What’s New in MS Research – November 2023

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

Milan, Italy served as the setting for cutting-edge science and high hopes last month, when multiple sclerosis (MS) researchers and clinicians from around the world gathered there in October for MSMilan2023, the 9th joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

The results from more than 1,900 studies were published at the session, which organizers note is the world’s largest MS research meeting. This edition of “What’s New in MS Research” provides a sense of the breadth and depth of findings presented in Milan. The studies highlighted below include encouraging study results on investigational medications that rely on new mechanisms of action to treat MS, ongoing evaluations of approved medications – including the first trial of a disease-modifying therapy that exclusively enrolled Black and Hispanic people – and research looking at the impact of menopause and diet on MS.

As always, we are excited to present this research to the MS community.

Study supports using high-efficacy medications from the start in relapsing MS

Is it better to begin treatment with a disease-modifying therapy (DMT) that offers high efficacy but may be associated with relatively frequent or significant side effects, or to start with a low- or moderate-efficacy medication with better tolerability and see if that treatment is sufficient, at least for the present?

It’s a question that people newly diagnosed with relapsing-remitting multiple sclerosis (RRMS) and their clinicians must consider carefully when weighing the choice of initial therapy. Fortunately, it also is a question receiving intense scrutiny from researchers, including investigators who reviewed data on 762 people with RRMS who began treatment in London, England between 2002 and 2022.¹

The people studied had an average age of 38.3 years when they started treatment, and had experienced an average of 1.1 relapses in the year before initiating a DMT. Their average Expanded Disability Status Scale (EDSS) was 2.1 at baseline, indicating mild impairment from MS. Seventy percent were females.

The study compared outcomes between 150 people who began treatment with a high-efficacy DMT, such as Ocrevus^® (ocrelizumab) or Tysabri^® (natalizumab), and 612 people who were prescribed low- or moderate-efficacy medications, including Tecfidera^® (dimethyl fumarate), Gilenya^® (fingolimod), and Copaxone^® (glatiramer acetate). In conducting their comparison, researchers matched study participants based on factors such as age, gender, number of relapses in the past year, and EDSS score. The main outcome measures were having no evidence of disease activity – defined by no relapses, no EDSS progression, and no new lesions as seen on magnetic resonance imaging (MRI) – at one year and two years after starting a medication.

At one year, people taking high-efficacy DMTs were 64% more likely than those on low- or moderate-efficacy DMTs to be without evidence of disease activity. At the two-year mark, they were 52% less likely to have no evidence of disease activity. Both results were statistically significant.

The investigators concluded that their findings suggest “that high-efficacy DMTs should be considered as [a] first option when discussing DMTs with treatment-naïve patients.” (“Treatment-naïve” refers to individuals who have not received any type of DMT previously.)

With more than two dozen DMTs approved by the Food and Drug Administration (FDA) for use in relapsing forms of multiple sclerosis, people with MS and their clinicians have an abundance of options to choose from when deciding which medication is best for them. Along with factors such as route of administration (e.g., a pill taken by mouth vs. a medication given by injection or infusion) and frequency of dosing, the benefit/risk profile of various treatments is a major consideration. This study and others examining the same question can facilitate more-informed discussions and decision-making on this important issue.

Are older people with highly active MS being under-treated?

Argentinian researchers analyzing data from a national patient registry found that less than one-quarter of people aged 50 years or older who had highly active relapsing-remitting multiple sclerosis (RRMS) were receiving high-efficacy disease-modifying therapies (DMTs).²

Of 950 people with RRMS who were 50 or older, 189 met the criteria for highly active MS, as defined by two or more relapses in the prior year and/or two or more new T2 gadolinium-enhancing lesions on MRI (gadolinium enhancement can indicate inflammatory activity).

While clinicians often prescribe high-efficacy DMTs to try to control highly active MS, only 23.2% of the 189 people received a high-efficacy therapy. The researchers found that the more relapses a person had experienced in the previous year, the more likely they were to be prescribed such a therapy. Conversely, the more comorbid conditions – such as hypertension or diabetes – people had, the less likely they were to receive a more-efficacious medication. Further, the likelihood of being prescribed a high-efficacy DMT declined steadily with age.

