The Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA). Skyrizi is also indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
The PsA approval was based on data from 2 randomized, double-blind, placebo-controlled phase 3 studies, KEEPsAKE-1 (ClinicalTrials.gov Identifier: NCT03675308) and KEEPsAKE-2 (ClinicalTrials.gov Identifier: NCTHAHA03671148), which compared the efficacy and safety of risankizumab, an interleukin-23 antagonist, to placebo in adults with active PsA who had an inadequate response or were intolerant to biologic therapy and/or nonbiologic disease-modifying antirheumatic drugs. The primary endpoint for both studies was the proportion of patients who achieved an American College of Rheumatology (ACR) 20 response at week 24.
Results from KEEPsAKE-1 and KEEPsAKE-2 showed that 57.3% and 51.3% of patients, respectively, treated with risankizumab 150mg achieved ACR20 at week 24 compared with 34% and 27% of patients who received placebo (P <.001). Risankizumab was also associated with improvements in ACR50 and ACR70 responses at week 24 vs placebo.
In patients with pre-existing dactylitis or enthesitis, treatment with risankizumab resulted in improvement in dactylitis and enthesitis. Among participants with coexistent plaque psoriasis receiving risankizumab, improvement in the skin lesions of psoriasis was also observed, as measured by the Psoriasis Area Severity Index (PASI 90) at week 24.
The safety profile of risankizumab in patients with PsA was consistent with that observed in patients with plaque psoriasis. The most common adverse reactions reported were upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
“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 Duncansville, Pa. and KEEPsAKE clinical trial investigator. “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.”
Skyrizi is supplied in a 150mg/mL single dose pen, a 150mg/mL single-dose prefilled syringe, and a 75mg/0.83mL single-dose prefilled syringe (carton of 2 syringes). Patients may self-inject Skyrizi after training in subcutaneous injection technique.
- 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://www.prnewswire.com/news-releases/us-fda-approves-second-indication-for-skyrizi-risankizumab-rzaa-to-treat-adults-with-active-psoriatic-arthritis-301466021.html
- Skyrizi. Package insert. AbbVie; 2021. Accessed January 24, 2022. https://www.rxabbvie.com/pdf/skyrizi_pi.pdf