TG Therapeutics’ ublituximab nearly eradicated a type of immune B-cell believed to be involved in multiple sclerosis, according to a Phase 2 clinical trial. The result was that none of the patients had a relapse during the first six months of the trial, which is continuing, researchers said. In addition, ublituximab reduced the brain and spinal cord lesions of the relapsing MS patients involved in the trial and prevented new ones from forming. The company will present the interim trial results in three poster presentations at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28. Meanwhile, researchers will continue to study the effectiveness of ublituximab, a B-cell-depleting antibody, versus a placebo, for another six months. The trial is being held at several U.S. medical facilities. Participants receive two initial infusions of ublituximab or a placebo on day 1 and 15 during the first 28 days. After this initial period, those in the placebo-group are also given ublituximab and followed for 52 weeks. A key trial finding was that over the initial 24 weeks of the trial, the treatment nearly wiped out a type of B-cell known as CD20 that scientists believe is involved in the development of MS. Only 1 percent of the B-cells remained after a month. While helpful immune T-cell numbers dropped slightly after the first ublituximab infusion, they bounced back quickly. Researchers also reported a reduction in patients' magnetic resonance imaging (MRI) lesions, with no new inflammatory lesions appearing during the six months. So far, none of the trial participants has had a serious adverse event. Most of the adverse events were mild or moderate and related to the infusions. The trial also demonstrated that speeding up infusions did not increase infusion-related reactions. The speed-up results indicated that — if proven effective and safe — ublituximab will be more convenient for patients than B-cell-depleting drugs that require infusions stretching over several hours.
MRI
The Consortium of Multiple Sclerosis Centers has updated guidelines for using magnetic resonance imaging to evaluate people suspected of having multiple sclerosis. Doctors use the MRI guidelines not only to diagnose MS but also to track treatment results. A task force is reviewing the new guidelines before they're published. The working document is called "Revised Guidelines of the CMSC MRI Protocol for the Diagnosis and Follow-up of MS." The task force, composed of neurologists, radiologists and imaging scientists experienced in MS, met in January 2017 to revise the guidelines. They also updated information about the situations for which standardized brain and spinal cord MRI scans should be used. One change is a recommendation that gadolinium, a contrast agent in scans, be used cautiously. The previous update, published in 2015, included no constraints on the use of gadolinium-based contrast agents. But soon after publication, information emerged showing that gadolinium, although not toxic, accumulates in the brain. This prompted the U.S. Food and Drug Administration to recommend limiting the use of gadolinium to “appropriate clinical circumstances.” To mirror the increased awareness of gadolinium deposits, the new guidelines say: “While there is no known central nervous system toxicity, these agents should be used judiciously, recognizing that gadolinium continues to play an invaluable role in specific circumstances related to the diagnosis and follow-up of individuals with MS.” Since 2009, the Consortium of Multiple Sclerosis Centers has addressed a number of other issues. One is encouraging the use of three-dimensional MRI for brain scans. Another is developing protocols for monitoring severe optic nerve inflammation and progressive multifocal leukoencephalopathy, or PML, a brain disease caused by a virus. The guidelines have been revised to recommend the specific timing of scans for monitoring PML. The update also includes recommendations for the timing of scans on patients receiving disease-modifying drugs. Since 2009, the guidelines have included recommendations on scans of radiologic isolated syndrome, a condition where MS-like MRI lesions are present without symptoms. And they have included provisions on the value of using MRI changes to evaluate treatment effectiveness. The centers' goal "is to standardize the MRI protocol and make these recommendations a useful guideline for neurologists, neuroradiologists, and related healthcare professionals during initial evaluations and during follow-up of patients with MS, and ultimately provide optimum care for those individuals dealing with this unpredictable disease,” June Halper, the centers' chief executive officer, said in a press release.
Magnetic resonance imaging (MRI) brain scans of children could reveal changes associated with multiple sclerosis (MS) before any symptoms are developed, according to a study by scientists at Yale University School of Medicine. The findings suggest that brain and spinal cord scans can identify children at high risk for developing MS.