The researchers concluded, “It is essential to improve therapeutic benefit/risk ratios in the older population with MS to better prevent disease progression in this age group.”

While this study shines a spotlight on an important issue, two caveats should be noted. First, there are significant differences between the Argentine and American healthcare systems, so practice patterns in Argentina may not reflect the situation in the United States. Second, the presence of comorbidities can affect the chances of experiencing side effects from DMTs, and advancing age can affect how well a person can tolerate those side effects, so the fact that use of high-efficacy therapies declines with age and with worse overall health is not surprising and likely reflects an effort to minimize risk.

At the same time, highly active MS has both an immediate and a long-term impact on health and quality of life, making it important to provide effective treatment. As the study’s authors noted, better understanding the benefit/risk ratio faced by people of various ages and with different medical conditions is essential to help people with MS and their clinicians avoid both under-treatment and undue exposure to side effects.

Ocrevus^® trial exclusively enrolling Black and Hispanic people yields encouraging results

More than 94% of Black and Hispanic people with relapsing MS had no relapses during 48 weeks of treatment with the disease-modifying therapy (DMT) Ocrevus^® (ocrelizumab).^{3, 4}

That finding emerged from the CHIMES study, the first clinical trial of a DMT conducted exclusively in Black and Hispanic people with MS. CHIMES – which stands for characterization of ocrelizumab in minorities with multiple sclerosis – was a Phase IV trial, meaning that it was conducted following the Phase III studies that companies conduct to secure Food and Drug Administration (FDA) approval of a medication. The study was sponsored by Genentech, a member of the Roche Group and the pharmaceutical company that markets Ocrevus.

The prospective, single-arm trial enrolled 182 Black or Hispanic people with relapsing MS who were 18 to 65 years old and who had an Expanded Disability Status Scale (EDSS) score of 0-5.5, indicating minimal to moderate MS disease burden. Sixty-two percent of the patients were Black, while 38% were Hispanic. The average age of study participants was 35.5 years, and 72.5% of the people in the trial were female. On average, study participants had begun experiencing symptoms 4.9 years before entering the trial and had been diagnosed with relapsing MS 2.9 years before starting the study.

The trial’s primary endpoint was no evidence of disease activity (NEDA) at Week 48. NEDA was defined as no relapse, no confirmed disability progression at Week 24, and no T1 gadolinium-enhancing lesion or new/enlarging T2 lesions on MRI – at Week 48. Forty-six percent of Black patients and 58% of Hispanic patients achieved NEDA at Week 48. Further, more than 94% of patients had no relapses over 48 weeks and no 24-week confirmed disability progression or T1 gadolinium-enhancing lesions. Forty-six percent of Black patients and 63.8% of Hispanic patients had no new or enlarging T2 lesions. Adverse events occurred in 80.2% of people, with 29.1% having an infusion-related reaction. While 5.5% of people had a serious adverse event, no deaths occurred. Researchers noted that the safety results of CHIMES were consistent with the findings of other trials of Ocrevus, with no new safety signals emerging.

“We know that Black and Hispanic/Latinx people with MS often experience more severe disease and greater disability compared with their white counterparts. But until now, there has been limited research conducted in these populations,” said Mitzi Joi Williams, MD, lead trial investigator, founding medical director at Joi Life Wellness MS Center in Atlanta, GA, and chairperson of MSAA’s African American Advisory Board. Dr. Williams added, “The CHIMES trial is a critical step in breaking the cycle of health inequity. The results, for the first time, provide evidence on the benefit of treatment in Black and Hispanic/Latinx people with MS.”
 
The CHIMES trial took several steps to overcome barriers to recruitment and promote retention among Black and Hispanic people with MS. Trial sites, which were located across the United States, Kenya, and Puerto Rico, included academic institutions, hospitals, outpatient clinics, community centers, and healthcare provider practices. To facilitate enrollment, trial-related materials were available in multiple languages (English, Spanish, and Swahili) and reviewed by an advisory panel to ensure understanding and cultural appropriateness. Trial participants were offered flexible scheduling options; appropriate compensation or reimbursement for loss of earnings, childcare, accommodation, travel, and meals; and utilization of ride-sharing companies for transportation. The CHIMES trial has been extended to three years to gather long-term data on MS progression among Black and Hispanic populations, with further results anticipated to be available in 2024.

