Evaluating change in disease activity needed to reflect meaningful improvement in quality of life for clinical trials in cutaneous lupus erythematosus - 01/09/20

Doi : 10.1016/j.jaad.2020.07.047

Srita Chakka, MD ^a,^b, Rebecca L. Krain, MD ^a,^b, Sarah Ahmed, MD ^a,^b, Josef Symon S. Concha, MD ^a,^b, Rui Feng, PhD ^c, Joan T. Merrill, MD ^d, Victoria P. Werth, MD ^a,^b,^⁎
^a Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania
^b Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania
^c Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania
^d Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma

^∗Correspondence to: Victoria P. Werth, MD, Department of Dermatology, Perelman Center for Advanced Medicine, Suite 1-330A, 3400 Civic Center Blvd, Philadelphia, PA 19104.Department of DermatologyPerelman Center for Advanced MedicineSuite 1-330A3400 Civic Center BlvdPhiladelphiaPA19104

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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.

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Key words : autoimmune skin disease, clinical trials, cutaneous lupus erythematosus, efficacy measures, patient-reported outcomes, quality of life

Abbreviations used : CLASI, CLASI-A, CLE, DLQI, DM, QoL, Skindex-E, Skindex-F, Skindex-S, SLE

Plan

	Funding sources: Supported by National Institutes of Health (K24-AR02207 and R01AR071653) and the U.S. Department of Veterans Affairs (Veterans Health Administration, Office of Research and Development and Biomedical Laboratory Research and Development).
	Conflicts of interest: None disclosed.
	IRB approval status: N/A; IRB protocol #805758.
	Reprints not available from the authors.