What’s New in MS Research: September 2020

Reviewed by MSAA Chief Medical Officer Barry A. Hendin, MD

Introduction

This edition of MSAA’s “What’s New in MS Research” article features highlights from the annual meetings of the American Academy of Neurology (AAN) and the Consortium of MS Centers (CMSC). Because of the ongoing COVID-19 pandemic, both of these meetings were held virtually. The breadth and timeliness of multiple sclerosis (MS) research are on full display in the items that follow. While not all of the reports are positive, the good far outweighs the rest, and encompasses not only promising research advances in MS, but also a potential role for a long-established DMT in treating COVID-19.

This iteration of What’s New in MS Research also features an update on stem cell therapy, shares important insights into patients’ priorities regarding treatment, details how adherence to treatment regimens translates into better outcomes over several years, examines a potential link between childbearing status and onset of progressive MS, and reports on sex-based differences in cognitive function in MS.

As you review these reports, please remember that each study summarized here, each new piece of knowledge about MS, and each treatment advance, all result from the willingness of people with MS to participate in vital research projects. To learn more about clinical trials, please visit mymsaa.org/clinicaltrials. For more information on the many resources and services offered by the Multiple Sclerosis Association of America (MSAA), please visit mymsaa.org.

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Evobrutinib shows efficacy up to 108 weeks in open-label extension study

An investigational agent that reduced the number of MS-related lesions seen on MRI and the annual relapse rate (ARR), relative to placebo, over 48 weeks of treatment, while demonstrating continued efficacy for up to two years after treatment initiation, a recent study found. [Montalban CMSC 2020]

The agent, evobrutinib, is a Bruton’s tyrosine kinase inhibitor (BTKI), meaning that it inhibits the activity of a protein – Bruton’s tyrosine kinase – that affects the B cells believed to play a role in the development of MS. In a Phase II trial that lasted 48 weeks, study subjects were assigned to receive either one of three different doses of evobrutinib, the approved medication Tecfidera^® (dimethyl fumarate), or placebo. At the end of that study, participants were given the option of continuing on in an open-label extension study in which all patients would receive 75 mg of evobrutinib once daily before increasing to 75 mg of the medication twice daily. That open-label extension study assessed the efficacy and safety of evobrutinib for up to 108 weeks. Roughly 80% of participants in the initial study – 213 people – opted to continue in the longer-term study.

Researchers found that people who had taken 75 mg of evobrutinib twice daily from the start of the first trial had an annualized relapse rate of 0.11, which was lower than that for placebo, at 48 weeks, with the ARR increasing by only one one-hundredth of a point to 0.12 at 108 weeks. They added that among patients taking evobrutinib, transient increases in liver enzymes seen in the 48-week trial were not observed in the open-label extension study.

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Government study evaluating Rebif^® (interferon beta-1a) as COVID-19 treatment

A long-approved MS therapy is among the newest options being evaluated for treatment of COVID-19.

The National Institute of Allergy and Infectious Diseases, the branch of the National Institutes of Health (NIH) led by Anthony S. Fauci, MD, announced in early August that it is studying the efficacy and safety of treating COVID-19 with the antiviral agent remdesivir and Rebif^® (interferon beta-1a). The combination regimen is being evaluated in a study called the Adaptive COVID-19 Treatment Trial 3 (ACTT 3), which seeks to enroll more than 1,000 hospitalized adults with COVID-19 at as many as 100 sites in the United States and abroad. [NIH]

Rebif was approved for the treatment of relapsing forms of MS in March 2002. An NIH press release noted, “Interferon beta-1a has the same amino acid sequence as a naturally occurring protein called interferon beta, which is part of a class of proteins called type 1 interferons. Infected cells normally produce type 1 interferons to help the immune system fight pathogens, especially viruses. Interferon beta has both antiviral and anti-inflammatory properties.

