Multiple sclerosis, effective oral therapy from the early stages of the disease

Every year in our country there are 3,600 new diagnoses of multiple sclerosis and the affected people are in total about 133 thousand, with a double prevalence in women than in men. The relapsing-remitting form represents about 85% of all cases and is distinguished by the alternation of attacks or relapses, of unpredictable duration, characterized by the onset of sudden neurological symptoms and phases of complete or partial remission. A pathology, therefore, which seriously undermines the quality of life of the people affected by it. For these patients, the positive role of ozanimod, an oral drug reimbursed in Italy since last September, is confirmed. At the European Academy of Neurology (EAN), which was held in Vienna from 25 to 28 June, 5 abstracts were presented on data from the pivotal studies and the extension study (Ole-Daybreak) with ozanimod. The results of the research, and more generally the news concerning the treatment of the disease, are presented today in an online press conference promoted by Celgene, now part of Bristol Myers Squibb. “Multiple sclerosis is one of the most common neurodegenerative diseases – says Luigi Maria Grimaldi, head of the Neurology Unit of the San Raffaele Giglio hospital in Cefalù -. It is a disease in which the immune system attacks myelin, the protective sheath that covers the nerve fibers, causing neurological deficits. In the Old Continent it involves 700 thousand people for a total of over 2.5 million patients all over the world. Symptoms are difficult to interpret as they are common to other diseases or conditions. It may therefore happen that the path to reach the diagnosis is sometimes long and complex. The neurological damage linked to demyelination is mostly irreversible ”. “Hence the need to have available therapies, such as ozanimod, effective from the early stages of the disease and well tolerated by the majority of patients – continues Diego Centonze, director of the complex operating unit of Neurology and of the Stroke Unit at IRCCS. Neuromed, in Pozzilli (Isernia), professor of Neurology at the University of Rome Tor Vergata and first author of the study – Ozanimod acts by modulating the immune response by interacting with the receptors of Sphingosine 1-Phosphate in particular on the isotypes most involved in the modulation of immune response and in the repair of myelin damage. “Among the studies conducted, one in particular, evaluated the efficacy of ozanimod in predominantly naive patients, that is, in those who had never received previous therapies.” In this exploratory analysis we analyzed 1,501 men and women: 71% were naive while the remaining 29% had already received therapy – underlines Centonze, first author of this analysis -. The aim was to evaluate long-term clinical and radiological outcomes (Ole-Daybreak study) in patients who are naive or experienced in previous disease modifing therapy (Dmt). In the pivotal phase 3 studies, the benefit associated with the early use of ozanimod was consistent regardless of previous exposure to a DMT and persisted over time, with an improving trend. Data from this long-term observational study in patients treated with ozanimod 0.92 mg for 5-6 years show sustained control of disease activity. The data recorded between the two groups of patients were substantially comparable and therefore both benefited from the treatment. Safety data also go in this direction and therefore the drug does not cause excessive side effects. This too was found both when it was administered as a first therapeutic option and in patients already treated with other types of treatments “. The symptoms of multiple sclerosis can vary from person to person. The most recurrent involve sight, sensitivity, motor activities or can manifest themselves with the so-called “invisible symptoms” such as fatigue, depression, attention or memory disorders, difficulty maintaining concentration, problems making calculations or planning complex activities and to carry out multiple activities at the same time. All the symptoms force the person with multiple sclerosis to redefine the organization of his life and projects in the short and long term. Cognitive deficits are not always identified, but they are present in 40% -70% of patients from the initial stages of the disease and are related to cerebral atrophy that occurs over time. “The pathology can lead to a significant and irreversible loss of brain volume – again Grimaldi – as well as to an alteration of cognitive functions if there is no timely therapeutic intervention. The data presented at EAN showed the action of ozanimod in preserving or improving cognitive functions in most of the patients examined. In fact, in the Sunbeam study and its extension (Ole-Daybreak), patients characterized by higher brain volumes at baseline, in particular thalamic volume, had a better performance on cognitive tests (symbol digit modalities test – Sdmt) than patients with lower volumes. This trend remained stable or improved over 4-5 years of treatment with ozanimod, which was associated with preserved or improved cognitive function in approximately 80% of patients with higher thalamic volume and in 66% of patients with brain volume. lower “. “We now have comforting data on the use of the new therapy for over four years, especially on the protective role it plays against cognitive decline and brain atrophy” she concludes.