As part of NeurologyLive®'s Year in Review, take a look at our most-read news in multiple sclerosis in 2023.
In 2023, 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.
In November, the FDA approved Sandoz's and Polpharma Biologics' injection treatment natalizumab-sztn (Tyruko; formerly known as PB006), the first biosimilar to the approved formulation of natalizumab (Tysabri; Biogen) for the treatment of adults with relapsing forms of multiple sclerosis (MS). With this indication, the therapy can be utilized for patients with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
The World Health Organization (WHO) published new editions of the Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), which now include 3 new therapies for the treatment of multiple sclerosis. Launched in 1977 to promote better access to medicines in developing countries, the WHO Model Lists have become a global policy tool for decisions related to the selection and universal coverage of medicines within all health systems.
Months after initial data was presented at the 2023 American Academy of Neurology Annual Meeting, investigators published the full dataset of the phase 3 TERIS study (NCT03122652) showing teriflunomide’s (Aubagio; Sanofi) impact in patients with preclinical demyelinating disease. All told, treatment with the agent resulted in an unadjusted risk reduction of 63% and an adjusted risk reduction of 72% relative to placebo, in preventing first clinical demyelinating event.
In a small-scale study of patients with non-active secondary progressive multiple sclerosis (SPMS), treatment with foralumab (Tiziana Life Sciences), an investigational anti-CD3 agent, resulted in improvements in clinical measures of fatigue and physical function. Findings showed that all 6 patients experienced improvement in at least 1 clinical measure of Expanded Disability Status Scale (EDSS), pyramidal score, or Modified Fatigue Impact Score (MFIS), and all but 1 (5 of 6) showed improvement on microglial PET imaging at 6 months.
Data from the phase 2 EMBOLD study (NCT03283826) showed that ATA188 (Atara Bio), an allogenic T-cell immunotherapy, did not meet its primary end point of change in confirmed disability improvement (CDI) among patients with non-active progressive multiple sclerosis (PMS) after 12 months of treatment. While the therapy showed a favorable safety profile, it did not demonstrate impacts on fluid and imaging biomarkers.
Post hoc data from the phase 3 ULTIMATE studies (NCT03277261; NCT03277248) showed that treatment with ublituximab (Briumvi; TG Therapeutics), a recently approved therapy for relapsing forms of multiple sclerosis (MS), resulted in greater improvements in fatigue in comparison with teriflunomide.
In September, the FDA issued a complete response letter to AstraZeneca for the supplemental biologics license application of ravulizumab (Ultomiris) as a potential treatment for patients with neuromyelitis optica spectrum disorder (NMOSD). In its response, the agency did not raise concerns about the provided evidence for the therapy, rather it requested modifications to enhance the Risk Evaluation and Mitigation Strategy (REMS) program.
The FDA accepted Viatris and Mapi Pharma’s new drug application (NDA) for its investigational agent GA Depot, a long-acting, once-monthly glatiramer acetate solution for the treatment of patients with relapsing forms of multiple sclerosis (MS). The agency is expected to have a decision on the therapy by March 8, 2024.
The International Advisory Committee on Clinical Trials in Multiple Sclerosis published an update to its 2008 guidelines on diagnosing suspected multiple sclerosis (MS), providing additional clarity on the key clinical and paraclinical red flags clinicians should be aware of.
Findings from the phase 1b dose-escalation, open-label OCARINA I study (NCT03972306), presented at the 2023 MSMilan, the 9th Joint ECTRIMS-ACTRIMS meeting, October 11–13, in Milan, Italy, showed that a 920 mg dose of subcutaneous ocrelizumab (Ocrevus; Genentech) was the most appropriate dose to use among patients with relapsing or primary progressive multiple sclerosis (MS). These results suggest that the selected dosage was well tolerated and provides a similar exposure to the FDA-approved 600 mg intravenous (IV) dose used in the phase 3 OCARINA II trial (NCT05232825).