What’s New in MS Research – November 2025

MSAA’s MSIN^® initiative helps to map the journey from first symptoms to diagnosis

More than three quarters of people with MS who participated in a recent research initiative experienced symptoms for one year or longer before being diagnosed, and 40% waited more than five years from symptom onset to diagnosis.¹

These findings underscore the need to better understand and more effectively address obstacles to timely recognition and diagnosis of MS. This is the primary focus of a presentation by the Multiple Sclerosis Implementation Network^® (MSIN^®), which is a patient-centric collaboration of clinicians; people with MS; advocacy organizations, including the Multiple Sclerosis Association of America (MSAA); academia; and industry. 


More than 400 participants responded to an online survey sent by MSAA to people living with MS and members of their care communities. When asked to identify barriers that contributed to delays in diagnosing their MS, the study participants’ top answers were:

• symptoms not recognized by self – 46%
• symptoms dismissed or not recognized by healthcare providers – 38%
• initial misdiagnosis – 25%

In analyzing time-to-diagnosis data based on how long ago a person was identified as having MS, researchers found that there has been no improvement in reducing diagnostic delays over the past 10 years. To gain clinician insights on addressing this challenge, MSIN hosted a 60-minute virtual discussion with seven neurologists, all of whom had provided insights via a pre-meeting survey.

The neurologists highlighted that the people with MS at greatest risk for experiencing a delay in diagnosis included men, people living in rural areas, people with a lower socioeconomic status, people with atypical symptoms, those outside the typical age range for MS onset, and those lacking access to primary care.

The physicians added that overcoming obstacles to timely diagnosis would require steps including: 


• broader awareness of MS among non-specialist clinicians and the public
• a better understanding of the diverse pathways that can lead to a diagnosis of MS
• targeted strategies for reaching underserved groups

Timely diagnosis of MS is critical for several reasons. Not only does it give people definitive answers to worrisome questions about their health, it also enables early initiation of disease-modifying therapies (DMTs), which have been shown to improve prognosis. While these findings are concerning, they serve a valuable function by identifying what complicates the diagnosis of MS and enabling medical professionals to prescribe several interventions that can help.

Other research presented at the ECTRIMS meeting and reported in this edition of “What’s New in MS Research” indicates that the latest iteration of the McDonald criteria for diagnosing MS, specifically the criteria’s new focus on paramagnetic rim lesions identified on magnetic resonance imaging, will help enhance and speed recognition of multiple sclerosis.

 

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MSAA’s MSIN^® initiative assesses the evidence for a wide range of MS interventions beyond DMTs

While extremely important, comprehensive management of MS entails far more than taking disease-modifying therapies (DMTs). Health promotion, attention to symptoms, and supportive care all play critical roles, but often are not as rigorously studied as DMTs, which must be evaluated in large clinical trials to receive FDA approval. As a result, it can be difficult for people with MS and their clinicians to know which other interventions have solid evidence supporting their efficacy and safety.

As an initial step toward bridging that evidence gap, the Multiple Sclerosis Implementation Network^® (MSIN^®) conducted a scoping review to assess the breadth and focus of research into various facets of MS management.² “A scoping review is useful to map the literature on evolving or emerging topics and to identify gaps. It may be a step before undertaking research or conducting another type of review, such as a systematic review.”³

MSAA’s MSIN initiative evaluated 1,049 articles in medical and scientific journals before identifying 208 studies that met its inclusion criteria. Those studies were authored by researchers in 33 countries, with the United States, Iran, Italy, Turkey, and Spain accounting for 69% of the studies.

The five most frequently studied aspects of MS outside of DMT’s were symptom management (53.8%), motor function and disability (44.2%), functioning (29.3%), cognitive function (21.2%), and psychological well-being (20.2%). In terms of the types of interventions evaluated, exercise led the way, representing 47.6% of the studies.

Roughly 14% of studies looked at multi-component interventions, such as programs that combined education, rehabilitation, exercise, and brain stimulation. Dietary and nutritional interventions constituted the least-researched area, being the focus of only 1.4% of studies. The authors of the scoping review noted that most of the evidence-based interventions evaluated were developed by single research teams without independent replication, a detail that is critical for validating study data.

As a next step from the scoping review, “each intervention will be prioritized based on the strength of the evidence, potential impact on patient outcomes, alignment with patient and stakeholder priorities, and feasibility of adoption and implementation across MSIN [clinical] sites.”

