"51675 Safety and efficacy of risankizumab in adult patients with moder" by Mark Lebwohl, Michael Bukhalo et al.
 

51675 Safety and efficacy of risankizumab in adult patients with moderate-to-severe plaque psoriasis with non-pustular palmoplantar involvement: changes in PPASI and PASI from 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). We assessed the improvement in palmoplantar psoriasis area and severity index (PPASI) and PASI in patients with moderate-to-severe non-pustular palmoplantar PsO (PPPsO). Methods: In IMMprint (NCT04713592), a phase 3b, double-blind, placebo-controlled study, patients (≥18 years) were randomized 1:1 to receive RZB 150mg (week 0, 4 and 16) or placebo (PBO). Starting at week 16, all patients received open-label RZB 150mg (PBO/RZB vs. RZB/RZB) every 12 weeks till week 40 with final evaluation at week 52. PPASI and PASI were assessed by Mixed-effect Model Repeat Measurement (MMRM) to handle missing data in Period A, and Observed Cases (OC) in Period B. Results: The change from baseline in PPASI (RZB vs. PBO, nominal p-value) was -11.3 vs. -6.1, p < 0.001 at week 16 and -16.9 vs. -17.2 (RZB/RZB vs. PBO/RZB) at week 52. The percent change from baseline in PPASI was -51.8 vs. -27.6, p <0.001 at week 16 and -76.1 vs. -78.7 (RZB/RZB vs. PBO/RZB ) at week 52. The change from baseline in PASI was -7.6 vs. -2.3, p < 0.001 at week 16 and -10.3 vs -9.4 (RZB/RZB vs. PBO/RZB) at week 52. The percent change from baseline in PASI among baseline ≥ 12 was -68.1 vs. -15.9, p < 0.001 at week 16 and -89.7 vs. -87.1 (RZB/RZB vs. PBO/RZB) at week 52. Conclusions: Treatment with RZB led to improved clinical responses in the patients with PPPsO with no new safety signal.

Volume

91

First Page

AB306

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