Background/Purpose: Community rheumatologists treating patients with Systemic Lupus Erythematosus (SLE) typically lack user-friendly tools to effectively track SLE disease activity. Current disease activity tools in SLE are resource and effort intensive, require special training and practice, take time, are difficult to implement in busy clinical practices and are of use almost exclusively to SLE researchers. Nonetheless, patient reported outcomes are recognized as important for patient care, and physician reimbursement (quality initiatives) and resource allocation are becoming tied to these outcomes. Here we report a novel user-friendly tool intended for daily clinical use In SLE.

Methods: Using our dataset of approximately 1,150 SLE patients from multiple countries and ethnicities that was accrued during the development of the LupusPRO, a disease targeted health outcome measure, we created multiple models with self reported SLE health survey items (LupusPRO), clinical variables (medications) and laboratory values that would  correlate best with physician disease activity assessments (Physician Global Assessment and SLEDAI). Using stepwise regression methods, we parsed our model to keep it simple, included few and easily accessible laboratory values so it can be performed in most locations, and expected minimal real-time physician involvement. “SIMPLE” index equation was derived from the regression model with the best fit (Simple disease assessment for People with LE). We then prospectively tested the correlation between SIMPLE Index and Total SLEDAI in an independent dataset (n= 150) of SLE patients.

Results: SIMPLE index has two parts (i) patient self-report 16 items and (ii) two laboratory values obtained within 10 days before/after the visit. Requisite physician input pertains to (1) interpretation of one blood and one urine lab result in the context of SLE diagnosis, and (2) addition of weighted scores using a mobile application on a smart phone/computer by health personnel. The SIMPLE equation is as follows:

SI= 2- (0.03) LSX+ 0.02(LIT)+0.28(DHS)+0.95(CSU)+0.04(CSD)+ 5.6(UL)+2.4(BL), where Simple Index: SI, LupusPRO Lupus Symptom domain: 3 items (LSX), Lupus Impact Tracker: 10 items (LIT), Change in Health Status: 1 Item (DHS), Self Report of Current use of corticosteroid: I item (CSU), Self Report of current daily corticosteroid dose (Prednisone equivalent in mg): 1 item (CSD), Urine Laboratory-Proteinuria (SLEDAI definition) (UL) and Blood Laboratory-Low complement C3/C4 (BL).

The SIMPLE index explained 55% variance of total SLEDAI score. In the second dataset, correlation of SIMPLE index with Total SLEDAI was strong (0.74, p=0.0001).

Conclusion: SIMPLE Index appears to correlate well with disease activity. It is easy, requires minimal physician training and involvement, and has the potential for quick integration into practice with minimal personnel resources. It also allows active patient engagement in care. Longitudinal studies are ongoing to confirm its utility and acceptability.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/simple-disease-assessment-for-people-with-lupus-erythematosus/