SAFETY AND TREATMENT NEWS
On January 20, 2012, the FDA issued a press release that reads in part: “the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).”
The virus is present in about ½ of all US adults, but usually doesn’t cause symptoms or any problem. In MS patients taking natalizumab and carrying the virus, the virus can go to the brain and cause a serious brain infection. The overall risk for developing PML is believed to be about 2 in 1,000 and this blood test along with other risk factors, including duration of treatment with Tysabri and previous treatment with other drugs that suppress the immune system, can help identify who is at a higher risk for this serious complication. It is important to note that this new test does not test for the brain infection itself, but rather identifies who has been exposed to the virus that causes PML.
A recent article published in Lancet Neurology reported that stem cells from a person’s own bone marrow (called autologous mesenchymal stem cells) were safely given to patients with secondary progressive multiple sclerosis. The study was conducted
in Europe and involved 10 people with secondary progressive MS who received an intravenous infusion of the stem cells.
The participants were followed for 10 months after the infusion for any adverse reactions. One patient developed a rash and two developed bacterial infections but the researchers did not find any serious adverse events in the 10 months following the infusion. In addition, the researchers also found some evidence of improved vision. Additional research is ongoing and will need to be conducted in many more patients but the procedure was well tolerated in this group.
The 4th Cooperative Meeting of the Consortium of MS Centers (CMSC) and Americas Committee for Treatment and Research in MS (ACTRIMS) will take place May 30 - June 2, 2012 in San Diego, CA. The meeting is for MS healthcare professionals and researchers and focuses on a wide range of clinical and research areas, from Basic Science and Environmental Factors to Disease and Symptomatic Management. If you are attending, please visit us at our NARCOMS booth.
NARCOMS Now will be covering the CMSC Annual Meeting with live blog posts and stories in future issues of this magazine. For more information on the meeting, visit www.cmsc-actrims.org, and watch for the blog posts on www.narcoms.org/narcoms_now