NeurologyLive® Year in Review 2024: Top Stories in Multiple Sclerosis

In 2024, the NeurologyLive^® staff was a busy bunch, covering clinical news and data readouts from around the world across a number of key neurology subspecialty areas. From major study publications and FDA decisions to societal conference sessions and expert interviews, the team spent all year bringing the latest information to the website's front page.

Over the past 12 months, there have been several significant advances in the field of multiple sclerosis (MS), including the first approved biosimilar to treat patients with relapsing forms of the disease. The improvements to therapeutics, powered by an increased effort from industry leaders, has expanded the ways in which clinicians can personalize treatments for patients with MS. With the amount of ongoing research, it's nearly impossible to narrow down just 10 stories that have impacted the MS field this year.

Scroll below as we highlight some of the most-read MS content on NeurologyLive^® this year. Click the buttons to read further into these stories.

1. Revised McDonald Diagnostic Criteria Signals New Era in Multiple Sclerosis Treatment

The 2024 revisions presented at the 40th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis mark a pivotal shift toward increased specificity through the addition of pathologically-specific biomarkers and expanding who can be diagnosed with MS. The 2024 revisions include some of the most substantial and paradigm-changing features since the inception of MS diagnostic criteria in 2001.

2. Switching From Anti-CD20 Therapy to Ublituximab Shows Promising Results in Phase 3b ENHANCE Trial

New interim data from the phase 3b ENHANCE trial (NCT05877963) of patients with multiple sclerosis (MS)demonstrated the tolerability of transitioning from treatment with intravenous (IV) anti-CD20 to ublituximab (Briumvi; TG Therapeutics), a novel monoclonal antibody approved therapy for relapsing forms of MS. These results suggest the successful transition of switching from anti-CD20 therapy to ublituximab for this patient population even with elimination of the starting dose.

3. Phase 3 DAYBREAK Trial Highlights Long-Term Efficacy of Ozanimod for Relapsing Multiple Sclerosis

New long-term data from the phase 3 open-label extension DAYBREAK trial (NCT02576717) presented at the 2024 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 29 to March 2, in West Palm Beach, Florida, showed sustained efficacy for measures of disease activity and progression with ozanimod (Zeposia; BMS), an FDA approved disease-modifying therapy for patients with relapsing forms of multiple sclerosis (RMS).

4. FDA Approves Single-Dose SelfJect Injector Delivery Device for Inflammatory and Autoimmune Conditions

The FDA has approved a new single-dose, pre-filled delivery device, named SeflJect, to be used for Acthar Gel (repository corticotropin injection; Mallinckrodt), a treatment indicated for a various number of chronic and acute inflammatory and autoimmune conditions, including multiple sclerosis (MS). SelfJect is intended to provide an appropriate subcutaneous dose of the therapy and may help improve patients' control of administration.

5. Nasal Foralumab Shows Attenuation of Microglial Activation, Clinical Stabilization in Non-Active Secondary Progressive MS With PIRA

Significant findings from an open-label expanded-access program revealed that treatment with investigational foralumab (Tiziana Life Sciences) resulted in damped microglial activation and clinical stability in patients with non-active secondary progressive multiple sclerosis (na-SPMS) who had progression independent of relapses (PIRA). Investigators are planning a double-blind, placebo-controlled, dose-ranging study of the agent in this population using (F-18)PBR06-PET, the main tool used to measure microglial activation, as a primary end point.

6. Survey Reveals High Burnout Rates Among Physicians in Multiple Sclerosis Across the United States

New findings from a small sample survey presented at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, held May 29 to June 2, revealed high rates of burnout and job stress among physicians treating patients with MS in the United States (US), while providing key insights into the sources of stress and burnout in the field. The hope is that these insights can help facilitate systemic changes to support MS physicians to offer the quality care for their patients.

7. Newly Developed DAAE Score Shows Promise in Identifying Patient Risk for Transition to Progressive MS

Using a systematic literature review and advanced methods, a group of study investigators recently published findings on the DAAE score, a newly developed clinical tool for estimating individual patient risk to transition to secondary progressive multiple sclerosis (SMPS). Over a 5-year period, the easy-to-use tool estimated patient risk consistently across datasets internationally; however, it needs additional validation in larger cohorts to be used for clinical risk estimation and personalized care for individual people with MS.

8. Phase 3 ENSURE Program of Vidofludimus Calcium Continues Following Positive Futility Analysis

According to an announcement from Immunic, an Independent Data Monitoring Committee (IDMC) review of unblinded, interim data from the phase 3 ENSURE program assessing vidofludimus calcium in patients with relapsing multiple sclerosis (RMS) was positive, advising that the trials continue as planned. ENSURE, which includes 2 phase 3 trials (ENSURE-1; ENSURE-2), uses time to first relapse up to 72 weeks as the primary end point.

9. Simvastatin Fails to Reduce Disease Progression in Phase 3 MS-STAT2 Trial of Secondary Progressive Multiple Sclerosis

In the phase 3 MS-STAT2 trial (NCT03387670), treatment with simvastatin, a medication for high cholesterol, was safe and well tolerated, but demonstrated no evidence of benefit in reducing disability progression rates in patients with non-active progressing secondary progressive multiple sclerosis (SPMS). Investigators plan to release additional analyses from the trial that cover secondary outcomes, fluid biomarkers, and MRI.

10. Tolebrutinib Shows Positive Results in Slowing Disability Progression for Non-Relapsing Secondary Progressive MS in Phase 3 HERCULES Trial

Announced late-breaking results from the phase 3 HERCULES trial (NCT04411641) showed that tolebrutinib (Sanofi), a Bruton’s tyrosine kinase (BTK) inhibitor, had a significant effect on disability accumulation compared with placebo in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Presented at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, held September 18-20, in Copenhagen, Denmark, the findings from this trial are the first to reveal a significant slowing of disability progression in this patient population, for which there is a large unmet need