Novartis and Microsoft Team Up to Create Software to Assess MS
In an effort to improve the assessment of MS and its symptoms, Novartis is partnering with Microsoft to develop technology based on a platform used for its popular Xbox gaming console. Inspired by the Kinect system, a “computer vision” for detecting movement, the two companies launched the Assess MS project, which uses similar software to get a more consistent reading of how a patient performs on assessment tests, potentially improving the evaluation of the progress of the disease and expedite the treatment process.
The project has been in development for several years with the goal of molding a reliable algorithm and design. The Assess MS system was recently used in a limited number of patients, but Novartis is now prepared to test it in practice.
To learn more about Assess MS, visit: http://news.microsoft.com/features/from-gaming-system-to-medical-breakthrough-how-microsoft-and-novartis-created-assess-ms/
FDA Grants Breakthrough Status to Ocrelizumab for the Treatment of Primary Progressive MS
The FDA has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (Ocrevus, Genentech) for the treatment of people with primary progressive multiple sclerosis (PPMS). The designation is based on positive results from the pivotal Phase 3 study (ORATORIO), which showed treatment with ocrelizumab significantly reduced disability progression and other markers of disease activity compared with placebo. Top-line results were presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015.
Genentech plans to pursue marketing authorization for both PPMS and relapsing multiple sclerosis (RMS) and will submit data from three pivotal Phase III studies to the FDA in the first half of 2016.
To learn more about ocrelizumab and its potential impact on the field of MS treatment, read Dr. Thomas P. Leist’s article in the November/December 2015 edition of Practical Neurology® magazine.
New Recommendations Published for Stratifying PML Risk in Natalizumab-Treated Patients
A new study offers a “simple and pragmatic” algorithm for incorporating anti-JCV antibody index testing and MRI monitoring into standard progressive multifocal leukoencephalopathy (PML) safety protocols for patients treated with natalizumab. According to authors, the practical consensus guideline is based on current evidence for the introduction into routine clinical practice of anti-JCV antibody index testing of immunosuppressant-naïve patients with MS, either currently being treated with, or initiating, natalizumab, based on their anti-JCV antibody status.
The study also offers specific recommendations for the frequency and type of MRI screening in patients with varying index-associated PML. According to the authors, the guideline will help physicians stratify and monitor risks of PML on an individualized basis.
—J Neurol Neurosurg Psychiatry.
2016 Feb; 87(2): 117-25.
Daclizumab HYP Yields Associated with Lower Relapse Rate and Lesion Count than Interferon Beta-1a
A new study suggests that daclizumab HYP has superior efficacy, compared to interferon beta-1a, for reduction of annualized relapse rate and lesions in patients with relapsing MS. Specifically, the annualized relapse rate was 45 percent lower with daclizumab HYP than with interferon beta-1a. Additionally, the number of new or newly enlarged hyperintense lesions on T2-weighted magnetic resonance imaging (MRI) over a period of 96 weeks was 54 percent lower with daclizumab HYP than with interferon beta-1a. However, daclizumab HYP was not associated with a significantly lower risk of disability progression at 12 weeks (20 percent versus 16 percent), the authors observed. Regarding adverse effects, rates of infection, rash, and abnormalities on liver-function testing were higher with daclizumab HYP than with interferon beta-1a, the authors noted.
—N Engl J Med. 2015 Oct 8;
Researchers Propose an MRI-defined Measure of Cerebral Lesion Severity to Assess Therapeutic Effects in MS
Two new cerebral MRI metrics have shown strong potential in tracking therapeutic response in relapsing MS, according to new findings. In a retrospective non-randomized pilot study to assess the sensitivity of the Magnetic Resonance Disease Severity Scale (MRDSS), patients received either daily glatiramer acetate (GA) or no disease-modifying therapy (noDMT) for two years. MRDSS was the sum of z-scores of T2 hyperintense lesion volume (T2LV), the ratio of T1 hypointense LV to T2LV (T1/T2), and brain parenchymal fraction (BPF) multiplied by negative 1. The authors compared the two groups by Wilcoxon rank sum tests, while within group change was assessed by Wilcoxon signed rank tests. They found that glatiramer acetate subjects had less progression than noDMT on T1/T2 and MRDSS; however, not on BPF and T2LV. While GA subjects worsened only on BPF, noDMT worsened on BPF, T1/T2, and MRDSS. “The T1/T2, an index of the destructive potential of lesions, may provide particular sensitivity to treatment effects,” the authors wrote. n
—J Neurol. 2016 Jan 11.
MS Society Touts Progress of Congressional Legislation Advancing research for neurological diseases
The National MS Society gave an advocacy update on proposed legislation that could play an important role in advancing funding and continued study of diseases such as multiple sclerosis (MS). Last month, during a Senate committee session, a modified version of the Advancing Research for Neurological Disease Act (H.R. 292/S.849) was unanimously approved. The bill would establish a data collection system run through the Centers for Disease Control and Prevention that would track the incidence and prevalence of neurological diseases. The information collected will provide a foundation for evaluating and understanding aspects of diseases, including the geography of diagnoses, variances in gender, disease burden, and changes in healthcare practices among patients.
If the Senate version passes, the House of Representatives and Senate will come together to negotiate a compromise between the Senate bill and the House version, the latter of which is stronger, according the National MS Society. As this process plays out, the society has promised to continue to “push for strong language to ensure that the data collection system is structured in a way that is most beneficial to researchers.” As part of this effort, the society will be contacting its members this month seeking support in contacting Congress to support of the bill.
Visit www.nationalmssociety.org for more information.