Background/Purpose: The AVISE Connective Tissue Disease test is a newly approved, commercially available test that combines autoantibody and biomarker levels to help diagnose systemic lupus erythematosus (SLE) and other connective tissue diseases. However, few studies have examined whether AVISE can predict future clinical diagnosis and outcomes in a real-world cohort. We evaluated the utility of AVISE in predicting SLE diagnosis and damage progression.

Methods: This longitudinal observational study enrolled patients of a single adult rheumatologist who underwent AVISE testing between April 1, 2014 and April 30, 2016. A ÒpositiveÓ AVISE test for SLE was defined as positive or moderate-positive scores. ÒNon-positiveÓ tests were defined as negative, moderate negative, equivocal, or indeterminate scores. SLE diagnosis was confirmed using SLICC/ACR classification criteria. Damage was evaluated using SLICC/ACR damage index (SDI) at baseline (t=0) and two years (t=2) after AVISE testing. Statistical analyses were performed using SPSS.

Results: The cohort consisted of 77 women and 6 men; 7 patients had long-established SLE at t=0. Among the remaining 76 patients, the most common confirmed diagnoses in those with a positive test was SLE, followed by UCTD and RA, at both t=0 and t=2 (Table 1).   Among those without established SLE at t=0, 53% of patients with a positive test vs. 25% in those with a negative test (p=0.04) had an SLE diagnosis at t=2. 

There was a significant difference in the number of SLICC clinical and immunologic diagnostic criteria fulfilled at t=0 and t=2 by patients with a positive vs. a non-positive AVISE test (Table 2).  There was also a significant difference in SDI between positive and non-positive patients, with positive patients having higher SDI at t=2 (Table 2). Among the individual AVISE result biomarkers, BC4d levels significantly correlated with the number of clinical SLE classification criteria at t=0 (r=0.24, p=0.02) and the SDI at t=0 (r=.28, p=0.01) and t=2 (r=0.34, p=0.002), yet EC4d and dsDNA levels did not.

Conclusion: AVISE CTD test results are predictive of eventual rheumatologic diagnosis, and BC4d levels are predictive of both SLICC/ACR classification criteria fulfillment and SDI in SLE patients. These data suggest that AVISE may be useful in standard rheumatologic care for establishing a SLE diagnosis and identifying patients at higher risk for adverse clinical outcomes.

Table 1. Suspected diagnoses at t=0 and t=2 in those without an established SLE diagnosis at baseline.

Table 2. Differences in mean SDI and number of SLICC lupus classification criteria met at t=0 and t=2 years between AVISE result groups