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

doi:10.1016/j.jaad.2019.01.066

Journal of the American Academy of Dermatology

Volume 80, Issue 5, May 2019, Pages 1344-1352

https://doi.org/10.1016/j.jaad.2019.01.066 Get rights and content

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Background

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.

Objective

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).

Methods

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

Results

The primary end point was not met. At week 16, 26.6% of subjects treated with 300 mg 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 300 mg of secukinumab had achieved ppPASI75. More Dermatology Life Quality Index responses of 0 or 1 were achieved with 300 mg of secukinumab (13.0%) than with placebo (4.3%) at week 16. At week 52, 43.1% of subjects receiving 300 mg of secukinumab had a Dermatology Life Quality Index response of 0 or 1. No unexpected adverse events were observed.

Limitations

Small sample size and characteristics of the PPP disease course.

Conclusion

Patients with PPP who were treated with secukinumab, 300 mg, showed benefit in terms of PPPASI75 responses over 52 weeks and improved quality of life.

Key words

palmoplantar pustular psoriasis

PPPASI75

quality of life

secukinumab

randomized controlled trial

Abbreviations used

adverse event

DLQI

Dermatology Life Quality Index

interleukin

odds ratio

PPP

palmoplantar pustular psoriasis

PPPASI75

75% improvement from baseline in palmoplantar Psoriasis Area and Severity Index score

TP1

treatment period 1

TP2

treatment period 2

WPAI-PSO

Work Productivity and Activity Impairment Questionnaire-Psoriasis

Cited by (0)

: Funding sources: Novartis sponsored the 2PRECISE study and provided funding for conduct of the study, data analysis, and medical writing assistance for the study's publication.

: Disclosure: Dr Mrowietz has received grants/honoraria as an investigator and/or consultant from Abbvie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Centocor, Dr Reddy's, Eli Lilly and Company, Foamix, Formycon, Forward Pharma, Janssen, Leo Pharma, Medac, MSD, Miltenyi Biotech, Novartis, VBL, and Xenoport. Dr Bachelez has received honoraria as a speaker and advisor from Abbvie, Amgen, Boehringer-Ingelheim, Celgene, Janssen, Leo Pharma, Eli Lilly and Company, Novartis, Pfizer, Sun Pharma, and UCB, and he has received research funding from Pfizer. Dr Burden has received research funding and honoraria from Abbvie, Almirall, Boehringer Ingelheim, Celgene, Janssen, Leo Pharma, Novartis, and UCB. Dr Rissler, Dr Sieder, Dr Orsenigo, and Dr Chaouche-Teyara are employees of Novartis.