Secukinumab for moderate-to-severe palmoplantar pustular psoriasis: Results of the 2PRECISE study.
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.
['Mrowietz|Ulrich|U|', 'Bachelez|Hervé|H|', 'Burden|A David|AD|', 'Rissler|Michael|M|', 'Sieder|Christian|C|', 'Orsenigo|Roberto|R|', 'Chaouche-Teyara|Kamel|K|']
D000328:Adult D000368:Aged D000911:Antibodies, Monoclonal D061067:Antibodies, Monoclonal, Humanized D003879:Dermatologic Agents D004311:Double-Blind Method D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D000071066:Patient Reported Outcome Measures D011565:Psoriasis D011788:Quality of Life D012720:Severity of Illness Index
secukinumab palmoplantar pustular psoriasis PPPASI75 quality of life randomized controlled trial