Secukinumab for moderate-to-severe palmoplantar pustular psoriasis: Results of the 2PRECISE study

Abstract

Palmoplantar pustular psoriasis (PPP) is a debilitating disease of the palms and/or soles that is resistant to treatment. Secukinumab, an anti-interleukin 17A monoclonal antibody, is highly efficacious in the treatment of moderate-to-severe psoriasis. The primary objective was to determine the rate of achievement of a 75% improvement from baseline in Palmoplantar Psoriasis Area and Severity Index (PPPASI75) with secukinumab at week 16 versus with placebo (at a 2.5% significance level). 2PRECISE was a phase 3b multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing treatment with 300mg of secukinumab (n=79), 150mg of secukinumab (n=80), and placebo (n=78) in subjects with moderate-to-severe PPP over a period of 52weeks. The primary end point was not met. At week 16, 26.6% of subjects treated with 300mg of secukinumab achieved PPPASI75 versus 14.1% of those who received placebo (P=.0411) (odds ratio, 2.62; 95% confidence interval, 1.04-6.60). At week 52, 41.8% of subjects treated with 300mg of secukinumab had achieved ppPASI75.More Dermatology Life Quality Index responses of 0 or 1 were achieved with 300mg of secukinumab (13.0%) than with placebo (4.3%) at week 16. At week 52, 43.1% of subjects receiving 300mg of secukinumab hadaDermatology Life Quality Index response of 0 or 1. No unexpected adverse events were observed. Small sample size and characteristics of the PPP disease course. Patients with PPP who were treated with secukinumab, 300mg, showed benefit in terms of PPPASI75 responses over 52weeks and improved quality of life.