Background/Purpose: Several novel SLE therapies are in development. Precision medicine aims to improve treatment practices and real-world outcomes. Certain factors, however, will likely reflect overall good outcomes even with current standard of care (SOC). Such factors need to be considered when assessing treatment-specific response markers in trials of novel therapies. Using an international SLE cohort, we aimed to identify factors associated with attaining favourable response states in SLE.

Methods: Patients were recruited into an international inception SLE cohort from 11 countries. To mimic a trial setting, we selected patients at the first visit in which they fulfilled a definition of active disease, comparable to a level reflecting entry to a clinical trial using ‘classic’ BILAG i.e. >=1 BILAG A and/or >= 2 BILAG B scores.

The first visit where the BILAG criteria were met was classified as their baseline visit. We examined the rates of, and factors associated with achieving outcomes at 12 months namely, ‘Major Clinical Response’ (MCR, defined as reduction to BILAG C in all domains, steroid dose of < = 7.5mg & SLEDAI < = 4) and ‘Improvement’ (defined as reduction to < = 1B score in previously active organs & no new BILAG A/B, stable or reduced steroid dose & no increase in SLEDAI). Univariate and multi-variate logistic regression with Least Absolute Shrinkage and Selection Operator (LASSO) and cross-validation in randomly split samples were used to build prediction models. Variables were ranked by the percentage of times selected by LASSO.

Results: In total, 924 patients (51% of the cohort) met criteria for active disease, including 820 (89%) women. The median [IQR] age and SLE disease duration were 30.6 [23.2 – 41.3] and 0.34 [0.12 – 0.71] years respectively. Common BILAG-2004 organ systems for which patients scored an A or B were renal (n = 480, 52%), haematological (n = 406, 44%), musculoskeletal (n = 335, 36%) and mucocutaneous (n = 317, 34%).

Outcome data at 12 months were available in 759 (82%) patients; MCR and Improvement were achieved in 114 (15%) and 261 (34%) respectively. Factors associated with a higher or lower probability of achieving MCR (selected by LASSO in >= 50% of the prediction models) are shown in Table 1.

Factors associated with a lower probability of achieving improvement in the active disease cohort were residence in Mexico (versus Canada), Hispanic and African (versus Caucasian) race/ethnicity, immunosuppressant use, low C3 or C4 and a higher SLEDAI score.

Conclusion: In active SLE receiving SOC, several factors are associated with the likelihood of achieving MCR and Improvement. Such factors are important to consider, potentially as stratification or minimisation factors, when designing clinical trials or precision medicine studies. Imbalances in geography, demographics, disease characteristics or background therapy may influence the interpretation of such trials.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/predictors-of-bilag-based-outcomes-in-patients-with-sle-analysis-from-the-systemic-lupus-international-collaborating-clinics-slicc-inception-cohort-and-masterplans-consortium/