FDA Approves Sotyktu (Deucravacitinib) for Moderate-to-Severe Psoriasis

Sotyktu Improved Symptoms in Over Half of Patients

The FDA approval was based on data from two studies: POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients.

Both trials compared deucravacitinib (6 milligrams once daily) with placebo and apremilast (Otezla; 30 milligrams twice daily), a pill that the FDA approved last year to treat mild, moderate, and severe plaque psoriasis.

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The researchers evaluated the patients’ response using two scores, the Psoriasis Area and Severity Index (PASI) and the Physician’s Global Assessment (sPGA) score.

The FDA deems a psoriasis treatment to be effective if there is a 75 percent reduction in the PASI score (PASI 75).

The studies found:

• At week 16, more than half of patients taking deucravacitinb (58 percent in PSO-1 and 53 percent in PSO-2) saw an improvement in symptoms, versus 35 percent and 40 percent receiving apremilast and about 12 percent receiving placebo.
• At week 24 in the two trials, 69 percent and 59 percent of people taking deucravacitinib achieved the symptom relief goal (PASI 75 response), versus 38 percent and 37 percent receiving apremilast.
• Among patients taking deucravacitinib who achieved the symptom relief goal at week 24, 82 percent continued to have good results on the drug at the one year mark.

“The data show deucravacitinib demonstrated superiority compared with apremilast and placebo in improving severity of psoriasis at week 16 and maintained effectiveness up to two years,” says Marisa Garshick, MD, a physician at MDCS Dermatology in New York City, who was not involved in the drug development.

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She adds that not only did deucravacitinib offer more impressive results than apremilast in the trials, it also has the advantage of being a once-daily dose while apremilast requires two doses a day.

Sotyktu Works in a Novel Way

Deucravacitinib is a TYK2 (allosteric tyrosine kinase 2) inhibitor. It’s the first and only drug of this kind approved for any disease, says Dr. Garshick. (The name Sotyktu references TYK2.)

TYK2, an enzyme, is a member of the Janus kinase (JAK) family of enzymes. These enzymes transmit signals for cell processes, including immune response, stimulating the immune cells to produce inflammatory proteins.

Medications called JAK inhibitors “inhibit” or interrupt the transmission of the signals, reducing inflammation.

The FDA has been scrutinizing JAK inhibitors used to treat autoimmune diseases such as rheumatoid arthritis because of concerns about potential side effects such as serious heart-related events, infections, and blood clots.

But deucravacitinib works differently than JAK inhibitors because it selectively targets the TYK2 pathway, posing fewer potential risks. During the two studies, “There were no reports of serious infections, thromboembolic [clot] events, or laboratory abnormalities as has been a concern with some of the JAK inhibitors,” adds Garshick.

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As a result, the FDA does not require Sotyktu to carry a so-called black box warning, as it mandates for JAK inhibitors.

Deucravacitinib is generally well tolerated by patients. “The most common side effects of Sotyktu are nasopharyngitis [the common cold], upper respiratory tract infection, headache, diarrhea, and nausea,” Garshik says.

Who Should Take Sotyktu?

Deucravacitinib will be a great option for those with moderate-to-severe psoriasis who prefer to avoid injections, says Garshick.

“While more studies are needed to determine where deucravacitinib should be in the treatment ladder, based on the side effect profile and efficacy, it seems reasonable to consider deucravacitinib a first-line therapy for some individuals, especially those who would like an oral medication,” she says.

It is important to note that treatment decisions will always be based on the individual case, so it is always best to speak with your provider, says Garshick. “Some of the study population included individuals who had previously been treated with biologics, so it may also be reasonable to consider deucravacitinib for someone who was previously treated with a biologic and prefers an alternative,” she says.

How Much Does Sotyktu Cost?

The current Wholesale Acquisition Cost pricing for Sotyktu is $6,164 for a 30-day supply, according to Bristol Myers Squibb, putting the cost for a year of therapy close to $75,000. The actual cost to the patient will depend on insurance coverage, says Garshick.

The drug manufacturer is “committed to providing assistance so that patients who need our medicines can access them and expedite time to therapy,” per the statement. Bristol Myers Squibb offers a support program to help patients whose doctors have prescribed deucravacitinib; for additional information, call 888-768-9588.

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