First-in-class oral medication approved for treatment of psoriasis

Plaque psoriasis is the most common form of psoriasis. About 80–90% of people with psoriasis experience plaque psoriasis.

Plaque psoriasis causes plaques on the skin that may be:

• raised
• inflamed
• scaly
• itchy
• painful

These plaques may look different on different skin colors. On white skin, the plaques may look red with a silvery white scale. On darker skin tones, the plaques may seem purple-gray or dark brown. They may also appear darker and thicker than on white skin.

Deucravacitinib is a once-daily prescription oral medication to treat moderate to severe plaque psoriasis. Currently, only the brand name medication Sotyktu is available as no generic versions are on the market yet.

It is appropriate for people who are candidates for systemic therapy or phototherapy for their psoriasis.

Approved by the Food and Drug Administration (FDA) in September 2022, the drug belongs to a class of drugs known as tyrosine kinase 2 (TYK2) inhibitors and offers a new approach for treating plaque psoriasis.

Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor. These drugs work by inhibiting a type of protein in immune cells called TYK2. It has been proven that this protein plays a central role in the cause of psoriasis.

In people with psoriasis, the immune system is overactive and sends more inflammatory signals than is necessary. TYK2 plays a role in transporting these signals all over the body. This can result in inflammation and the formation of the plaques seen in plaque psoriasis.

It is unknown why blocking the signals from the TYK2 molecule can help reduce psoriasis symptoms.

Currently, deucravacitinib is the only medication with FDA approval that can selectively target the TYK2 molecule.

It is a 6-milligram (mg) tablet taken orally once a day, with or without food. The tablet should not be crushed, cut, or chewed.

In phase 3 clinical trials, Sotyktu taken once a day proved to be more effective than placebo and more effective than apremilast (Otezla) taken twice a day.

Phase 3 of the trials involved 1,684 patients aged 18 and older with moderate to severe plaque psoriasis.

The trials were multinational, multi-center, randomized, double-blind, placebo controlled studies that lasted 52 weeks.

At 16 weeks, a larger number of participants treated with deucravacitinib reported an absence of itch, burning, pain, stinging, and tightness of the skin compared with placebo.

Deucravacitinib was proven to have greater efficacy than the placebo and apremilast at 16 weeks and 24 weeks during trials.

The positive response to deucravacitinib continued to 52 weeks.

There are a number of treatment options for plaque psoriasis.

These include:

• topicals
• phototherapy
• systemics, such as biologics or oral treatments
• complementary or integrative therapies

A doctor will help decide the best treatment option for a patient based on symptom severity and reactions to treatment.

Deucravacitinib is recommended for patients who would be good candidates for systemic therapy. These are prescription drugs that work throughout the entire body.

For some patients, systemic treatments like deucravacitinib may be beneficial if topical treatments or phototherapy are ineffective or intolerable.

Systemic oral treatments currently available include:

• cyclosporine
• acitretin (Soriatane)
• methotrexate
• apremilast (Otezla)
• tofacitinib (Xeljanz, Xeljanz XR)
• off-label systemics

In clinical trials, deucravacitinib was compared with apremilast. Both medications are oral systemics but work differently.

Like deucravacitinib, apremilast works by inhibiting an enzyme. But it targets a different enzyme from deucravacitinib. Apremilast inhibits an enzyme called phosphodiesterase 4 (PDE4). This enzyme is responsible for the majority of the inflammatory process within cells. This in turn can impact inflammation in psoriasis.

Apremilast is a 30-mg tablet taken twice daily after a 5-day phase in period.

In trials, deucravacitinib was shown to be more effective than apremilast and with fewer side effects.

Deucravacitinib can cause side effects. The most commonly reported side effects include:

• upper respiratory infections
• herpes simplex (cold sores)
• mouth ulcers
• canker sores
• folliculitis
• increase in blood creatine phosphokinase
• acne

Other possible side effects include:

• serious allergic reactions
• elevation in triglyceride levels
• elevation in liver enzymes
• cancer
• increased risk of infections
• rhabdomyolysis

Some people may not be appropriate candidates for deucravacitinib due to underlying conditions.

Before taking deucravacitinib, talk with your doctor if you have:

• an active infection
• tuberculosis
• hepatitis B
• hepatitis C
• liver problems
• kidney problems
• high triglycerides
• a plan to become pregnant or are pregnant
• a plan to breastfeed or are breastfeeding
• recently received or are due to receive a vaccine

People taking deucravacitinib should not take a live vaccine.

A healthcare professional should check a person for active infections before they begin taking deucravacitinib.

Plaque psoriasis can cause patches of scaly and itchy skin all over the body that may be painful.

Deucravacitinib is a newly approved treatment for people with moderate to severe plaque psoriasis.

Clinical trials found that this oral medication is more effective than currently available oral medications in helping to clear or mostly clear psoriasis plaques. It is also better tolerated with fewer adverse side effects than older medications.

The medication can cause side effects in some people. Those who are or plan to be pregnant, receive a live vaccine, or have certain underlying health conditions should take special precautions when taking this medication.