Australian study finds evidence of enduring benefit from Mavenclad^®

Does Mavenclad^® (cladribine) continue to provide benefit after people with MS have completed the treatment course of four doses administered over roughly two years, or should subsequent re-dosing be considered?

The question is an important one because the oral disease-modifying therapy (DMT) has proven efficacy in treating relapsing forms of MS but also may be associated with increased risk for cancer. Because of the medication’s safety profile, its FDA-approved prescribing information notes that “use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.”⁵

To understand the long-term efficacy of Mavenclad and assess the potential need for additional dosing, Australian investigators are following 156 people with MS who are taking the medication.⁶ The researchers are tracking the patients’ levels of serum neurofilament light chain (sNfL) and serum Glial Fibrillary Acidic Protein (sGFAP), which are thought to be markers of inflammation and neurodegeneration. They also are assessing changes in Expanded Disability Status Scale (EDSS) scores and cognitive assessments.

At the MSMilan2023 meeting in Milan last month, the researchers reported findings on 56 study participants for whom they have 30 months’ worth of data. Those patients had statistically significant decreases in both sNfL and sGFAP from baseline through 30 months, indicating a positive effect on inflammation and neurodegeneration. Meanwhile, there was no change in average EDSS score or measures of cognitive function over the 30-month period, suggesting an enduring stabilizing impact on disability and cognition. While the study is ongoing and will be reporting data on more people over more time, the results available thus far point toward ongoing benefit and have not identified a waning of effect that might warrant consideration of re-dosing.

Briumvi^® shows reduction in brain volume loss and new lesion formation

People with relapsing MS who received the infused disease-modifying therapy (DMT) Briumvi^® (ublituximab-xiiy) in two clinical trials had significantly less thalamic volume loss over two years than study participants who received the oral DMT Aubagio^® (teriflunomide), researchers reported.

The findings emerged from an analysis of the ULTIMATE 1 and ULTIMATE 2 Phase III trials. Based on other findings from those studies, the Food and Drug Administration approved Briumvi in December 2022 for the treatment of relapsing forms of MS. In an analysis presented at the MSMilan2023 meeting, researchers focused on changes in volume of the thalamus, the section of the brain that is responsible for relaying motor and sensory signals to the cerebral cortex.

In examining magnetic resonance imaging (MRI) data on almost 1,100 patients participating in the two studies, investigators found that people receiving Briumvi had 22% less loss in thalamic volume from baseline to Week 96 than study participants receiving Aubagio, with the difference being statistically significant. Meanwhile, people taking Aubagio had roughly a four-times greater increase in T1 hypointense lesion volume, a marker of brain tissue loss, over 96 weeks than people receiving Briumvi. That difference also was statistically significant. Investigators added that in people receiving Briumvi, “New T1 and T2 lesion formation was almost completely suppressed after the first year of treatment.”⁷

Examining the long-term efficacy and safety of evobrutinib

Eighty-seven percent of people with relapsing forms of MS who took the investigational medication evobrutinib had no evidence of clinical worsening (NEcW) after five years on the oral therapy, researchers reported.⁸

Evobrutinib belongs to a class of medications called Bruton’s tyrosine kinase inhibitors, or BTKis. Bruton tyrosine kinase (BTK) is an enzyme that plays a key role in the activation and inflammatory activity of B cells, immune-system cells that have been implicated in multiple sclerosis. Scientists hope that BTK inhibition will provide clinicians with a new means of combating MS. Several BTK inhibitors are in late stages of evaluation in MS, while some BTK inhibitors already are approved for treatment of leukemia and other cancers.

