Session Information
Date: Sunday, November 13, 2016
Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment II: Clinical Trial Design
Session Type: ACR Concurrent Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose: A positive ANA test is one of ACR Revised Criteria for Classification of SLE, as well as the SLICC classification. The ANA test provides a direct initial assessment of autoantibody response in candidate patients of systemic autoimmune rheumatic diseases (SARD). As a follow-up to the
Methods: ANA test at 1/80 screening dilution was performed in 269 sequentially selected patients with SLE diagnosis, 918 healthy individuals, and 558 patients with non-SARD conditions (arterial hypertension, diabetes mellitus, dyslipidemia, various cancers, psychiatric diseases, and HCV/HIV infection). ANA interpretation was the consensus of 3 independent readers using 2 HEp-2 cell slide brands at 400x mag. Conversely, sequentially selected individuals presenting >1/640 titer DFS ANA pattern in a large clinical laboratory within a 2-year period had the diagnosis assessed by interview with the respective physician.
Results: Among 269 consecutive SLE patients, 96.3% had a positive ANA with the following principal nuclear patterns: homogeneous (29.3%), coarse speckled (14.7%), fine speckled (40.1%). One patient (0.3%) had the DFS pattern and the reactivity to DFS70 confirmed by ELISA. Conversely, among 118 ANA+ healthy individuals and 102 ANA+ patients with miscellaneous non-SARD conditions, 33.1 and 16.7% presented the DFS pattern, respectively. In addition, the 327 consecutive high-titer DFS individuals presented mostly non-SARD conditions or non-specific clinical presentation. Only 7 had possibly SARD-related presentations: 1 anti-phospholipid syndrome, 1 “possible” SLE (polyarthritis, arthritis, chronic urticaria), 1 WG, 1 DLE, 1 primary biliary cirrhosis, and 1 RA.
Conclusion: Well-defined anti-DFS ANA, confirmed by antigen-specific reflex testing, should not be considered a criterion for SLE – either in the ACR or SLICC classification criteria.
To cite this abstract in AMA style:
Andrade LEC, Damoiseaux J, Satoh M, Chan EKL, Prado M, Mariz H, Agustinelli R, Dellavance A. High Titer ANA Not Necessarily a Valid Criterion for Lupus – Proposal of a Modification to the Criteria for Classification of SLE [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/high-titer-ana-not-necessarily-a-valid-criterion-for-lupus-proposal-of-a-modification-to-the-criteria-for-classification-of-sle/. Accessed .« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/high-titer-ana-not-necessarily-a-valid-criterion-for-lupus-proposal-of-a-modification-to-the-criteria-for-classification-of-sle/