New Phase 3 Data Reports on Risankizumab for Psoriatic Arthritis

New phase 3 results from AbbVie indicate that risankizumab (SKYRIZI) improved disease activity across joint and skin symptoms among patients with psoriatic arthritis.

The data were reported from the KEEPsAKE-1 and KEEPsAKE-2 trials, which evaluated the interleukin-23 (IL-23) inhibitor in adult patients with active psoriatic arthritis. The trials also included patients who had an inadequate response (or were intolerant) to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

The primary endpoint sought by the investigators was ACR20 response at week 24.

Thus, in both the KEEPsAKE-1 and KEEPsAKE-2 trials, 57% and 51% of patients, respectively, who had received risankizumab achieved ACR20 response—compared with 34% and 27% of patients, respectively, who received placebo.

In terms of ranked secondary endpoints, more patients on risankizumab demonstrated significant improvements in skin clearance, physical function, and minimal disease activity.

The safety profile of the inhibitor was noted to be generally consistent with safety findings in previous studies of psoriasis. As such, serious adverse events occurred in 2.5% of risankizumab patients in the KEEPsAKE-1 trial and 4.0% in the KEEPsAKE-2 trail—versus 3.7% and 5.5% on placebo.

Further, the rates of adverse events leading to discontinuation for those on risankizumab was 0.8% and 0.9% in KEEPsAKE-1 and KEEPsAKE-2 trials, respectively. For those on placebo, the discontinuation rates were 0.8% and 2.3%, respectively.

"We are encouraged by these positive results showing the potential of risankizumab in psoriatic arthritis," said Michael Severino, MD, vice chairman and president, AbbVie in a statement. "These results underscore our commitment to research that can provide health care practitioners with important treatment options for patients with psoriatic disease."