated with a drastic reduction in clinical relapses and a reduction in inflammatory activity (as seen on brain scans), compared to treatment with interferon. Answer unprecedented continues .
The results of phase II are very interesting, but not ready for routine use, he said. We need to learn more about long-term efficacy and side effects. C This is our challenge in the coming years. Once a year treatment
Between December 2002 and July 2004, 334 patients in Europe and the United States were included in the study.
The patient died of a blood disorder known as mediated autoimmune idiopathic thrombocytopenic purpura ().
Moran said that the death could have been avoided if ITP was recognized as a side effect of treatment.