Srita Chakka1, Rebecca L Krain1, Sarah Ahmed1, Josef Symon S Concha1, Rui Feng2, Joan T Merrill3, Victoria P Werth4. 1. Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania; Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania. 2. Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania. 3. Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma. 4. Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania; Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: werth@pennmedicine.upenn.edu.
Abstract
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: We aimed to define the degree of improvement in disease activity meaningful to a patient's quality of life. 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: 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: This is a retrospective study of prospectively collected data at a single site. 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. Published by Elsevier Inc.
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: We aimed to define the degree of improvement in disease activity meaningful to a patient's quality of life. 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: 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: This is a retrospective study of prospectively collected data at a single site. 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. Published by Elsevier Inc.
Entities:
Keywords:
autoimmune skin disease; clinical trials; cutaneous lupus erythematosus; efficacy measures; patient-reported outcomes; quality of life
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