The efficacy and safety of crisaborole in paediatric patients with allergic dermatitis

Expert Name
Dr. Peter Lio
Expert Affiliation
Northwestern University Feinberg School of Medicine, Chicago, USA
AAD 2021

Crisaborole is indicated for the topical treatment of mild-to-moderate atopic dermatitis. It is effective and safe in treating patients aged ≥2 years with allergic dermatitis irrespective of atopic comorbidities.

Crisaborole ointment 2% is an anti-inflammatory inhibitor of phosphodiesterase 4. It is available in the USA for topical treatment targeting paediatric patients with mild-to-moderate allergic dermatitis (AD) who are at an increased risk of other atopic comorbidities. Two phase 3 trials (NCT02118766 and NCT02118792) with a randomised, double-blind, vehicle-controlled design were conducted in patients with AD aged ≥2 years. Patients were randomly assigned with a 2:1 ratio to receive crisaborole or a vehicle. The aim was to assess the improvement and time to improvement in Investigator’s Static Global Assessment (ISGA) and Severity of Pruritus Scale (SPS) outcomes.

In a posthoc analysis, patients were stratified by history of asthma and/or allergies. The median age was similar across groups (12 years). Significantly higher proportions of crisaborole- than vehicle-treated patients achieved ISGA success, ISGA clear or almost clear, and SPS improvement. Concerning safety, crisaborole had a low frequency of treatment-related adverse events. The most common treatment-related adverse event was application-site pain. One serious adverse event was reported but appeared not related to the treatment.

  1. Lio P, et al. Efficacy and Safety of Crisaborole in Patients With Mild-to-Moderate Atopic Dermatitis With and Without Comorbid Allergies or Asthma. Poster 26304. AAD VMX 2021, 23-25 April.