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

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

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Eczema
Atopic Dermatitis
Dermatology
Quality of Life
Research Personnel
Skin Diseases

Keywords

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

ASJC Scopus subject areas

  • Dermatology

Cite this

Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis. / Simpson, Eric L.; de Bruin-Weller, Marjolein; Eckert, Laurent; Whalley, Diane; Guillemin, Isabelle; Reaney, Matthew; Chen, Zhen; Nelson, Lauren; Qin, Shanshan; Bansal, Ashish; Gadkari, Abhijit.

In: Dermatology and Therapy, Vol. 9, No. 4, 01.12.2019, p. 799-805.

Research output: Contribution to journalArticle

Simpson, EL, 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, vol. 9, no. 4, pp. 799-805. https://doi.org/10.1007/s13555-019-00333-2
Simpson, Eric L. ; de Bruin-Weller, Marjolein ; Eckert, Laurent ; Whalley, Diane ; Guillemin, Isabelle ; Reaney, Matthew ; Chen, Zhen ; Nelson, Lauren ; Qin, Shanshan ; Bansal, Ashish ; Gadkari, Abhijit. / Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis. In: Dermatology and Therapy. 2019 ; Vol. 9, No. 4. pp. 799-805.
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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.",
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author = "Simpson, {Eric L.} and {de Bruin-Weller}, Marjolein and Laurent Eckert and Diane Whalley and Isabelle Guillemin and Matthew Reaney and Zhen Chen and Lauren Nelson and Shanshan Qin and Ashish Bansal and Abhijit Gadkari",
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T1 - Responder Threshold for Patient-Oriented Eczema Measure (POEM) and Children’s Dermatology Life Quality Index (CDLQI) in Adolescents with Atopic Dermatitis

AU - Simpson, Eric L.

AU - de Bruin-Weller, Marjolein

AU - Eckert, Laurent

AU - Whalley, Diane

AU - Guillemin, Isabelle

AU - Reaney, Matthew

AU - Chen, Zhen

AU - Nelson, Lauren

AU - Qin, Shanshan

AU - Bansal, Ashish

AU - Gadkari, Abhijit

PY - 2019/12/1

Y1 - 2019/12/1

N2 - 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.

AB - 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.

KW - Adolescents

KW - Atopic dermatitis

KW - CDLQI

KW - Dupilumab

KW - POEM

KW - Quality of life

KW - Responder threshold

KW - Validation

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