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Dermatol Ther (Heidelb). 2018 Dec;8(4):605-619. doi: 10.1007/s13555-018-0263-0. Epub 2018 Oct 22.

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

Author information

1
Department of Dermatology, Oregon Health and Science University, Portland, OR, USA. simpsone@ohsu.edu.
2
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
3
Division of Allergy-Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA.
4
Department of Pediatrics, University of Colorado School of Medicine, Denver, CO, USA.
5
Division of Pediatric and Adolescent Dermatology, Rady Children's Hospital-San Diego, San Diego, CA, USA.
6
Department of Dermatology, University of California, San Diego, CA, USA.
7
Department of Pediatrics, University of California, San Diego, CA, USA.
8
Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
9
Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
10
Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
11
Anacor Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., New York, NY, USA.

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

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