Long-Term Efficacy and Safety of an IL-23i Through ~5 Years in PsA (KEEPsAKE 1)

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Author(s):

Mauro Keiserman, Kim Papp, Douglas White, Angela Crowley, Joseph F. Merola, Hayley Barnard, Ana Biljan, Thomas Iyile, Lingfeng Luo, Douglas Ashley, Arathi R. Setty, Hayato Yamazaki, and Frank Behrens

Abstract or description:

This poster reports long-term efficacy, including radiographic endpoints, and safety of risankizumab (RZB) through 244 weeks in biologic-naive patients with active psoriatic arthritis (PsA) in the Phase 3 KEEPsAKE 1 study. Following the 24-week, double-blind, placebo-controlled period (Weeks 0–24), the open-label extension period (Weeks 25–316) assessed long-term efficacy and safety in patients who continued RZB. Through 244 weeks, RZB achieved efficacy in clinical manifestations of PsA. RZB continues to be well tolerated with no new safety signals identified through 244 weeks of treatment. 

Change from baseline in modified Total Sharp Score (mTSS) was a ranked secondary endpoint in the KEEPsAKE program and did not meet statistical significance at Week 24. 

ACR50/70 at Week 24 were nonranked prespecified endpoints and not adjusted for multiplicity. 

The proportion of patients with no radiographic progression (as defined by change from baseline mTSS ≤ 0.0) at Week 24 was a prespecified, nonranked endpoint; thus, no statistical or clinical conclusions can be made. 

Adverse reaction rates observed in clinical trials and long-term extension studies may not predict rates observed in clinical practice. 

OLE LIMITATION: In an open-label extension, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out. 

As Observed (AO) analysis: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates. 

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