By carefully assessing and implementing various health promotion, symptom management, and supportive steps in this manner, MSIN’s effort can help drive adoption of truly comprehensive MS care.

 

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Study finds that the 2024 version of McDonald criteria speeds MS diagnosis

For almost a quarter of a century, clinicians assessing people for possible multiple sclerosis have relied on guidelines developed by an international panel led by neurologist Ian McDonald. Those guidelines, known as the McDonald criteria, have been updated four times since they were unveiled in 2001, with the most recent revisions being made in 2017 and 2024. Each update was intended to enhance the accuracy and speed of MS diagnosis by incorporating the latest available evidence.

So, how well do the 2024 guidelines improve upon the performance of their earlier versions from 2017?

Fairly well, according to researchers who examined that question by studying the records of 163 people at Royal Melbourne Hospital Neuroimmunology Centre in Australia.⁴ The individuals were evaluated at the hospital between 2013 and 2022. All of them had either clinically isolated syndrome (CIS) or radiologically isolated syndrome (RIS). In CIS, a person has symptoms of a single demyelinating event but does not yet meet the full criteria for MS. In RIS, a person has magnetic resonance imaging (MRI) findings suggestive of MS but no symptoms indicative of the disease. People with CIS or RIS are at an elevated risk for MS.

Study participants were between 18 and 50 years of age when they had a CIS event or RIS imaging finding. All had their first, or baseline, clinic visit within six months of that event or finding. Their average age at CIS or RIS was 31.4 years. Seventy-three percent were female.

Based on the 2024 criteria, 133 of the people – or 81.6% of the total – warranted a diagnosis of MS at baseline. By contrast, only 122 people (74.9% of the total) fulfilled the 2017 criteria for diagnosis at baseline. Further, applying the 2024 criteria facilitated earlier recognition of MS. With this revised criteria, diagnosis was made an average of 6.5 months after a first CIS event or RIS imaging finding, versus 7.8 months following an initial event or finding with the 2017 criteria.

Notable features of the 2024 McDonald criteria include adding the optic nerve as a site where the presence of lesions supports the diagnosis of MS. This supports the use of two ophthalmologic technologies to identify optic nerve involvement. In addition, two relatively recent MRI assessments – the central vein sign (CVS) and paramagnetic rim lesions (PRLs) – are cited as indicators that can support the diagnosis of MS in certain situations. Based on the Australian study’s findings, it would appear that those features and other diagnostic guidance new to the 2024 criteria are helping to find more people with MS, and to find them faster.

 

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Study supports role of paramagnetic rim lesions in confirming diagnosis of MS

When a panel of experts updated the McDonald criteria for diagnosis of multiple sclerosis last year, panel members said that identification of paramagnetic rim lesions, or PRLs, on magnetic resonance imaging (MRI) could be used to confirm the presence of MS in certain circumstances. A study conducted at several MS centers and reported in September 2025 at the annual ECTRIMS meeting supports this addition to the McDonald criteria.⁵

PRLs are lesions that have a thin, dark rim encircling them on MRI. The rim is composed of iron-rich cells, which is significant because iron can contribute to neurotoxicity through oxidative stress and other harmful biological processes. In the study reported at ECTRIMS, researchers examined how the presence of PRLs on the baseline brain MRI of 420 people evaluated for possible MS correlated with a diagnosis of MS based on the 2017 version of the McDonald criteria, which did not factor the presence of PRLs into diagnostic decision-making.

The researchers found that considering the presence and number of PRLs seen on imaging was a reliable means of identifying whether someone with symptoms suggestive of multiple sclerosis actually did or did not have the disease. Further, as the number of PRLS seen on imaging increased from one or more to four or more, the ability to distinguish between the presence or absence of MS improved considerably.

Among study participants, factors associated with the presence of one or more PRLs included:

• age, with people who were less than 40 years old being two times more likely than older people to have PRLs
• sex, with males twice as likely as females to have PRLs on imaging
• race, with Black people almost twice as likely as people of other racial backgrounds to have multiple paramagnetic rim lesions

Noting that their study was the “largest, prospective, international study on diagnostic performance of PRL in MS,” researchers said that their findings support “the inclusion of PRL in the 2024 McDonald criteria by demonstrating PRL as a broadly applicable imaging biomarker.”

