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Risankizumab Receives FDA Approval for Active Psoriatic Arthritis


AbbVie announced the FDA approval to their IL-23 inhibitor risankizumab-rzaa (Skyrizi) for treatment of active psoriatic arthritis (PsA) in adult patients based on the results of the KEEPsAKE-1 and KEEPsAKE-2 trials.

The FDA has approved risankizumab-rzaa (Skyrizi; AbbVie) for the treatment of adults with active psoriatic arthritis (PsA), according to a release from AbbVie.1

Risankizumab-rzaa is an inflammatory pathway interleukin(IL)-23 inhibitor and this is the second indication that it is being approved for. It is also approved for the treatment of adults with moderate to severe plaque psoriasis in 2019. This most recent approval is based on the results of the KEEPsAKE-1 (NCT03675308) and KEEPsAKE-2 (NCT03671148) trials.

"In the pivotal KEEPsAKE trials, SKYRIZI demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis," said Alan J. Kivitz, MD, CPI, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Pennsylvania and KEEPsAKE clinical trial investigator, in the aforementioned 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 KEEPsAKE-1 and KEEPsAKE-2 trials were phase 3 studies assessing the efficacy and safety of the therapy in adults with PsA as well as those who had responded inadequately or with intolerance to biologic therapy and/or disease-modifying antirheumatic drugs (DMARDs).

The primary endpoint sought by KEEPsAKE investigators was an American College of Rheumatology 20% improvement (ACR20) response at week 24. Data showed:1

  • In KEEPsAKE-1 and KEEPsAKE-2, 57.3% and 51.3% of patients receiving risankizumab achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5%and 26.5% receiving placebo. Risankizumab also demonstrated improvements in ACR50 and ACR70 responses compared to placebo at week 24.
  • Risankizumab showed improvements in other key manifestations of PsA compared to placebo at week 24, including improvements in dactylitis and enthesitis for patients with pre-existing dactylitis and enthesitis.
  • Patients with coexistent plaque psoriasis receiving risankizumab-rzaa saw improvements in the skin lesions of psoriasis, compared to placebo, as measured by the Psoriasis Area Severity Index (PASI 90) at week 24.
  • Risankizumab showed a statistically significant improvement in physical function, compared to placebo, as measured by the Health Assessment Questionnaire-Disability Index at week 24, with a mean difference of 0.20 in KEEPsAKE-1 and 0.16 in KEEPsAKE-2

The rates of adverse events (AEs) leading to discontinuation for patients. treated with risankizumab was 0.8% and 0.9% in both trials, respectively. For those on placebo, the discontinuation rates were 0.8% and 2.3%, respectively.

Thomas Hudson, MD, senior vice president of Research and Development and chief scientific officer of AbbVie, emphasized the benefit of a cross-indicated biologic approved for patients with potentially both plaque psoriasis and PsA.

"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, MD, senior vice president of research and development and chief scientific officer with 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."


1. U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis. Published January 21, 2022. Accessed January 28, 2022. https://news.abbvie.com/news/press-releases/us-fda-approves-second-indication-for-skyrizi-risankizumab-rzaa-to-treat-adults-with-active-psoriatic-arthritis.htm?view_id=2421

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