Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families

Eric L. Simpson*, Amy S. Paller, Mark Boguniewicz, Lawrence F. Eichenfield, Steven R. Feldman, Jonathan I. Silverberg, Sarah L. Chamlin, Lee T. Zane

*Corresponding author for this work

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Introduction: The impact of crisaborole ointment, a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD), on quality of life (QoL) was assessed in two identically designed phase 3 studies (AD-301: NCT02118766; AD-302: NCT02118792, both at http://www.clinicaltrials.gov). Methods: In both studies, patients aged ≥ 2 years with mild to moderate AD per the Investigator’s Static Global Assessment were randomly assigned 2:1 to receive crisaborole or vehicle twice daily for 28 days. QoL was assessed using the Children’s Dermatology Life Quality Index (CDLQI) (2–15 years), the Dermatology Life Quality Index (DLQI) (≥ 16 years), and the Dermatitis Family Impact Questionnaire (DFI) (parents/caregivers/family of patients aged 2–17 years). Established QoL score severity bands provided clinical context. Results: Greater mean improvement in QoL was observed in crisaborole-treated patients than in vehicle-treated patients at day 29 [mean change from baseline (∆BL), CDLQI: − 4.6 vs. − 3.0; P < 0.001; DLQI: − 5.2 vs. − 3.5; P = 0.015]. At baseline, more than half the patients had a “moderate effect” or higher of AD on QoL. At day 29, there was a trend toward more crisaborole- than vehicle-treated patients having “small effect” to “no effect”, The QoL of parents/caregivers/family improved more for crisaborole-treated than for vehicle-treated patients (∆BL, DFI: − 3.7 vs. − 2.7; P = 0.003). Conclusion: Crisaborole treatment results in clinically meaningful improvement in QoL for patients and their parents/caregivers/families. Trial Registration: AD-301: http://www.clinicaltrials.gov, NCT02118766; AD-302: http://www.clinicaltrials.gov, NCT02118792. Funding: Anacor Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., New York, NY.

Original languageEnglish (US)
Pages (from-to)605-619
Number of pages15
JournalDermatology and Therapy
Volume8
Issue number4
DOIs
StatePublished - Dec 1 2018

Keywords

  • Atopic dermatitis
  • Crisaborole
  • Eczema
  • PDE4
  • Phosphodiesterase 4
  • Quality of life
  • Topical treatment

ASJC Scopus subject areas

  • Dermatology

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