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KEEPSaKe-1 Trial in Psoriatic Arthritis - IL-23 Inhibition is Effective

Jan 12, 2022 6:32 pm

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. 

The author has received compensation as an advisor or consultant on this subject

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