CAN we give each person with multiple sclerosis the most appropriate treatment based on the characteristics of their disease? In the last 20 years, research on this neurodegenerative disease has made great strides and now it is time to give more and more patient-friendly answers. Some of these will come from leading multiple sclerosis experts gathered virtually from 13 to 15 October in 37th Ectrims congress. As he explains to us Maria Pia Amato, professor of Neurology at the University of Florence, primary at the Careggi AOU and president of Ectrims.
Professor Amato, what does it mean to be able to personalize multiple sclerosis therapy?
“It means being able to understand what the characteristics of the disease are right from the diagnosis and follow its evolution over time, so as to be able to give the best therapy at any time. To do this we need to know even better the mechanisms by which multiple sclerosis develops, we must to have markers available to help us understand how it will go on and how much it will respond to therapies, we need to have new molecules with innovative mechanisms of action available. This is why research on multiple sclerosis is always in turmoil. During the Congress they will be presented , for example, the results of numerous studies on possible diagnostic and prognostic markers of the disease, both laboratory and imaging. In particular, it will be discussed how these markers can help the neurologist in the diagnosis of the disease, in the identification of patients with more aggressive forms and increased risk of progression and in assessing response to therapies . In short, to personalize the therapy as much as possible. Furthermore, new data will be presented on the genesis of the disease from an immunological point of view, on the interactions between the immune system and the microbiome, and on the role of so-called immunosenescence on the development of MS and on the response to therapies. Thanks to therapies, in fact, people with MS live longer so we need to understand what happens to their immune system with aging. On the innovative molecules front, a session of the congress will be dedicated to the preliminary results of potentially neuroprotective and remyelinating drugs “.
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What will be the major news on the front of the drugs closest to arrive on the market?
“Over the last 20-30 years, numerous therapies have been developed (15-18) for the treatment of this pathology, especially for the most widespread forms, those called relapsing-relapsing (RR), with a significant improvement in the natural history of Despite the progress achieved, there is room for the development of new molecules capable of providing a therapeutic alternative not only for patients with RR disease but also for the progressive, more aggressive forms for which they are Therapeutic possibilities are still scarce. During the Congress we will talk a lot about Bruton’s Tyrosine Kinase (BTK) inhibitors, promising drugs that interfere with Tyrosine Kinases, enzymes that participate in intracellular signaling pathways and play a crucial role in proliferation, differentiation and cell survival. Bruton’s tyrosine kinase, in particular, is also expressed by the B cells of the immune system, involved in lla pathogenesis of multiple sclerosis. Its inhibition is therefore a very interesting mechanism of action and studies are underway on the action of this class of molecules in different forms of the disease. Furthermore, the BTK inhibitors are small molecules potentially capable of crossing the blood-brain barrier to reach the central nervous system where they could act on inflammation and counteract the progression of the disease in progressive forms. In addition to the results of the BTK inhibitor trials, phase 3 efficacy and safety data of a new anti-CD20 drug, ublituximab, will be presented compared with teriflunomide in relapsing remitting forms of the disease. The characteristic of this drug is its fast mode of administration: one hour of intravenous infusion every six months is enough “.
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You have worked a lot on pediatric MS, are there any news that will be presented at the congress?
“Although it represents a small proportion of the MS patient population (about 3-10%), pediatric MS is constantly being studied, at least for two reasons. On the one hand, due to the high disease activity in this age group. and the significant impact on the motor and cognitive skills of patients once they reach adulthood, on the other hand because the clinical onset in children / adolescents is very likely close to the biological onset of the disease, and gives us the opportunity to study the interaction of the environmental and genetic component of the disease at a very early stage. The results of two important population studies will be presented during the congress: the first was conducted on patients from the Italian MS Registry and coordinated at the University of Florence, and compared very early onset forms (<10 anni) con le forme più tardive (esordio >10 years), showing a greater resilience than the former. The second was conducted by the MSBASE International MS Registry and coordinated by the University of Melbourne, and analyzed possible prognostic factors and the role of highly effective therapies in pediatric forms of the disease “.
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The other forms of the disease at the center of many studies because with fewer therapeutic options available are the progressive forms, what novelties emerge from the congress?
“In recent years we have changed the way we look at these forms of disease. The new vision of MS is that of a continuum, of a disease that is progressive from its onset – there has been talk of silent progression – albeit in area of strong individual heterogeneity. In this sense, studies will be presented on a new way of evaluating progression, called PIRA (progression independent of relapse activity). The concept of continuous progression also emerges from the analysis of the Opera 1 and 2 trials on ocrelizumab and in real life studies based on the Italian Registry coordinated at the University of Florence and on the Barcelona cohort. Today we know that neurodegeneration is present from the earliest stages of the disease, even if it becomes predominant over time, and that inflammation is also present in the more advanced stages, even if it is more characteristic of the early stages “.
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The Italian MS Registry has been cited by her several times. What do we learn from real world data?
“The Italian registry currently collects over 72 thousand cases. A database that allows us to extrapolate data on the safety and efficacy of drugs in the long term, much longer than that analyzed in the trials that led to the marketing of the drugs, and on patients much less selected. And then thanks to statistical methodologies it is possible to carry out comparative studies between molecules. Finally, it is possible to study optimization algorithms of treatment strategies, to decide for example whether to start immediately with powerful drugs or when and how to switch to another therapy. All this, always, to try to personalize the treatment for each patient “.
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