FDA Approves New Drug for Severe Plaque Psoriasis — Here’s What You Need to Know

Here’s how this new oral medication works, how it compares to other treatments, and whether it might be an option for you.

Dermatologists and their patients have been hoping for a more effective oral therapy, according to Dr. Aanand Geria, a New Jersey-based dermatologist. It’s possible it may be here with a new drug: deucravacitinib.

Sold under the brand name Sotyktu, the drug has just been approved by the Food and Drug Administration for moderate to severe plaque psoriasis.

“It’s very possible this may become the go-to medication for adults,” says Geria. “Clinical trials have shown some exciting developments, including more safety than older drugs used for psoriasis. Also, it’s an oral medication, which many patients prefer over injections.”

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How the new drug works

Deucravacitinib is a TYK2 inhibitor, and it’s the first drug using that mechanism — which Geria says is important.

Inside an immune cell, TYK2 functions as a messenger, telling the cells when to multiply or increase inflammation. New skin cells are normally created only when and where these types of signals indicate.

Geria explains that with psoriasis, TYK2 is overactive and sends out too many signals, causing overactivity in skin production. That’s why plaques are scaly and tough — they’re dense with new skin cells layering on top of one another.

“Sotyktu is the only once-daily, FDA-approved pill that selectively blocks and targets TYK2 signals,” says Geria. “Blocking these signals reduces psoriatic symptoms.”

Difference from other treatments

That mechanism of action differs from another medication used for psoriasis — a JAK inhibitor under the brand name Xeljanz — which tamps down a greater breadth of immune responses.

While that can reduce inflammation and handle infections, it also decreases immune system function overall, Geria says, which means patients may be more susceptible to other types of illness.

Another commonly prescribed medication is a phosphodiesterase 4 (PDE4) inhibitor, under the brand name Otezla, which is also an oral treatment. This works by targeting PDE4, an enzyme that controls how much inflammation is within cells.

One more type of treatment is biologics. These work by blocking reactions in the immune system that can lead to psoriasis, according to the American Academy of Dermatology Association.

Biologics approved by the FDA to treat psoriasis specifically include brand names like:

• Cosentyx
• Enbrel
• Tremfya
• Cimzia
• Humira
• Remicade

“Clinical trials have indicated that deucravacitinib is comparable to biologics and superior to some of the older versions of those,” says Geria. “Trials have also found results that are better than Otezla.”

Challenges with treatment

Every medication, even aspirin, comes with potential side effects. For deucravacitinib, there was a higher risk compared with the placebo of upper respiratory infections, mouth ulcers, and herpes simplex.

Although people may experience headache, diarrhea, and nausea, more incidence of these were reported among people taking placebos than deucravacitinib.

Also, like other medications, insurance coverage may be an issue for some patients, Geria says. First-time patients may be eligible for a free trial since the manufacturer, Bristol-Myers Squibb, has a “bridge program,” which is when someone who’s insured for the drug can receive it for free while awaiting a coverage decision.

Patient assistance programs may also be available, providing discounted medication for low-income, uninsured, or underinsured patients who meet specific guidelines.

Information on both programs can be found on the manufacturer’s website.

When to ask your doctor about the new drug

If you’ve just been diagnosed with psoriasis and you’re not on treatment yet, it’s unlikely deucravacitinib will be a first step for addressing your plaques, says Geria.

First-line treatment is usually corticosteroids, especially for mild to moderate psoriasis. These come in different forms, such as ointments, oils, creams, gels, lotions, sprays, shampoos, and foam.

Light therapy is another option, Geria says, particularly for moderate to severe psoriasis. This can be used on its own or together with medication. It involves exposing the skin to controlled amounts of a certain type of ultraviolet light.

If you have been taking medication but it isn’t working well, that doesn’t automatically mean switching drugs completely, says New York-based dermatologist Dr. Michele Green of Mount Sinai and Lenox Hill Hospital. A first step may be to change the dosage, for example, or to incorporate more lifestyle changes like increased use of moisturizer or using an anti-itch cream if you find yourself scratching more often.

Deucravacitinib may be an option when other treatments aren’t effective and especially if plaques are becoming more frequent.

“There are usually multiple strategies within a treatment plan, in addition to any medications, so it’s important to talk with your doctor about what might work well for you,” Green says. “Tailoring treatment so it’s specific to your needs is always the best approach.”