At the 24-week mark, 57.3% of patients receiving risankizumab achieved ACR20, compared with 33.5% of patients on placebo (P<0.001).
Eight of the study’s secondary endpoints also showed significant improvement, including skin (PASI 90) and nail (mNAPSI and PGA-F) psoriasis endpoints, minimal disease activity, and resolution of enthesitis and dactylitis (P<0.001).
For patients with greater than 3% of their body surface area impacted by psoriasis at baseline, a significantly greater proportion of patients achieved PASI 90 alleviation of symptoms with risankizumab versus placebo (52.3% vs. 9.9%; P<0.001).
Risankizumab also produces significant improvements in ACR50 (33.4% vs. 11.3%) and ARC70 (15.3% vs. 4.7%).
Dr. Kristian Reich, who studies inflammatory skin diseases at University Medical Center Hamburg-Eppendorf, in Germany, and was not involved in the study, says ACR50 would be a preferable treatment goal over ARC20. Risankizumab is currently “miles away” from that goal, he tells Reuters Health by email.
“In principle, the paper shows disappointing results clearly indicating that TNF and IL-17 inhibitors but not IL-12/23 or IL-23 inhibitors are the main therapies in PsA,” says Dr. Reich.
“We want to overcome the toxicity of cDMARDs by using more powerful and safer biologics and not having to combine biologics with cDMARDS because alone they do not work well enough,” he says.
Citing a full year of data (52 weeks) from a second KEEPsAKE trial, however, Dr. Kristensen noted that risankizumab’s mode of action – which is immune-modulating, rather than immune-effector inhibiting—may lead to further improved symptoms with longer use.
“I really believe that the interesting data is long-term data with this mode of action,” that is, p19 inhibition, Dr. Kristensen says. “Risankizumab responds gradually over time instead of climbing to a rapid but clamped response.”
The biopharmaceutical company AbbVie, which manufactures and markets risankizumab under the trade name Skyrizi, funded and participated in the design of the two KEEPsAKE trials. Dr. Kristensen has financial ties to the company.
- 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. 2022 Feb;81(2):225–231. Epub 2021 Dec 15.