Background Predicting which SLE patients are at increased risk for clinically meaningful flares may be useful in making management decisions.
Objectives To identify demographic and disease-related predictors for flares.
Methods Baseline demographic and SLE-related disease activity characteristics were evaluated for their ability to predict new SLE flares by wk 24 in the combined dataset of 562 patients receiving placebo + standard therapy from the belimumab BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) phase 3 trials. Flare (moderate-severe) was defined according to the modified SLE Flare Index (SFI) or as the development of 1 new BILAG A or 2 new B organ domain scores. Baseline variables included race, age, gender, BMI, SELENA-SLEDAI (SS; mean score, range, and 24 items with ≥30/group), PGA, BILAG A-E scores, ACR diagnostic criteria, SLICC damage index, SLE duration, and concurrent medications. A ≥10% absolute difference (% flare - % no flare) or ≥50% increase ([% flare - % no flare]/% no flare) was considered clinically meaningful.
Results By wk 24, 142 patients (25.3%) receiving placebo had a flare by BILAG and 72 (12.8%) by SFI. By both flare indices, SS ≥12, serologic markers, and moderate-severe disease activity involving renal, hematologic, and vasculitic domains were predictors of flare, as was prednisone use (table). Immunosuppressives, antimalarials, and other concomitant medications did not predict flare.
Conclusions SLE patients on standard therapy alone with moderate-severe renal, vasculitic, hematologic, or serologic disease activity were at increased risk of having a clinically meaningful flare over 24 wk.
Disclosure of Interest R. van Vollenhoven Grant/Research support from: GlaxoSmithKline/Human Genome Sciences, M. Petri Consultant for: GlaxoSmithKline/Human Genome Sciences, R. Levy Speakers Bureau: GlaxoSmithKline/Human Genome Sciences, S. Navarra Speakers Bureau: GlaxoSmithKline/Human Genome Sciences, J. Buyon Grant/Research support from: Human Genome Sciences, Consultant for: GlaxoSmithKline/Human Genome Sciences, Z. Zhong Shareholder of: Human Genome Sciences, Employee of: Human Genome Sciences, W. Freimuth Shareholder of: Human Genome Sciences, Employee of: Human Genome Sciences, R. Cervera Grant/Research support from: GlaxoSmithKline/Human Genome Sciences, Consultant for: GlaxoSmithKline/Human Genome Sciences