This year’s Annual Congress of the European League against Rheumatism (EULAR) kicked off with exciting new Delphi-consensus derived draft classification criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN), which were jointly presented by both the American College of Rheumatology (ACR) and EULAR.
The committees are seeking to unify a field that has been historically divided by multiple existing criteria used for SLE and LN disease classification. While existing classification criteria, such as the British Isles Lupus Assessment Group Index (BILAG) based combined lupus assessment (BICLA) and the revised ACR criteria are mutually characteristic of high sensitivities and low specificities. The new ACR / EULAR criteria are aimed at increasing specificity and maintaining a high sensitivity by incorporation of specific clinical trial entry criteria, as well as clinical and immunological domain-specific weight scores.
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Professor Aringer and colleagues introduced antinuclear antibody (ANA) levels of greater than 1:80 as entry criterion for classification of SLE and LN. As in previous classification criteria, the ACR / EULAR draft criteria feature clinical and immunological domains for classification of disease severity. However, unlike previous attempts, each domain is given a weighing score correlating to the importance for SLE / LN diagnosis.
Using the new classification algorithm, positive kidney histology results no longer qualify alone for classification of LN. Instead, the researchers have assigned the highest weight score on the renal biopsy results, while other clinical criteria, such as fever have been given the lowest weighted score. The cut-off score for positive classification was derived by physicians’ ability to diagnose SLE / LN in patients using the clinical and immunological weighted scores.
The new ACR / EULAR classification criteria for SLE / LN are currently validated across 36 international SLE / LN cohorts, with researchers attempting to apply the classification criteria scoring system to 1,000 patients and compare these results to 1,000 patients in a control groups. The researchers were particularly excited about the prospect of identifying SLE patients with low disease activity, a patient population GlobalData believes is underrepresented in current randomised controlled trials (RCT) for SLE and LN.
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The researchers' preliminary analysis, fever in the absence of an infection with a low weighted score, was potentially very predictive in identifying patients with mild SLE disease activity, which increases the chances of improving further deterioration of disease symptoms by interfering early on in the disease pathophysiology.
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