Psoriasis, Aifa OKs Reimbursement of New Oral Therapy

The Italian Medicines Agency (AIFA) has approved the reimbursement of deucravacitinib for the treatment of moderate to severe plaque psoriasis. From today, patients who fail conventional therapy can benefit from a new treatment. The oral therapy – a note reports – has an innovative and selective mechanism of action that allows to reach levels of efficacy and safety lasting over time. The decision of the AIFA follows the similar one of 2023 of the European Medicines Agency. Deucravacitinib is a first-in-class oral inhibitor of tyrosine kinase 2 (Tyk2) and is the first of a new class of “small molecules”. It acts selectively on Tyk2, inhibiting the signaling of interleukin-23 (IL-23), interleukin-12 (IL-12) and type I interferons (Ifn). These are cytokines that play an important role in the pathogenesis of psoriasis and other immune-mediated diseases. The therapeutic innovation is being presented today in Rome, at a press conference promoted by Bristol Myers Squibb.

“More than one and a half million people in Italy alone are affected by psoriasis and 500,000 of these patients have the moderate to severe form – underlines Antonio Costanzo, full professor of Dermatology and director of the UOC of Dermatology at the IRCCS Istituto clinico Humanitas Rozzano, Milan – It is an inflammatory skin disease that has a chronic and relapsing course. It manifests itself above all with red and scaly plaques generally distributed symmetrically on the elbows, knees, hands, feet, scalp and even ears. It is caused by an anomalous activation of the immune system that translates into skin inflammation, excessive proliferation of epidermal cells and the formation of new blood vessels in the dermis. The current treatments available can reduce the symptoms and the most evident manifestations but we are not yet able to completely eradicate the disease”.

To obtain the green light from AIFA – it is stated – the phase 3 clinical study program Poetyk Pso-1, Pso-2 and the long-term extension (Poetyk Pso-Lte) was conducted. The efficacy and safety of deucravacitinib vs apremilast and placebo were evaluated. The oral therapy demonstrated a long-lasting response over time, maintaining and improving the efficacy of multiple psoriasis indicators (Pasi 75, Pasi 90 and sPga 0/1). The latest data presented at the Spring Symposium 2024 of the European Academy of Dermatology and Venereology showed Pasi 75 response rates maintained for up to 4 years in patients continuously treated with deucravacitinib (Poetyk Pso-Lte). The clinical value of this new oral drug was also demonstrated in the most difficult to treat areas such as the scalp, where it was significantly more effective than placebo and apremilast.

“Patients with moderate to severe psoriasis have unmet needs – highlights Maria Concetta Fargnoli, full professor of Dermatology and Venereology at the University of L’Aquila and head of the UOC General and Oncological Dermatology Du at the S. Salvatore Hospital – The disease requires a treatment that is effective, rapid and safe and that allows long-term control of psoriasis. The new therapy responds to these needs also thanks to its broad-spectrum mechanism of action. In fact, it does not perform a selective inhibition on a single molecule, but can simultaneously modulate multiple cytokines involved in the pathogenesis of the disease. Furthermore, it is a ‘manageable’ treatment thanks to oral administration to be carried out only once a day. It does not present pharmacological interactions, does not require dose adjustments and can be taken with or without food”.

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“Deucravacitinib, as an oral therapy, optimizes the management of the disease and simplifies the patient’s treatment path – says Valeria Corazza, president of Apiafco-Associazione psoriasici italiani amici Fondazione Corazza – Psoriasis, like many other dermatological diseases, has a strong impact on daily life as the symptoms are very visible and cause a strong sense of shame and frustration. Even if it is not infectious or contagious, the affected person tends to limit social contacts due to the embarrassment it generates. It is also often associated with other diseases or conditions such as obesity, diabetes, metabolic syndrome, psoriatic arthritis or depression. It should not be underestimated and all therapeutic innovations capable of normalizing the course of the disease are welcome”.

“We welcome with great satisfaction the recent decision of the Italian Medicines Agency – concludes Cosimo Paga, Executive Country Medical Director, Bristol Myers Squibb – Deucravacitinib, the result of Bristol Myers Squibb’s research, is a treatment with great potential, as has been demonstrated in registration studies, and it is important that this new therapeutic option is now available to patients in Italy too. At Bristol Myers Squibb we have been pioneers in the study of the immune system, both in the field of autoimmune diseases and in the field of immuno-oncology. We are not stopping here, but we are continuing our commitment to immunology by studying deucravacitinib in various other indications such as psoriatic arthritis or Sjogren’s syndrome. Our goal is to find innovative therapeutic solutions and improve the quality of life of patients compromised by debilitating diseases that cause significant physical, emotional and social consequences”.

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