Last week, Bristol Myers Squibb announced the FDA approval of Sotyktu (deucravacitinib), which, according to the company, is the only approved TYK2 inhibitor worldwide and the first innovation in oral treatment for moderate-to-severe plaque psoriasis in nearly 10 years.
The approval was granted as the result of Phase 3 clinical trials that demonstrated “superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis.”
In a 2021 study published in JAMA Dermatology, it was reported that psoriasis, a widely prevalent, chronic, systemic immune-mediated disease, affects approximately 7.5 million people in the U.S. Plaque psoriasis affects 90 percent of those patients and appears on the skin as round or oval plaques that are typically covered by silvery-white scales. In the United States, nearly 2 million people have cases of the disease that are considered moderate-to-severe.
“Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical program,” said clinical investigator and dermatologist April Armstrong, MD, in a press release. “People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”
Positive results in the clinical trial were seen at both 16 and 24 weeks, and continued through 52 weeks. The treatment is recommended for adult patients who are candidates for systemic therapy or phototherapy, and it’s not recommended for use in combination with other potent immunosuppressants. At week 16, the most common adverse reaction was upper respiratory infections and 2.4 percent of patients experienced reactions that caused them to discontinue the medication (though this number was higher with patients taking either the placebo or Otezla).
“Despite the availability of therapies, many people living with plaque psoriasis in the United States are untreated or undertreated,” said Leah M. Howard, president and CEO of the National Psoriasis Foundation, in a press release. “The FDA approval of a new oral treatment is exciting news for the psoriasis community. We welcome this new treatment option.”
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