April 26, 2024 News by Marisa Wexler, MS Machine learning model predicts CIS to MS conversion risk: Study A new machine learning model is able to predict the risk of converting from clinically isolated syndrome, or a first event of multiple sclerosis (MS)-like symptoms, to clinically definite disease, a study found. “Our study developed a machine-learning model that not only provides a numerical estimate of the…
April 17, 2024 News by Steve Bryson, PhD NfL blood levels predict CIS to MS conversion: Clinical trial data High blood levels of the nerve damage biomarker neurofilament light chain (NfL) significantly increased the risk of people with clinically isolated syndrome (CIS) converting to definite multiple sclerosis (MS), according to an analysis of clinical trial data. CIS patients with higher NfL levels also made the transition earlier…
January 17, 2023 News by Steve Bryson, PhD Early Progression Independent of Relapses Linked to Worse Disability Within the first 12 years after the onset of symptoms, about one-fourth of people with clinically isolated syndrome ā or a first episode of multiple sclerosis (MS) symptoms ā showed a worsening of disability independent of relapses, a study reports. This type of disease progression, called progression independent…
November 3, 2022 News by Lindsey Shapiro, PhD #ECTRIMS2022 ā Job Prospects Can Slowly Take a Hit After CIS Diagnosis In the years after a diagnosis of clinically isolated syndrome (CIS) ā a first episode of neurological symptoms suggestive of multiple sclerosis (MS) ā the odds of maintaining employment progressively decrease, according to a recent study. The risk of decreasing or losing employment was particularly high among individuals…
February 28, 2022 News by Marisa Wexler, MS #ACTRIMS2022 ā Iron Rim Lesions Linked to More Severe Disease Iron rim lesions, or specific regions of chronic inflammation seen on MRI scans of the brain, are associated with greater disability and poorer outcomes in multiple sclerosis (MS), a study indicates. These findings “could support the use of iron rim lesions as an imaging biomarker for disease severity and…
February 2, 2022 News by Marisa Wexler, MS Combined Data May Predict Person’s Risk of Advancing From CIS to MS A novel algorithm that combines genetic, environmental, and clinical data could be useful for predicting whether people with a first onset ofĀ multiple sclerosis (MS)-like disease ā known as clinically isolated syndrome (CIS)Ā ā will experience relapses or a worsening of their disease over time. The…
December 7, 2021 News by Steve Bryson, PhD Oral Contraceptives Do Not Increase Risk of 2nd Attack, Worse Disease The use of oral contraceptives does not increase the risk of a second attack of symptoms or the progression of disability in women with clinically isolated syndrome (CIS) or early stage multiple sclerosis, a study demonstrated. Notably, the researchers also “did not find a protective effect on disability…
October 19, 2021 News by Marta Figueiredo, PhD #ECTRIMS2021 ā Spinal Cord Lesions Predictive of SPMS Conversion in CIS Editorās note: TheĀ Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13ā15. GoĀ hereĀ to see the latest stories from the conference. Lesions…
October 14, 2021 News by Marisa Wexler, MS #ECTRIMS2021 ā Brain Lesions Help Predict Long-term Disability Editorās note: TheĀ Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13ā15. GoĀ here to see the latest stories from the…
December 2, 2020 News by Steve Bryson, PhD Aubagio Slows Grey Matter, Whole Brain Atrophy in CIS, Study Finds Studied for the first time,Ā Aubagio (teriflunomide) slowed the loss of cortical grey matter and whole-brain volume in people with clinically isolated syndrome (CIS) during two years of therapy, a study found. The treatment was especially effective in those without brain lesions before treatment.
