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,” KEEPsAKE clinical trial investigator Dr. Alan J. Kivitz said in a press release. “This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with active psoriatic arthritis, alongside a quarterly dosing schedule that may fit their patients’ lifestyle.”
The drug also improved symptoms of dactylitis and enthesitis.
AbbVie developed Skyrizi in collaboration with privately-held Boehringer Ingelheim.
FDA has approved multiple interleukin-23 inhibitors, including Janssen’s (NYSE:JNJ) Stelara (ustekinumab) and Tremfya (guselkumab) as well as Sun Pharma’s (NSE:SUNPHARMA) Ilumya (tildrakizumab).
AbbVie is billing Skyrizi as the only FDA-approved IL-23 “for adults with moderate to severe plaque psoriasis and active psoriatic arthritis that can be administered with a single injection four times a year.” To be used at that interval, the drug requires two starter doses at weeks 0 and 4.
ABBV shares ticked down 0.77% to $131.98.
The Dow Jones U.S. Pharmaceuticals Index was down a similar amount, falling 0.95% to $7.21.
Filed Under: Rheumatology