 

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Study demonstrates no evidence of disease activity in more than 80% of newly diagnosed people receiving Kesimpta^®

More than four out of five people with newly diagnosed multiple sclerosis who received Kesimpta^® (ofatumumab) as their first MS medication had no evidence of disease activity within six to 18 months of starting treatment.⁶

That finding emerged from the Phase IV AGNOS study, which was conducted at several MS treatment centers across the United States. Kesimpta is a monoclonal antibody that depletes B cells, which are immune cells that play a key role in MS. In 2020, the FDA approved the medication for treatment of relapsing-remitting multiple sclerosis (RRMS). After beginning treatment with three weekly doses, people with MS take monthly doses of the medication, typically by self-injection.

Because a growing body of evidence indicates that early intervention in relapsing MS can enhance long-term outcomes, investigators wanted to assess the efficacy and safety of Kesimpta as an initial treatment started soon after diagnosis. Study participants were ages 18 to 35 years old, had been diagnosed with a relapsing form of MS within six months prior to entering the study, and had not received any other disease-modifying therapy (DMT).

The study’s primary endpoint was having no evidence of disease activity, as assessed by three different measures, within six to 18 months of starting treatment with Kesimpta. The three measures were (1) no relapses, (2) no three-month confirmed disability progression, and (3) no evidence of disease activity on magnetic resonance imaging (MRI). Researchers also looked at other measures of treatment efficacy and safety. Further, they compared study participants’ MRI scans and performance on tests of physical function, with those of healthy controls matched by age and gender. (People in the control group did not receive Kesimpta.)

Eighty-one percent of the study’s 95 participants with MS met the primary endpoint. In terms of safety, common adverse events included headache (27.7%), muscle pain (26.1%), fatigue (20.2%), and COVID-19 (16.0%). Serious adverse effects were reported by 6.7% of the people with MS receiving Kesimpta and by 4.9% of the healthy controls, who were not treated. Investigators deemed 2.5% of the serious adverse effects to be treatment-related. None of the people with MS stopped treatment due to adverse effects.

An exploratory analysis showed similar results between the people with MS receiving Kesimpta and the healthy controls in terms of changes in brain volume, in performing a test of manual dexterity, and in a timed 25-foot walk. However, the study did not have a sufficiently large number of people to make statistically significant comparisons between the two groups.

In summarizing their findings, the study’s authors concluded that their research “confirms the efficacy of [Kesimpta] in participants with very early, recently diagnosed, treatment-naive RRMS.” They added, “Functional performance and imaging outcomes in [Kesimpta]-treated participants appeared broadly similar to those observed in healthy controls up to 18 months. Safety findings were consistent with prior reports. These findings support Kesimpta as a highly effective first-line therapy in early RRMS.”

 

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Study demonstrates low relapse and disability progression rates with Mavenclad^® use in people ages 50 years and older

People with MS who started taking the disease-modifying therapy (DMT) Mavenclad^® (cladribine) at or after 50 years of age had low average rates of relapse and 24-week confirmed disability progression, according to a real-world evidence study.⁷

The study focused on 993 people with MS who began taking the oral DMT in 2017 or later. Almost all (94.4%) of the study participants had a relapsing form of MS. Researchers divided those individuals into three age groups: 50-54 years old, 55-59 years, and age 60 years or older.

The average number of relapses in the 12 months before initiating Mavenclad ranged from 0.24 in people ages 60 years or older to 0.41 in people ages 50-54 years. By contrast, the annualized relapse rate (ARR) after starting Mavenclad ranged from 0.03 among people ages 60 and older to 0.07 in study participants who were ages 50 to 54.

An ARR of 0.07 means that in the course of a 12-month period, seven people out of 10,000 will experience a relapse. The rate of confirmed disability progression over 24 weeks was also low, at 0.06 across all three age groups studied. The average rate of switching from Mavenclad per 100 person-years ranged from 3.0 in people ages 50 to 54 years, to 3.94 in those ages 60 and older. This means that in any given year, more than 96% of study participants taking Mavenclad remained on the DMT.

Commenting on their findings, the study’s authors concluded, “This analysis demonstrates [that Mavenclad] treatment is highly effective and has very high treatment persistence in older [people with multiple sclerosis] who still experience relapses.”

