Session Information
Date: Monday, October 22, 2018
Title: Systemic Lupus Erythematosus – Clinical Poster II: Biomarkers and Outcomes
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: SLE diagnosis can be challenging especially at the early stages, and existing classification criteria are biased towards classifying patients with long-standing disease. A joined ACR/EULAR initiative has introduced a new set of criteria (herein referred to as 2017 criteria), using positive ANA test as an entry criterion coupled with variably-weighed clinical and immunological criteria (Tedeschi et al., 2018). We compared the sensitivity of the 2017 criteria against the SLICC 2012 and ACR 1997 criteria in an early SLE cohort.
Methods: Consecutively registered patients aged ≥15 years diagnosed with SLE during 01/2012-12/2016 by an expert physician and followed-up for ≥6 months in the University Hospitals of Heraklion and “Attikon” (Athens). All sets of criteria (ACR 1997, SLICC 2012, 2017) were applied at the time (± 3 months) of physician-based diagnosis and also at last follow-up. Cases were assessed for disease severity (according to the BILAG definitions and the use of lupus treatments) and the SLICC/ACR organ damage index.
Results: 341 patients were included [91.5% women, 98.8% Caucasian, mean (SD) age at diagnosis 42.1 (15.3) years] with mean disease duration 32.3 (SD 18.2) months. At the time of diagnosis, more patients were classified with the 2017 criteria (79.5%), followed by the SLICC (75.4%) and the ACR (67.2%) criteria. A total 39 patients (11.4%) met only the 2017 criteria and 25 patients (7.3%) met only the SLICC criteria. The former had increased frequency of fever, synovitis, anti-dsDNA or anti-Sm autoantibodies. In contrast, SLICC-only classified patients had increased rates of chronic cutaneous lupus, alopecia, mouth ulcers, haematological disease, anti-phospholipid antibodies and hypocomplementemia (Table 1). At last follow-up, the sensitivity of the 2017, SLICC and ACR criteria were 84.5%, 89.4% and 78.6%, respectively. Among 25 patients (7.3%) who were ANA negative, thus failing to meet the entry criterion, 23 scored above the threshold of ≥10 points in the 2017 criteria. Patients classified according to the 2017 criteria did not differ from SLICC-classified patients regarding disease severity (mild/moderate/severe: 46.5%/33.7%/19.8% vs. 46.2%/33.8%/20.0%, respectively) and organ damage.
Conclusion: Both the 2017 and the 2012 SLICC criteria are more sensitive than the ACR criteria in classifying early SLE. The new criteria enable the classification of more patients with synovitis and positive autoantibodies whereas the SLICC criteria have increased sensitivity for hematologic disease, suggesting that they may need to be combined to assure maximum capture of patients for clinical trials. The majority of ANA-negative patients scored above the 2017 classification threshold, suggesting that inclusion of ANA as an additional item (instead of entry criterion) could further enhance the sensitivity of the new SLE criteria at early stages.
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Table 1. Prevalence of each manifestation included in the SLICC 2012 criteria and the 2017 criteria, in patients who fulfil only the SLICC or the 2017 criteria at the time of SLE diagnosis. |
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Time of SLE diagnosis according to physician |
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Fulfilling only SLICC 2012 (%) |
Fulfilling only 2017 criteria (%) |
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No of patients (%) |
25 (7.3%) |
39 (11.4%) |
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SLICC 2012 items |
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acLE/scLE |
72% |
74.4% |
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cdcLE |
24% |
10.2% |
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Non-scarring alopecia |
52% |
20.5% |
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Mucosal ulcers |
44% |
7.7% |
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Synovitis |
52% |
94.9% |
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Serositis |
8% |
10.2% |
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Renal disorder |
4% |
2.6% |
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Neurologic disorder |
4% |
7.7% |
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Haemolytic anemia |
12% |
2.5% |
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Leukopenia |
36% |
25.6% |
|
Thrombocytopenia |
28% |
12.8% |
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Anti-dsDNA |
4% |
15.4% |
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Anti-Smith |
0 |
5.1% |
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aPL |
20% |
7.7% |
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Low complement |
40% |
17.9% |
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Coombs test |
8% |
2.5% |
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ANA |
84% |
100% |
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Biopsy-proven nephritis |
4% |
2.5% |
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2017 criteria items |
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ANA (entry criterion) |
84% |
100% |
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Constitutional |
4% |
12.8% |
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Alopecia or ulcers |
56% |
23.1% |
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acLE |
48% |
74.3% |
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scLE or DLE |
16% |
7.7% |
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Synovitis |
52% |
94.9% |
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Delirium |
0 |
0 |
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Psychosis |
0 |
0 |
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Seizures |
0 |
2.5% |
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Acute pericarditis |
12% |
2.5% |
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Serositis |
0 |
5.1% |
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Leukopenia |
20% |
25.6% |
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Thrombocytopenia or hemolysis |
32% |
15.4% |
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Proteinuria |
0 |
0 |
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Class III or IV LN |
0 |
2.5% |
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Class II or V LN |
4% |
0 |
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aPL |
20% |
5.1% |
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Low C3 or low C4 |
24% |
7.7% |
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Low C3 and low C4 |
16% |
10.2% |
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Anti-dsDNA or anti-Smith |
4% |
20.5% |
To cite this abstract in AMA style:
Adamichou C, Nikolopoulos D, Bortoluzzi A, Papastefanakis E, Fanouriakis A, Kalogiannaki E, Gergianaki I, Sidiropoulos P, Bertsias G. Increased Sensitivity Οf Τhe New (2017) Αnd Τhe 2012 SLICC As Compared Τo Τhe Acr 1997 Classification Criteria Ιn Early Systemic Lupus Erythematosus (SLE): The 2017 Αnd 2012 Criteria May Classify Non-Overlapping Subgroups Οf Patients [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/increased-sensitivity-%ce%bff-%cf%84he-new-2017-%ce%b1nd-%cf%84he-2012-slicc-as-compared-%cf%84o-%cf%84he-acr-1997-classification-criteria-%ce%b9n-early-systemic-lupus-erythematosus-sle-the-2017/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/increased-sensitivity-%ce%bff-%cf%84he-new-2017-%ce%b1nd-%cf%84he-2012-slicc-as-compared-%cf%84o-%cf%84he-acr-1997-classification-criteria-%ce%b9n-early-systemic-lupus-erythematosus-sle-the-2017/