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

Publication date: Available online 1 February 2019

Source: Journal of the American Academy of Dermatology

Author(s): Ulrich Mrowietz, Hervé Bachelez, A. David Burden, Michael Rissler, Christian Sieder, Roberto Orsenigo, Kamel Chaouche-Teyara

Abstract

Background

Palmoplantar pustular psoriasis (PPP) is a debilitating disease of the palms and/or soles that is resistant to treatment. Secukinumab, an anti-IL-17A monoclonal antibody, is highly efficacious in the treatment of moderate to severe psoriasis.

Objective

The primary objective was ppPASI75 response with secukinumab at Week 16 vs. placebo (2.5% significance level).

Methods

2PRECISE was a phase 3b multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing secukinumab 300 mg (n=79) and 150 mg (n=80) to placebo (n=78) in subjects with moderate to severe PPP over 52 Weeks.

Results

The primary endpoint was not met. At Week 16, 26.6% of subjects with secukinumab 300 mg achieved ppPASI75 vs.. 14.1% with placebo (P=0.0411) [OR: 2.62; 95% CI: 1.04, 6.60]. At Week 52, 41.8% of subjects with secukinumab 300mg had ppPASI75. More DLQI 0/1 responses were achieved with secukinumab 300 mg (13.0%) vs. placebo (4.3%) at Week 16. At Week 52, 43.1% of subjects receiving secukinumab 300 mg had DLQI 0/1. No unexpected adverse events were observed.

Limitations

Small sample size and characteristics of PPP disease course.

Conclusion

PPP patients treated with secukinumab 300 mg showed benefit in ppPASI75 responses over 52 weeks and improved quality of life.

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