Called ofatumumab, it is a highly effective therapy for adults with relapsing remitting multiple sclerosis (Smrr), targeting B cells. Particular signs: it is a highly effective treatment at home. The patient administers it at home, subcutaneously. The drug Kesimpta *, developed by Novartis, has obtained the green light from the Italian drug agency Aifa for reimbursement for those forms in which the patient has exacerbations followed by periods with milder or absent symptoms. “It is always an important result when a new weapon arrives to fight the disease. In this case even more so, in some respects – explains today during a meeting in Milan Maria Trojano, full professor of Neurology at the University of ‘Aldo Moro ‘of Bari and director of the complex operating unit Neurology and Neurophysiopathology of the University Hospital Policlinico di Bari – The molecule has been shown to have a high efficacy and is placed in this category of drugs. It has a very good safety-efficacy ratio: in the 2 years of observation of the phase 3 studies it has not been shown to give adverse events more frequently than a first-line drug, injectable or oral. And the biggest advantage is being easy to use. Why drugs of this class of which we already have need for intravenous infusions and patients are forced to come to our centers, with consequent crowding of people and risks of infection com and during the period of the pandemic “.” Having a highly effective drug that can be self-administered under the skin – continues Trojano – improves the patient’s quality of life “. Ofatumumab has “a very specific mechanism of action, as it affects a subpopulation of white blood cells which are B lymphocytes, whose role today appears to be fundamental in demyelination and in some aspects of neurodegeneration – explains the specialist – They are cells that can activate the T lymphocytes, the most well-known protagonists of the disease; and yet they can transform themselves into plasma cells and produce autoantibodies against some central nervous system antigens and produce cytokines. And they form follicles in some phases of the disease in the patients’ meninges. we understand well how going to attack them is certainly advantageous because all these mechanisms are kept in check “. Multiple sclerosis is a chronic neuroinflammatory disease that hinders the normal functioning of the brain, optic nerves, and spinal cord through inflammation and tissue loss, leading to varying degrees of physical and emotional disability over time. In Italy alone, it affects 130,000 people and its incidence is about 3,400-3,500 new cases per year, most of it in the youngest and most productive segment of society (20-40 years), with a double prevalence in women than in men. About 85% of those diagnosed initially have the relapsing remitting form. It can begin with the patient who has “blurred vision and eye pain” or with “difficulty walking or moving limbs”, or with “cerebellar type disorders”, describes Claudio Gasperini, director of the complex operating unit. of Neurology and Neurophysiopathology at the San Camillo-Forlanini hospital and coordinator of the Group of the Italian Society of Neurology (Sin) for multiple sclerosis. And there is “a whole set of symptoms even less frequent, ranging from fatigue to depression, up to epileptic seizures”. Hence “truly heterogeneous localization related” expressions in which the disease can affect, from the brain to the marrow. This means, continues the expert, that it is “a difficult disease to diagnose, even if in recent years we have refined our ability to make a diagnosis, we have changed the diagnostic criteria, there has been an information campaign and awareness raising on clinical symptoms. , precisely because it is important to make an early diagnosis in order to start treatment as early as possible “. In recent years “many things have changed – observes Mario Alberto Battaglia, president of the Italian Multiple Sclerosis Foundation and general director of the Italian Multiple Sclerosis Association (Aism) – It is always emphasized that multiple sclerosis is one of those diseases in which research has yielded results most important in the last 25 years, for the ability to face it as a whole “. “And if about 50 years ago people faced a difficult disease for which there was nothing to be done, today the perspectives are different and it is also possible, if we intervene adequately with the approaches available today, almost never reach that severe disability that once led, “says Battaglia. “The goal we set ourselves as specialists – continues Gasperini – is to make the patient undertake an appropriate and specific therapeutic path for his clinical picture, the right ‘dress’ for the right patient, right from the onset of the disease. the progression, reducing the frequency and number of relapses, allows us to limit the disability of patients and to improve their quality of life “. Regarding the new high-efficacy therapy ofatumumab, the two phase 3 twin studies Asclepios I and II, on which the Aifa approval is based, showed a reduction in annual relapses of more than 50% compared to teriflunomide and a reduction the relative risk of 3-month confirmed disability progression greater than 30%. In terms of efficacy, nearly 9 out of 10 patients reach the state of no evidence of disease activity (Neda-3) in their second year of treatment. And the safety profile is similar to that of a first-line treatment for multiple sclerosis. Ofatumumab is administered with a self-injecting pen, once a month directly at home. “Evidence shows that early initiation of highly effective treatment can have long-term positive outcomes in improving the patient’s quality of life,” Trojano notes, according to which the ofatumumab profile “sets it to become a first-rate treatment. choice for patients with relapsing and remitting forms “. “We are proud – commented Giuseppe Pompilio, Value, Access & Regional Partnership Head of Novartis Italy – to be able to have a highly effective home treatment today, the result of a collaborative process motivated by the desire to provide concrete answers to patients’ needs, guaranteeing access to care in ever-shorter time frames as well as services able to support them in their disease management. A commitment to support an increasingly efficient, sustainable and patient-friendly healthcare, in line with the Pnrr address which combines health and assistance home care “.