Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial

In this RCT (n=507, 100 placebo), a significantly greater proportion of patients on risankizumab (RK), an IgG1 monoclonal antibody selective to IL-23 protein, achieved treatment response at week 16 and with long-term continuous RK vs. withdrawal to placebo at 52 and 104 weeks.

SPS commentary:

In the study, a PASI 90 response at week 16 was achieved in 73.2% of those receiving risankizumab and 2.0% of placebo; a static Physician’s Global Assessment (sPGA) score of 0/1 was achieved by 83.5% and 7.0%, respectively (p<0.001 for both).

In part B of the study, those who achieved an sPGA score of 0/1 were re-randomized 1:2 to risankizumab or placebo every 12 weeks. An sPGA score of 0/1 at week 52 (primary endpoint) was achieved in 97 patients (87.4%) receiving risankizumab vs 138 patients (61.3%) receiving (placebo-adjusted difference of 25.9%; 95% CI 17.3%-34.6%;P <0.001).

JAMA Dermatology