Laboratory studies suggest that the normal interferon response is suppressed in some people after infection with SARS-CoV-2, the virus that causes COVID-19. In the laboratory, type 1 interferon can inhibit SARS-CoV-2 and two closely related viruses, SARS-CoV and MERS-CoV. In addition, two small randomized controlled trials suggest that treatment with interferon beta may benefit patients with COVID-19.” The NIH added that preliminary evidence from earlier trials showed that COVID-19 patients who received remdesivir recovered sooner than those receiving placebo.

The NIH said that the study will focus on hospitalized adults with laboratory-confirmed SARS-CoV-2 infection with evidence of lung involvement (including a need for supplemental oxygen), abnormal chest X-rays, or illness requiring mechanical ventilation. Patients will be randomized in a 1:1 ratio to receive either subcutaneous interferon beta-1a plus remdesivir or remdesivir alone. The study will be a double-blind trial, with neither patients nor clinicians knowing who is receiving the combination therapy and who is receiving remdesivir plus a placebo.

“Investigators will evaluate whether time to recovery is shorter in the combination therapy group relative to the remdesivir-only group,” the NIH said, adding that the trial will also evaluate outcomes including mortality.

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Stem cell therapy for MS: Examining the impact on cognition

Stem cell therapy continues to be the subject of intense interest in MS, with several small and modest-sized studies yielding encouraging results in terms of clinical and imaging markers of disease status. As that research moves forward, investigators are evaluating the impact of stem cell therapy not only on MS itself but also on patients’ overall health and function. A recent randomized, double-blind crossover study examined preliminary cognitive outcomes in 28 patients who had stem cell therapy for their MS. [Walker CMSC 2020]

Seventeen of the patients in the study had relapsing-remitting MS, seven had secondary-progressive MS, and four had primary-progressive MS. Fifteen study subjects were female, and 13 were male. The patients’ average age was 37 years, and their average Expanded Disability Status Scale (EDSS) score was 4.27.

Those patients were randomized to receive either a single intravenous infusion of autologous (from their own bodies) stem cells or a sham infusion at the start of the trial (Week 0). They then were observed for 24 weeks, with monitoring including neuropsychological assessment at Weeks 0 and 24. At Week 24, the people who had received a sham infusion initially received an infusion of stem cells, while those who received stem cells at Week 0 had a sham infusion. The patients were monitored for an additional 24 weeks, and underwent another neuropsychological assessment at Week 48.

The study’s authors reported that in the period immediately after treatment, patients showed relative stability in most cognitive tasks. They added, however, that “decline was observed in some aspects of attention/information processing speed, visual learning and memory, as well as language. Improvement was noted in verbal learning and memory, as well as visual perception.” They continued that in patients who received stem cells at the outset of therapy, which enabled assessment of treatment impact over the full 48 weeks, “there was a trend for performance to return to pre-treatment baseline, with the exception of visual learning and memory.”

Those observations led the researchers to conclude: “Except for visual learning and memory there appears to be little detrimental effect of [stem cell] therapy on cognition. While some changes may occur in the initial period following treatment, these appear to be transient and, in general, return to baseline over time.”

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The primary factor shaping patients’ treatment choices

Concern about disability was the primary factor driving choice of treatment among people with relapsing-remitting multiple sclerosis (RRMS), according to a survey of 78 patients. [Bardsley CMSC 2020]

Australian researchers had those people complete a survey in which the patients rank-ordered several factors from most to least important in influencing their choice of an MS therapy. The factors included perception of drug safety, perception of efficacy, ease of use, mode of administration, mechanism of action, concern about disability, requirement for follow-up safety monitoring, balance of risk/benefit, and value of discussion with an MS nurse and neurologist.

The people completing the survey were roughly equally divided between those starting an initial treatment, those switching to treatments, and those who were stable on treatment.

Thirty-one of the 78 participants (39.7%) said concern about disability was their main consideration, while 16 (20.2%) cited perception of treatment efficacy, and 11 (14.1%) said perception of safety most influenced their decisions related to treatment. Those priorities were consistent across patients new to treatment, switching treatment, or stable on treatment, the study authors reported.

