Plaque psoriasis, CE approval for first TYK2 inhibitor

Rome, 5th April. (beraking latest news Salute) – The European Commission (EC) has approved deucravacitinib, a first-in-class oral tyrosine kinase 2 (TYK2) inhibitor for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib is the first oral therapy with a novel mechanism of action approved for this indication in the past 10 years. The therapeutic novelty was illustrated today in Milan at a press conference promoted by Bristol Myers Squibb (Bms).
The decision of the EC – explains the pharmaceutical company in a note – is based on the results of the Phase 3 clinical studies POETYK PSO-1 and POETYK PSO-2, which demonstrated the superior efficacy of deucravacitinib, taken once a day, compared to placebo and apremilast taken twice daily, at weeks 16 and 24, with responses maintained through 52 weeks. Additional data from the POETYK PSO LTE (long term extension) study supported the approval. The POETYK clinical study program has demonstrated a consistent safety profile in patients over three years of continuous treatment.
“Psoriasis is a chronic immune-mediated systemic disease – says Piergiorgio Malagoli, Head of the PsoCare Unit of the Irccs Policlinico San Donato in Milan -. Nine out of ten patients suffer from forma vulgaris, or plaque psoriasis, characterized by distinct oval or round plaques, usually covered with whitish scales. In Italy – underlines the specialist – an estimated number of 1.8 million patients with psoriasis, of which about 500,000 have the moderate to severe form. It causes severe itching combined with pain, a burning sensation, tightness and dryness of the skin, cracking, scaling, redness and even bleeding. Because of these symptoms, the disease is very disabling and compromises the quality of life and productivity in the workplace. It is calculated, in fact, that over 90% of patients complain of a heavy impact on emotional well-being?.
“The European approval of deucravacitinib undoubtedly represents an important milestone – adds Antonio Costanzo, Full Professor of Dermatology and director of the UOC of Dermatology at Irccs Istituto Clinico Humanitas – Rozzano, Milan -. AND? an oral therapy whose administration is very easy as it must be taken only once a day. It also does not require laboratory monitoring. Clinical trials have demonstrated significant and sustained efficacy of deucravacitinib on multiple key endpoints, including skin clearance and symptom intensity. From a clinical point of view – observes Costanzo – it is a small molecule and the main therapeutic innovation is the very high selectivity of its mechanism of action. It manages to block only one protein, TYK2, essential for some receptors underlying the pathogenesis of psoriasis. At the same time, it does not inhibit other proteins such as JAK1, JAK2 or JAK3. All this translates into an?excellent efficacy of the treatment which also has good levels of safety and tolerability?.
From the two phase 3 clinical studies – the note details – it emerges that the most common adverse reaction is upper respiratory tract infection (18.9%) more frequently nasopharyngitis. The incidence of serious infections was 0.6%, compared with 0.5% in the placebo group. Most infections were mild or moderate in severity and did not lead to treatment discontinuation. In the first 16 weeks, infections occurred in 29.1% of treated patients, compared with 21.5% of those receiving placebo. The rate of infections and serious infections with deucravacitinib did not increase until week 52. The long-term safety profile in the extension study was consistent with findings from the Phase 3 studies.
In Europe there are an estimated 14 million cases and the disease can occur at any age. AND? very widespread also in Italy where it affects about 3% of the population. ?In our country there is the problem of limited access to highly specialized medicines – continues Malagoli – At the moment only a few reference healthcare structures, authorized at national level, administer the most innovative therapies. Dermatologists in the area hardly recommend medicines that they cannot prescribe to their clients. This situation can create problems, especially for patients affected by the most severe forms of psoriasis?. ?Another unsatisfied need of Italian patients is to obtain long-term disease control – underlines Costanzo -. For several years we have had very advanced treatments such as monoclonal antibodies or biological drugs. However, they are injection therapies and require the cold chain, so their administration can be very complex. Could having an oral drug such as deucravacitinib, which has a good level of efficacy and safety, also available in Italy in the future, be a great advantage?