 

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Large, three-year study shows that Ocrevus^® cuts risk of disease progression in PPMS

A three-year study of more than 1,000 people with primary-progressive multiple sclerosis (PPMS) found that the disease-modifying therapy Ocrevus^® (ocrelizumab) significantly reduced the risk of disability progression, including diminished hand function, investigators report.⁸ The Phase IIIb ORATORIO-HAND trial enrolled adults with PPMS who were ages 65 years or younger. Study participants were assigned at random to receive either a 600-mg infusion of Ocrevus (505 of the participants) or placebo (508 of the participants) every six months for 144 weeks or until 344 progression events were recorded. These “344 progression events” refer to the entire group’s incidence of reduced function as determined by a lower score on one of the assessments, such as the EDSS or the 9-Hole Peg Test.

The people in the study had Expanded Disability Status Scale (EDSS) scores ranging from 3.0 to 8.0. The EDSS is a 10-point scale in which higher scores indicate a greater degree of disability. By enrolling patients with EDSS scores ranging as high as 8.0, researchers allowed inclusion of people with more advanced MS.

The study’s primary endpoint was a combination of two measures, referred to as a “composite” primary endpoint. The first was time to onset of 12-week confirmed disability progression as assessed by performance on the 9-Hole Peg Test, which evaluates manual dexterity. A 20% or greater worsening in performance relative to baseline results was considered confirmed disability progression.

The second measure in this composite primary endpoint was confirmed disability progression as indicated by an increase from baseline in EDSS score. In addition to looking at outcomes for the group as a whole, researchers also tracked the performance of a subset of patients who had evidence of disease activity on their magnetic resonance imaging (MRI) scans at screening or baseline.

After a median treatment duration of 143 weeks, 32.7% of study participants receiving Ocrevus and 40.4% of those receiving placebo met the composite endpoint for 12-week confirmed disability progression. The difference between the two groups represented a 30% reduction in risk of progression with use of Ocrevus. That difference was statistically significant.

Looking at the composite endpoint’s two components individually, 16.7% of people receiving Ocrevus and 24.9% of those in the placebo group had confirmed disease progression in terms of the 9-Hole Peg Test and hand function. That difference amounted to a 41% reduction in risk with Ocrevus and was statistically significant.

Meanwhile, 23% of people who were treated with Ocrevus and 30.8% of those receiving placebo had disability progression as gauged by change in EDSS score. In terms of this measure, Ocrevus use was associated with a statistically significant 33% reduction in risk relative to placebo.

Among study participants with MRI evidence of disease activity at screening or baseline (prior to starting treatment), Ocrevus reduced the risk of disease progression by a statistically significant 55%. While 45.9% of subset members receiving placebo met the composite primary endpoint of confirmed progression, only 26.8% of their counterparts receiving Ocrevus had progression as measured by the 9-Hole Peg Test, EDSS score, or both.

Turning to safety, the rates of adverse events were similar between the two groups. In the Ocrevus group, 74.9% of people had at least one adverse event and 12.8% had a serious adverse event. In the placebo group, 71.1% of people had an adverse event, with 13.2% reporting a serious adverse event. Three percent of people receiving Ocrevus and 2.4% of those given placebo stopped receiving their infusions due to an adverse event.

Ocrevus is the only disease-modifying therapy approved by the Food and Drug Administration for treatment of primary-progressive MS, although several other DMTs are in late stages of investigation for use in the condition. The results of this trial hopefully will provide the 10% to 15% of people with MS who have the primary-progressive form of the disease with further encouragement regarding the therapy’s efficacy and reassurance in terms of its safety.

 

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Gray matter brain atrophy on MRI predicts progression independent of relapse in early MS

Progression independent of relapse activity, or PIRA, has come to be recognized as a silent-but-significant cause of increased disability in people with MS.

Now, a team of European researchers has shown that decreases in the brain’s gray matter, which is strongly associated with memory, information processing, and movement, as measured by magnetic resonance imaging (MRI), are associated with elevated risk for PIRA in the five years following a first demyelinating event.⁹

Those researchers studied 100 people who had experienced a demyelinating event. The study participants had an average age of 32.3 years. Two-thirds were female. At baseline, only 35% met the full criteria for a diagnosis of MS, although all had one or more symptoms indicating demyelination.

Researchers evaluated the people at baseline, and at 6, 12, 36, and 60 months. Assessments included the Expanded Disability Status Scale (EDSS), 9-Hole Peg Test (9HPT), and Timed 25-Foot Walk (T25FW), as well as MRI measures of the grey and white matter in the brain. In simplest terms, white matter facilitates communication between different parts of the brain, while gray matter is responsible for the actual processing of information. A person was considered to have PIRA if scores on the EDSS, 9HPT, or T25FW, changed for the worse when comparing one’s initial test score to that of a subsequent test.

