AbbVie, a global biopharmaceutical company, announced the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis.
The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of Skyrizi in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs). Across the two phase 3 studies, Skyrizi met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender and painful joints.
"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, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We're 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 maintains a dosing regimen for PsA that is consistent with the existing regimen for moderate to severe plaque psoriasis patients
