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.
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.
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.
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.