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Multicenter Study
. 2020 Aug 1;156(8):901-906.
doi: 10.1001/jamadermatol.2020.1698.

Creation and Validation of Classification Criteria for Discoid Lupus Erythematosus

Scott A Elman  1 , Cara Joyce  2 , Kara Braudis  3 , Benjamin F Chong  4 , Anthony P Fernandez  5 , Fukumi Furukawa  6 , Minoru Hasegawa  7 , Hee Joo Kim  8 , Sara J Li  1 , Christine G Lian  1 , Jacek C Szepietowski  9 , Victoria P Werth  10   11 , Joseph F Merola  1   12
Affiliations
Multicenter Study

Creation and Validation of Classification Criteria for Discoid Lupus Erythematosus

Scott A Elman et al. JAMA Dermatol. .

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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Chong reported receiving personal fees from Viela Bio, Inc, and Beacon Bioscience, Inc, grants from Daavlin Corporation, and other from Pfizer, Inc, and Biogen, Inc, outside the submitted work. Dr Fernandez reported receiving personal fees from AbbVie, Inc, and UCB, grants and personal fees from Novartis International AG and Mallinckrodt Pharmaceuticals, and serving as principal investigator for a phase 2b clinical trial from Pfizer, Inc, and Corbus Pharmaceuticals outside the submitted work. Dr Fernandez reported receiving research support from Mallinckrodt Pharmaceuticals, Novartis International AG, Pfizer, Inc, and Corbus Pharmaceuticals; serving as a consultant for AbbVie, Inc, Novartis International AG, Mallinckrodt Pharmaceuticals, and UCB; and serving as a speaker/teacher for AbbVie, Inc, Novartis International AG, and Mallinckrodt Pharmaceuticals. Dr Szepietowski reported serving as a consultant for AbbVie, Inc, Biogenetica International Laboratories, Leo Pharma A/S, Merck-Serono, Novartis International AG, Pierre Fabre, Sandoz, Inc, and Toray Corporation and a speaker for AbbVie, Inc, Astellas Pharma, Inc, Actavis Generics, Adamed Pharma SA, Berlin-Chemie Mennarini, Bioderma Laboratories, Fresenius SE & Co, Janssen-Cilag BV, Leo Pharma A/S, Takeda Pharmaceutical Company Limited, and Vichy Laboratories outside the submitted work. Dr Werth reported serving as a consultant for Celgene Corporation, Incorporated, Medimmune, LLC, Resolve Therapeutics, LLC, Genentech, Inc, Idera, Inc, Janssen Pharmaceutica, Eli Lilly and Company, Pfizer, Inc, Biogen, Inc, Bristol-Myers Squibb, Gilead Sciences, Inc, Amgen, Inc, Medscape, Nektar Therapeutics, Incyte Corp, EMD Serono, CSL Behring, Principia Biopharma, Inc, Crisalis BioTherapeutics, Viela Bio, Inc, argenx SE, Kyowa Kirin, Inc, Regeneron Pharmaceuticals, AstraZeneca plc, Octapharma AG, and GlaxoSmithKline and receiving grants from Celgene Corporation, Incorporated, Janssen Pharmaceutica, Pfizer, Inc, Biogen, Inc, Gilead Sciences, Inc, Corbus Pharmaceuticals, Genentech, Inc, AstraZeneca plc, Viela Bio, Inc, CSL Behring, and Syntimmune, Inc. Dr Merola reported serving as a consultant and/or investigator for Merck Research Laboratories, AbbVie, Inc, Dermavant Sciences, Eli Lilly and Company, Novartis International AG, Janssen Pharmaceutica, UCB, Celgene Corporation, Incorporated, Sanofi Regeneron Pharmaceuticals, Almirall SA, Sun Pharmaceutical Industries, Ltd, Biogen, Inc, Pfizer, Inc, Incyte Corp, Aclaris Therapeutics, Inc, EMD Serono, Avotres Therapeutics LLC, and Leo Pharma A/S outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Area Under the Receiver Operating Characteristic Curve (AUC) for the Final Model of Discoid Lupus Erythematosus Classification Criteria
See this image and copyright information in PMC

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