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Measuring long-term disease control in patients with atopic dermatitis: A validation study of well-controlled weeks

Langan, Sin�ad M.; Stuart, Beth; Bradshaw, Lucy; Schmitt, Jochen; Williams, Hywel C.; Thomas, Kim S.

Authors

Sin�ad M. Langan

Beth Stuart

Jochen Schmitt

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HYWEL WILLIAMS HYWEL.WILLIAMS@NOTTINGHAM.AC.UK
Professor of Dermato-Epidemiology



Abstract

Background:Because atopic dermatitis (AD) is a relapsing, remitting disease, assessing long?term control is important. Well controlled weeks (WCWs) have been used to assess asthma long?term control, but never validated for AD.
Objectives: To assess feasibility, validity and interpretability of WCWs in AD patients.
Methods: Three studies of patients with moderate?to?severe AD including 4?6 months of daily/weekly symptom and treatment use data were evaluated (Study A: n=336; Study B: n=60; Study C: n=224). WCWs were defined by worsening symptoms and increased medication use. Feasibility, construct validity and interpretability of WCWs were determined by assessing missing data, association with validated AD outcomes, and floor/ceiling effects. Analysis used linear and logistic regression.
Results: WCWs were feasible to collect ? 95.2% (study A) and 94.7% (study B) contributed data for at least half of the weekly data?points, and 93.2% and 88.7% contributed to all data?points up to 4 months. WCWs were significantly associated with validated AD severity instruments including patient-reported (POEM) and objective signs (EASI, TIS and SASSAD). The odds of experiencing a WCW if AD severity was clear/mild was 5.8 (95% confidence interval (CI) 3.5 to 9.7), 1.9 (95%CI 0.8 to 4.4) and 8.1 (95%CI 4.5 to 14.6) in Studies A, B and C, respectively. WCWs were associated with ceiling effects? 31.6% (study A) and 37.5% (study B) of participants had no WCWs for >90% of the time.
Conclusions: WCWs are valid and feasible for measuring long?term control in AD trials. However, ceiling effects and burden of data collection may limit use.

Citation

Langan, S. M., Stuart, B., Bradshaw, L., Schmitt, J., Williams, H. C., & Thomas, K. S. (2017). Measuring long-term disease control in patients with atopic dermatitis: A validation study of well-controlled weeks. Journal of Allergy and Clinical Immunology, 140(6), 1580-1586. https://doi.org/10.1016/j.jaci.2017.02.043

Journal Article Type Article
Acceptance Date Feb 9, 2017
Online Publication Date Apr 26, 2017
Publication Date 2017-12
Deposit Date Feb 13, 2017
Publicly Available Date Mar 29, 2024
Journal Journal of Allergy and Clinical Immunology
Print ISSN 0091-6749
Electronic ISSN 1097-6825
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 140
Issue 6
Pages 1580-1586
DOI https://doi.org/10.1016/j.jaci.2017.02.043
Keywords AD, long?term control, outcome measures
Public URL https://nottingham-repository.worktribe.com/output/898045
Publisher URL http://www.sciencedirect.com/science/article/pii/S0091674917306772

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