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Utility of the AVISE Connective Tissue Disease Test in Predicting Lupus Diagnosis and Progression
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 retrospective chart review, AVISE Lupus was evaluated for its utility in predicting SLE disease development and damage progression. The results indicated that a positive AVISE Lupus test was associated with a confirmed SLE diagnosis at follow-up appointments.
Using electronic health record (EHR) data from 01/2016 to 12/2020, linked with HealthCore and Medicare medical and pharmacy claims and cost data, two cohorts were established: the AVISE cohort and the tANA cohort. AVISE and tANA test results were classified as positive, negative, or indeterminate and stratified based on test results. Multivariable logistic regression was used to estimate odds ratios (OR) comparing the likelihood of SLE medication initiation and SLE diagnosis between the AVISE and tANA cohorts.
The significantly greater likelihood of SLE diagnosis and SLE medication initiation in AVISE positive vs. tANA positive patients demonstrates superior clinical actionability, potentially shortening the time to diagnosis. AVISE negative patients experienced a greater decrease in outpatient lab testing post-test relative to tANA negative patients, supporting the superior negative predictive value of AVISE vs. tANA.
The main cohort included 21,827 AVISE testing episodes and the tANA arm included 22,778. A total of 2,437 (11.2%) patients tested positive by AVISE compared to 5,364 (23.6%) of tANA positive patients. Among patients with no baseline prescription for SLE medication(s), AVISE positive patients were more likely to initiate SLE medications compared to tANA positive patients (43% vs. 32%, OR = 1.57, 95% CI 1.41-1.76). The treatment effect was larger in patients new to the practice within the preceding year, 55% vs. 33% (adjusted OR = 2.77, 95% CI 2.31-3.32). AVISE positive patients were over five-fold more likely to be diagnosed with SLE as compared to the tANA patients, 31% vs. 8% (OR = 5.11, 95% CI 4.43-5.89), and similar in the 5 new patient cohort 30% vs. 6% (OR = 6.34, 95% CI 5.12-7.86). Linked Columbus-Medicare data revealed a greater decrease in post-test vs. pre-test mean annualized outpatient lab testing in AVISE negative (-$985, p < 0.0001) vs. tANA negative (-$356, p<0.0001) patients.
Methods
Patients who had undergone AVISE Lupus testing were assessed for SLE diagnosis. The criteria used for these assessments was from the Systemic Lupus International Collaborating Clinics (SLICC) and the American College of Rheumatology (ACR). SLE damage was analyzed according to the Systemic Lupus International Collaborating Clinics Damage Index (SDI) at the time of AVISE testing (t=0) and 2 years later (t=2).
Conclusions
The AVISE Lupus test can aid in SLE evaluation by predicting SLE disease development and future damage progression.
Results
Among 117 patients without a previous diagnosis of SLE, 65% of patients who tested positive developed SLE at t=2, compared with 10.3% of patients who tested non-positive (p<0.0001). AVISE-positive patients fulfilled significantly more SLICC diagnostic criteria than AVISE-non-positive patients at both t=0 (3.8±2.1 vs 1.9±1.1, p=0.001) and t=2 (4.5±2.2 vs 2.1±1.2, p<0.0001). AVISE-positive patients also had had significantly higher SDI at t=2 (1.9±1.3 vs 1.03±1.3, p=0.01). BC4d levels correlated with the number of SLICC criteria at t=0 (r=0.33, p<0.0001) and t=2 (r=0.34, p<0.0001), as well as SDI at t=0 (r=0.25, p=0.003) and t=2 (r=0.26, p=0.002).
References:
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Lupus Sci Med., 2020 Mar 18;7(1):e000345. doi: 10.1136/lupus-2019-000345. eCollection 2020.