FDA Approves Risankizumab-rzaa for Treatment of Adults with Active Psoriatic Arthritis


In a pair of pivotal studies, risankizumab-rzaa (Skyrizi) met the primary endpoint of American College of Rheumatology 20% improvement response at week 24 compared to placebo.

Officials with the FDA have approved a second indication for risankizumab-rzaa (Skyrizi; AbbVie) for the treatment of adults with active psoriatic arthritis (PsA), based on results from 2 pivotal studies.

According to an AbbVie press release, the KEEPsAKE-1 and KEEPsAKE-2 studies evaluated the efficacy and safety of risankizumab-rzaa in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy or non-biologic disease-modifying antirheumatic drugs (DMARDs).

PsA is a heterogeneous, systemic inflammatory disease affecting the joints and skin. The immune systems of patients with PsA cause inflammation that can lead to skin lesions associated with psoriasis, as well as pain, fatigue, and stiffness in the joints. PsA affects approximately 30% of patients with psoriasis.

“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,” Thomas Hudson, MD, senior vice president of reserch and development and chief scientific officer at AbbVie, said in the press release. “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.”

Both studies met the primary endpoint of American College of Rheumatology 20% improvement (ACR20) response at week 24 compared to placebo, according to the press release. They also demonstrated significant improvements across several other manifestations of PsA, including joint swelling, tenderness, and pain.

KEEPsAKE-1 and KEEPsAKE-2 are both phase 3, multicenter, randomized, double-blind, placebo-controlled studies. KEEPsAKE-1 evaluated risankizumab-rzaa in patients with PsA who had an inadequate response or intolerance to at least 1 DMARD. KEEPsAKE-2 evaluated the treatment in patients who had an inadequate response to biologic therapy and/or DMARDs.

In KEEPsAKE-1 and KEEPsAKE-2, 57.3% and 51.3% of patients receiving risankizumab-rzaa, respectively, achieved the primary endpoint of ACR20 at week 24, compared with 33.5% and 26.5%, respectively, of patients receiving placebo. Researchers also noted improvements in ACR50 and ACR70 responses compared to placebo at week 24, in addition to improvements in dactylitis and enthesitis for patients with pre-existing dactylitis and enthesitis.

Patients with coexistent plaque psoriasis who received risankizumab-rzaa saw improvements in the skin lesions associated with psoriasis, compared with placebo, as measured by the Psoriasis Area Severity Index at week 24. Risankizumab-rzaa also showed a statistically significant improvement in physical function compared to placebo, as measured by the Health Assessment Questionnaire-Disability Index at week 24. In this measurement, researchers found a mean difference of 0.20 in the KEEPsAKE-1 trial and 0.16 in the KEEPsAKE-2 trial.

“In the pivotal KEEPsAKE trials, Skyrizi demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis, and dactylitis,” Alan J. Kivitz, MD, CPI, KEEPsAKE clinical trial investigator, said in the 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 overall safety profile observed in patients with PsA who were treated with risankizumab-rzaa is generally consistent with the safety profile in patients with plaque psoriasis, according to the press release. Serious adverse effects can include allergic reactions and increased risk of infections.

Risankizumab-rzaa has a dosing regimen for PsA that is consistent with the existing regimen for moderate to severe plaque psoriasis. It is administered as a single 150 mg subcutaneous injection 4 times a year after 2 starter doses at week 0 and 4, and can be administered alone or in combination with DMARDs.


US FDA Approves Second Indication for Skyrizi (Risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis. News release. AbbVie; January 21, 2022. Accessed January 24, 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

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