FDA Approves SKYRIZI™ to treat Plaque Psoriasis

On Tuesday, April 23, 2019, the United States Food and Drug Administration (FDA) announced that it had approved the drug SKYRIZI to treat certain adults with plaque psoriasis.1 Since no single treatment works for everyone, it is helpful to have multiple options for treating psoriasis.

The new medication is aimed at adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1 Systemic therapy refers to medicines that affect the whole body, like pills or injections, rather than treatments that are placed on patches of affected skin, like lotions or creams. Phototherapy involves exposing affected skin to ultraviolet light under controlled conditions in a doctor’s office.2

More about SKYRIZI (risankizumab-rzaa)

SKYRIZI is an interleukin-23 (IL-23) inhibitor, which means it blocks the action of IL-23, an important molecule for regulating the immune system. The medication was developed as part of a joint effort between two international drug companies: Boehringer Ingelheim and AbbVie. AbbVie is leading the development and commercialization of SKYRIZI globally.1

“People living with plaque psoriasis can be profoundly impacted by their disease both physically and emotionally,” said Stacie Bell, vice president of research and medical affairs at the National Psoriasis Foundation. “The approval of a new therapy represents an important step forward in the treatment of psoriasis, offering dermatologists another option to help patients achieve their treatment goals.1

More about plaque psoriasis and what causes it

Psoriasis is a common skin condition that affects around 3.2% of adults in the United States.3 Plaque psoriasis is the most common form of the disease. It is most frequently found on the scalp, knees, elbows, and lower back. Plaque psoriasis generally appears as red, raised, scaly, and often itchy or painful patches on the skin. These symptoms are caused by an overactive immune system, which causes skin cells to grow abnormally quickly.4 The dysfunctional immune response is also responsible for the redness, inflammation, and itching associated with psoriasis.

How effective is SKYRIZI?

Approval of SKYRIZI was based on results from four Phase III clinical research studies. This type of study looks at the safety and efficacy of a drug being considered to treat people for a specific condition.

The results showed that at 16 weeks, after two doses of the medication, 75% of people in the study had psoriasis-free skin on 90% of their body, compared to only about 2-5% of people taking the placebo.1

After one year, a full 82% had clear skin on 90% of their body, and a majority (up to 60%) had no psoriasis patches at all. Between 80 and 88% of people who experienced 90-100% clear skin by week 16 on the medication maintained that response after a full year.1 This is important, because medicines for psoriasis may stop working for some people, over time.

How does SKYRIZI work?

SKYRIZI is an injectable drug that disrupts a specific immune system factor called interleukin-23. IL-23 seems to be involved in stimulating inflammation, or swelling, in the body. Researchers believe that IL-23 is involved in a number of diseases where the immune system attacks the body and causes swelling and other kinds of tissue damage. Blocking this molecule may help tamp down the inflammation, redness, and itching that underlie many psoriasis symptoms.1

How do you take SKYRIZI?

Patients in clinical trials for Skyrizi received 150 mg of the medicine administered in two injections under the skin. People received an initial dose at the start of treatment and a second dose four weeks later. After that, patients received the medication every 12 weeks, for maintenance therapy.1

What are possible side effects?

SKYRIZI can lower your body’s ability to fight infections since it affects your immune response. It is important to tell your doctor or healthcare provider if you have been exposed to tuberculosis or if you experience signs of infection when taking the medication. The most common side effects among people in the trial included upper respiratory infections (13%), headache (3.5%), and fatigue (2.5%).1

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