FDA Updates TYSABRI(R) (natalizumab) Label to Include Anti-JC Virus Antibody Status as a PML Risk Factor. Read bulletin
first dose of Gilenya (fingolimod). The patient had completed 6 hours of monitoring after the first dose without incident, but died less than 24 hours after the first dose. The exact cause of death has not been established. FDA is working closely with the manufacturer of Gilenya (Novartis Pharmaceuticals) to evaluate the post-market report of death. The patient was also treated with metoprolol, a beta blocker, and amlodipine, a calcium channel blocker. At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation. Read more in FDA Drug Safety. Possible role for certain proteins (tau, GFAP, MOG and NFL) found in the cerebral fluid as biomarkers identifying the different subtypes of multiple sclerosis. Multiple Sclerosis Journal January 17, 2012 Two patients with highly active relapsing MS who were treated with subcutaneos alemtuzumab, had significant improvement and tolerated subcutaneos alemtuzumab well without the typical infusion- associated adverse events. Multiple Sclerosis Journal January 17, 2012 Patients with secondary progressive multiple sclerosis involving the visual pathways (expanded disability status score 5.5-6.5) participated in the UK in a research using intravenous infusion of autologous bone-marrow-derived mesenchymal stem cells. One patient developed a transient rash shortly after treatment; two patients had self-limiting bacterial infections 3-4 weeks after treatment. There were no serious adverse events. There was some improvement after treatment in visual acuity and visual evoked response latency but no significant effects on color vision, visual fields, macular volume, or retinal nerve fiber layer thickness. Lancet Neurology. 2012 Jan 9. A systematic review of data from both randomized controlled trials and observational settings on the tolerability and adherence of multiple sclerosis disease-modifying therapies, revealed that the most common adverse events were flu-like symptoms (interferon therapies only) and injection-site reactions. A total of 151 papers were selected for analysis; 33% were classified as randomized controlled trials and 62% as observational studies. Most of the papers concerned interferon preparations and glatiramer acetate; the limited available information on mitoxantrone and natalizumab precluded extensive examination of these. There were no marked differences in tolerability or adherence data from randomized controlled trials and observational studies, but the incidence of adverse events remained high in lengthy studies and discontinuations accumulated with time. Multiple Sclerosis Journal January 16, 2012 In multiple sclerosis, iron accumulation in brain tissue may reflect a multiplicity of pathological processes. Hence, iron may have the unique potential to serve as an in vivo magnetic resonance imaging tracer of disease pathology. Two patients with multiple sclerosis and one non-multiple sclerosis donor were studied with 7 Tesla magnetic resonance imaging scanner and a 3D multi-gradient echo sequence. The study showed that this echo magnetic resonance imaging is a sensitive technique for the identification of iron in the brain tissue of patients with multiple sclerosis. However, magnetic resonance imaging-identified iron does not necessarily reflect pathology and may be seen in apparently normal tissue. Brain. 2011 Dec
measures contribute to unemployment in MS. A total of 101 individuals with MS underwent a brief neuropsychological battery and completed questionnaires related to vocation, mood, fatigue, and personality. Neurological impairment was measured with the Expanded Disability Status Scale (EDSS). It was found that EDSS and performance on measures assessing information processing speed (Symbol Digit Modalities Test (SDMT)), and persistence were the strongest predictors of employment status. Multiple Sclerosis Dec 19
The course of progressive multifocal leukoencephalopathy (PML) in natalizumab-treated patients and cessation of the drug associated with recurrence of disease activity are related to clearance of the drug. Specific features of this IgG4 antibody (i.e. halfantibody exchange) may result in underestimated drug levels. The study showed that natalizumab levels in 10 patients with relapsing MS, using a recently developed sensitive assay was detectable up to 200 days after cessation of therapy. Multiple Sclerosis December 19 A study found that obstructive sleep apnea was frequent in MS and associated with fatigue but not sleepiness and independent of MS-related disability. Multiple Sclerosis Dec. 19 The purpose of this study was to determine predictors of severe (versus mild/moderate) relapses and poor or fair (versus complete) recovery in patients aged 18 years or less with MS or clinically isolated syndrome (CIS). It was found that optic nerve involvement was associated with a severe initial demyelinating event, while non-White race , localization to the cerebral hemispheres, or encephalopathy showed a trend towards increased severity of the initial demyelinating event. A similar association with race was found for severe second events. A severe IDE initial demyelinating event was associated with incomplete recovery, with similar trends for second and third events. Incomplete recovery from the first event predicted incomplete second event recovery. Multiple Sclerosis Dec. 19 |
Maria A Reyes-Velarde, MD, MPH hablemosdeeem.com |
Latest News 2012
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