Evaluating change in disease activity needed to reflect meaningful improvement in quality of life for clinical trials in cutaneous lupus erythematosus.
autoimmune skin disease
clinical trials
cutaneous lupus erythematosus
efficacy measures
patient-reported outcomes
quality of life
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
received:
29
05
2019
revised:
28
06
2020
accepted:
08
07
2020
pubmed:
20
7
2020
medline:
31
8
2021
entrez:
20
7
2020
Statut:
ppublish
Résumé
Outcome measures of clinical trials in cutaneous lupus erythematosus (CLE) should reflect clinically meaningful improvement in disease activity, as measured by the Cutaneous Lupus Disease Area and Severity Index activity score (CLASI-A). We aimed to define the degree of improvement in disease activity meaningful to a patient's quality of life. The change in the CLASI-A in 126 patients needed to predict meaningful change in QoL, as defined by the Emotions and Symptoms subscales of the Skindex-29, was evaluated by linear regression models. In patients with an initial CLASI-A of ≥8, a 42.1% or ≥7-point and a 31.0% or ≥5-point decrease in CLASI-A predicts meaningful improvement in the Emotions and the Symptoms subscales, respectively. This is a retrospective study of prospectively collected data at a single site. A CLASI-A score of ≥8 for trial entry allows for inclusion of patients with milder disease where CLASI-A improvement by ≥50% is clinically significant and meaningful.
Sections du résumé
BACKGROUND
BACKGROUND
Outcome measures of clinical trials in cutaneous lupus erythematosus (CLE) should reflect clinically meaningful improvement in disease activity, as measured by the Cutaneous Lupus Disease Area and Severity Index activity score (CLASI-A).
OBJECTIVE
OBJECTIVE
We aimed to define the degree of improvement in disease activity meaningful to a patient's quality of life.
METHODS
METHODS
The change in the CLASI-A in 126 patients needed to predict meaningful change in QoL, as defined by the Emotions and Symptoms subscales of the Skindex-29, was evaluated by linear regression models.
RESULTS
RESULTS
In patients with an initial CLASI-A of ≥8, a 42.1% or ≥7-point and a 31.0% or ≥5-point decrease in CLASI-A predicts meaningful improvement in the Emotions and the Symptoms subscales, respectively.
LIMITATIONS
CONCLUSIONS
This is a retrospective study of prospectively collected data at a single site.
CONCLUSIONS
CONCLUSIONS
A CLASI-A score of ≥8 for trial entry allows for inclusion of patients with milder disease where CLASI-A improvement by ≥50% is clinically significant and meaningful.
Identifiants
pubmed: 32682879
pii: S0190-9622(20)32216-7
doi: 10.1016/j.jaad.2020.07.047
pmc: PMC8106875
mid: NIHMS1613233
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1562-1567Subventions
Organisme : NIAMS NIH HHS
ID : K24 AR002207
Pays : United States
Organisme : NIAMS NIH HHS
ID : R01 AR071653
Pays : United States
Informations de copyright
Published by Elsevier Inc.
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