Higher Systemic Exposure to Crisaborole of Children Versus Adults With Psoriasis Is Unlikely

September 19, 2019

By Brian Hoyle

CHICAGO -- September 18, 2019 -- The likelihood of children with psoriasis having a higher systemic exposure to crisaborole than adults after topical application is low, according to a study presented here at the 2019 Annual Meeting of the American College of Clinical Pharmacology (ACCP).

“Crisaborole systemic exposures in children (≥2 years) at [the] maximum possible dose are unlikely to exceed systemic exposure at the maximum possible dose in adults,” reported Vivek Purohit, PhD, Pfizer, Inc., Groton, Connecticut, and colleagues.

Prior results from 2 randomised, double-blind, vehicle-controlled phase 3 studies involving >1,000 subjects showed that twice-daily application of crisaborole was effective and well tolerated in children and adults with mild to moderate AD. The only evident side effect was pain at the site of application in 4% of the subjects.

The current study was done to correlate systemic exposure parameters with ointment dose, with the aim of determining whether systemic exposure was similar in healthy children and adults and those with AD or psoriasis.

The data came from 3 phase 1 studies (C3291009, C3291010, C3291019) in healthy adults, 2 phase 1b studies (C3291006, C3291007) in patients aged 12 to 17 years with mild to moderate AD, and 1 phase 1b study (C3291012) in adult patients with mild to very severe psoriasis.

Results showed that systemic exposure was higher in patients with atopic dermatitis or psoriasis than in healthy volunteers.

The various data models used indicated that when the ointment was applied to similarly sized areas of the skin, the systemic exposure was similar regardless of age.

Even when applying the highest possible ointment dose (corresponding body surface area, 90%), the paediatric systemic exposure to crisaborole was unlikely to exceed that of adults.

Funding for the study was provided by Pfizer, Inc.

[Presentation title:Patient- and Disease-Characteristic Predictors of Systemic Exposure to Crisaborole. Abstract 071]