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Original Investigation
June 17, 2020

Creation and Validation of Classification Criteria for Discoid Lupus Erythematosus

Author Affiliations
  • 1Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 2Department of Public Health Sciences, Loyola University, Chicago, Illinois
  • 3Department of Dermatology, University of Missouri, Columbia
  • 4Department of Dermatology, The University of Texas Southwestern Medical Center, Dallas
  • 5Department of Dermatology, Cleveland Clinic Foundation, Cleveland, Ohio
  • 6Department of Dermatology, Takatsuki Red Cross Hospital, Takatsuki, Japan
  • 7Division of Medicine, Department of Dermatology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan
  • 8Department of Dermatology, Gachon Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea
  • 9Department of Dermatology, Venereology and Allergology, University of Medicine, Wroclaw, Poland
  • 10Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania
  • 11Department of Dermatology, University of Pennsylvania, Philadelphia
  • 12Division of Rheumatology, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Dermatol. Published online June 17, 2020. doi:10.1001/jamadermatol.2020.1698
Key Points

Question  Can a broadly applicable set of classification criteria be developed to classify a lesion or a rash as discoid lupus erythematosus for research purposes?

Findings  In this diagnostic study, previously defined candidate criteria items were applied prospectively to 215 patients at international academic dermatology centers who were identified as having discoid lupus erythematosus or a disease mimicker. Features were compared between groups, and candidate models were identified using best subsets logistic regression analysis to select 1 final model yielding a points-based system for discoid lupus erythematosus classification.

Meaning  This diagnostic study presents the initial validation of classification criteria for discoid lupus erythematosus for use in clinical research.

Abstract

Importance  Classification criteria are the standardized definitions that are used to enroll uniform cohorts for research studies. They emphasize high specificity and are distinct from diagnostic criteria. No universally recognized classification criteria currently exist for discoid lupus erythematosus (DLE), which has led to problematic heterogeneity in observational and interventional clinical studies across the field.

Objective  To create and validate classification criteria for DLE using 12 previously defined candidate criteria items.

Design, Setting, and Participants  For this diagnostic study, candidate criteria items were prospectively applied by dermatologists and dermatopathologists at clinical visits of patients with DLE or a condition that could be confused for DLE, termed a DLE mimicker, at academic dermatology practices across the United States, Poland, Japan, and South Korea. Data were collected from December 1, 2017, to February 1, 2019, and analyzed from March 1 to September 19, 2019.

Main Outcomes and Measures  Clinical features among these 2 groups were calculated and compared with χ2 or Fisher exact tests. Candidate models were identified using best subsets logistic regression analysis. Improvement tests, fit statistics, and discrimination were considered to choose a final model.

Results  Nine sites contributed 215 patients, 15 of whom had missing or incomplete data. The final model for DLE classification criteria includes only clinical variables: atrophic scarring (3 points), location in the conchal bowl (2 points), preference for the head and neck (2 points), dyspigmentation (1 point), follicular hyperkeratosis and/or plugging (1 point), and erythematous to violaceous in color (1 point), with an area under the receiving operating characteristic curve of 0.91 (95% CI, 0.87-0.95). A score of at least 5 points yields a sensitivity of 84.1% and a specificity of 75.9% in the classification of DLE, with increasing scores yielding higher specificity.

Conclusions and Relevance  These findings provide the initial validation of classification criteria for DLE for use in observational and clinical trials.

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