September 24, 2020 News by Marta Figueiredo, PhD Older Age at DMT Discontinuation Linked to Sustained NEDA in CIS Patients Older age at disease-modifying therapy (DMT) discontinuation is the main predictive factor of sustained “no evidence of disease activity” (NEDA) in people starting DMT immediately after being diagnosed with clinically isolated syndrome (CIS), according to a study in Austria. In particular, patients discontinuing DMT at age 45 or…
September 21, 2020 News by Marta Figueiredo, PhD Pregnancy Delays Likely MS Onset by About 3 Years, Large Study Finds After a pregnancy or childbirth, most women who went on to develop clinically isolated syndrome (CIS)Ā did so about three years later than those who were never pregnant, a large and multicenter study reported. Multiple pregnancies or births, however, were not seen to further affect CIS onset. More research is…
August 21, 2020 News by Marisa Wexler, MS FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration (FDA) has approved Novartis‘ Kesimpta (ofatumumab) as a self-administered treatment for adults with relapsing forms of multiple sclerosis (MS), meaning those withĀ clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). According to Novartis,…
June 19, 2020 News by Forest Ray PhD Immune B-cell Subsets Correlate with MS Progression, Study Finds Australian scientists have discovered subsets of immune cells that differ between people who have multiple sclerosis (MS) and those who donāt. Because the prevalence of these cells correlates with autoimmune attacks, they represent potential targets for MS therapies. The study, āIgG3Ā +Ā B…
May 15, 2020 News by InĆŖs Martins, PhD EBV Infections Evident in All 901 MS Patients in German Study Supporting evidence that infection with Epstein-Barr virusĀ (EBV) could be one of the root causes ofĀ multiple sclerosis (MS), a recent study found all of its 901 early disease patients carry antibodies against this virus, meaning that all are or have been exposed to it. The study, “…
March 26, 2020 News by Marta Figueiredo, PhD FDA Approves Zeposia (Ozanimod), Oral Therapy for All with Relapsing MS The U.S. Food and Drug Administration (FDA) has approved ZeposiaĀ (ozanimod) oral capsules to treat adults with relapsing forms ofĀ multiple sclerosisĀ (MS), includingĀ relapsing-remitting MS (RRMS), Ā active secondary progressive MS (SPMS), and clinically isolated syndromeĀ (CIS). Due to the COVID-19 pandemic, however, when it will arrive in clinics…
November 21, 2019 News by Iqra Mumal, MSc Immunoadsorption May Be Superior to Plasma Exchange in Treating Steroid-resistant Relapses in MS A blood-cleansing process known as immunoadsorption appears to be superior to plasma exchange in treating relapses that donāt respond to conventional steroid therapy in people with multiple sclerosis (MS) or clinically isolated syndrome (CIS), a study reports. These findings were reported in āSafety and efficacy of immunoadsorption…
November 18, 2019 News by Patricia Inacio, PhD Novel MRI Marker Better at Predicting MS Progression, Study Reports A large retrospective study suggests that a magnetic resonance imaging (MRI) marker ā called ābrain atrophied T2 lesion volumeāĀ ā could help predict the timing of multiple sclerosis (MS) progression. According to the study, this marker was the only MRI parameter capable of predicting disease progression, compared with other…
November 11, 2019 News by Iqra Mumal, MSc Early Damage on Brain Scans and Greater 5-Year Disability Help Predict 30-Year Outcomes in MS, Study Finds A 30-year study of outcomes in multiple sclerosis (MS) patients reports that radiological findings in the first year of disease onset, and the amount of disability evident at five years, helps to predict both the likelihood of a person advancing toĀ secondary progressive MS (SPMS) and long-term survival. The study,…
September 26, 2019 News by Marisa Wexler, MS MRI Marker May Be Better at Predicting MS Disease Progression, Study Finds The volume of atrophied (shrunken) regions in the brain, as visible through magnetic resonance imaging (MRI) scans, can predict disease progression in people with multiple sclerosis (MS), new research reveals. The finding was published in the journalĀ Radiology in an article titled, “Atrophied Brain T2 Lesion Volume…
August 27, 2019 News by Ana Pena PhD Central Vein Sign Maintains Potential as MS Diagnostic Marker, European Study Shows Detecting changes to the brain’s central vein using common magnetic resonance imaging (MRI) scans is a useful and accurate strategy to enhanceĀ diagnosis of multiple sclerosis (MS), a new study shows. Analysis of more than 4,000 brain lesions, obtained from contrast-enhanced MRI scans collected from eight neuroimaging European…
August 19, 2019 News by Marisa Wexler, MS Imaging That Captures Damage to Brain in CIS Helps in Determining Likelihood of MS, Study Says Imaging techniques that measure damage to the brain, in addition to those that detect lesions, may be useful in predicting likely disease progression in people with clinically isolated syndrome (CIS), a study found. The study, “Early imaging predictors of longer term multiple sclerosis risk and severity…
July 30, 2019 News by Steve Bryson, PhD Early MRI Screening Can Predict Long-term MS Disability, Help Guide Treatment, Study Says Routine screening throughĀ magnetic resonance imaging (MRI) of people with multiple sclerosis (MS) can predict long-term disease progression ā leading to more certainty and informing better treatment choices, a 15-year study reported. The study, titled āEarly imaging predictors of long-term…
