FDA first approved AbbVie’s (NYSE:ABBV) interleukin-23 inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis in 2019. Now, the agency has extended the approval to include adults with active psoriatic arthritis (PsA), which affects almost one out of three people with psoriasis.
To win the new indication, AbbVie provided data from the KEEPsAKE-1 and KEEPsAKE-2 pivotal studies. Those studies tested Skyrizi in adults with active PsA, including refractory patients.
In the placebo-controlled KEEPsAKE trials, Skyrizi met the primary endpoint of ACR20 at week 24. ACR20 is a composite measure from the American College of Rheumatology that refers to 20% improvement across several variables, including swollen, tender and painful joints.
“In the pivotal KEEPsAKE trials, Skyrizi demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis,” said Dr. Alan J. Kivitz, KEEPsAKE clinical…