Multiple sclerosis: Improve monitoring, inform treatment decisions

<p>Multiple sclerosis (MS) is an autoimmune disease that causes the body's immune system to destroy myelin, the fatty substance that coats and protects <a href="axons">axons</a> in the brain and spinal cord. This damage prevents the transmission of nerve signals between different parts of the brain, spinal cord, and other parts of the body. It also leads to the death of the affected nerve cells.&nbsp;</p>

A neurologist’s diagnosis of MS is usually based on medical history, a neurological exam, <a href="https://www.siemens-healthineers.com/magnetic-resonance-imaging/clinical-specialities/neuro-mr-imaging" target="_blank">magnetic resonance imaging</a> (MRI), and sometimes <a href="cerebrospinal fluid">cerebrospinal fluid</a> (CSF) analysis and blood tests to rule out other conditions. Although there is currently no cure for MS, it is possible to reduce disease flare-ups and slow the progression of disability with disease-modifying drugs. Biogen and other companies have made significant advances in these drugs, which help to control MS increasingly well. There are now over 16 treatments approved for MS.[1] However, the disease can vary significantly – both from person to person and over time in a single person – which complicates treatment decisions. Regular MRI monitoring is necessary to assess how a person with MS is doing on their specific treatment. It helps doctors see whether the treatment is adequately controlling the disease or if a higher efficacy or alternate treatment is needed. The monitoring can also detect potentially dangerous side effects as early as possible.

The complexity of MS and the subjective nature of routine clinical assessments mean that treating MS is more of an art than a science. In an ambitious collaboration project, the biotechnology company Biogen, a major player in MS drug development, is working to change this by introducing digital technology into routine care to enable more quantitative and reliable measurements for monitoring patients with MS. Ten leading clinical centers in the U.S., Germany, and Spain partnered with Biogen in 2016 to use real-world data from sources such as digital neuro-performance tests, imaging studies, and optional blood testing to gain a better understanding of MS and potentially transform patient care. By fall 2021, the <a href="https://www.mspaths.com/" target="_blank">MS PATHS</a> program (Multiple Sclerosis Partners Advancing Technology and Health Solutions) had collected more than 30,000 imaging datasets from more than 18,000 unique patients.

Through a collaboration with Siemens Healthineers, the program also includes the MS PATHS Image Evaluation (MSPie) prototype¹, which aims to provide MRI-based metrics at the point of care and integrated into the radiologist’s workflow. MRI scans provide physicians with a significant amount of information that they use to monitor MS disease activity and progression. The aim of MSPie is to provide quantifiable information on the most important imaging biomarkers in MS: the number and volume of new lesions, and measures of brain atrophy. MSPie also requires a harmonized MRI protocol at the participating sites so that examinations from different sites can be compared and the highest possible imaging quality achieved.

MSPie¹ uses artificial intelligence (AI) to aid radiologists in MRI-based assessments of MS. Immediately after image acquisition, MSPie automatically identifies and counts lesions that have developed since the patient’s last MRI, while also quantifying the overall lesion burden. MSPie also provides a robust and precise evaluation of brain volume to quantify atrophy. Radiologists can review and verify the results before they are stored in the picture archiving and communication system (PACS) for access by the treating physician. The data generated by AI-based brain and lesion segmentation and volumetric measurements may help radiologists and neurologists to objectively evaluate MS disease activity, progression, and therapy response. In turn, this can support them in making reliable data-driven treatment decisions for individual patients.

A more precise classification of MS patients that is based on the underlying biological differences and changes over time as studied in the MS PATHS program may enable new treatments that are more targeted to the individual’s disease status, prognosis, and treatment response. Making such advances a reality will require close cooperation between pharmaceutical companies, academic institutes, patient societies, medical technology firms, and bioinformatics companies – in other words, exactly the type of collaboration described in this article.