July 24, 2019 News by Alejandra Viviescas, PhD Conversion to MS Among Taiwanese with CIS Low and Disease Course Mild, Study Finds The percentage of Taiwanese who develop multiple sclerosis (MS) after an episode of clinically isolated syndrome (CIS) is lower than that reported for other ethnicities, and those who do progress are likely to have a milder disease course, a study found, supporting how factors like geography and genetics…
April 9, 2019 News by Ana Pena PhD Menstruation Onset, Pregnancies and Breastfeeding Habits Don’t Influence MS Risk, Study Suggests A woman’s age at her first menstruation, or becoming pregnant and breastfeeding does not substantially influence the long-term risk of multiple sclerosis (MS) or the risk of increased disability, a study of a large number of patients withĀ clinically isolated syndrome…
April 3, 2019 News by Marisa Wexler, MS Cleveland Clinic Neurologist Applauds Mayzent’s FDA Approval, But Surprised by Those It May Not Treat When theĀ U.S. Food and Drug Administration approvedĀ the disease-modifying therapy Mayzent forĀ relapsing types of multiple sclerosis, itĀ specified in its label that the treatment was for people withĀ clinically isolated syndrome, relapsing-remitting MS, and ā importantly āĀ secondary progressive MSĀ provided they have "active" disease. The approval is good news, an MS researcher and physician saidĀ toĀ Multiple Sclerosis News TodayĀ in an interview, but "surprising" in that the FDA's decision was largely based on a trial that didn't involve CIS patients and wasn't focused on responses among particular types of SPMS. āIt's the first time that I've seen in the MSĀ field that regulatorsĀ made an approval designation ā activeĀ secondary progressive MS ā based on an underpowered subgroupĀ analysis,ā saidĀ Robert Fox, MD, a neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. Novartis'Ā medication, as a first oral therapy approved in the U.S. forĀ a form ofĀ SPMS,Ā is a big step forward in MS treatment, he said. But details of the FDA's decisionĀ caughtĀ him off guard. Fox served on the steering committee for the EXPAND Phase 3 clinical trial ,Ā on which the FDA decision was largely based.Ā His clinic was also one of the sites treating and evaluating patients in this pivotal study. Results of the EXPAND trial showed thatĀ Mayzent could reduce the risk of disability progression at three months (the trialās primary endpoint, or goal) by 21% in treatedĀ SPMS patients, compared to those given aĀ placebo. Among those with active SPMS (meaning with relapses), a 33% reduction was observed. The treatment, an S1P modulator that works in part to keep lymphocytes from entering the brain to trigger inflammation,Ā alsoĀ decreased the annualized relapse rate by 55% and improved cognitive processing speed in all treated patients.Ā āWhat was found, and I think quite clearly found in a large-size study, was that siponimod in patients with secondary progressive MS clearly slowed the progression of clinical disability over the course of the trial,ā Fox said. āIt's a statistical concept ā obviously patients either progress or they don't progress ā but on an overall basis there was a 21% slowing in the rate of progression of clinical disability.ā The FDAās decision is particularly important for SPMS patients. While Ocrevus (ocrelizumab) alsoĀ treats all relapsing MS forms and people with primary progressive disease (PPMS), it's an intravenous therapy given every six months. Mavenclad (cladribine), approved for relapsing patients in the U.S. just days after Mayzent, is another oral and active disease therapy. To Fox, Mayzent seemed to reach beyond only those secondary progressive patients with clinically active disease. āReally, this is the only drug that's been found to be effective in secondary progressive MS," he said. āTo that degree, it stands alone.ā That's why two points in the FDA's decisionĀ surprised him. The firstĀ is the label's specific mention of clinically isolated syndrome. CISĀ is defined asĀ theĀ first clinical presentationĀ of this diseaseĀ ā aĀ neurological episode that lasts at least 24 hours, and is characterized by inflammatory demyelination (the loss of myelin, the protective coat surrounding neurons). Ā For clinicians like Fox, CIS is a first manifestation of MS ā a kind of "mono sclerosis."Ā Since thereās only one documented attack, it canāt yet be considered multiple sclerosis, āas the multiple hasn't happened,ā Fox said, but many "in the field consider CIS to be ā¦ an early stage of MS." āIf the patient has a whole bunch of lesions on their brain [as seen on an MRI scan] and they had a single clinical event, ah, probably, they have MS,ā he said. Regulatory bodies like the FDA,Ā however,Ā have historically considered CIS to be its own separate entity. That makes this decision doubly surprising, according to Fox, since the EXPAND trial only enrolled patients with SPMS, not CIS. Ā āIt's the first time I've seen them approve for CIS specifically when there wasn't a trial in CIS,āĀ Fox said. āI agree with it ā I don't have a problem with it ā it just surprised me that the regulators were so progressive in their appreciation of MS.ā The second ā and far more unsettling ā surpriseĀ wasĀ the FDAās decision toĀ only approve Mayzent for āactiveā SPMS patients, instead of all SPMS patients. This decision didnāt come out of nowhere, he noted, but it remains puzzling in the context of the EXPAND trial.