SAT0195 Impact of mycophenolate mofetil and/or corticosteroid treatment on outcomes of belimumab treatment in SLE. (23rd January 2014)

• Record Type: Journal Article
• Authors: Schneider, M.; Buyon, J.; Dooley, M.A.; Ginzler, E.M.; Cooper, S.; Zhong, Z.J.; Keenan, G.F.; Merrill, J.T.
• Is Part Of: Annals of the rheumatic diseases. Volume 71(2012)Supplement 3
• Page Start: 537
• Page End: 538
• Publication Date: 2014-01-23
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2012-eular.3142
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: 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. Objectives: To compare SLE responder index (SRI) rates in patients treated with MMF or corticosteroids in the placebo (standard therapy alone) vs belimumab dosing groups. Methods: 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. Results: 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 . Conclusions: 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. Disclosure of Interest: 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