Demographics and Baseline Disease Characteristics of Early Responders to Crisaborole for Atopic Dermatitis

J Drugs Dermatol. 2020 Jun 1;19(6):619-624.

Abstract

Introduction: Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). This post hoc, pooled analysis identified demographic characteristics associated with early response to crisaborole.

Methods: Early response was defined as day 8 Investigator’s Static Global Assessment (ISGA) success (clear [0] or almost clear [1] with ≥2-grade improvement), ISGA clear/almost clear, or Severity of Pruritus Scale (SPS) response (≥1-point improvement). Correlations between early response and day-29 response were calculated.

Results: Patients were more likely to be early ISGA success responders if they were aged <12 years (P=0.0023), were white (P=0.0316), had moderate baseline disease by ISGA (P=0.0003), had not received prior AD treatment (P=0.0213), had disease duration shorter than or equal to the median (≤6.45 years; P=0.0349), or did not concurrently use antihistamines (P=0.0148). Similar early response results were observed for patients achieving ISGA clear or almost clear; however, they were more likely to have mild baseline disease by ISGA (P<0.0001) or mild percentage of treatable body surface area involvement (5 to <16; P<0.0001). Patients aged <12 years (P=0.0001) or with moderate baseline disease (P=0.0475) were more likely to be early responders based on SPS criteria. By all 3 definitions, patients who achieved early response at day 8 were more likely to be responders at day 29 (P<0.0001).

Conclusion: Based on this analysis, patients aged <12 years were more likely to be early responders to crisaborole per all 3 definitions. Early response to crisaborole was a predictor of response at day 29.

Clinical trial registration: ClinicalTrials.gov, NCT02118766 and NCT02118792 J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.5095THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Publication types

  • Meta-Analysis

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Age Factors
  • Boron Compounds / administration & dosage
  • Boron Compounds / therapeutic use*
  • Bridged Bicyclo Compounds, Heterocyclic / administration & dosage
  • Bridged Bicyclo Compounds, Heterocyclic / therapeutic use*
  • Child
  • Child, Preschool
  • Demography
  • Dermatitis, Atopic / drug therapy*
  • Female
  • Humans
  • Male
  • Ointments
  • Phosphodiesterase 4 Inhibitors / administration & dosage
  • Phosphodiesterase 4 Inhibitors / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • United Kingdom
  • United States

Substances

  • Boron Compounds
  • Bridged Bicyclo Compounds, Heterocyclic
  • Ointments
  • Phosphodiesterase 4 Inhibitors
  • crisaborole

Associated data

  • ClinicalTrials.gov/NCT02118766
  • ClinicalTrials.gov/NCT02118792