Ā InĀ compiling trial results, investigators did a subgroup analysis ā as they often do, almost as an aside for research reasons ā and found more favorableĀ responses to Mayzent treatmentĀ in patients with active inflammation beforeĀ the trial's start, those it determined to be with "active" disease. Ā āThere was a third of patients who had a relapse in the two years prior to enrollment, and those patients actually had a 30% slowing in disability progression, compared to the 21% overall,ā Fox said. This certainly does suggest that Mayzent can be more effective in people with active disease ā but there's a catch. The trial itself was not designed to make such a distinction. It enrolled SPMS patients regardless of activity, and its priority goal was changes in disease progression across all who were treated with Mayzent or given a placebo. Ā āWhat's important is that the trial was powered for the overall outcome. It was not powered for subgroup analysis,ā Fox said,Ā considering this a crucial point.Ā In clinical studies, being āpoweredā refers to theĀ enrollingĀ of whatever specific number of participants a study needs to ensureĀ itsĀ results will reach statistical significance. More people are redundant and, as such, an unnecessary cost; fewer could mean that trial's conclusions cannot be supported by rigorous scientific measures.Ā In other words, Fox said, the only conclusions that can be drawn from the EXPAND study reliably ā with rigor ā are based on data drawn from all its SPMSĀ patients, not aĀ subgroup with active disease. This trial āfollowed over 1,600 patients for the clinicalĀ disability. These are purposely powered so that you're not following twice as many people as you need toĀ ā¦ you're powered for that primary outcome,ā he said. āSo, how could they [the FDA] look at a subgroupĀ analysis and make an approval decision based on a subgroupĀ analysis that was underpowered?ā The neurologist gave as examplesĀ other subgroup differences found in trial analyses that didn't affect regulatory approval ā but to his mind, equally could have.Ā One was an analysis findingĀ female SPMS patients respondedĀ to the therapy better than males,Ā showing lesser disease progression. "So why didn't they just approve it for the females and not the males?" Fox asked. But, when asked, Fox did not think the labelĀ toĀ necessarily be an error. "My point is the absurdity of it," he said. "How could they make the regulatory approval based on a subgroupĀ analysis that wasn't powered for conclusions?" He was also particularly troubled becauseĀ the FDAĀ ādidn't define what āactiveā means āĀ is it just a relapse, or is it MRI disease activity?"Ā For many clinicians, āactiveā SPMS refers to ongoing inflammation that can be observed on MRI (magnetic resonance imaging) scans. In EXPAND, however, the active subgroup was defined as patients with clinical relapses within two years of being enrolled in the trial. Fox worries about this apparent lack of a regulatory definition of "active" SPMS, since āobviously, the insurance companies are going to seize upon that, and they're going to look for every way they can to avoid covering it for patients.ā Mayzent, Fox agreed,Ā is likely to be expensive. The therapy is reported to carry a U.S. list price ofĀ $88,500 a year. āI always have a concern about the cost of these drugs. They're all fearfully expensive,ā he said, noting he treats SPMS patients. His focus now is on working to ensure that possible regulatory and financial hurdles wonāt pose too much of an obstacle for patients, especially those with SPMS. āI don't know what the insurance companies are going to do with this, but I'm hoping that it is available for my patients, and I say that as their clinician,ā Fox concluded.
October 15, 2018 News by Ana Pena PhD #ECTRIMS2018 – Smoking and Vitamin D Deficiency Likely to Worsen CIS Prognosis, Model Suggests Smoking and low levels of vitamin D can worsen prognosis for people with clinically isolated syndrome (CIS), researchers who developed a model for predicting long-term disability progression report. Their study, āPredicting the course of CIS patients adding…
October 12, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 ā In CIS Patients, Early Lesions in Specific Brain Area Linked to Worse Disability 30 Years Later, Study Shows Lesions in the infratentorial region of the brain at the onset ofĀ clinically isolated syndrome (CIS) and lesions in white matter one year after CIS onset are associated with worse disability 30 years later, a study reports. The study, āEarly MRI predictors of long-term multiple sclerosis outcomes:…
August 29, 2018 News by Jose Marques Lopes, PhD Poor Sleep Common in MS, Linked to Fatigue, Depression, and Anxiety, Study Reports Poor sleep quality is very common among patients with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS), and is associated with a lower quality of life, and greater fatigue, depression and anxiety, according to a real-world study in patients treated with Betaferon (interferon beta-1b). The study, ā…
August 8, 2018 News by Iqra Mumal, MSc Number, Location, Size of Lesions on MRI Can Predict Progression to MS, Study Shows The number, location, and size of lesions can help predict the risk of progression from clinically isolated syndrome (CIS) to multiple sclerosis (MS) within one year, a new study shows. The study, āMRI in predicting conversion to multiple sclerosis within 1Ā year,ā was published in the journal…