TY - JOUR
T1 - Use of SLICC criteria in a large, diverse lupus registry enables SLE classification of a subset of ACR-designated subjects with incomplete lupus
AU - Aberle, Teresa
AU - Bourn, Rebecka L.
AU - Chen, Hua
AU - Roberts, Virginia C.
AU - Guthridge, Joel M.
AU - Bean, Krista
AU - Robertson, Julie M.
AU - Sivils, Kathy L.
AU - Rasmussen, Astrid
AU - Liles, Meghan
AU - Merrill, Joan T.
AU - Harley, John B.
AU - Olsen, Nancy J.
AU - Karp, David R.
AU - James, Judith A.
N1 - Funding Information:
This study was performed in accordance with the principles of the Declaration of Helsinki and approved by the Oklahoma Medical Research Foundation (OMRF) Institutional Review Board. Study participants were previously enrolled to the Lupus Family Registry and Repository (LFRR)5 and provided written informed consent, detailed clinical questionnaire information, connective tissue disease screening questionnaire responses,6 demographic information, blood samples and medical records, which were reviewed for ACR1 and SLICC3 criteria and for medication history (see online supplementary methods, supplementary figure 1).
Funding Information:
1Department of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA 2Cincinnati Children’s Hospital Medical Center and US Department of Veterans Affairs Medical Center, Cincinnati, Ohio, USA 3Division of Rheumatology, Penn State Milton S. Hershey Medical Center, University Drive, Hershey, Pennsylvania, USA 4Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA 5Departments of Medicine and Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA
Funding Information:
Funding Research reported in this publication was supported by the US NIH through the National Institute of Allergy and Infectious Disease (U19AI082714, U01AI101934 and R37AI24717), Institutional Development Awards (IDeA) from the National Institute of General Medical Sciences (P30GM103510 and U54GM104938), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (P30AR053483, P30AR070549), the National Human Genome Research Institute (U01HG008666), the National Heart, Lung, and Blood Institute (R24HL105333) and the National Institute of Diabetes and Digestive and Kidney Diseases (R01DK107502). This work was also supported by the US Department of Veterans Affairs (I01BX001834). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, the Department of Veterans Affairs or the US government. The study sponsors had no role in the study design; in the collection, analysis and interpretation of the data; in the writing of the report or in the decision to submit the paper for publication. NJO reports grants from Mallinckrodt Pharmaceuticals, Resolve Therapeutics, Horizon Pharmaceuticals, Roche/Genentech and Aurinia Pharmaceuticals outside the submitted work. All other authors declare no conflicts of interest.
Funding Information:
Ethics approval Oklahoma Medical Research Foundation Institutional Review Board.
PY - 2017/1
Y1 - 2017/1
N2 - Objective: SLE is traditionally classified using the American College of Rheumatology (ACR) criteria. The Systemic Lupus International Collaborating Clinics (SLICC) recently validated an alternative system. This study examined large cohorts of subjects with SLE and incomplete lupus erythematosus (ILE) to compare the impact of ACR and SLICC criteria. Methods: Medical records of subjects in the Lupus Family Registry and Repository were reviewed for documentation of 1997 ACR classification criteria, SLICC classification criteria and medication usage. Autoantibodies were assessed by indirect immunofluorescence (ANA, antidouble-stranded DNA), precipitin (Sm) and ELISA (anticardiolipin). Other relevant autoantibodies were detected by precipitin and with a bead-based multiplex assay. Results: Of 3575 subjects classified with SLE under at least one system, 3312 (92.6%) were classified as SLE by both systems (SLEboth), 85 only by ACR criteria (SLEACR-only) and 178 only by SLICC criteria (SLESLICC-only). Of 440 subjects meeting 3 ACR criteria, 33.9% (149/440) were SLESLICC-only, while 66.1% (n=291, designated ILE) did not meet the SLICC classification criteria. Under the SLICC system, the complement criterion and the individual autoantibody criteria enabled SLE classification of SLESLICC-only subjects, while SLEACR-only subjects failed to meet SLICC classification due to the combined acute/subacute cutaneous criterion. The SLICC criteria classified more African-American subjects by the leucopenia/lymphopenia criterion than did ACR criteria. Compared with SLEACR-only subjects, SLESLICC-only subjects exhibited similar numbers of affected organ systems, rates of major organ system involvement (∼30%: pulmonary, cardiovascular, renal, neurological) and medication history. Conclusions: The SLICC criteria classify more subjects with SLE than ACR criteria; however, individuals with incomplete lupus still exist under SLICC criteria. Subjects who gain SLE classification through SLICC criteria exhibit heterogeneous disease, including potential major organ involvement. These results provide supportive evidence that SLICC criteria may be more inclusive of SLE subjects for clinical studies.
AB - Objective: SLE is traditionally classified using the American College of Rheumatology (ACR) criteria. The Systemic Lupus International Collaborating Clinics (SLICC) recently validated an alternative system. This study examined large cohorts of subjects with SLE and incomplete lupus erythematosus (ILE) to compare the impact of ACR and SLICC criteria. Methods: Medical records of subjects in the Lupus Family Registry and Repository were reviewed for documentation of 1997 ACR classification criteria, SLICC classification criteria and medication usage. Autoantibodies were assessed by indirect immunofluorescence (ANA, antidouble-stranded DNA), precipitin (Sm) and ELISA (anticardiolipin). Other relevant autoantibodies were detected by precipitin and with a bead-based multiplex assay. Results: Of 3575 subjects classified with SLE under at least one system, 3312 (92.6%) were classified as SLE by both systems (SLEboth), 85 only by ACR criteria (SLEACR-only) and 178 only by SLICC criteria (SLESLICC-only). Of 440 subjects meeting 3 ACR criteria, 33.9% (149/440) were SLESLICC-only, while 66.1% (n=291, designated ILE) did not meet the SLICC classification criteria. Under the SLICC system, the complement criterion and the individual autoantibody criteria enabled SLE classification of SLESLICC-only subjects, while SLEACR-only subjects failed to meet SLICC classification due to the combined acute/subacute cutaneous criterion. The SLICC criteria classified more African-American subjects by the leucopenia/lymphopenia criterion than did ACR criteria. Compared with SLEACR-only subjects, SLESLICC-only subjects exhibited similar numbers of affected organ systems, rates of major organ system involvement (∼30%: pulmonary, cardiovascular, renal, neurological) and medication history. Conclusions: The SLICC criteria classify more subjects with SLE than ACR criteria; however, individuals with incomplete lupus still exist under SLICC criteria. Subjects who gain SLE classification through SLICC criteria exhibit heterogeneous disease, including potential major organ involvement. These results provide supportive evidence that SLICC criteria may be more inclusive of SLE subjects for clinical studies.
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U2 - 10.1136/lupus-2016-000176
DO - 10.1136/lupus-2016-000176
M3 - Article
C2 - 28409015
AN - SCOPUS:85033791919
SN - 2053-8790
VL - 4
JO - Lupus Science and Medicine
JF - Lupus Science and Medicine
IS - 1
M1 - e000176
ER -