AbbVie said its drug Skyrizi (ingredient: risankizumab) obtained the U.S. FDA authorization to treat adults with active psoriatic arthritis (PsA).
The FDA approval was based on the results of the KEEPsAKE-1 and KEEPsAKE-2 trials which tested Skyrizi in adults with PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).
In the two phase 3 studies, Skyrizi met the primary endpoint of ACR20 response at week 24, compared to placebo, and showed significant improvements across several other manifestations of PsA, including swollen, tender, and painful joints, the company said.
"Patients often do not suspect a connection between their psoriasis skin symptoms and the joint pain, swelling, and stiffness they may be experiencing, potentially leading to a delay in diagnosis and treatment of psoriatic arthritis," said Thomas Hudson, senior vice president of research and development at AbbVie.
He said he was proud to expand the use of Skyrizi to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms.
Skyrizi’s dosing regimen is the same as the existing one for moderate to severe plaque psoriasis – a single 150mg subcutaneous injection four times a year after two starter doses at week 0 and week 4. Skyrizi can be administered alone or in combination with DMARDs.
Alan J. Kivitz, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Duncansville, Pa., and KEEPsAKE clinical trial investigator, said Skyrizi showed improvements across many psoriatic arthritis symptoms, including joint pain, enthesitis, and dactylitis in the pivotal KEEPsAKE studies.
“This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with PsA, alongside a quarterly dosing schedule that may fit their patients' lifestyle.”
AbbVie and Boehringer Ingelheim jointly developed Skyrizi, with AbbVie leading development and commercialization globally.