Complement Activation in Patients With Probable Systemic Lupus Erythematosus and Ability to Predict Progression to American College of Rheumatology - Classified Systemic Lupus Erythematosus

 

  • Positive AVISE
    Lupus Test Results:

The study clearly establishes a link between the superiority of the AVISE test and the benefit to patients through early treatment intervention. Delayed diagnosis can lead to increased disease burden and diminished quality of life.

Diagnosis

6X greater odds

AVISE Lupus [+]1 vs traditional ANA [+]2 establishing SLE diagnosis following AVISE

Treatment Initiation

3X greater odds

AVISE Lupus [+]1 vs traditional ANA [+]2 initiating SLE treatment following AVISE

  • Negative AVISE
    Lupus Test Results:

The study demonstrated that a negative AVISE test is more conclusive than the standard of care, as it is reflected by the lower number of repeat testing and fewer follow-up visits. Convincingly ruling out lupus is often a critical step for achieving diagnostic clarity for the patient and reducing costs on the system.

Repeat Testing

3.5X less frequent

AVISE Lupus vs. traditional ANA tested patients in a mean 285 days of follow up for AVISE and 305 days of follow-up for tANA

Repeat Testing

3.5X less frequent

AVISE Lupus vs. traditional ANA tested patients in a mean 285 days of follow up for AVISE and 305 days of follow-up for tANA

Laboratory Cost

2X lower

AVISE Lupus [-] vs traditional ANA [-] in first six-month follow-up period

Follow-up Visits

1 fewer visits

AVISE Lupus [-] vs traditional ANA [-] in first sixth-month follow-up period

References:
1. AVISE Lupus + = Tier 1 and Tier 2 Positive.
2. tANA + = ANA (IFA) 1:160 ≥ and/or one or more of the following
positive: anti-dsDNA, anti-smith.

Summary

In this cross-sectional, multi-center prospective study, the frequency of cell-bound complement activation products (CB-CAPs) was evaluated as a marker of complement activation in patients with suspected systemic lupus erythematosus (SLE).  This biomarker was examined as a predictor of the evolution of probable SLE into SLE as classified by the American College of Rheumatology (ACR) criteria.

Methods

Patients suspected of having SLE and who fulfilled three ACR classification criteria for SLE (probable SLE) were enrolled. In addition, this study included patients with established SLE as classified by both the ACR and the Systemic Lupus International Collaborating Clinics (SLICC) criteria, patients with primary Sjögren's disease, and patients with other rheumatic diseases. Individual CB-CAPs were measured by flow cytometry, and positivity rates were compared to those of commonly assessed biomarkers, including serum complement proteins (C3 and C4) and autoantibodies. The frequency of a positive multianalyte assay panel (MAP), which includes CB-CAPs, was also evaluated. Probable SLE cases were followed up prospectively.

Conclusions

Complement activation occurs in some patients with probable SLE and can be detected with higher frequency by evaluating CB-CAPs and MAP than by assessing traditional serum complement protein levels. A MAP score above 0.8 predicts transition to classifiable SLE according to ACR criteria.

Results

The 92 patients with probable SLE were diagnosed more recently than the 53 patients with established SLE, and their use of antirheumatic medications was lower. At the enrollment visit, more patients with probable SLE were positive for CB-CAPs (28%) or MAP (40%) than had low complement levels (9%) (P = 0.0001 for each). In probable SLE, MAP scores of >0.8 at enrollment predicted fulfillment of a fourth ACR criterion within 18 months (hazard ratio 3.11, P < 0.01).

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References:

  • Arthritis Rheumatol., 2020 Jan;72(1):78-88. doi: 10.1002/art.41093. Epub 2019 Nov 25.
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