Further, 97% of participants said they were satisfied with the process by which they arrived at a treatment decision, and 92% reported feeling extremely comfortable with their treatment decision.

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Why taking your disease-modifying therapy (DMT) faithfully really matters

Here’s a simple way people with MS can reduce their risk of needing a cane, walker, or wheelchair in the years ahead while increasing the likelihood that they will have fewer relapses: Be sure to take your medicine when you’re scheduled to take it. [Amezcua CMSC 2020]

That common-sense but often disregarded advice is supported in convincing fashion by a study that looked at more than 15,000 people with MS and their medication-taking habits over six years. Researchers matched people who took their disease-modifying therapy (DMT) in an adherent manner (as judged by having medication in their possession – a “filled prescription” – at least 80% of the time) with those considered non-adherent.

People in the adherent group had a lower average number of relapses compared to those who were non-adherent (0.153 vs. 0.201), had a significantly longer time to first relapse, and were 19% less likely to use a cane or walker and 40% less likely to use a wheelchair than people who were non-adherent.

“This study highlights the importance of DMT adherence in slowing disease progression,” the researchers concluded. While that finding may be straightforward, the reasons people do not take their medication as prescribed can be complex, involving attitudes and concerns, side effects, financial issues, and more. Given the benefits to be had from complying with medication schedules, as outlined above, there is compelling reason for patients to talk honestly with their clinicians about factors that may be affecting their adherence to treatment and then working together to find ways to overcome those obstacles.

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“We need to talk…” Varying clinician and patient recollections about discussions on disease progression

Ninety-seven percent of clinicians participating in a recent survey said that they discuss disease progression with MS patients, but only 32.7% of people with MS report having talked about the subject with their physician or other healthcare provider (HCP). [Williams 2020]

What might explain that disparity, which emerged when the “MS in the 21st Century” initiative surveyed 105 HCPs and 113 people with MS?

A definitive explanation may not be possible, but it’s important to note that the survey was based on participants’ recollections rather than, say, a review of visit notes. A clinician may recall discussing disease progression when he or she did not, and a patient may have engaged in a conversation about disease progression but not recall it. Further, clinicians may talk about disease progression with some but not all of their patients – based on where each person is in the course of his or her MS – while a patient can speak only to his or her own experience. Whatever the answer may be, another statistic to emerge from the survey may be even more significant: 30.9% of the people with MS participating in the survey said that they did not feel empowered to initiate a conversation about disease progression, or were waiting for their clinician to raise the topic.

The bottom line: Be proactive and raise the subject of disease progression with your clinician. Understanding what may occur, or already is occurring, can help both of you respond more effectively. While the conversation may be uncomfortable, it’s an important one to have, and as with most things in life, sooner is better than later.

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Does MS put a woman at increased risk for abuse? Disturbing survey findings

For women, the burdens imposed by multiple sclerosis may include increased risk for being subjected to physical, sexual, or other forms of violence, according to a study involving 200 women with MS. [Pol-Patil]

The study subjects were drawn from more than 800 women with MS who saw a neurologist at the Partners MS Center in Boston from late July to late October 2019. Of the 200 women who agreed to complete the study’s questionnaire, 65% were married or with a long-term partner, 67% were employed full-time or part-time, and 93% identified as heterosexual, while 4% were bisexual and 2.5% were homosexual. The participants’ median age was 49 years, and the average duration of their MS was 13 years.

Thirty-eight percent of the study participants reported having been subjected to some form of abuse at any point in time. By comparison, 29% of women in the overall population say that they have experienced abuse at some point in their lives.

Among the survey participants who reported having experienced abuse:

• 14.4% reported abuse in the prior 12 months
• 20% said they had experienced physical and/or sexual abuse
• 25% reported verbal abuse
• 55% reported a history of both physical and verbal abuse

Women who were married or in a domestic partnership were more likely to report having experienced abuse than women who were single, and having current neurologic disability was associated with a greater likelihood of having been subjected to verbal abuse.

