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Table 1 Predictivity of anti-dsDNA antibodies in SLE flares

From: Predictive biological markers of systemic lupus erythematosus flares: a systematic literature review

Assay Number of patients (n) Findings Study
Positive results
 CLIF 61 67% of patients in the group with exacerbations had persistent anti-dsDNA ab versus 27% in the patient group without exacerbations Oelzner et al., 1996 [14]
 CLIF 299 Increased level at baseline was a risk factor for flare in the haematological system (p = 0.003) Petri et al., 2009 [10]
 CLIF 65 Cases, defined as experiencing a surge in anti-dsDNA from 0 to 3+/4+, or from 1+ to 4+, within a period of less than 12 months, were more likely to experience a severe flare than controls (OR 6.3 (CI 2.0–19.9), p = 0.02) Pan et al., 2014 [25]
 Farr 487 Frequency of renal flare was lower in patients with sustained reductions in anti-dsDNA ab (> 10% from baseline levels for at least 2/3 of all observed values) than in patients with stable or increasing antibody levels Linnik et al., 2005 [24]
 Farr 130 All 15 major exacerbations were preceded by an increase of the anti-dsDNA ab levels, with a doubling time of less than 6 weeks for 13 patients. There were four other patients with an increase in anti-dsDNA levels who did not show any exacerbation Swaak et al., 1982 [11]
 Farr 143 A continuous increase in the anti-dsDNA ab was found for all patients in the 24 weeks preceding exacerbations with a doubling time < 10 weeks Swaak et al., 1986 [12]
 Farr 78 A sharp drop in anti-dsDNA ab, usually preceded by a rise, was related to a serious exacerbation Swaak et al., 1979 [4]
 Farr 151 Anti-dsDNA increase started 4 months prior to the relapse and reached a maximum at the moment of relapse whereas no fluctuations were observed in patients with persistently inactive disease Coremans et al., 1995 [15]
 Farr 23 Presence of anti-dsDNA abs (> 5 IU/ml) or increase (> 25%) was associated with a high risk of renal flare Matrat et al., 2011 [29]
 Farr 199 Patients with anti-dsDNA ab (> 15 IU/ml) had a greater risk of developing proliferative glomerulonephritis than patients without auto-antibodies (p = 0.048) Cortés-Hernàndez et al., 2004 [22]
 ELISA 70 Anti-dsDNA antibodies were detected in 14 (93.3%) of 15 patients with subsequent lupus nephritis, compared with 24 (72.7%) of 33 patients with active SLE and no nephritis (p = ns) and nine (73%) patients with inactive SLE and no nephritis (p = ns). Sensitivity for severe lupus nephritis was 100% Meyer et al., 2009 [30]
 Farr and EliA 48 All 22 exacerbations were accompanied by changes in anti-dsDNA (> 25%) in one or both assays Hillebrand et al., 2013 [26]
 CLIF and ELISA 53 Increase in anti-dsDNA ab predicted flares with M-SLEDAI and M-LAI indices Ho et al., 2001 [17]
 CLIF, ELISA and Farr 72 89% of the exacerbations were preceded by a significant increase in anti-dsDNA ab levels (defined as ≥ 2 titres by the C. luciliae test or ≥ 25% and at least 100 IU/ml by the ELISA or ≥ 25% and at least 30 IU/ml by the Farr assay) ter Borg et al., 1990 [13]
 ELISA and Farr 34 Patients with rises in IgG class anti-dsDNA ab by ELISA (≥ 6 IU/ml) or in anti-dsDNA by Farr assay (≥ 15 IU/ml) had a significantly higher cumulative risk for relapses, with a median time of 2.3 and 2.1 months respectively Bootsma et al., 1997 [16]
 NA 189 Persistently positive anti-dsDNA after cyclophosphamide treatment was an independent predictor of renal flares Mok et al., 2004 [23]
 NA 218 The combination of complement C3, C4 and anti-dsDNA antibody is reasonably specific for predicting lupus flares in the preceding 4 weeks To et al., 2011 [28]
 NA 562 Elevated titres (≥ 200 IU/ml) at baseline were independent predictors of moderate-to-severe flares at week 52 Petri et al., 2013 [9]
Negative results
 CLIF 27 Serial measurements of anti-dsDNA ab were poor markers of exacerbation. Lloyd and Schur, 1981 [19]
 Farr 48 Changes in anti-dsDNA ab failed to correctly predict a change in disease activity Abrass et al., 1980 [18]
 Farr 202 Fluctuations in anti-dsDNA ab were poor predictors of disease exacerbations according to SLEDAI Esdaile et al., 1996 [20]
 Farr 120 No consistent association between anti-dsDNA ab positivity and risk of flare defined by SLEDAI Mirzayan et al., 2000 [6]
 Farr 46 Baseline anti-dsDNA ab failed to predict renal relapses El Hachmi et al., 2003 [8]
 ELISA 23 Anti-dsDNA ab were not predictive of flare Steiman et al., 2010 [21]
 Farr and CLIF 73 No difference between the patients who flared and the patients who did not Walz LeBlanc et al., 1994 [31]
 NA 57 Percentage of patients who had positive anti-dsDNA ab at the time of the diagnosis was not higher in patients with a subsequent exacerbation Tomioka et al., 2008 [7]
 NA 110 Anti-dsDNA ab were not identified as a predictor of flare Swaak et al., 1989 [5]
 NA 218 Anti-dsDNA lacks sensitivity in predicting serosal and neuropsychiatric lupus flares To et al., 2011 [27]
  1. anti-dsDNA ab anti-double-stranded DNA antibodies, CI confidence interval, CLIF Crithidia luciliae immunofluorescence, ELISA enzyme-linked immunosorbent assay, EliA automated enzyme fluoroimmunoassay, M-LAI Modified Lupus Activity Index, M-SLEDAI Modified Systemic Lupus Erythematosus Disease Activity Index, NA not available, ns not significant, OR odds ratio, SLE systemic lupus erythematosus, SLEDAI Systemic Lupus Erythematosus Disease Activity Index