Researchers at Duke University want to determine if data collected through an iPhone app can ably capture individual experiences in people with multiple sclerosis to improve doctor-patient communication and overall disease understanding. According to a National MS Society report, the researchers want to investigate the benefits combining mobile phone-based data with machine learning (the ability of a smartphone to mimic human behavior) and patient participation. The study is currently enrolling MS patients, 18 or older, live in the United States and be able to read and understand English. Participants must own or have daily access to an iPhone (iOS 9 or greater) to download a free, MS Mosaic app from the Apple Store. The app is not yet available for Android phones. The rationale behind the study is that MS can be an extremely complex condition, with symptoms ranging from numbness, walking difficulty, to vision impairment and fatigue. Each patient's experience is different and can be affected by medication, emotional health, and environmental factors. This complexity can complicate research. Study participants will receive daily, weekly and monthly questionnaires to fill about their symptoms. Daily surveys should take no longer than a minute to complete, and weekly surveys about ten minutes. Initial registration should take about 20 minutes, the NMSS report says. In some of the surveys, participants will be asked to perform specific tasks while holding or using the mobile phone, like walking 25 steps, turning around, then walking back 25 steps – while holding the phone. Other tests include tapping on the phone screen repeatedly to test motor speed, coordination and fatigue, or playing a pattern game to assess short-term memory. These tasks should take about five minutes each. Patients can choose not to answer some of the questions or to participate in certain tasks. All information is collected through the app, and will be sent to a secure data server. Participants can export data to share with a healthcare provider. Each person will be identified by a code, and data will be analyzed in a way that maintains confidentiality. Researchers, however, be able to identify a participant should they need to do so for "research integrity or legal purposes," the report states. Questions regarding this study can be answered by sending an email to [email protected].
“I’m sorry, these files take forever to copy,” the woman at the registration desk says, breaking the silence that had settled between us while she uploaded MRI scans from the CD I gave her moments earlier. “I know it can be a…
The U.S. Food and Drug Administration (FDA) has approved the marketing of Cognigram, a medical device developed by the cognitive science company Cogstate to evaluate a patient’s cognitive health. This device may be a…
A new study draws a reverse link between the number of MRI scans of multiple sclerosis patients who are on interferon-beta 1a and doctors declaring there is evidence of the patients’ disease worsening. When doctors looked at one scan, rather than multiple ones, they were more likely to say that…
(Editor’s note: Tamara Sellman continues her occasional series on the MS alphabet with this first of two columns about terms starting with the letter “G.”) When it comes to multiple sclerosis, mastering an understanding of the disease means you need to…
MSBase and icometrix have joined efforts in a large-scale project to identify imaging markers of multiple sclerosis (MS) that could help diagnose the disease in its early stages. The combination of magnetic resonance imaging (MRI) information collected from MS patients with clinical information from the MSBase Registry can offer new insights in disease progression, potentially leading to new predictive tools for MS. It may also promote more standardized use of imaging measures in clinical practice. With more than 52,000 MS patients, the MSBase Registry is an international database committed to collecting patients’ information as well as sharing, tracking and evaluating overall outcome data in MS and other neurological conditions. Until now, the MSBase Registry included only descriptive information regarding patients' imaging analysis results, with no access to full imaging data. This joint, large-scale project will include MRI scan data routinely acquired in clinical setting taking advantage of icometrix’s software platform, MSmetrix. “We wish to unlock the power of MRI for personalized monitoring in MS," Helmut Butzkueven, director of MSBase, said in a press release. "The MSBase Scientific Leadership group has selected MRI integration as the top strategic priority for MSBase. We believe that already conducted MRI scans represent an enormous missed opportunity, because advanced measurements to assess change over time from these scans are not currently in practical use.” Butzkueven said MSBase "will test the predictive power of this unlocking of MRI data in the first phase," with a total of 10,000 MRI data points in at least 3,000 MS patients from all over the world. The project is expected to identify disease progression markers that could help detect early signs of MS by MRI evaluation. This investigator-initiated collaboration between icometrix and the MSBase Foundation is being supported by three global pharmaceutical giants: Novartis, Biogen and Roche. “MRI measures play an essential part in the complex puzzle of MS,” said Danny Bar Zohar, global head of neuroscience development at Novartis. “Partnering with MS Base and icometrix in this exciting project will bring the acquisition of high-quality real world data to the next level, ultimately improving the outcome of people living with MS.”
