Background/Purpose: Post hoc analyses from the BLISS trials demonstrated that patients with high baseline B-lymphocyte stimulator (BLyS) levels (≥2 ng/ml) had an increased risk of a clinically meaningful flare over 1 year.

Objectives: BLyS levels are not routinely collected in clinical practice; analyses were conducted to identify clinical variables that may predict high BLyS levels in patients with SLE high disease activity.

Methods: Data from BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) were pooled (GSK200619). High disease activity was defined as anti-dsDNA positive and low complement (low C3 and/or low C4). Those subjects with high disease activity and elevated BLyS levels (≥2 ng/ml) were examined. Univariate and stepwise logistic regression were employed to identify a subset of baseline factors (e.g. demographic, disease activity, laboratory, biomarker and SLE medication usage) predictive of high baseline BLyS levels. Only baseline factors at the 0.05 significance level entered the final logistic regression as covariates.

Results: A total of 243 out of 1664 (15%) subjects had high disease activity and high baseline BLyS levels (≥2 ng/ml). Most subjects were female (n=221, 91%); mean age was 34 (10.2 SD) years, and mean SELENA-SLEDAI score was 11.5 (4.39 SD). Significant baseline predictors of high baseline BLyS levels included positive anti-Smith (≥15 U/ml; χ2 = 10.96, p<0.01), low C3 (χ2 = 7.85, p<0.01), anti-dsDNA (>200 IU/ml; χ2 = 7.28, p<0.01) and anti-dsDNA (80–200 IU/ml; χ2 = 3.57, p=0.058), use of immunosuppressant medication (χ2 =11.74, p<0.01), proteinuria (≥0.5 g/24 h; χ2 = 10.48, p<0.01) and elevated C-reactive protein (>3 mg/L; χ2 = 40.69, p<0.01).

Conclusion: Positive anti-Smith, low C3, positive anti-dsDNA, immunosuppressant usage, proteinuria, and elevated C-reactive protein were predictors of high BLyS and may be useful clinical parameters in identifying SLE patients with high disease activity at risk of flare.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/baseline-factors-that-predict-high-blys-levels-in-patients-with-systemic-lupus-erythematosus-sle-and-high-disease-activity/