Researchers recently assessed efficacy and safety outcomes in 124 people who had participated in a 48-week, Phase II trial of evobrutinib and then continued to receive the medication for up to 240 weeks in a long-term, open-label study. In the 48-week trial, patients were randomly assigned to receive one of the following treatment regimens:

• placebo for the first 24 weeks followed by 25 mg of evobrutinib once-daily for the remaining 24 weeks
• 25 mg of evobrutinib daily
• 75 mg of evobrutinib once daily
• 75 mg of evobrutinib twice daily
• another disease-modifying therapy (DMT), dimethyl fumarate

On entering the long-term, open-label study, patients received 75 mg of evobrutinib once a day before transitioning to 75 mg twice daily.

The 87.1% overall proportion of patients having NeCW at Week 240 reflected strong performance across these dose groups. For example, at the end of the earlier, 48-week trial, 70.8% of people who started on placebo and then switched to 25 mg of evobrutinib daily had no evidence of clinical worsening. After switching to 75 mg twice daily in the long-term, open-label trial, 90% of those patients had no evidence of clinical worsening at Week 240.

Looking at the 164 evobrutinib-treated patients in the long-term study (including the 124 who had reached Week 240, and others who had not reached Week 240 at the time the data were analyzed), 26.2% reported treatment-related adverse events (TEAEs), with 2.4% reporting serious TEAEs. Researchers noted, “The safety profile [of evobrutinib] remains consistent with that previously reported.”

Tolebrutinib and lesion formation in MS: 144-week data from long-term study

Tolebrutinib is a Bruton’s tyrosine kinase inhibitor (BTKi) being evaluated for a potential role in treating relapsing MS. A Phase II trial found an association between use of the investigational medication and a reduction in new gadolinium-enhancing lesions on Tesla 1 (T1) magnetic resonance imaging (MRI) and in new or enlarging lesions on Tesla 2 (T2) MRI. That trial evaluated four different doses of tolebrutinib – ranging from 5 mg per day to 60 mg each day – and investigators saw a dose-dependent relationship between the oral medication and lesion reduction, with higher doses generally associated with fewer lesions.⁹

Based on those encouraging findings, researchers went on to assess the ongoing impact of tolebrutinib on MS lesions in a long-term safety [LTS] study. In Part A of the study, participants continued on whatever dose of tolebrutinib they had received in the earlier trial. In Part B of the study, all patients received 60 mg per day. At the MSMilan2023 meeting in Milan, investigators shared data on 103 patients for whom they had 144 weeks’ worth of MRI data. All the patients had relapsing MS. Sixty-nine percent were women, and their average age was 37.7 years.

At Week 144, the average number of new, gadolinium-enhancing T1 lesions appearing since the prior scan at Week 96 (approximately one year earlier) were:

• 0.5 for people receiving 5 mg per day of tolebrutinib initially before moving to 60 mg per day (the “5mg/60mg” group”)
• 0.48 for the 15mg/60mg group
• 0.49 for the 30mg/60mg group
• 0.48 for the 60mg/60mg group

The average number of new or enlarging T2 lesions at Week 144 was even lower for each group. Further, the great majority of people in all groups had no new gadolinium-enhancing lesions on T1 MRI, with no additional lesions seen in 79.2% of people in the 5mg/60mg group, 72% in the 15mg/60mg cohort, 87% in the 30mg/60mg group, and 79.3% in the 60mg/60mg group.

The researchers concluded, “Participants treated with tolebrutinib show a stable, low rate of formation of new [gadolinium-] enhancing T1 lesions and new/enlarging T2 lesions between LTS [Week] 96 and [Week] 144, supporting the efficacy of tolebrutinib in reducing acute inflammation in people with relapsing multiple sclerosis.”

Assessing impact of frexalimab on lesion formation in open-label study

Ninety-six percent of people with relapsing MS who took a high dose of the investigational medication frexalimab developed no new gadolinium-enhancing lesions on Tesla 1 (T1) magnetic resonance imaging (MRI) over a 24-week period, and 91% had no new or enlarging lesion on Tesla 2 (T2) MRI. Meanwhile, 80% of people with relapsing MS taking a lower dose of the medication had no new T1 gadolinium-enhancing lesions and 74% had no new or enlarging T2 lesions after 24 weeks.¹⁰

Those findings emerged from the open-label portion of a Phase II study of frexalimab, a monoclonal antibody that may modify B-cell and T-cell activation and innate immune cell function, potentially reducing inflammation without depleting those immune-system cells. Frexalimab targets the CD40/CD40L pathway that has been implicated in the development of MS.

