每日一次口服治疗，Sotyktu于欧盟获批治疗成人银屑病

On March 29, Bristol-Myers Squibb (BMS) announced that the European Commission approved its self-developed drug Sotyktu (deucravacitinib) for adult patients with moderate to severe plaque psoriasis who are suitable for systemic treatment. The drug has previously been approved by the US FDA for the treatment of adult patients with moderate to severe plaque psoriasis and has been applied for marketing in China.

Psoriasis, commonly known as psoriasis, is a chronic inflammatory skin disease with a long course and a tendency to relapse, and some cases almost never recover throughout their lives. The disease mainly affects young adults and has a greater impact on the physical health and mental status of patients. In addition, psoriasis may increase the risk of other serious conditions (such as cardiovascular disease). A large number of studies have proven that psoriasis is an immune-mediated inflammatory skin disease, and its onset is related to inflammatory cell infiltration and inflammatory factors.

It is a first-in-class oral selective tyrosine kinase 2 (TYK2) inhibitor and the only approved TYK2 inhibitor in the world. The drug is the first innovation in the oral treatment of moderate to severe plaque psoriasis in the past decade. TYK2 is an intracellular signaling kinase that mediates the signaling of interleukin (IL)-23, IL-12, and type I interferon (IFN), which are natural cytokines involved in inflammation and immune responses. Different from the JAK inhibitors already on the market, deucravacitinib binds to the regulatory domain of TYK2 to inhibit its activation through a unique "allosteric inhibition" mechanism, thereby blocking the downstream cell signaling pathways and immune responses mediated by it, thereby avoiding the occurrence of related cardiovascular events or venous thromboembolism adverse events.

The approval of deucravacitinib in the EU is based on the results of the Phase 3 POETYK PSO-1 clinical study and the POETYK PSO-2 clinical study. The two trials, which included 666 patients and 1020 patients respectively, were designed to evaluate the efficacy and safety of deucravacitinib compared with apremilast and placebo in adults with moderate to severe plaque psoriasis. The co-primary endpoints were the proportion of patients with a ≥75% improvement in Psoriasis Area and Severity Index (PASI) score and sPGA 0/1 (static physician global assessment of complete/near complete clearance of skin symptoms) at week 16. Key secondary endpoints include the proportion of patients achieving PASI 75, PASI 90 and sPGA 0/1 at week 16 compared with comparator, as well as other measures comparing deucravacitinib with placebo and comparator.

The data showed that at week 16, the proportion of patients in the deucravacitinib group who achieved PASI 75 (Psoriasis Area and Severity Index improvement of at least 75%) in both trials was 58.7% and 53.6%, compared with 12.7% and 9.4%, and 35.1% and 40.2% in the apremilast group, respectively. The trial also met all secondary endpoints, with deucravacitinib demonstrating significant and clinically meaningful improvements in symptom burden and quality of life measures. In addition, deucravacitinib was well tolerated, with low discontinuation rates due to adverse reactions.

In addition, POETYK PSO long-term extension (LTE) trial data also provides support for this approval. In May 2022, Bristol-Myers Squibb announced the two-year results of the POETYK PSO-LTE trial. The results showed that the clinical efficacy of the drug was maintained during the two-year study. At the 60th week of the trial, the proportion of patients reaching PASI 75 and sPGA 0/1 were 77.7% and 58.7% respectively.

Dr. April Armstrong, a clinical investigator on the POETYK PSO-1 trial and associate dean and professor of dermatology at the University of Southern California, commented: "Sotyktu has the potential to become the new standard of oral care treatment for patients with moderate to severe plaque psoriasis. This therapy can help patients achieve clearer skin. This is confirmed by POETYK Proven in PSO clinical programs. People with moderate to severe plaque psoriasis face significant burdens in their daily lives, and Sotyktu can be a preferred first-line systemic treatment option."