In Italy there are about 133 thousand people suffering from multiple sclerosis, a neurodegenerative autoimmune disease affecting the central nervous system. Multiple sclerosis is the leading cause of neurological disability among young adults and it is estimated that around 3,800 new people, mostly women, are affected by this disease every year in our country. Multiple sclerosis, since its diagnosis, changes life and forces the person and his family to redefine the organization and projects in the short and long term with an impact on both the emotional and physical spheres. The most frequent form is the relapsing-remitting one which affects over 113 thousand people in our country (85% of cases). It is characterized by the alternation of phases, of unpredictable duration, characterized by the onset of sudden neurological deficits with others of remission (complete or partial).
Today to ozanimod oral therapyfor this category of patients, is able to prevent brain atrophy related to cognitive impairment, as indicated by the data of 13 different abstracts related to studies conducted on ozanimod, presented by Bristol Myers Squibb at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (Ectrims), which closed on October 28 in Amsterdam. This latest scientific evidence was presented yesterday at an online press conference.
“The reduction of brain tissue is closely related to cognitive impairment, especially in the relapsing-remitting form – he underlines Massimiliano Calabrese, associate professor of Neurology at the University of Verona and medical director at the Neurology B of the Integrated Aou of Verona -. Two studies (based on data from the Sunbeam, Radiance and Daybreak trials) were presented in Amsterdam which indicated that patients treated with a highly effective therapy such as ozanimod manifest a slowing of brain tissue loss (assessed by magnetic resonance imaging) and the consequent cognitive deterioration, compared to patients treated with Interferon beta 1 ° “.
The pathology, “if not controlled – still Calabrese – can lead to serious consequences: on the life of the patient who risks losing his autonomy and his active role in society; on the patient’s family who has to take charge of his assistance in daily life; and on the national health system which has to face huge direct and indirect costs. Think that multiple sclerosis has total costs that amount to over six billion euros a year. Becomes It is therefore essential to have available treatments capable of blocking the disease at an early stage thus preventing the progression of physical and cognitive disability and thus preserving the patient’s quality of life “. The interim analysis of the Phase 3 Daybreak Ole study on ozanimod was also presented at Ectrims. The long-term efficacy of the therapy – reads a note – was maintained after more than 60 months of treatment. It was found that 68% of enrolled patients were relapse-free at the study cut-off date.
“The new data on ozanimod reinforce the results obtained in the pivotal trials – he stresses Eleonora Cocco, associate professor of Neurology at the University of Cagliari and manager of the Multiple Sclerosis Center, Binaghi hospital, Cagliari -. Ozanimod is confirmed as a molecule with a good safety profile as no new adverse events have emerged in prolonged use. The same applies to efficacy, which has been maintained over time both from a clinical and neuro-radiological point of view. Multiple sclerosis is a complex disease – he adds – and the symptoms may vary and the most recurrent affect vision, sensitivity and motor activities. Fatigue, depression, disturbances in attention or memory, difficulty in maintaining concentration, problems with calculations or planning activities also often occur. Cognitive deficits are not always diagnosed, but they are present in 40% -70% of patients from the early stages of the disease and are related to brain atrophy that occurs over time. Early diagnosis and treatment are important to help preserve physical and cognitive function ”.
Finally, Bristol Myers Squibb announced new retrospective analyzes of serological outcomes and clinical outcomes related to vaccination for Covid-19 in patients treated with ozanimod, in the open-label extension (Ole-Daybreak) phase of the clinical development program in patients with relapsing multiple sclerosis. “100% of the study participants who had been vaccinated against Covid 19 with mRNA vaccines had a serological response – concludes Cocco -. This confirms the safety profile of the drug which can be administered in conjunction with immunization against Covid-19. It should be remembered that during the early stages of the pandemic, one in ten patients decided not to receive all the treatments for fear of contagion. Now that we have already reached the fourth dose of the vaccine, it is necessary to have certain proof that the new therapies do not interfere with anti-Covid prophylaxis. The new study presents interesting and above all reassuring data on ozanimod and immune memory ”.