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

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.

Keywords: Atopic dermatitis; Crisaborole; Eczema; PDE4; Phosphodiesterase 4; Quality of life; Topical treatment.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram. Enrollment, randomization, treatment, and follow-up
Fig. 2
Fig. 2
Validated QoL assessment scales and subscales. Superscript letter a indicates that subscale analysis for DFI has not been validated
Fig. 3
Fig. 3
Mean change from baseline in a CDLQI ages 2–15 years, b CDLQI ages 4–15 years, c DLQI, and d DFI scores (pooled analysis, ITT population)
Fig. 4
Fig. 4
Severity bands for a CDLQI and b DLQI overall (pooled analysis, ITT population)

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