On September 9, 2022, Bristol-Myers Squibb announced that the US Food and Drug Administration (FDA) has approved Sotyktu (deucravacitinib) for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu is not recommended for use in combination with other potent immunosuppressants. Sotyktu is expected to be available in the US in September 2022.
Notably, Sotyktu (deucravacitinib) is a first-line, oral sex-selective histotyrosine kinase 2 (TYK2) inhibitor, and the only TYK2 inhibitor approved globally. It represents the first innovative oral treatment for moderate to severe plaque psoriasis in nearly 10 years.
The approval is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated that once-daily Sotyktu was more effective than placebo and twice-daily Otezla in treating 1,684 patients aged 18 years and older with moderate to severe plaque psoriasis. Compared to placebo and Otezla, Sotyktu showed better efficacy at weeks 16 and 24, and the response to Sotyktu lasted for 52 weeks.
“Sotyktu has the potential to become a new standard of care for patients with moderate to severe plaque psoriasis because it helps patients achieve cleaner skin, a fact confirmed in the POETYK PSO clinical program,” said Dr. April Armstrong, Associate Dean and Professor of Dermatology at the University of Southern California, a clinical investigator in the POETYK PSO-1 trial. "People with moderate to severe plaque psoriasis face a significant burden, and Sotyktu is a popular first-line systemic treatment option."
Regarding safety, in the POETYK PSO trial, at week 16, the most common adverse events in Sotyktu patients (≥1% and higher than placebo) were upper respiratory tract infection (19.2%), elevated serum creatine phosphokinase (2.7%), herpes simplex (2.0%), oral ulceration (1.9%), folliculitis (1.7%), and acne (1.4%).1 Additionally, adverse events leading to discontinuation occurred in 2.4% of Sotyktu patients, 3.8% of placebo patients, and 5.2% of Otezla patients.
Sotyktu is under regulatory review by the European Medical Association and other health authorities worldwide for the treatment of moderate to severe plaque psoriasis, and by the Japanese Ministry of Health, Labour and Welfare for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis, and erythrodermic psoriasis.
