FDA Approves Skyrizi, an IL-23 Biologic, for Psoriatic Arthritis

Psoriasis and psoriatic arthritis (PsA) are clearly closely connected, which is why some medications work for people with either diagnosis. Now psoriatic arthritis patients have an additional medication in their treatment arsenal, thanks to the recent FDA approval of risankizumab (Skyrizi).

Risankizumab is a type of biologic drug that blocks interleukin-23 (IL-23) an inflammatory protein that’s involved in immune system overactivity in psoriasis and PsA. The FDA first approved this drug in 2019 for the treatment of psoriasis, but it wasn’t clear until recently whether it would also work well for PsA. After reviewing data from two large phase 3 studies, the FDA agreed last week to approve it for PsA.

According to findings from the KEEPsAKE-1 and KEEPsAKE-2 trials, more than half of the PsA patients who used risankizumab for 24 weeks met the trials’ primary endpoint of ACR20 response,  which meant that their condition had improved by at least 20 percent.

Risankizumab users had fewer swollen, tender, and painful joints. Study participants in the placebo groups were significantly less likely to have this improvement. About 34 percent of those who got a placebo in KEEPsaKE-1 and about 27 percent of those who used a placebo in KEEPsaKE-2 achieved an ACR20 response.

PsA patients who used risankizumab also had greater improvements in dactylitis (“sausage” fingers or toes) and enthesitis (inflammation of the points at which ligaments attach to bone). Those who had psoriasis lesions saw improvements in their skin as well.

Like many other biologics, Skyrizi is given by an injection under the skin. Another IL-23 inhibitor biologic drug is guselkumab (Tremfya), which is also FDA-approved to treat both PsA and psoriatic arthritis. Tremfya is usually administered every two months, whereas Skyrizi is usually given every three months.

Possible side effects of risankizumab include fatigue, headaches, skin infections, and upper respiratory tract infections. Although less common, it may also cause serious allergic reactions (often characterized by trouble breathing and swelling of the mouth, tongue, or throat). Like other biologics, risankizumab also makes you somewhat more susceptible to developing serious infections.

As with any medication, your doctor can help you weigh the risks and benefits of this medication and help select a treatment that’s most apt to work best for you.

AbbVie, which manufactures risankizumab (Skyrizi), and Janssen Pharmaceuticals, which manufactures guselkumab (Tremfya), are corporate sponsor of the Global Healthy Living Foundation. They do not provide input on the editorial content we publish.

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