Examining the association between pruritus and quality of life in patients with atopic dermatitis treated with crisaborole

S Ständer; G Yosipovitch; A G Bushmakin; J C Cappelleri; T Luger; W L Tom; W C Ports; M A Zielinski; A M Tallman; H Tan; R A Gerber

doi:10.1111/jdv.15712

Examining the association between pruritus and quality of life in patients with atopic dermatitis treated with crisaborole

J Eur Acad Dermatol Venereol. 2019 Sep;33(9):1742-1746. doi: 10.1111/jdv.15712. Epub 2019 Jul 7.

Authors

S Ständer¹, G Yosipovitch², A G Bushmakin³, J C Cappelleri³, T Luger⁴, W L Tom^{5

6}, W C Ports³, M A Zielinski⁷, A M Tallman⁸, H Tan³, R A Gerber³

Affiliations

¹ Center for Chronic Pruritus, University Hospital Münster, Münster, Germany.
² Miami Itch Center, Miller School of Medicine, University of Miami, Miami, FL, USA.
³ Pfizer Inc., Groton, CT, USA.
⁴ University Hospital Münster, Münster, Germany.
⁵ University of California, San Diego, CA, USA.
⁶ Rady Children's Hospital-San Diego, San Diego, CA, USA.
⁷ Pfizer Inc., Collegeville, PA, USA.
⁸ Pfizer Inc., New York, NY, USA.

PMID: 31132182
DOI: 10.1111/jdv.15712

Abstract

Background: Pruritus is a leading cause of reduced health-related quality of life (QoL) in atopic dermatitis (AD). Crisaborole ointment is a non-steroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate AD. In identical Phase 3 studies (NCT02118766, NCT02118792), crisaborole reduced disease and pruritus severity versus vehicle.

Objective: Quantify the relationship between pruritus and QoL using data from these studies.

Methods: Patients aged ≥2 years were randomly assigned 2 : 1 to receive crisaborole:vehicle twice daily for 28 days. QoL was measured at baseline and day 29 using the Dermatology Life Quality Index (DLQI; patients aged ≥16 years), the Children's Dermatology Life Quality Index (CDLQI; patients aged 2-15 years) and the Dermatitis Family Impact (DFI; caregivers of patients aged 2-17 years). Pruritus was measured using the Severity of Pruritus Scale (SPS), a 4-point scale from 0 ('no itching') to 3 ('bothersome itching/scratching that disturbs sleep'), and captured morning and evening via electronic diary. Data from crisaborole and vehicle arms were pooled for this analysis. A repeated-measures longitudinal model was used to estimate relationships between pruritus (SPS) and QoL (DLQI, CDLQI and DFI in separate analyses).

Results: One thousand five hundred and twenty two patients received crisaborole or vehicle. A linearity assumption for the relationship between SPS and DLQI (n = 294), CDLQI (n = 1200), and DFI (n = 1293) was appropriate. For DLQI, SPS score of 0 was associated with 'no negative effect on patient QoL'; SPS score of 1 was associated with 'small effect on patient QoL'; SPS score of 2 was associated with 'moderate effect on patient QoL'; and SPS score of 3 was associated with 'very large effect on patient QoL'. The pattern of relationships between SPS and CDLQI and DFI was similar.

Conclusions: The relationships between SPS and DLQI, CDLQI and DFI substantiate the significant link between pruritus and patient/caregiver QoL in AD.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Adolescent
Adult
Aged
Boron Compounds / therapeutic use*
Bridged Bicyclo Compounds, Heterocyclic / therapeutic use*
Child
Child, Preschool
Dermatitis, Atopic / drug therapy*
Double-Blind Method
Female
Humans
Infant
Male
Middle Aged
Ointments
Pruritus / drug therapy*
Quality of Life*
Severity of Illness Index

Substances

Boron Compounds
Bridged Bicyclo Compounds, Heterocyclic
Ointments
crisaborole

Grants and funding

Pfizer Inc