The director and founder of The MS Center for Innovations in Care provided perspective on some of the significant strides made in recent years to improve the care and access to affordable treatments for patients with multiple sclerosis.
Over the years, treating multiple sclerosis (MS), an autoimmune disorder, has been significantly improved through disease-modifying therapies (DMTs) that reduce the risk of relapses and new MS plaques in the central nervous system. Additionally, traditional injectable DMTs have now been complemented by the availability of oral medications and intravenous infusion therapies, making it easier for some patients to adhere to their treatment regimens. More recently, the field has seen increased interest in biosimilar medications that may ultimately lower the cost burden for patients with the disease.
At MSMilan 2023, the joint ECTRIMS-ACTRIMS meeting, held October 11-13, in Milan, Italy, several clinicians, including Barry Singer, MD, spoke in a product theatre session on precision medicine, sponsored by Octave Bio. Octave is the current developers of the MS Disease Activity test, the first and only multivariate biomarker blood test that provides an accurate measurement of patients disease state. This test helps clinicians support DMT selection based on disease phenotype, evaluate stability vs slow decline, and monitor new MS symptoms, among other things.
Following the presentation, Singer, director and founder of The MS Center for Innovations in Care, sat down with NeurologyLive® to discuss the session and how the biomarker-based activity test speaks to where MS treatment is currently. As part of a new iteration of NeuroVoices, he provided commentary on the importance of relying on biomarkers as well as the introduction of newly approved biosimilars. Furthermore, he spoke on the potential benefits biosimilar bring to the field and the process in which they go through.
Barry Singer, MD: Well, now that we have a disease activity score that we can use in clinical practice, we can identify which patients may require particular attention. High disease activity with a score of nine or ten may prompt immediate monoclonal antibody therapy to control the disease. Conversely, patients with lower scores may benefit from milder treatments for multiple sclerosis. While the score isn't the sole factor, it's a valuable part of the information we consider when making treatment decisions. I've adjusted treatment for some patients based on their disease activity score. During our session, we discussed the significance of specific biomarkers, such as GFAP (glial fibrillary acidic protein) and neurofilament light, which can help inform clinical decisions.
Having biomarkers in the clinic is crucial. They allow us to monitor patients not just at a single time point but continuously over time to ensure effective disease control. These biomarkers provide objective measures that are cost-effective and convenient. They can offer a more accessible way to assess patients' conditions compared to regular MRI scans, which can be time-consuming and expensive.
The approval of the natalizumab biosimilar is a significant development. It's important to understand the rigorous process they undergo for approval. Biosimilars must have an identical amino acid sequence and tertiary structure to the reference product. While there may be slight variations in glycoproteins, it's crucial to ensure equivalence. Long-term safety and effectiveness need continued monitoring, as these medications might not have undergone extensive clinical trials. The cost-saving potential of biosimilars is significant, which can make high-efficacy therapy more accessible worldwide. This shift may take time, as both healthcare professionals and patients need education on these alternatives.
The pace of adaptation will largely depend on factors like payer support in the United States. However, it may take time for neurologists and patients to feel comfortable with the idea of switching from a brand-name product to a biosimilar. Education will play a crucial role in ensuring everyone understands the cost-saving benefits and the rigorous approval process biosimilars undergo. Monitoring long-term safety and effectiveness will also be essential as we move forward.
There has been a wealth of interesting data across various topics. One area of interest is general wellness in MS patients, addressing conditions like anxiety and depression, which can impact disease progression. Studies on the Mediterranean diet and its effects have been intriguing. Additionally, factors like high cholesterol, lipid levels, and obesity have been associated with increased disability, presenting opportunities for neurologists to improve overall wellness. While there haven't been groundbreaking advancements in disease-modifying therapies at this meeting, it's expected that 2024 will bring developments in BTK inhibitors and CAR-T cell therapy for MS. I would have liked to see more on remyelination, but perhaps that will emerge in the future.
Over the past decade, we've seen promising trials focusing on non-pharmacological interventions for managing symptoms. Cognitive behavioral therapy has shown potential in addressing fatigue, and there have been studies on alternative approaches like acupuncture. The field is becoming more rigorous in studying the effectiveness of various symptom management methods. However, the need for new therapeutics remains, particularly in the management of neuropathic pain, and this is an area where we look forward to further advancements.