Secukinumab for moderate-to-severe palmoplantar pustular psoriasis: Results of the 2PRECISE study - 12/04/19
, Hervé Bachelez, MD, PhD b, c, A. David Burden, MD d, Michael Rissler, PhD e, Christian Sieder, PhD e, Roberto Orsenigo, MD f, Kamel Chaouche-Teyara, PhD eAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : palmoplantar pustular psoriasis, PPPASI75, quality of life, secukinumab, randomized controlled trial
Abbreviations used : AE, DLQI, IL, OR, PPP, PPPASI75, TP1, TP2, WPAI-PSO
Plan
| 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. |
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| 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. |
Vol 80 - N° 5
P. 1344-1352 - mai 2019 Retour au numéro
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