During a routine exam with my neurologist recently, I asked her a question I’d never thought to ask before: “Why do you order regular MRIs of my brain, but not of my spine?” Interestingly, within a few days of my exam, a Harvard Med School study was…
MS News That Caught My Eye This Week: Brain Scans, Spasticity, Tecfidera Study and Cigarettes
In case you missed them, here are some news stories that appeared in MS News Today that caught my eye over the past week. **** Harvard Study Finds No Link Between Clinical Exams and MRIs in Some MS Patients I’m really not surprised…
Physical disability may have no link to brain lesion volume in some patients with multiple sclerosis (MS), concludes a recent study led by Dr. Rohit Bakshi, a neurology and radiology professor at Harvard Medical School. The study, “Characterizing Clinical and MRI Dissociation in Patients with Multiple Sclerosis,” appeared in the Journal…
Editor’s note: Patient columnist Laura Kolaczkowski attended the 31st annual Consortium of Multiple Sclerosis Centers conference in New Orleans. The information in this article was taken from an interview session with the physicians. The use of gadolinium, which is the contrast agent often used during MRIs for multiple…
Taking Lemtrada (alemtuzumab) for two years inhibited magnetic resonance imaging (MRI) disease activity in patients with relapsing-remitting multiple sclerosis (RRMS) for more than six years, the CARE-MS I clinical trial extension study found. Researchers presented their study, “Durable Efficacy of Alemtuzumab on MRI Disease Activity Over 6 Years in Treatment-Naive RRMS Patients With…
Multiple sclerosis patients who start Rituxan (rituximab) treatment are three times more likely to have unchanged or improved brain-scan readings than worse ones, according to a study. Holy Name Medical Center researchers presented the findings at the Consortium of Multiple Sclerosis Centers annual meeting in New Orleans, May 24-27. The presentation…
A smartphone app has been designed to collect lots of information related to your multiple sclerosis – things such as physical and cognitive test results, MRI images, and even genetic data. The hope is that via the app researchers will be able to collect a lot of patient data…
4 Ways Ocrevus Can Improve Your Life
It’s been less than a month since Ocrevus was approved by the FDA, and the buzz hasn’t died down. Though there is some trepidation, the MS community is incredibly excited about what the new “game-changing” medication can do for patients all across the country. Here are just a few…
On March 27, 2013, my primary care physician called me about MRI results from the day before. He and the radiologist concurred; they had found evidence of brain lesions consistent with multiple sclerosis. Following protocol, he sent me to the best specialist in Seattle to confirm diagnosis. His was a preliminary diagnosis. In the…
A new test can show how exercise is benefiting people with multiple sclerosis (MS) and other neurological conditions. The evaluation of muscle health in individuals with MS, spinal cord injuries and other severe nerve damage conditions is usually done with magnetic resonance imaging (MRI) and other expensive equipment. Researchers in the…
Kinesiology professor Richard van Emmerik and his colleagues at the University of Massachusetts Amherst recently received a two-year $833,000 grant from the U.S. Department of Defense to create an improved diagnostic test for multiple sclerosis (MS). The scientists expects their research to help an estimated 2.3 million people worldwide who live with…
Last updated April 26, 2023 A key test for identifying multiple sclerosis (MS) during diagnosis, or to confirm a relapse, is magnetic resonance imaging (MRI.) For those who’ve never had to undergo an MRI, the thought of having this test might be terrifying. Being encased in a magnetic…
The MS world lost a very important person on Feb. 8. Britain’s Sir Peter Mansfield, Nobel Laureate, passed away at the age of 83. For most of us, his name means little, but his work revolutionized the way multiple sclerosis is diagnosed, and the way progression of the disease…
MicroRNAs in the blood could serve as biomarkers to monitor the progression of multiple sclerosis (MS), as well as help identify which mechanisms are at play in each patient, such as inflammation and tissue damage, according to new research. The findings were reported in the study, “Association Between Serum…
Siemens Healthineers and Biogen will collaborate to develop new magnetic resonance imaging (MRI) applications that can quantify key markers of multiple sclerosis (MS). “By bringing together the shared expertise of both Siemens Healthineers and Biogen in imaging and neurology, respectively, we seek to develop new measurement tools that…
Repeated magnetic stimulation of the brain may help to rebuild the brain’s network in patients with multiple sclerosis (MS), leading to improved working memory, researchers reported. But more studies are necessary to confirm the procedure’s safety and efficacy as a treatment for MS. Results were published in a study titled…
Certain contrast agents used during magnetic resonance imaging (MRI) may accumulate in specific brain areas and contribute to disease duration and severity in patients with multiple sclerosis (MS), according to a new study published in the Multiple Sclerosis Journal. The study, “Gadopentetate But Not Gadobutrol Accumulates In The…
I’m sure all of us with multiple sclerosis have had at least one magnetic resonance imaging (MRI) scan. Most likely, more than one. MRIs are designed to scan and provide detailed pictures of the body, the brain included. The test can reveal scars (plaque lesions) on the brain and the…
The less oxygen that a mouse with multiple sclerosis (MS) has in the gray matter of its brain, the more mental and physical deterioration it is likely to have, a new study suggests. The study confirms previous research indicating a connection between low oxygen levels in a mouse’s gray matter and the development…
Royal Philips recently announced the introduction of the IntelliSpace Portal 9.0, the latest edition of its advanced comprehensive visual analysis and quantification platform for neurological disorders. The platform was presented at the 2016 Radiological Society of North America Annual Meeting (RSNA), taking place through Dec. 2 in Chicago. Currently a work in…
Royal Philips will introduce a new suite of magnetic resonance (MR)-based software applications at the upcoming Radiological Society of North America’s 102nd Scientific Meeting and Annual Assembly (RSNA 2016; #RSNA16) Nov. 27 to Dec. 2 in Chicago. Philips’ Ingenia family of digital MRI systems provides radiologists with a unique set…
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