In the initial, 12-week portion of the study, participants received either high-dose frexalimab, low-dose frexalimab, or placebo. In the open-label portion that followed, the people who had received frexalimab initially remained on the medication, while the people who had been on placebo were switched to either high-dose or low-dose frexalimab. Among the people who had started the study on placebo and then went on to receive a high dose of the study medication, the average monthly count of new gadolinium-enhancing T1 lesions declined from 2.3 before they received frexalimab to 0.4 after 12 weeks on the medication. For people who moved from placebo to low-dose frexalimab, that average count declined from 3.7 to 0.6 over 12 weeks of treatment.

Researchers added that no new safety concerns emerged during the open-label portion of the trial. They noted that the most common adverse events were uncomplicated cases of mild or moderate COVID-19, nasopharyngitis (“the common cold”), and headache.

The investigators concluded, “These findings provide proof of concept for targeting CD40L in MS and support development of frexalimab as a potential high-efficacy, non-depleting MS therapy.”

Study finds that injected Ocrevus^® is as effective as IV Ocrevus in suppressing brain lesions

Administering Ocrevus^® (ocrelizumab) twice a year by 10-minute subcutaneous injection is as effective as delivering the monoclonal antibody via longer twice-yearly intravenous infusions in suppressing brain lesions in people with relapsing or primary-progressive forms of MS, according to the medication’s parent company (Genentech).¹¹ This comparable impact on brain lesions was one of the key findings of the OCARINA II study reported at the MSMilan2023 meeting last month. The Phase III, global, randomized study is evaluating the pharmacokinetics, safety, and radiological and clinical effects of the subcutaneous formulation of Ocrevus compared with Ocrevus intravenous (IV). It has enrolled 236 patients with relapsing MS (RMS) or primary-progressive MS (PPMS). The study’s primary endpoint is non-inferiority in a measure of the serum concentration of subcutaneously injected Ocrevus from Day One to 12 weeks after injection compared to IV infusion. Secondary endpoints include the total number of active, gadolinium-enhancing T1 lesions at eight and 12 weeks, and new or enlarging T2 lesions at 12 and 24 weeks, as well as safety outcomes.

Genentech reported that Ocrevus subcutaneous injection was non-inferior to Ocrevus IV infusion as measured by blood levels of the medication from Day One to 12 weeks (3,500 dayµg/mL for subcutaneous injection vs. 2,750 dayµg/mL for IV infusion). Similarly, the company said, peak Ocrevus blood concentrations were similar for subcutaneous injection and IV infusion, at 132 µg/mL and 137 µg/mL, respectively.

In terms of impact on brain lesions, people in the Ocrevus subcutaneous injection arm of OCARINA II had an average 0.54 T1 gadolinium-enhancing lesions at baseline and an adjusted lesion rate of 0.00 at 24 weeks. Their counterparts in the Ocrevus IV arm of the trial had an average 0.98 T1 gadolinium-enhancing lesions at baseline and a 0.00 adjusted lesion rate at the 24-week mark. Both groups also saw the adjusted lesion rate for new or enlarging T2 lesions reach 0.00 at the 24-week mark.

Genentech reported that the safety profile of Ocrevus subcutaneous injection was consistent with the established safety profile of Ocrevus IV infusion. No new safety signals were identified for Ocrevus subcutaneous injection. The most common adverse events (AEs) in the Ocrevus subcutaneous injection group were injection reactions (48% of all exposed patients), all of which were either mild or moderate. The most common AEs in the Ocrevus IV infusion group were infusion-related reactions (17%). A total of four and seven serious AEs were experienced by 2.5% and 3.4% patients in the Ocrevus subcutaneous and IV infusion groups, respectively.

The company added that OCARINA II data will be submitted to health authorities around the world in the months ahead. Ocrevus IV is the only therapy approved in the United States for both relapsing forms of MS and PPMS. The investigational subcutaneous formulation combines Ocrevus with Halozyme Therapeutics’ Enhanze^® drug delivery technology.

