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SAT0192 Post-hoc analysis to assess effect of belimumab in patients on mycophenolate mofetil with renal manifestations at baseline
  1. F. Houssiau1,
  2. M.A. Dooley2,
  3. C. Aranow3,
  4. D. D’Cruz4,
  5. A. Askanase5,
  6. D.A. Roth6,
  7. S. Cooper7,
  8. Z.J. Zhong7,
  9. W. Freimuth7,
  10. E.M. Ginzler8
  11. and BLISS-52/-76 Study Groups
  1. 1Cliniques Universitaires St Luc, Brussels, Belgium
  2. 2University of North Carolina, Chapel Hill
  3. 3Feinstein Institute for Medical Research, Manhasset, United States
  4. 4St. Thomas’ Hospital, London, United Kingdom
  5. 5NYU School of Medicine, New York
  6. 6GlaxoSmithKline, King of Prussia
  7. 7Human Genome Sciences, Inc., Rockville
  8. 8SUNY Downstate Medical Center, Brooklyn, United States

Abstract

Background Mycophenolate mofetil (MMF) is an accepted induction and maintenance therapy in lupus nephritis. In the phase 3 BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) SLE trials, patients on MMF at baseline (BL) treated with belimumab + standard therapy demonstrated an enhanced treatment differential in the composite SLE Responder Index endpoint: 24.6%. 36.1% and 52.2% with placebo (standard therapy alone), and belimumab 1 and 10 mg/kg, respectively.

Objectives To determine whether there was additional benefit from belimumab in patients with renal involvement receiving MMF in the BLISS trials.

Methods Patients with BL renal manifestations treated with MMF ± belimumab were assessed for improvement in renal parameters (by reduction in BILAG A/B/C scores and SELENA-SLEDAI).

Results 189 patients were on MMF at BL. 29.6% had ≥1 renal SELENA-SLEDAI item; 15.3% had BILAG renal A/B and 40.2% had renal C scores; 40.2% had proteinuria >0.5 g/24 h. Renal SELENA-SLEDAI improvement was seen by wk 52 in 27.8%, 52.6%, and 63.2% of patients with placebo, and belimumab 1 and 10 mg/kg, respectively (table). Assessment of BILAG renal improvement (requiring BL A/B scores) was difficult due to the small numbers of patients: 3/8 (37.5%), 4/9 (44.4%), and 7/12 (58.3%) improved with placebo, and belimumab 1 and 10 mg/kg, respectively; of patients with BL BILAG A/B/C, the corresponding numbers were 7/35 (20.0%),11/34 (32.4%), and 11/36 (30.6%).

Table 1. Improvement in SELENA-SLEDAI renal organ system and items

Conclusions The BLISS trials excluded patients with severe active lupus nephritis. The sample size for this analysis was reduced by restricting analysis to patients taking MMF at BL. The data, however, suggest that belimumab may provide additional benefit in patients with SLE with continued renal activity despite treatment with MMF.

Disclosure of Interest F. Houssiau Consultant for: GlaxoSmithKline/Human Genome Sciences, M. Dooley Grant/Research support from: GlaxoSmithKline/Human Genome Sciences, Consultant for: GlaxoSmithKline/Human Genome Sciences, C. Aranow Grant/Research support from: GlaxoSmithKline/Human Genome Sciences, Consultant for: GlaxoSmithKline/Human Genome Sciences, D. D’Cruz Consultant for: GlaxoSmithKline/Human Genome Sciences, A. Askanase: None Declared, D. Roth Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, S. Cooper Shareholder of: Human Genome Sciences, Employee of: 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, E. Ginzler Grant/Research support from: GlaxoSmithKline/Human Genome Sciences, Consultant for: GlaxoSmithKline/Human Genome Sciences

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