"51652 Safety and efficacy of risankizumab in adult patients with moder" by Mark Lebwohl, Michael Bukhalo et al.
 

51652 Safety and efficacy of risankizumab in adult patients with moderate to severe plaque psoriasis with non-pustular palmoplantar involvement: change in DLQI and achievement of DLQI 0/1 results from the Phase 3b IMMprint trial

Document Type

Conference Proceeding

Publication Date

9-1-2024

Publication Title

J Am Acad Dermatol

Abstract

Introduction: Risankizumab (RZB) is an IL-23 inhibitor approved for the treatment of moderate-to-severe psoriasis (PsO). Here, we assess improvement in dermatology life quality index (DLQI) in patients with non-pustular palmoplantar psoriasis (PPPsO) PPPsO receiving risankizumab (RZB). Methods: IMMprint (NCT04713592) is a phase 3b double-blind, placebo-controlled study evaluating the safety and efficacy of RZB in patients with predominately PPPsO. Eligible patients (≥18 years) were randomized 1:1 to receive RZB 150mg (week 0, 4 and 16) or placebo (PBO). At week 16, all patients received open-label RZB 150mg every 12 weeks (PBO/RZB vs. RZB/RZB) till week 40 with a final evaluation at week 52. DLQI was assessed by Mixed-effect Model Repeat Measure analysis to handle missing data in period A and Observed Cases in period B. Safety was monitored throughout the study. Results: The change from baseline in DLQI (RZB vs. PBO, nominal p-value) was -4.5 vs. -0.5, p < 0.001) at week 16 and -8.2 vs. -8.3 (PBO/RZB vs. RZB/RZB) at week 52. The proportion of patients achieving DLQI 0/1 was 25.3% vs. 4.6%, p < 0.001 at week 16 and 35.6% vs. 46.9% (PBO/RZB vs. RZB/RZB) at week 52. The proportion of patients who achieved DLQI reduction ≥4 among baseline DLQI ≥ 4 was 58.6% vs 33.3%, p < 0.001 at week 16 and 65.7% vs. 76.2% (PBO/RZB vs. RZB/RZB) at week 52. No new safety signals were indicated. Conclusions: Systemic-eligible patients with moderate-to-severe PPPsO treated with RZB demonstrated improved quality of life assessed by DLQI.

Volume

91

Issue

3

First Page

AB306

Share

COinS