Is the average age at the time of MS onset increasing? More than 100 years of data from Norway suggest so

From 1920 to 1969, only 2.6% of people diagnosed with relapsing-remitting multiple sclerosis (RRMS) in two Norwegian counties experienced their first MS symptoms after age 40. From 2011 to 2022, that proportion more than quadrupled to 11.9%.¹²

The researchers presenting those results say their findings are in keeping with other reports from elsewhere in the world. They added that, in step with other reports, their analysis showed that the trend toward an increase in later-onset MS was more evident in women than in men. Further, the researchers found a bimodal pattern of MS-symptom onset, with one peak at around 30 years of age and a second peak between ages 40 and 45.

The findings emerged from an analysis of data on 3,364 people diagnosed with MS in the Norwegian counties of Hordaland and Møre og Romsdal between 1920 and 2022. Norway, like many other northern countries, has a relatively high incidence of MS and, as a result, a long history of tracking the disease. The researchers noted, “The mean age at onset significantly increased throughout the study period, despite a decrease in time from symptom onset to diagnosis,” noting that those findings were statistically significant.

Welcome news on menopause and disability worsening in MS

An Australian study of more than 200 women with clinically isolated syndrome or relapsing MS found that the onset of menopause was not associated with significant worsening of disability.¹³

Researchers explained that they looked for an association because, “There is emerging evidence that the post-menopausal period may represent a time of more-rapid disease progression for women with multiple sclerosis.” They added, “Following menopause, concentrations of protective sex hormones are at their lowest, which may have a deleterious effect on neurodegeneration in MS.”

The investigators conducted a retrospective study that analyzed data on 205 women recruited from eight MS centers across Australia in 2018 and 2019. They tracked the participants’ Expanded Disability Status Scale (EDSS) scores over 10 years spanning the pre-menopausal and post-menopausal periods. Using a statistical technique called inflection point analysis, they looked at whether the slope of change in EDSS scores became steeper following menopause, which would indicate that the “change of life” also represented a change in the pace of disability worsening.

While the researchers saw a trend toward post-menopausal worsening of MS disability, they said that menopause did not constitute a significant inflection point in terms of changes in EDSS scores. They added, however, that further studies are needed to explore potential links between menopause and other aspects of clinical progression, such as the risk of transition from relapsing forms of MS to secondary-progressive multiple sclerosis.

Study finds that better eating equates with fewer MS symptoms

A study involving more than 5,000 people with MS in the United Kingdom has found that a diet rich in fruits, legumes, and vegetables is associated with a lower burden of several MS symptoms, while a traditional Western diet is linked to more symptoms.¹⁴

Researchers drew on the UK MS Register, a national database that records information of clinical status, lifestyle factors, and health outcomes in people with MS to examine data from 2016 on 2,278 people and data from 2022 on 2,887 people. Most people included in the analysis were female, White, and had relapsing forms of MS. The average age of study subjects was 54 years.
Based on participants’ reported eating habits, they identified people who followed what the investigators termed a “prudent” eating pattern, meaning that fruits, legumes, and vegetables were major components of the people’s diets. They also identified people who followed a “Western” diet, which researchers defined as consisting heavily of biscuits, cakes and pies, chips, and takeaway (“take-away” being British English for “take-out,” or “fast food”).

The researchers found that following the “prudent” eating pattern was associated with lower scores (meaning less disability) on the MS Walking Scale (MSWS) and MS Impact Scale-Physical (MSIS). They also had a lower frequency of severe depression compared to other people in the study. By contrast, following the Western dietary pattern was associated with higher scores – indicating greater disability – on the MSWS and MSIS. There also was a higher frequency of fatigue, severe depression, and severe anxiety among people following the Western diet relative to other people studied.

While citing a need for prospective studies to confirm the results of their study, the researchers concluded, “These findings suggest a role for diet in symptom management” in people with MS.

