Efficacy and safety of crisaborole in patients with mild-tomoderate atopic dermatitis and other atopic comorbidities

Jonathan M. Spergel, Michael S. Blaiss, Peter Lio, Aharon Kessel, Wendy C. Cantrell, Liza Takiya*, John L. Werth, Michael A. O'Connell, Chuanbo Zang, Michael J. Cork

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Background: Crisaborole is a nonsteroidal anti-inflammatory phosphodiesterase 4 inhibitor that is approved for the treatment of patients with mild-to-moderate atopic dermatitis (AD); however, the efficacy and safety of crisaborole in patients with AD and other atopic comorbidities have not been investigated. Objective: This post hoc pooled analysis of the pivotal phase III studies (CrisADe CORE 1 and CORE 2) assessed the efficacy and safety of crisaborole versus vehicle in patients aged ≥ 2 years with mild-to-moderate AD and other atopic comorbidities. Methods: Patients with mild-to-moderate AD and a medical history of asthma, allergic rhinitis, or food allergies were identified. Efficacy assessments included the proportion of patients who achieved Investigator's Static Global Assessment (ISGA) success at day 29, ISGA clear or almost clear at day 29, and improvement in the Severity of Pruritus Scale score at week 4. Safety was assessed via treatment-emergent adverse events (TEAEs). Results: This analysis included 1522 patients (crisaborole, 1016; vehicle, 506); 26.2, 15.9, and 16.5% had a medical history of asthma, allergic rhinitis, and food allergies, respectively. The mean age was 12.2 years. A significantly greater proportion of patients treated with crisaborole achieved ISGA success at day 29 compared with patients treated with vehicle for most subgroups analyzed. Furthermore, a significantly greater proportion of patients treated with crisaborole achieved ISGA clear or almost clear at day 29 across all subgroups and demonstrated improvement in the Severity of Pruritus Scale score at week 4 versus patients treated with vehicle in most of the subgroups. Overall,most TEAEs weremild ormoderate in severity; themost common treatment-related TEAE in patients with atopic comorbiditieswas application-site pain (crisaborole, 5.1%; vehicle, 1.7%). Conclusion: Crisaborole was efficacious and well tolerated in patients with mild-to-moderate AD and other atopic comorbidities, which suggested that crisaborole should be considered for the management of AD in this population.

Original languageEnglish (US)
Pages (from-to)425-431
Number of pages7
JournalAllergy and asthma proceedings
Volume42
Issue number5
DOIs
StatePublished - Sep 1 2021

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Immunology and Allergy

Fingerprint

Dive into the research topics of 'Efficacy and safety of crisaborole in patients with mild-tomoderate atopic dermatitis and other atopic comorbidities'. Together they form a unique fingerprint.

Cite this