KEEPSaKe-1 Trial in Psoriatic Arthritis - IL-23 Inhibition is Effective Save
The results of the KEEPSaKE-1 study in psoriatic arthritis (PsA) has been published and shows that risankizumab (RIZ), an IL-23 inhibitor, showed significant clinical improvements when given to active PsA patients who failed or were intolerant to ≥1 csDMARD.
This was a phase III, randomised, placebo-controlled, double-blind that enrolled 964 active PsA patients, who were given either risankizumab 150 mg or placebo (PBO) at weeks 0, 4 and 16. Patients were allowed to stay on background agents, including methotrexate (65%), other DMARDs (~10%), prednisone (~20%) and NSAIDs (~63%). The primary endpoint was the ACR20 response at week 24.
At week 24, significantly greater ACR20 responses were seen with RIZ (57.3% vs placebo, 33.5%; p<0.001). Similarly, all other secondary endpoints strongly favored RIZ, including skin and nail psoriasis, minimal disease activity, enthesitis and dactylitis (p<0.001).
There were no unexpected adverse events and serious adverse events were low at 1.0% and 1.2%, respectively.
Risankizumab is already approved for use in active plaque psoriasis and appears to be effective in active PsA as well.