Selective IL-23 inhibitor shows long-term efficacy in active PsA

KEEPsAKE 1 and 2 trials demonstrated high efficacy of the IL-23 blocker risankizumab in adult patients with active psoriatic arthritis independent of previous therapy.

The inhibitor's effect on cutaneous manifestations was previously known

The phase 3 programme KEEPsAKE was established to assess the efficacy of risankizumab in psoriatic arthritis. “We already know that it has an important effect on cutaneous manifestations,” Prof. Kim Papp (Probity Medical Research, Canada) said during the presentation of the 100-week results of the trial programme1. The (positive) 24-week results of the double-blind study period were already presented previously2,3. At this time, all patients entered an open-label extension period and placebo patients were switched to risankizumab 150 mg every 12 weeks. 

In both the KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 trial (NCT03671148), 1,407 participants with active PsA were included who had inadequate response or intolerance to either ≥1 conventional disease-modifying drug in the KEEPsAKE1 trial or to a previous biologic in KEEPsAKE2. The primary endpoint of the double-blind study period was the proportion of participants achieving 20% improvement according to the American College of Rheumatology (ACR 20), a common study endpoint in rheumatology, at week 24.

Beautiful results, and exceptional skin response

“These results are beautiful. We can see at week 24 that about 60% achieve an ACR20 response within the expected results for an effective therapy in PsA,” Prof. Papp explained (P<0.001 vs placebo2,3). In the extension phase, there was a further modest increase until week 40. A similar profile was seen in the KEEPsAKE 2 trial. From week 40 onwards, response was maintained until week 100. “Minimal disease activity is a new buzzword because it shows how well we control both cutaneous and arthritic disease,” Prof. Papp said. Depending on the statistical analysis used, between 38.2% and 44.6% of participants in the KEEPsAKE1 and 33.0% and 40.0% in the KEEPsAKE 2 trial achieved this endpoint.

The superiority of risankizumab was also evident for a couple of additional efficacy endpoints, e.g. in different quality-of-life measures and changes in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue score. Moreover, the response of the skin was exceptional with more than 70% achieving a Psoriasis Area and Severity Index (PASI) 90 response.

Risankizumab was generally well tolerated with what Prof. Papp described as a “quiet safety profile”.

  1. Papp K, et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Trials. D3T01.1D, EADV Congress 2022, Milan, Italy, 7‒10 September.
  2. Kristensen LE, et al. Ann Rheum Dis. 2021;80:1315–6.
  3. Östör A, et al. Ann Rheum Dis. 2021;80:138–9.