References

¹ Al-Araji S, Moccia M, Jha A, et al. Real-world comparison of high efficacy versus low/moderate efficacy DMTs in treatment naïve relapsing-remitting multiple sclerosis patients using propensity score matching. MSMilan2023. P724/1420. Mult Scler J. 2023; 29:(3S) 623.

² Ysrraelit MC, Piedrabuena MA, Fiol M, et al. Selection of high efficacy disease modifying therapies in multiple sclerosis patients older than 50 years. MSMilan2023. P734/1544. Mult Scler J. 2023; 29:(3S) 633.

³ Williams MJ, Vartanian T, Reders A, et al. One-year analysis of efficacy and safety in Black and Hispanic patients with relapsing multiple sclerosis receiving ocrelizumab treatment in the CHIMES trial. MSMilan2023. P691/711. Mult Scler J. 2023; 29:(3S) 597-8.

⁴ Genentech. First-ever clinical trial exclusively in Black and Hispanic/Latinx people living with multiple sclerosis shows Genentech’s Ocrevus effectively manages disease activity. October 10, 2023. South San Francsico, CA. Available at https://www.gene.com/media/press-releases/15005/2023-10-10/first-ever-clinical-trial-exclusively-in. Accessed November 12, 2023.

⁵ MAVENCLAD^® (cladribine) tablets, for oral use. [Prescribing information.] EMD Serono, Inc.: Rockland, MA. September 2022.

⁶ Maltby V, Leaz R, Xavier A, et al. Cladribine: a multicentre, long-term efficacy and Biomarker Australian Study (CLOBAS) – results from the first 30 months. MSMilan2023. P656/1564. Mult Scler J. 2023; 29:(3S) 572.

⁷ Arnold DL, Steinman L, Hartung HP, et al. Ublituximab reduces thalamic volume loss and new lesion formation in participants in the ULTIMATE I and II Phase 3 studies. MSMilan2023. P162/1262. Mult Scler J. 2023; 29:(3S) 246-7.

⁸ Montalban X, Wollinsky J, Arnold DL, et al. Update on long-term safety and efficacy of evobrutinib, a Bruton’s tyrosine kinase inhibitor, over 5 years from an ongoing Phase 2 open-label extension. MSMilan2023. P706/1280. Mult Scler J. 2023; 29:(3S) 610.

⁹ Reich D, Traboulsee A, Oh J, et al. MRI outcomes from the long-term extension study of tolebrutinib in participants with relapsing multiple sclerosis: 3-year results. MSMilan2023. P684/1478. Mult Scler J. 2023; 29:(3S) 592.

¹⁰ Vermersch P, Granziera C, Mao-Draayer Y, et al. Phase 2 efficacy and safety of frexalimab: 6-month results of a novel CD40L inhibitor in relapsing multiple sclerosis. MSMilan2023. P275/134. Mult Scler J. 2023; 29:(3S) 332.

¹¹ Genentech. Genentech’s Ocrevus twice-yearly, 10-minute subcutaneous injection was non-inferior to intravenous infusion and provided near-complete suppression of brain lesions. October 11, 2023. South San Francsico, CA. Available at https://www.businesswire.com/news/home/20231010331768/en/Genentech%E2%80%99s-Ocrevus-Twice-Yearly-10-Minute-Subcutaneous-Injection-Was-Non-Inferior-to-Intravenous-Infusion-and-Provided-Near-Complete-Suppression-of-Brain-Lesions. Accessed November 17, 2023.

¹² Habbestad A, Willumsen JS, Aarseth JH, et al. Changing age of multiple sclerosis onset from 1920 to 2022: a population-based study in western Norway. MSMilan2023. P449/2058. Mult Scler J. 2023; 29:(3S) 492.

¹³ Bridge F, Sanfilippo P, Skibinaz O, et al. The impact of menopause on the clinical
trajectory of multiple sclerosis. MSMilan2023. P460/885. Mult Scler J. 2023; 29:(3S) 436-7.

¹⁴ Simpson-Yap S, Coe S, Neate S, et al. Healthier dietary intake is associated with less clinical severity in people with multiple sclerosis: a cross-sectional study within the UK MS Register. MSMilan2023. P380/3122. Mult Scler J. 2023; 29:(3S) 1068.

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