Risankizumab: The Only IL-23 Inhibitor FDA-Approved for Adults with Moderate to Severe Plaque Psoriasis and Active Psoriatic Arthritis Advances

Ground-breaking data from two phase 3 studies showed that risankizumab-rzaa demonstrated improvement in psoriatic arthritis (PsA) symptoms, including swollen, tender and painful joints after meeting the primary endpoint of ACR20 at week 24.^1,2

In the phase 3 KEEPsAKE 1 trial, 964 patients with active PsA were randomized and received risankizumab 150 mg or placebo at weeks 0, 4,and 16.¹ Of these patients, 57.3% achieved the primary endpoint of ACR20 at week 24 vs 33.5% of patients on placebo.

The phase 3 KEEPsAKE 2 trial randomized 444 patients with PsA who had previously demonstrated inadequate response or intolerance to biological therapies (Bio-IR) and/or conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR).² Researchers administered risankizumab 150 mg or placebo at weeks 0, 4, and 16 within a 24-week, double-blind treatment period. At week 24, 51.3% of patients receiving risankizumab achieved the primary endpoint of ACR20 vs 26.5% of patients receiving placebo.

In both studies, risankizumab met all secondary endpoints; in the phase 3 KEEPsAKE 1 trial researchers reported differences in skin and nail psoriasis endpoints, minimal disease activity, and resolution of enthesitis and dactylitis.¹

These data supported the pivotal FDA approval of risankizumab-rzaa for the treatment of adults with active psoriatic arthritis as of January 21^st, 2022.³ Currently, risankizumab-rzaa is the only IL-23 inhibitor to be approved for adults with moderate to severe plaque psoriasis and active psoriatic arthritis, administered with a single injection 4 times a year after 2 starter doses at weeks 0 and 4.

References

1. Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022;81(2):225-231. doi:10.1136/annrheumdis-2021-221019
    
2. Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. Published online November 23, 2021. doi:10.1136/annrheumdis-2021-221048
    
3. U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis. Press release. Abbvie; 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