Over five years of follow-up, 37% of study participants had at least one PIRA event, with some meeting more than one criterion for PIRA. Twenty-eight percent had a decline in their Timed 25-Foot Walk, while 15% saw their EDSS score worsen and 4% had decreased performance on the 9HPT, which assesses manual dexterity.

Researchers examined the MRI scans of study participants who did and did not experience progression independent of relapse (PIRA). They found that a 1% decrease in the overall volume of grey matter in the brain, or a 1% decrease in the volume of cortical gray matter, was associated with nearly a double risk for PIRA (1.72-fold and 1.75-fold increased risk respectively). Investigators did not identify an association between change in the brain’s deep gray matter or white matter, and an increased risk of PIRA.

Summarizing their findings, the researchers said, “PIRA events are frequent within five years of the first demyelinating event.” They added that the association between decreased gray matter and increased risk for PIRA points to “neurodegeneration as a key contributor to early disability accumulation in MS.”

By documenting how frequently early disease progression occurs even in the absence of relapse and using MRI findings to highlight the role of neurodegeneration, this study provides further support for “getting out in front” of MS disability through a proactive approach to providing effective treatments.

 

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What six minutes today may reveal about your MS status three years from now

People with MS who were able to walk the length of roughly a little less than five football fields in six minutes had better physical and cognitive status three years later than others with MS who walked shorter distances over six minutes.¹⁰

Researchers reported that outcome after studying 402 people with MS whotook the 
6-Minute Walk Test (6MWT), which physicians use to assess the function of people with neurological, musculoskeletal, respiratory, and other conditions. Investigators divided study participants into two groups based on whether they walked more or less than 446 meters, which translates into 488 yards, or just less than five football fields (not including end zones!).

There were 282 people in the group walking more than 446 meters. More than 99% of those people had relapsing-remitting MS. By contrast, among the 120 people walking less than 446 meters, 22.8% had secondary-progressive MS and 6.9% had primary-progressive MS.

As might be expected, the people walking further than 446 meters had more favorable baseline scores of physical and cognitive function than those walking shorter distances. For example, in the group walking greater than 446 meters, the average baseline Expanded Disability Status Scale (EDSS) score was 1.13, while people in the group walking less than 446 meters had a baseline EDSS of 3.15, indicating a greater degree of disability. The EDSS is a 10-point scale that measures progression and disability in MS. The lower numbers assess mobility as well as other abnormal neurological findings, while the higher numbers are largely determined by ambulation and one’s walking ability.

Over three years of follow-up, those who walked less than 446 meters had greater declines than the longer walkers in several key tests. These assessments included the 9-Hole Peg Test, which measures finger dexterity; the timed 25-meter walk test, which gauges walking speed; the Symbol Digit Modalities Test, which evaluates information processing speed; and the California Verbal Learning Test, Second Edition, which looks at verbal learning skills and memory deficits.

The study’s authors concluded that “these results support the integration of functional thresholds like the 6MWT into clinical decision-making to better predict disease trajectory, personalize care, and optimize long-term monitoring.”

As the authors note, this study identifies a tool that clinicians may find useful in shaping treatment plans and patient-monitoring schedules. What would not be useful, however, is for people with MS to attribute undue significance to the results of a single, six-minute test. Distance is not destiny. Walking less than a certain threshold on any given day is not cause to become discouraged or to believe that further decline is inevitable. Rather, it is reason to consider how you can take good care of yourself to “go the distance” by enjoying enhanced health in the years ahead.

 

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Does the location of where a person with MS lives affect what clinicians evaluate at visits?

A study by researchers from Johns Hopkins indicates that socioeconomics play a role in what people with MS are asked when they see their clinician.¹¹

The researchers identified 260 people with multiple sclerosis. Based on the addresses of these individuals, they divided them into three groups reflecting their neighborhoods’ degree of socioeconomic advantage or disadvantage as measured by the Area Deprivation Index. Study participants had an average age of 51.3 years. Seventy-eight percent were women; 51% were Black, and 49% were White.

