At week 24, 51.3% of patients who received risankizumab-rzaa achieved the primary end point of an ACR20 response, compared with 26.5% of patients who received placebo, a statistically significant difference (P<0.001). A greater proportion of patients receiving risankizumab-rzaa than those who received placebo also achieved the secondary end points (P<0.05). Also at week 24, ACR50 and ACR70 response rates for patients who received risankizumab-rzaa were statistically significantly improved compared with patients who received placebo. The percentage of patients who achieved an ACR50 response was 26.3% in the risankizumab-rzaa group, compared with 9.3% in the placebo group (P<0.001). The ACR70 response rates were 12% for the risankizumab-rzaa group and 5.9% for the placebo group (P<0.05).
Serious adverse events were reported for 4% of patients who received risankizumab-rzaa and 5.5% of patients who received placebo. Serious infections were reported for 0.9% of patients who received risankizumab-rzaa and 2.3% of patients who received placebo.
The open-label period—to evaluate safety, tolerability and efficacy—is ongoing for both studies.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- News release: U.S. FDA approves second indication for risankizumab-rzaa (Skyrizi) to treat adults with active psoriatic arthritis. AbbVie Inc. 2022 Jan 21.
- Kristensen LS, 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 Feb;81(2):225–231.
- Ostor 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. 2022 Mar;81(3):351–358. Epub 2021 Nov 23.
