Crisaborole Safe, Efficacious in Atopic Dermatitis, With or Without Allergic Rhinitis

Crisaborole was found to be safe and efficacious for treatment in patients with mild to moderate atopic dermatitis, regardless of past medical history of allergic rhinitis, according to study results presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, held virtually from November 13 to 15.

Investigators of this post hoc study reviewed pooled data from the phase 3 studies, CrisADe CORE 1 (ClinicalTrials.gov Identifier: NCT02118766) and CORE 2 (ClinicalTrials.gov Identifier: NCT02118792). To determine the efficacy and safety of crisaborole in patients with mild to moderate atopic dermatitis with and without comorbid allergic rhinitis, the researchers analyzed findings from a patient population aged 2 years or older and who had been diagnosed with mild to moderate atopic dermatitis. These patients were randomly assigned 2:1 to either twice-daily crisaborole or vehicle, for 28 days.

Success was defined as an Investigator’s Static Global Assessment (ISGA) score of “clear” (or 0) and “almost clear” (or 1) with an improvement of 2 or more grades from baseline at day 29, which served as the primary outcome for the study. Patients were stratified by past medical history of allergic rhinitis.

A total of 163 patients were selected to apply crisaborole while 79 patients received vehicle. These patients (mean age, 11.7 and 10.9 years, respectively) had a past medical history of allergic rhinitis. Moderate disease was seen in 61.4% of the crisaborole group and in 65.8% of those assigned vehicle. Of the patients without a past medical history of allergic rhinitis (mean age, 12.4 and 12.3 respectively), 853 received crisaborole therapy and 427 were given vehicle. Moderate disease was noted in 61.3% and 61.1% of these patients, respectively.

At day 29, the ISGA success rate was 36.6% (95% CI, 28.7%-44.6%) compared with 18.7% (95% CI, 9.7%-27.7%) in patients with a past medical history of allergic rhinitis (P =.003). A success rate of 31.3% (95% CI, 27.9%-34.6%) vs 22.5% (95% CI, 18.2%-26.8%) was observed in patients without a past medical history of allergic rhinitis (difference, P = .002). The researchers noted that an ISGA score of clear or almost clear was achieved by 55.9% (95% CI, 48.0%-63.8%) vs 29.2% (95% CI, 18.8%-39.6%) of patients with a past medical history of allergic rhinitis (difference, P =.0001), and 49.0% (95% CI, 45.4%-52.6%) compared with 36.6% (95% CI, 31.3%-41.8) with a past medical history of allergic rhinitis (difference, P =.0001).

As no new safety concerns were identified, and based on their overall findings, the researchers suggested that crisaborole ointment, 2%, is safe and efficacious for the treatment of mild to moderate atopic dermatitis “regardless of [past medical history] of [allergic rhinitis].”

Reference

Spergel J, Blaiss M, Lio P, et al. Efficacy of crisaborole in patients with mild-to-moderate atopic dermatitis with and without comorbid allergic rhinitis. Presented at: the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting (Virtual Experience); November 13-15, 2020. Abstract P500.