Performance of Antinuclear Antibodies for Classifying Systemic Lupus Erythematosus: A Systematic Literature Review and Meta‐Regression of Diagnostic Data

Leuchten, Nicolai; Hoyer, Annika; Brinks, Ralph; Schoels, Monika; Schneider, Matthias; Smolen, Josef S; Johnson, Sindhu R.; Daikh, David I.; Dörner, Thomas; Aringer, Martin; Βertsias, George

doi:10.1002/acr.23292

Cited by 147 publications

(113 citation statements)

References 91 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…A systematic review of Medline, Embase, and the Cochrane database identified 13,080 patients from 64 studies reporting ANA by immunofluorescence on HEp‐2 cells. Meta‐regression of the operating characteristics of ANA found a sensitivity of 97.8% (95% CI 96.8–98.5%) for ANA of ≥1:80, supporting use of ANA as an entry criterion . Since some SLE centers do not have access to HEp‐2 ANA, and in view of ongoing work on the standardization of serology and potential future advances in the field, the steering committee and additional autoantibody consultants (MJF and PLM) recommended the provision “or an equivalent positive ANA test.…”

Section: Resultsmentioning

confidence: 99%

“…During the phase I Delphi exercise, 58% of SLE experts did not feel comfortable and an additional 19% were uncertain about classifying a patient with SLE in the absence of ever having a positive ANA . The systematic literature review and meta‐regression of data on 13,080 subjects demonstrated ANA ≥1:80 to have a sensitivity of 98% with a lower limit of the 95% CI at 97% . In the phase I early SLE cohort, 99.5% of the 389 SLE patients were ANA positive .…”

Section: Discussionmentioning

confidence: 99%

“…The purpose of phase I was to test ANA as a potential entry criterion and identify candidate criteria that should be considered for SLE classification using both data‐based and expert‐based methods, including the patient perspective. Phase Ia comprised a systematic literature review of Medline, Embase, and the Cochrane databases with meta‐regression to evaluate the operating characteristics of ANA testing for consideration as an entry criterion . Phase Ib consisted of a Delphi exercise of international SLE experts from the Americas, Europe, and Asia .…”

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

Aringer

Costenbader

Daikh

et al. 2019

Arthritis & Rheumatology

Self Cite

1,585

1,096

View full text Add to dashboard Cite

Objective To develop new classification criteria for systemic lupus erythematosus (SLE) jointly supported by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Methods This international initiative had four phases. 1) Evaluation of antinuclear antibody (ANA) as an entry criterion through systematic review and meta‐regression of the literature and criteria generation through an international Delphi exercise, an early patient cohort, and a patient survey. 2) Criteria reduction by Delphi and nominal group technique exercises. 3) Criteria definition and weighting based on criterion performance and on results of a multi‐criteria decision analysis. 4) Refinement of weights and threshold scores in a new derivation cohort of 1,001 subjects and validation compared with previous criteria in a new validation cohort of 1,270 subjects. Results The 2019 EULAR/ACR classification criteria for SLE include positive ANA at least once as obligatory entry criterion; followed by additive weighted criteria grouped in 7 clinical (constitutional, hematologic, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and 3 immunologic (antiphospholipid antibodies, complement proteins, SLE‐specific antibodies) domains, and weighted from 2 to 10. Patients accumulating ≥10 points are classified. In the validation cohort, the new criteria had a sensitivity of 96.1% and specificity of 93.4%, compared with 82.8% sensitivity and 93.4% specificity of the ACR 1997 and 96.7% sensitivity and 83.7% specificity of the Systemic Lupus International Collaborating Clinics 2012 criteria. Conclusion These new classification criteria were developed using rigorous methodology with multidisciplinary and international input, and have excellent sensitivity and specificity. Use of ANA entry criterion, hierarchically clustered, and weighted criteria reflects current thinking about SLE and provides an improved foundation for SLE research.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

Aringer

Costenbader

Daikh

et al. 2019

Arthritis & Rheumatology

Self Cite

1,585

1,096

View full text Add to dashboard Cite

show abstract

“…Medical history and blood tests did not reveal signs of a small vessel vasculitis due to a rheumatic disease. Sporadic case reports of PXE associated with systemic lupus erythematodes seem unlikely due to negative titer of antinuclear antibodies (ANA) [11]. Therefore, a microvascular manifestation of PXE may be responsible for the decrease of AB-Indices following exercise.…”

Section: Discussionmentioning

confidence: 99%

A Case of Pseudoxanthoma Elasticum with Microvascular Alterations: Possible Explanations and Causes

Stumpf¹,

Steinmetz²,

Skowasch³

et al. 2017

Orthop Muscular Syst

View full text Add to dashboard Cite

“…Nearly all SLE patients exhibit ANA at diagnosis, with a 1:80 immunofluorescent titer showing up to 98% sensitivity but 75% specificity for SLE classification. 16 ANA are also found in individuals with many other autoimmune diseases, malignancies, hepatic diseases, unaffected family members of lupus patients, and even up to 14% of healthy individuals, 17 especially with increasing age. Therefore, a positive ANA serves as a necessary but insufficient criterion for SLE classification or diagnosis, but not as a definitive test.…”

Section: Systemic Lupus Erythematosus (Sle)mentioning

confidence: 99%

Biomarkers in connective tissue diseases

Jog

James

2017

Journal of Allergy and Clinical Immunology

View full text Add to dashboard Cite

Autoimmune connective tissue diseases are clinically variable, making biomarkers desirable for assessing future disease risk, supporting early and accurate diagnosis, monitoring disease activity and progression, selecting therapeutics, and assessing treatment response. Because of their correlations with specific clinical characteristics and often with disease progression, autoantibodies and other soluble mediators are considered potential biomarkers. Additional biomarkers may reflect downstream pathological processes or may appear due to ongoing inflammation and damage. Because of overlap between diseases, some biomarkers have limited specificity for a single autoimmune connective tissue disease. This review describes select current biomarkers that aid in diagnosis and treatment of several major systemic autoimmune connective tissue disorders: systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, and ANCA-associated vasculitides. Newly proposed biomarkers that target various stages in disease onset or progression are also discussed. Newer approaches to overcome the diversity observed in these diseases and to facilitate personalized disease monitoring and treatment are also addressed.

show abstract

Performance of Antinuclear Antibodies for Classifying Systemic Lupus Erythematosus: A Systematic Literature Review and Meta‐Regression of Diagnostic Data

Cited by 147 publications

References 91 publications

2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

A Case of Pseudoxanthoma Elasticum with Microvascular Alterations: Possible Explanations and Causes

Biomarkers in connective tissue diseases

Contact Info

Product

Resources

About