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FDA Approves Skyrizi for Psoriatic Arthritis Following Promising Clinical Trials

Posted on February 25, 2022
Medically reviewed by
Ariel D. Teitel, M.D., M.B.A.
Article written by
Emily Wagner, M.S.

  • The U.S. Food and Drug Administration (FDA) recently approved the biologic Skyrizi for treating adults with active psoriatic arthritis (PsA).
  • The approval came after two clinical trials found that more than 50 percent of those who received the drug saw improvements in their PsA and plaque psoriasis symptoms.
  • Skyrizi works by inhibiting an inflammatory protein known as interleukin-23 (IL-23), which targets inflammation.

On the heels of two promising clinical trials, the FDA has approved Skyrizi (risankizumab-rzaa) for treating active PsA in adults. The new indication means the biologic drug has the FDA’s nod for treating both moderate to severe plaque psoriasis and PsA.

PsA is caused by an overactive immune system that attacks the body’s joints, tendons, and ligaments. It affects about 30 percent of people living with psoriasis. Skyrizi, manufactured by AbbVie, was originally approved by the FDA in April 2019 for adults with moderate to severe plaque psoriasis. The expanded approval to PsA came in late January of this year.

“This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with active psoriatic arthritis,” said Dr. Alan J. Kivitz, medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Duncansville, Pennsylvania and a lead investigator in the Skyrizi clinical trials.

Now, Skyrizi is the only FDA-approved IL-23 inhibitor for treating people with moderate to severe plaque psoriasis and PsA that can be given with a single injection four times a year. Other IL-23 inhibitors are available but require more annual doses.

Improved Symptoms for More Than Half of Study Participants

In a pair of phase 3 clinical trials — KEEPsAKE 1 and KEEPsAKE 2 — researchers determined Skyrizi significantly improves PsA symptoms when compared to a placebo (sugar pill).

They found that 57.3 percent of participants in KEEPsAKE 1 and 51.3 percent of those in KEEPsAKE 2 responded to the therapy after 24 weeks of treatment, compared to 33.5 percent and 26.5 percent of participants who received the placebo.

Improvements included reduced inflammation around the joints and less swelling of the fingers and toes. Some participants with both PsA and plaque psoriasis saw improvements in their skin lesions after 24 weeks of treatment.

How Does Skyrizi Work?

Skyrizi is a biologic therapy, made from human-made antibodies. These antibodies are able to target specific areas of the immune system to help dampen the inflammation that causes PsA and other autoimmune diseases.

Skyrizi works by binding directly to a specific part a cytokine (protein) called IL-23, known to cause inflammation. This stops the protein from triggering inflammation, which in turn can stop the formation of plaques and alleviate joint pain, stiffness, and swelling.

Potential Side Effects

According to AbbVie, Skyrizi may cause side effects, including serious allergic reaction such as fainting, lightheadedness, swelling, breathing difficulties, chest tightness, hives, and itching. It also can increase a person’s risk for infections, as can other biologics.

All updates must be accompanied by text or a picture.
Ariel D. Teitel, M.D., M.B.A. is the clinical associate professor of medicine at the NYU Langone Medical Center in New York. Review provided by VeriMed Healthcare Network. Learn more about him here.
Emily Wagner, M.S. holds a Master of Science in biomedical sciences with a focus in pharmacology. She is passionate about immunology, cancer biology, and molecular biology. Learn more about her here.

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