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- W2313532890 abstract "<h3>Background</h3> Corticosteroids, antimalarials, and immunossuppressants, including mycophenolate mofetil (MMF), were permitted as background standard therapy in patients participating in the belimumab BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) SLE phase 3 trials. Belimumab is a B-lymphocyte stimulator-specific inhibitor approved for treatment of SLE combined with standard therapy. <h3>Objectives</h3> To compare SLE responder index (SRI) rates in patients treated with MMF or corticosteroids in the placebo (standard therapy alone) vs belimumab dosing groups. <h3>Methods</h3> Post-hoc analysis examined manifestations of SLE in patients treated with MMF or corticosteroids in the placebo vs belimumab arms by reviewing baseline (BL) SELENA-SLEDAI and BILAG organ domain scores. Response rates at 52 wk were assessed by SRI. <h3>Results</h3> 189 patients entered the trials on MMF. Patients whose BL manifestations included renal (proteinuria with MMF 26.5% vs no MMF 11.6%) or vasculitic (MMF 9.5% vs no MMF 6.2%) activity were more likely to be receiving treatment with MMF or corticosteroids. Corticosteroid use was also more frequent in patients with positive immunologic findings: low complement, corticosteroids 68.3% vs no corticosteroids 60.6%; and anti-double-stranded DNA, corticosteroids 75.7% vs no corticosteroids 68.2%. SRI rates are shown in table. <h3>Conclusions</h3> The subset of patients treated with MMF ± corticosteroids at entry in the BLISS trials does not appear to be random. Trends of increased renal disease and vasculitis, low complement, and anti-double-stranded DNA suggest these patients represent a more active SLE population. In post-hoc analysis, addition of belimumab in patients receiving these background therapies suggests the possibility of greater benefit than in the overall population. <h3>Disclosure of Interest</h3> M. Schneider Consultant for: GlaxoSmithKline/Human Genome Sciences, Speakers Bureau: GlaxoSmithKline/Human Genome Sciences, J. Buyon Grant/Research support from: Human Genome Sciences, Consultant for: GlaxoSmithKline/Human Genome Sciences, M. Dooley Grant/Research support from: GlaxoSmithKline/Human Genome Sciences, Consultant for: GlaxoSmithKline/Human Genome Sciences, E. Ginzler Grant/Research support from: GlaxoSmithKline/Human Genome Sciences, Consultant for: GlaxoSmithKline/Human Genome Sciences, S. Cooper Shareholder of: Human Genome Sciences, Employee of: Human Genome Sciences, Z. Zhong Shareholder of: Human Genome Sciences, Employee of: Human Genome Sciences, G. Keenan Shareholder of: Human Genome Sciences, Employee of: Human Genome Sciences, J. Merrill Consultant for: GlaxoSmithKline/Human Genome Sciences" @default.
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- W2313532890 date "2013-06-01" @default.
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- W2313532890 title "SAT0195 Impact of mycophenolate mofetil and/or corticosteroid treatment on outcomes of belimumab treatment in SLE:" @default.
- W2313532890 doi "https://doi.org/10.1136/annrheumdis-2012-eular.3142" @default.
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