After reviewing records of what clinicians evaluated over the course of four visits for each study participant, the researchers found that people in the group with the greatest degree of socioeconomic disadvantage were:

• 61% less likely to be evaluated for mood
• 69% less likely to be asked about sleep
• 60% less likely to be asked about physical activity
• 52% less likely to have a diet/nutrition evaluation
• 3.8 times more likely to be asked about their smoking status

While noting that, “Additional research is needed to more fully understand the role of clinician and patient factors in these differences,” the researchers wrote, “Based on our findings, continued efforts to standardize aspects of the MS clinical visit and provider training to increase awareness of these trends may offer opportunity to reduce existing disparities in MS care.”

 

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Two studies highlight how diet affects MS disability

Following a plant-based diet is associated with reduced disability in people with MS, while consuming relatively large amounts of ultra-processed foods is linked to greater disability.

Those are the bottom-line findings from two long-term studies conducted by a team of British and Australian researchers.^{12, 13}

The first study drew on data from the UK MS Register to assess the dietary habits of 3,740 people with MS over six years.¹² Study participants completed the 130-item EPIC-Norfolk Food Frequency Questionnaire. Researchers then assigned each person a score indicating the degree to which each individual’s eating habits aligned with the Mediterranean-DASH Intervention for Neurodegenerative Delay, or MIND, diet. The eating plan – which emphasizes intake of leafy greens, berries, nuts, whole grains, fish, and olive oil, while limiting red meat, butter, cheese, pastries, and fried foods – has been shown in several studies to have neuroprotective effects.

The researchers then looked to see if there was a correlation between study participants’ MIND Diet scores and the degree of MS-related disability and fatigue that those people reported when they completed the MS Impact Scale-Physical (MSIS-P) and Fatigue Severity Scale (FSS). They found that higher MIND scores were associated with less disability and less fatigue, as well as with higher quality of life. All of those associations were statistically significant.

The second study also drew on data from the UK MS Register and participants’ answers to questions on the EPIC-Norfolk Food Frequency Questionnaire.¹³ This time, however, researchers looked at the experience of 1,829 people with MS over eight years and focused on consumption of ultra-processed foods, such as sausages, chicken nuggets, and fish sticks.

In this study, people who had higher scores over time on a scale used to measure consumption of ultra-processed foods had greater self-reported MS-related disability at the end of the study period. The study did not, however, identify consistent associations between higher scores on the ultra-processed food scale and fatigue. Commenting on their findings, the researchers concluded, “Interventions targeting reductions in ultra-processed food content may be a worthwhile focus to improve disability” in people with MS.

 

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Verbal memory issues: A first sign of cognitive decline in people with MS who are physically stable?

Difficulty with verbal memory is often the first sign of cognitive problems in people with MS who appear to be stable physically, a team of Turkish investigators report.¹⁴

Those researchers explained that diminished cognitive function often goes unnoticed when people with MS do not have obvious signs of physical decline. In an effort to speed recognition of cognitive issues in such people, the researchers sought to determine which of three commonly used neuropsychological tests — the California Verbal Learning Test-II (CVLT-II), Brief Visuospatial Memory Test- Revised (BVMT-R), and Symbol Digit Modalities Test (SDMT) — most often and most rapidly identifies cognitive deterioration in people with MS who have stable motor performance.

The researchers recruited 190 people with MS who had demonstrated no progression in physical disability over a five-year period. Annually, each study participant completed the CVLT-II, which assesses verbal memory; the BVMT-R, which evaluates visual learning and memory; and the SDMT, which gauges cognitive processing speed and attention. Cognitive decline was defined as a significant decrease in performance in any test compared to a prior score on that test.

Seventy-six of the study participants had no evidence of cognitive decline over five years. Of the 114 people whose test performance did indicate diminished cognitive function, 52 (or 45% of those experiencing a decline) had a significant drop on their score in the CVLT-II. Forty people, or 35% of those who experienced a decline in test scores, had diminished performance on the BVMT-R, while the remaining 22 people first showed signs of cognitive decline with worse scores on the SDMT. Analysis showed that the results for all three tests were statistically significant.

The study’s authors wrote, “These findings suggest that verbal learning and memory may serve as a sentinel marker for cognitive progression independent of motor worsening, reflecting an early form of cognitive progression independent of relapse activity.” They added, “Incorporating verbal memory assessments into routine follow-up could enhance early detection of cognitive impairment and support timely intervention strategies to preserve long-term cognitive health in MS.”

 

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Sandoz announces launch of Tyruko^®

Editor’s note: To follow is late-breaking news not associated with ECTRIMS 2025.

