Selective IL-23 inhibitor achieves long-term disease control in many patients with active PsA

Risankizumab demonstrated a maintained efficacy over 100 weeks in the treatment of active psoriatic arthritis (PsA); efficacy increased up to week 40 and was maintained until the end of the study, independent of previous therapy. Remarkably, up to 44.6% of patients achieved a control of both cutaneous and arthritic disease.

The efficacy and safety of the selective IL-23 blocker risankizumab in PsA was assessed in the phase 3 trial programme KEEPsAKE. “We already know that risankizumab has an important effect on cutaneous manifestations,” said Dr Kim Papp (Probity Medical Research, Canada) during the presentation of the 100-week results of the trial programme [1]. The (positive) 24-week results of the double-blind study period were already presented previously [2,3]. At 24 weeks, 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 trials (NCT03671148), 1,407 participants with active PsA who had inadequate response or intolerance to either ≥1 conventional disease-modifying drug in the KEEPsAKE1 trial or to a previous biologic in KEEPsAKE2 were included. The primary endpoint of the double-blind study period was the proportion of participants achieving 20% improvement according to the American College of Rheumatology 20% response (ACR20), a common study endpoint in rheumatology, at week 24.

“These results are beautiful. We can see at week 24 that about 60% achieves an ACR20 response, which is within the expected results for an effective therapy in PsA,” Dr Papp explained (P<0.001 vs placebo) [2,3]. In the extension phase, there was a further modest increase until week 40. A similar profile was seen in both KEEPsAKE trials. From week 40 onwards, response was maintained until week 100 (see Figure). “Minimal disease activity is a new buzzword because it shows how well we control both cutaneous and arthritic disease,” Dr Papp said. Depending on the statistical analysis used, between 38.2% and 44.6% of participants in the KEEPsAKE 1 and 33.0% and 40.0% in the KEEPsAKE 2 trial achieved this endpoint.

Figure: Maintenance of ACR at week 100 in patients originally randomised to risankizumab [1]



AO, as observed; NRI-MI, as observed with missing data imputed as non-responder except those missing due to COVID-19 or geo-political conflict in Ukraine and Russia, which lay on multiple imputation.

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 Dr 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.

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Posted on 5 November, 202222 February, 2024