Less than half of the women (47%) who experienced abuse had sought professional help in dealing with the resultant trauma.

The study authors’ conclusions included two important points: “Intimate partner violence in married or partnered women with MS may be more prevalent than previously recognized. Lower than expected anonymous questionnaire response rates suggest persistent patient discomfort in addressing this difficult matter.” The researchers note that they will continue recruiting subjects to further investigate this issue, which will help to raise awareness.

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Exploring a possible link between childbearing history and onset of progressive MS

It long has been known that women are at an increased risk for MS relative to men, but a recent study now raises the prospect that a woman’s childbearing status may affect her risk for earlier onset of progressive multiple sclerosis. [Zeydan 2020] A group of researchers from Mayo Clinic – who stress the need for this issue to be examined in a larger study – recently mapped disease course in 134 women and 68 men with progressive forms of MS. Those patients included both people with primary-progressive MS and those who transitioned from relapsing-remitting multiple sclerosis (RRMS) to secondary-progressive MS.

Among the women in the group, the 32 patients who had not given birth to a child had onset of progressive multiple sclerosis at an average age of 41.4 years, almost six years earlier than the average age for the 95 women who had delivered one or more children. That difference was statistically significant. Further, women who had delivered four or more children had an average age of progressive MS onset that was six years later than those who had delivered one to three children (52.6 years vs. 46.4 years, with the difference again being statistically significant).

Looking at the subgroup of patients who transitioned from RRMS to secondary-progressive MS, women who had not delivered a child also had a younger average age of RRMS diagnosis compared to those who did have children (27.5 years vs. 33.0 years, a statistically significant difference). Similarly, having given birth to four or more children was associated with a later average age of RRMS diagnosis than having delivered one to three children (35.8 years vs. 32.4 years, with the difference again being statistically significant).

While the findings are intriguing, the authors note that several questions require further investigation, including “whether MS-associated factors lead to nulliparity [not having delivered a child] either by choice or due to biological reasons.”

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Cognitive dysfunction in MS: Exploring sex-based differences

Men with MS have a higher risk for cognitive dysfunction than women with MS. That’s the conclusion investigators reached after using neuropsychological assessments and magnetic resonance imaging (MRI) of the brain to evaluate cognitive performance in 1,052 people with relapsing-remitting MS. [Uher AAN 2020]

In comparing men with women, the researchers adjusted their findings for factors such as age, Expanded Disability Status Scale (EDSS) score, education level, and depression. They found that 30% of men had abnormal cognitive screening, as opposed to 26% of women, with the male subjects performing slightly worse than female subjects in terms of verbal memory and information-processing speed. The sex-based differences in cognitive performance remained statistically significant after adjustment for extent of brain atrophy and lesion burden as seen on MRI.

Interestingly, while a higher proportion of men than women had evidence of cognitive dysfunction, women were slightly – but statistically significantly – more likely than men to think that they had cognitive issues.

The researchers concluded from their findings that male gender should be viewed as a risk factor for cognitive issues in MS. However, the fact that more than one-quarter of both men and women experienced such issues, underscores the importance that all patients, their care partners, and their clinicians, be attuned to the cognitive burdens of having MS.

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High blood pressure is undertreated in people with multiple sclerosis

Slightly more than one-third of people with MS who met the latest criteria for having hypertension, or high blood pressure, were being treated for the condition, according to an analysis of more than 9,700 patients. [Bassi 2020]

Researchers drew on information from the Multiple Sclerosis Partners Advancing Technology and Health Solutions, or MS PATHS, international database, which is funded by Biogen Inc., to conduct their analysis. Of 9,760 people with recorded blood pressure measurements in the database, 2,718 (27.9%) had at least two readings with systolic blood pressure of 130 mm Hg or higher and/or diastolic blood pressure of 80 mm Hg or higher. In 2017, the American Heart Association defined hypertension as a blood pressure of 130/80 mm Hg or greater.

