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OP0232 Sustained safety and efficacy over 10 years with belimumab (BEL) plus standard systemic lupus erythematosus (SLE) therapy (SOC) in patients with SLE
  1. DJ Wallace1,
  2. EM Ginzler2,
  3. JT Merrill3,
  4. RA Furie4,
  5. W Stohl5,
  6. W Chatham6,
  7. A Weinstein7,
  8. J McKay8,
  9. WJ McCune9,
  10. M Petri10,
  11. J Fettiplace11,
  12. D Roth12,
  13. B Ji13,
  14. A Heath14
  1. 1Cedars-Sinai Medical Center, Los Angeles
  2. 2SUNY Downstate Medical Center, Brooklyn
  3. 3Oklahoma Medical Research Foundation, Oklahoma City
  4. 4Northwell Health, Great Neck
  5. 5University of Southern California Keck School of Medicine, Los Angeles
  6. 6University of Alabama at Birmingham, Birmingham
  7. 7Washington Hospital Center, Washington DC
  8. 8Oklahoma State University Center for Health Sciences, Tulsa
  9. 9University of Michigan, Ann Arbor
  10. 10Johns Hopkins University School of Medicine, Baltimore, United States
  11. 11GSK (at the time of study), Uxbridge, United Kingdom
  12. 12GSK, Philadelphia, United States
  13. 13GSK, Uxbridge, United Kingdom
  14. 14GSK, Raleigh-Durham, United States

Abstract

Background Preliminary safety and efficacy data from the Phase II BEL open-label extension study (LBSL02; NCT00071487) have been reported.

Objectives Here we present the final 10-year data.

Methods This was a multicentre, open-label, continuation trial (BEL112626; NCT00583362) of BEL + SoC in patients with a satisfactory response in the parent study. Patients received intravenous BEL 10 mg/kg every 4 weeks. Baseline was prior to the first ever dose of BEL.

Results Of 298 patients in the continuation trial, 131 (44%) remained at Year 10. Total BEL exposure was 2154 patient-years. Adverse events (AEs) remained stable or decreased (Table). Two deaths (pseudomonal lung infection; cytomegaloviral pneumonia) were possibly related to BEL. SLE Responder Index (SRI) response increased (Figure). A British Isles Lupus Assessment Group (BILAG) flare (1 new A/2 new B scores) occurred in 72.6% of patients and 41.9% had a severe flare (SLE Flare Index). Prednisone dose decreased from baseline to Year 10 (Table). Of patients receiving >7.5 mg/day baseline prednisone, 32.6% (14/43) decreased their dose to ≤7.5 mg/day by Year 10; 9.5% (9/95) of patients receiving baseline prednisone ≤7.5 mg/day had a dose increase to >7.5 mg/day.

Table 1

Conclusions Over 10 years BEL + SoC was well tolerated and the rates and nature of AEs were consistent with the known profile of BEL. Efficacy was maintained and prednisone use decreased in those receiving >7.5 mg/day at baseline.

Acknowledgements Study funded by GSK. Editorial assistance provided by Katie White, PhD, Fishawack Indicia Ltd, UK; funded by GSK.

Disclosure of Interest D. Wallace Grant/research support from: GSK, Consultant for: GSK, E. Ginzler Grant/research support from: GSK, J. Merrill Grant/research support from: GSK, Bristol-Myers Squibb, Consultant for: Anthera Pharmaceuticals, Inc., GSK, EMD Serono, Inc., Lilly, AstraZeneca, Bristol-Myers Squibb, UCB, Celgene, Biogen, R. Furie Grant/research support from: GSK, Consultant for: GSK, W. Stohl Grant/research support from: GSK, Pfizer, Consultant for: Johnson & Johnson, W. Chatham Grant/research support from: GSK, A. Weinstein Grant/research support from: GSK, HGS, Consultant for: GSK, HGS, J. McKay Grant/research support from: GSK, MedImmune, Anthera Pharmaceuticals, Inc., Johnson & Johnson, Lilly, Xencor, Inc., W. McCune Grant/research support from: GSK, Lilly, M. Petri Grant/research support from: GSK, Consultant for: GSK, J. Fettiplace Shareholder of: GSK, Employee of: GSK, D. Roth Shareholder of: GSK, Employee of: GSK, B. Ji Shareholder of: GSK, Employee of: GSK, A. Heath Shareholder of: GSK, Employee of: GSK

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