Tyruko^® (natalizumab-sztn), the first approved biosimilar for the long-term treatment of multiple sclerosis (MS), is now available in the United States. Marketed by Sandoz, Tyruko is a biosimilar to Tysabri^® (natalizumab), and as with Tysabri, Tyruko is approved to treat relapsing forms of MS. These include clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary-progressive MS (SPMS).

Because it is a biosimilar to Tysabri, Tyruko is given at the same dosage and via the same administration as Tysabri (IV infusion every four weeks), while also carrying the same benefits and risks. A rare but serious risk of Tysabri, as well as certain other immunosuppressants, is the development of progressive multifocal leukoencephalopathy (PML), an often-fatal viral infection of the brain. Caused by the John Cunningham virus (JCV) – an often-dormant virus found in the brain of a portion of healthy individuals – the risk of developing PML can be reduced by testing for JCV antibodies in advance.

Although Tyruko was originally approved by the Food and Drug Administration (FDA) in 2023, the launch of Tyruko was delayed as the makers waited for the approval of a John Cunningham virus (JCV) antibody test. Similar to Tysabri, Tyruko is available through a Risk Evaluation and Mitigation Strategy (REMS) program to inform healthcare providers and patients about the risk of PML associated with this treatment. Sandoz has partnered with Labcorp in developing this JCV testing, and Sandoz will cover the cost for eligible patients.

 

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References

1. Freeman L, Gomez A, Balasubramanian B, et al. The journey from first symptoms to MS diagnosis: how lived experiences inform the work of the MSIN. P2025. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
2. Obekpa EO, Silveira SL, Yamal J-M, et al. Evidence-based health promotion, symptom management, and supportive care interventions for people with multiple sclerosis: a scoping review. P433. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
3. Mak S, Thomas A. Steps for Conducting a Scoping Review. J Grad Med Educ. 2022 Oct;14(5):565-567. doi: 10.4300/JGME-D-22-00621.1. PMID: 36274762; PMCID: PMC9580325.
4. Abad-Inchaurrondo I, Lu S, Lui E, et al. Performance of the 2024 McDonald diagnostic criteria for multiple sclerosis. P1005. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
5. Lee J, Renner B, Amin M, et al. Diagnostic performance of paramagnetic rim lesions in multiple sclerosis in a large, prospective, multicenter cohort: insights from the CAVS-MS Study. P916. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
6. Hendin B, Wray S, Okuda D, et al. AGNOS: A Phase 4 study of ofatumumab in treatment-naïve participants with very early relapsing-remitting multiple sclerosis compared with healthy controls. P428. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
7. Spelman T, van der Walt A, Havrdova E, et al. Real-world experience with cladribine tablets in older age groups in the MSBase Registry. P1985. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
8. Giovannoni G, Arias L, Bove R, et al. Ocrelizumab vs placebo in primary progressive MS: efficacy and safety results of the Phase IIIb ORATORIO HAND study. P128. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
9. Olivieri E, Collorone S, Foster M, et al. Gray matter atrophy predicts Progression Independent of Relapse Activity [PIRA] in the first five years after the first demyelinating event. P1937. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
10. Unal GD, Caliskan C, Zengin E, Ozakas S. The 6-minute threshold: tracking three-year disability and cognition in multiple sclerosis. P1921. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
11. Bhattarai J, Jones M, Hughes A. Neighborhood-level socioeconomic disadvantage and clinical care characteristics in multiple sclerosis. P1954. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
12. Yu M, Simpson Yap S, Coe S, et al. Adherence to the MIND diet is associated with reduced disability and fatigue and improved quality of life in people with multiple sclerosis: a 6-year longitudinal analysis from the UK MS Register. P431. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
13. Simpson-Yap S, Yu M, Coe S. Higher ultraprocessed food scores significantly predict greater disability over 8 years’ follow-up in the UK MS Register prospective cohort study. P929. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.
14. Unal GD, Caliskan C, Samadzade U, Aydin E. Verbal memory as a leading indicator of cognitive decline in multiple sclerosis with stable physical function. P913. ECTRIMS 2025. September 24-26, 2025. Barcelona, Spain.

 

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For More Information

For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.

Written by Tom Garry, Medical Writer
Reviewed by Dr. Barry Hendin, MSAA Chief Medical Officer
Edited by Susan Wells Courtney, MSAA Senior Writer

Medical details and study results provided in MSAA’s published materials are for informational purposes only and are not to be considered as treatment advice or recommendations. Readers are encouraged to consult a healthcare professional before making any changes to their current treatment regimen.