Only 997 of those 2,718 people, or 36.7%, were receiving treatment with anti-hypertensive medication. However, as blood pressure levels rose, the proportion of people receiving treatment also increased: More than 46% of those with blood pressure values of 140/90 mm Hg or more had been prescribed antihypertensive medication.

With optimizing overall health a key strategy for reducing the impact of multiple sclerosis, these finding would suggest the importance of people with MS having an “on the cuff” discussion with their clinicians about keeping blood pressure below hypertensive levels.

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Identifying and eliminating disparities in the African American experience with multiple sclerosis

The need to better understand the African American experience is particularly important in MS, a disease in which African Americans have higher incidence rates and faster progression in many disease manifestations than their white peers, yet frequently encounter disparities in care. [LeGrand 2020 CMSC]

To address this need, the Multiple Sclerosis Association of America (MSAA) recently convened “The African American Experience & MS Advisory Board.” Eleven healthcare professionals (HCPs), 13 people with MS, and three care partners attended a half-day meeting to provide their views on problems faced by African Americans living with MS. The goal of the meeting was to facilitate dialogue that would enable development of programmatic initiatives and interventions to address unmet needs in the African American community.

The study’s author noted that during the meeting, patient members “expressed that they are often discredited, ignored, or approached with skepticism and disrespect when reporting their symptoms or concerns. This inevitably leaves many feeling powerless and anxious regarding communications with their HCPs.” The people with MS participating in the meeting also noted that they rarely develop strong relationships with neurologists and other HCPs, and pointed to a need for more education directed toward the African American community and greater representation in clinical trials. Healthcare professionals participating in the meeting acknowledged these challenges, noting that “disease-specific information at the provider-patient level is often encumbered by specific personal and system-wide factors, including systemic racism.”

The patients on the advisory board panel recommended development of peer-to-peer forums that would offer interpersonal support and guidance. They also endorsed the creation of public service announcements and an African American MS patient registry. Meanwhile, the primary recommendation from the healthcare professionals participating in the meeting was to develop targeted education for individuals with MS, care partners, and providers. Finally, the care partners saw a need for educational support on topics including techniques for lifting/moving a patient, patient exercise needs, and means of coping with the stresses of acting as a care partner. They also recommended considering the development of care partner retreats.

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Survey suggests a need for vaccination education among MS patients

Thirty-two percent of people with MS participating in an online research project reported that they do not receive an annual flu shot, while slightly higher proportions said they do not feel well informed about flu shots or other immunizations. [Crispino CMSC 2020]

Those gaps in vaccination practice and knowledge emerged from a Fall 2019 survey of 1,962 people with MS. Conducted by the Multiple Sclerosis Association of America (MSAA), the 27-question survey was developed to better understand how people with MS perceive and talk with their clinicians about seasonal influenza vaccination and other immunizations.

Key findings include:

• 36% of respondents said they did not feel well informed about immunizations generally
• 38% said they do not feel well informed about flu shots specifically
• 38% said they believe that a flu shot or other immunization will interfere with their disease-modifying therapy (DMT) or worsen their MS
• 42% said they worried about adverse events from a flu shot or other immunization

The 32% of participants who reported not receiving a flu shot in the prior year said that they also did not anticipate receiving a vaccination against seasonal influenza in the year ahead. However, the study author noted that the survey was conducted prior to the COVID-19 outbreak, and that people’s attitudes and plans may have changed in light of the pandemic.

Among the one-third of respondents who had not received a flu shot in the prior year, common reasons for opting against the vaccination included concerns about side effects; worries that the vaccine was not safe for people generally and/or specifically for people with MS; concern about interference with DMTs; and a sense that it was not needed.

Meanwhile, large majorities of participants reported talking with their clinicians about flu shots and other immunizations, with 68% saying they talk with their MS neurologists and 80% indicating that they discuss the topic with their general practitioner or primary care provider. Further, most participants view healthcare professionals (HCPs) as their most trusted source of information about flu shots, while only 5% or fewer reported that television/radio, employers, friends, or family were the sources they trusted most. In a finding with important implications for the topics MS clinicians address in the often-constrained time they have for patient counseling, 75% of respondents said they would prefer to receive information on flu shots and other immunizations from their MS neurologist.

