Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis

Eric L. Simpson, Marjolein de Bruin-Weller, Laurent Eckert, Diane Whalley, Isabelle Guillemin, Matthew Reaney, Zhen Chen, Lauren Nelson, Shanshan Qin, Ashish Bansal, Abhijit Gadkari

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

Introduction: The Patient-Oriented Eczema Measure (POEM) assesses patient-reported frequency of atopic dermatitis (AD) symptoms, while the Children’s Dermatology Life Quality Index (CDLQI) measures the impact of skin disease on health-related quality of life (HRQoL) in children. There is currently no threshold for clinically meaningful within-person change in POEM or CDLQI scores in adolescents. Here we empirically derive within-person thresholds of meaningful within-person change in POEM and CDLQI scores in adolescents with moderate-to-severe AD. Methods: Data were used from a phase 3, randomized, double-blind, placebo-controlled trial of dupilumab in adolescents (aged ≥ 12 to < 18 years) with moderate-to-severe AD. Anchor-based methods were employed using the mean change in POEM and CDLQI scores from baseline to week 16 linked with a 1-point improvement in Patient Global Assessment of Disease (PGAD), a score of “a little better” on the Patient Global Assessment of Treatment effect (PGAT), a 50–74% improvement from baseline in the Eczema Area and Severity Index (EASI-50–74), and a 1-point improvement in Investigator’s Global Assessment (IGA) score. Results: A mean change of − 7.8 and − 5.6 in the POEM score was associated with PGAD and PGAT anchors, respectively. EASI-50–74 was associated with a mean change in POEM score of − 8.2, while the IGA anchor was associated with a mean change of − 7.9 in POEM score. The mean changes in CDLQI score associated with PGAD and PGAT anchors were − 6.4 and − 6.6, respectively, while CDLQI mean scores changed by − 8.3 and − 8.0 for the EASI and IGA anchors, respectively. Conclusion: In adolescents (aged ≥ 12 to < 18 years) with moderate-to-severe AD, a within-person change of 6–8 points in POEM and CDLQI scores, independently, can be considered a reasonable responder threshold for clinically meaningful change in each of the two scales, respectively. Trial Registration: ClinicalTrials.gov Identifier: NCT03054428. Funding: Sanofi and Regeneron Pharmaceuticals, Inc.

Original languageEnglish (US)
Pages (from-to)799-805
Number of pages7
JournalDermatology and Therapy
Volume9
Issue number4
DOIs
StatePublished - Dec 1 2019

Keywords

  • Adolescents
  • Atopic dermatitis
  • CDLQI
  • Dupilumab
  • POEM
  • Quality of life
  • Responder threshold
  • Validation

ASJC Scopus subject areas

  • Dermatology

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    Simpson, E. L., de Bruin-Weller, M., Eckert, L., Whalley, D., Guillemin, I., Reaney, M., Chen, Z., Nelson, L., Qin, S., Bansal, A., & Gadkari, A. (2019). Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis. Dermatology and Therapy, 9(4), 799-805. https://doi.org/10.1007/s13555-019-00333-2