A randomized phase 3b study evaluating the safety and efficacy of risankizumab in adult patients with moderate-to-severe plaque psoriasis with non-pustular palmoplantar involvement

Abstract

Background: In plaque psoriasis, palmoplantar areas are more difficult to treat.

Objective: Evaluate the safety and efficacy of risankizumab (RZB) versus placebo (PBO) for the treatment of palmoplantar psoriasis.

Methods: Patients were randomized to RZB or PBO for 16 weeks followed by RZB through week 52. The primary and secondary end points were achievement of palmoplantar Investigator's Global Assessment of "clear" or "almost clear" with ≥2-point reduction from baseline (ppIGA 0/1), achievement of ≥75%, ≥90%, and 100% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 75, PPASI 90, PPASI 100) and achievement of static Physician Global Assessment of "clear" or "almost clear" with ≥2-point reduction from baseline (sPGA 0/1) at week 16. Safety was based on treatment-emergent adverse events.

Results: RZB demonstrated significant efficacy compared to PBO at week 16 in the patients achieving ppIGA 0/1 (33.3% vs 16.1% [P = .006]), PPASI 75 (42.5% vs 14.9% [P < .001]), PPASI 90 (27.6% vs 5.7% [P < .001]), sPGA 0/1 (32.2% vs 11.5% [P < .001]), and PPASI 100 (17.2% vs 1.1% [P < .001]). Results improved through week 52 with no new safety signals.

Limitation: No biologic comparator.

Conclusions: RZB demonstrated good tolerance and efficacy in palmoplantar psoriasis.

Keywords: clinical trial; palmoplantar psoriasis; risankizumab.