A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

• SLE Responder Index (SRI) response rate [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]

  A patient that has an SRI response has all 3 of the following:

  • ≥4 point reduction from baseline in SELENA SLEDAI score,

  AND

  • No worsening (increase of <0.30 points from baseline) in Physician's Global Assessment (PGA),

  AND

  • No new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (ie, at Week 52).

  
  

• Time to first severe flare (SLE Flare Index) [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
  
• Reduction in prednisone dose [ Time Frame: Baseline, Weeks 40-52 ] [ Designated as safety issue: No ]
  Percent of subjects whose average prednisone dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52 in subjects receiving greater than 7.5 mg/day at baseline.
  
  

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.