In summarizing the survey results, study author Alexis Crispino noted, “There is still work to be done and information to be widely distributed.” She added that a “gap in understanding and education regarding the importance of flu shots and vaccinations in the MS patient population,” suggests the need to explore “future interventions aimed at targeted education on this issue and improved communication between HCPs and their MS patients.”

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Providing phenotype-specific education to inform treatment choices: There’s an app for that

The effort to individualize MS care to optimal effect for each patient has been greatly enhanced in recent years by the identification of distinct phenotypes, or forms, of multiple sclerosis that have different clinical courses and responses to disease-modifying therapies (DMTs).

Of course, for people with MS to be full partners in formulating treatment plans that draw on this knowledge, they need to know which phenotype they have and understand how that form of MS tends to present over the years. A recent research initiative found that one in five people with MS lack this critical information. [Rudell CMSC 2020]

The finding emerged from an analysis of data entered by more than 3,700 people with MS into My MS Manager^™, a HIPAA-compliant patient app developed in a collaboration between the Multiple Sclerosis Association of America (MSAA) and @Point of Care. (@Point of Care also created a complementary app for clinicians, Multiple Sclerosis@Point of Care; the two apps facilitate information sharing between patients and their clinicians.)

The analysis of patient-entered data found that 20% of people with MS using the app did not know what phenotype – such as relapsing-remitting MS (RRMS), secondary-progressive MS SPMS), or primary-progressive MS (PPMS) – they had. This lack of information tended to be most pronounced in patients between 20 and 39 years of age. While the finding speaks to an ongoing educational need, other results to emerge from the analysis underscored the benefits of the app and revealed how information interests varied by participant phenotype. For example, people with RRMS most often watched the apps’ videos on wellness tips and MS symptoms, while the most popular videos for people with SPMS focused on types of MS and the importance of long-term treatment. Among people with primary-progressive MS, the videos of greatest interest addressed who gets MS and the assistance available from MSAA.

The data analysis also yielded important insights into the demographics of people with MS. The ratios of females to males with various MS phenotypes accorded with those identified in other studies and databases, such as the MSBase Registry. Specifically, there were three times as many females as males for most phenotypes, although that sex differential declined to 1.5 female-to-male for SPMS. The study’s authors noted that males with PPMS are twice as likely as females to experience clinical deterioration over a 10-year period, making it important for clinicians to identify PPMS promptly in those patients and initiate an approved therapy for them. Considering the totality of their findings, the authors of the analysis concluded, “The My MS Manager^™ patient app facilitates MS patients’ ability to record their clinical phenotype, access educational videos—including those addressing phenotype, and empower them to better understand MS phenotypes and implications for treatment choices for discussion with their clinicians. This will ensure optimal treatment choices.”

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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

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References

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Bardsley B, Haynes J, Cinc E, et al. Exploration of factors which influence treatment decisions of patients with multiple sclerosis. Abstract DXT09. Consortium of Multiple Sclerosis Centers (CMSC) 2020 Virtual Annual Meeting. Available at https://cmscscholar.org/virtual-celebration-poster-presentations-v2/. Accessed August 7, 2020.

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National Institutes of Health (NIH). NIH clinical trial testing remdesivir plus interferon beta-1a for COVID-19 treatment begins. August 6, 2020. Available at https://www.nih.gov/news-events/news-releases/nih-clinical-trial-testing-remdesivir-plus-interferon-beta-1a-covid-19-treatment-begins. Accessed August 11, 2020.

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Zeydan B, Atkinson E, Smith C, et al. Nulliparity is associated with earlier evolution of progressive multiple sclerosis in women. American Academy of Neurology (AAN) 2020 Science Highlights Presentations. S24.001. Available at https://cslide-us.ctimeetingtech.com/aan2020/attendee/eposter/poster/2080. Accessed June 24, 2020.