AIFA has approved the Reimbursement of a new oral therapy for moderate and severe psoriasis. Over one and a half million people in Italy suffer from this disease, 500 thousand of which are of the most aggressive forms. It is a chronic inflammatory disease of the skin which manifests itself, as explained by website of the Higher Institute of Health«with thickened areas (erythematous plaques) covered with silvery-gray scales that, in some cases, can be itchy (pruritic)». They usually concentrate on the elbows, knees, scalp, face, hands and feet but can also arise elsewhere. The cause lies in the complex mechanism between immune system and environmental factors in subjects genetically predisposedin which an excessively rapid epithelial reproduction mechanism is triggered and the creation of new blood vessels in the dermis which lead to the creation of plaques.
Psoriasi it is not entirely curable and it is a chronic and recurring disease. But among the treatments to effectively control the disorders there is a new one: it is the deucravacitinibto turn to if other therapies do not work. It is an oral inhibitor of the protein tyrosine-chinase 2 (TYK2), the first of a new class of so-called “small molecules”. Aifa is thus following the EMA’s decision last year. Deucravacitinib acts selectively by inhibiting the signaling of interleukin-23 (IL-23), interleukin-12 (IL-12) and type I interferons (IFN), cytokines that are fundamental in the onset of psoriasis symptoms and other diseases in which the immune system causes pathological situations, triggering immune responses directed against the body itself. The essential novelty is that the therapy acts precisely on more cytokines involvedattacking a protein on which none of the other therapies available to patients acted, and it is convenient because it consists of an oral administration once a day, with or without food, and without interactions with other drugs.
The Phase 3 clinical trials have therefore led the AIFA to give the green light to reimbursement. The new therapy has in fact demonstrated good efficacy over time, up to four years with continuous administration, improving many aspects of the symptoms, particularly in areas that are particularly complex to treat such as the scalp. “You cannot cure psoriasis because it is a chronic disease, so we are talking about patients who have a very long history of the disease. However, the green light from the Italian Medicines Agency (AIFA) to the reimbursement of a new oral therapy (deucravacitinib) for moderate or severe psoriasis is a very important result – he explained Cosimo PaysExecutive Country Medical Director, Bristol Myers Squibb, all’Adnkronos Health at the presentation of the new therapy – this therapy allows us to treat and try to manage the symptoms for as long as possible and have new opportunities when previous therapies fail to maintain the response”.
Returning to psoriasis, the disease It can arise at any agewith no difference between men and women, but it usually appears for the first time between 15 and 35 years old. And as mentioned, it presents a cyclical trend with periods marked by mild or absent disorders to other more difficult ones, with a level of severity that varies from patient to patient. “Like all diseases that affect the skin, psoriasis often causes discomfort in the affected person, pushing them to avoid social occasions that could highlight the damaged areas of skin – explains the ISS – for this reason, the quality of life can be affected and the disease can represent a social problem. Psoriasis is not a contagious or infectious disease and cannot be transmitted from person to person”.