Is Skyrizi approved for treating psoriatic arthritis?

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Official answer

by Drugs.com

Yes, Skyrizi was approved in January 2022 to treat psoriatic arthritis in adults. Skyrizi was also approved in April 2019 to treat moderate-to-severe plaque psoriasis in adults. A third indication, moderate-to-severe Crohn's disease in adults, was cleared by the FDA in June 2022.

The Skyrizi (risankizumab-rzaa) approval for psoriatic arthritis was supported by two Phase 3, placebo controlled studies, KEEPsAKE-1 and KEEPsAKE-2.

  • In these studies, adult participants treated with Skyrizi received four maintenance doses a year, after first receiving two initiation doses. The study included patients who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) and/or biologics.
  • Results demonstrated improved skin and joint symptoms, and physical function at week 24 when compared to a placebo.
  • In both studies, significantly more patients treated with Skyrizi achieved the primary endpoint ACR20 (a composite measure that captures at least a 20% improvement in swollen and tender joints, plus other measures) at 24 weeks when compared to the group that received placebo. Overall, 57.3% and 51.3% of patients receiving Skyrizi achieved ACR20 (a composite measure that captures at least a 20% improvement in swollen and tender joints, plus other measures) compared to 33.5% and 26.5% of those receiving placebo, respectively.
  • The sponsor reports that no new safety risks were observed in the psoriatic arthritis studies. Skyrizi can lead to serious side effects such as allergic reactions and increased risk of infections. The most common side effects include upper respiratory infections (13%), headache (3.5%), fatigue (2.5%), injection site reactions (1.5%), and tinea (fungal) infections (1.1%).

    • Psoriatic arthritis is an inflammatory arthritis associated with plaque psoriasis. Over 30% to 40% of people with plaque psoriasis may develop psoriatic arthritis. Common symptoms are pain, swelling and stiffness, fatigue and loss of ability to fully use the joint.

    Other treatments approved by the FDA to treat psoriatic arthritis include:

  • Cosentyx (secukinumab)
  • Enbrel (etanercept)
  • Humira (adalimumab)
  • Stelara (ustekinumab)
  • Otezla (apremilast)

    • This is not all the information you need to know about Skyrizi for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Skyrizi product information here, and discuss this and any questions you have with your doctor or other health care provider.

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