FDA Approves New Oral Drug Sotyktu for Adults With Plaque Psoriasis | MyPsoriasisTeam

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FDA Approves New Oral Drug Sotyktu for Adults With Plaque Psoriasis

Medically reviewed by Kevin Berman, M.D., Ph.D.
Written by Maureen McNulty
Posted on November 11, 2022

  • Adults with moderate-to-severe plaque psoriasis now have a new oral treatment option: deucravacitinib, sold as Sotyktu.
  • This medication is the first and only treatment option in its drug class.
  • Clinical trials found that deucravacitinib was more effective and led to fewer side effects than a current plaque psoriasis treatment option.

The U.S. Food and Drug Administration (FDA) recently approved a new medication to treat plaque psoriasis. Deucravacitinib, sold as Sotyktu, is the first once-daily oral drug approved to treat this condition in nearly 10 years. In clinical trials, participants with plaque psoriasis showed greater symptom improvement than those taking a placebo (sugar pill) or a current treatment called apremilast (sold Otezla).

“The last two decades have seen one breakthrough after another in the development of new biologics, all injectable, for psoriasis,” said Dr. Mark Lebwohl, dean for clinical therapeutics at the New York-based Icahn School of Medicine at Mount Sinai, in a statement from the National Psoriasis Foundation. “Deucravacitinib’s approval is a major milestone for those of us treating psoriasis as the drug has clinical efficacy comparable to biologics but is safer than older drugs used for psoriasis.”

What Is Sotyktu?

Sotyktu is the first FDA-approved tyrosine kinase 2 (TYK2) inhibitor. It works by blocking the TYK2 protein, which is involved in processes that send signals to the skin that can trigger plaque psoriasis. The medication is currently the only option in its class — it is the only available treatment that works by blocking this protein.

This medication is available in tablets that are taken once per day by mouth. While it can be taken with food, it cannot be crushed or cut.

Who Can Take Sotyktu?

The drug is indicated for adults 18 and up with moderate to severe plaque psoriasis, an autoimmune condition in which the immune system causes the overgrowth of skin cells and itchy, scaly lesions on the skin. To be eligible for this treatment, a person needs to be an eligible candidate for systemic therapy (treatments that travel throughout the body in the bloodstream) or phototherapy (a type of light treatment).

The medication should not be taken by anyone who is pregnant or breastfeeding. Before starting the drug, you should be tested for tuberculosis and hepatitis. You should have your triglycerides monitored while on the medication, as well as your liver enzymes if you have a known or suspected liver disease. You also shouldn’t receive any live vaccines while taking it.

Clinical Trial Results

The FDA approved the drug based on data from two clinical trials, POETYK PSO-1 and POETYK PSO-2. In these trials, more than 1,600 people took either deucravacitinib, a placebo, or apremilast, which is a twice-daily oral plaque psoriasis treatment option. Researchers tracked symptoms using the Psoriasis Area and Severity Index (PASI) and static Physician’s Global Assessment (sPGA) — tools that measure psoriasis severity.

The researchers found that people taking deucravacitinib had more improvements in their plaque psoriasis compared to those taking a placebo or apremilast.

After 24 weeks, the researchers found these results:

  • About 60 percent to 70 percent of participants achieved PASI 75, meaning they had 75 percent improvement in their psoriasis severity scores as measured by PASI.
  • About 30 percent to 40 percent of individuals reached PASI 90.
  • About 50 percent to 60 percent of participants achieved sPGA 0/1 (their plaque psoriasis was rated “clear” or “almost clear”).

Researchers found these results to be long-lasting. Among people who achieved PASI 75, 4 out of 5 still had the same score one year later.

Side Effects

The studies also identified some deucravacitinib side effects. The most common include:

  • More frequent infections, including upper respiratory infections or herpes simplex infections
  • Mouth sores
  • Acne
  • Folliculitis (inflammation, including itching or discomfort, of the hair follicles)
  • High levels of blood creatine phosphokinase, which may be a sign of muscle breakdown

Serious side effects were rare and occurred less often in people taking deucravacitinib as compared to those taking apremilast. Five people developed serious infections, including pneumonia and COVID-19. Other serious side effects included pericarditis (inflammation of the tissue surrounding the heart) and cholecystitis (inflammation of the gallbladder). Across all clinical trials, three individuals developed lymphoma.

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    Posted on November 11, 2022
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    Kevin Berman, M.D., Ph.D. is a dermatologist at the Atlanta Center for Dermatologic Disease, Atlanta, GA. Review provided by VeriMed Healthcare Network. Learn more about him here.
    Maureen McNulty studied molecular genetics and English at Ohio State University. Learn more about her here.

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