Table 4.

Effect of placebo or belimumab plus standard therapy on anti-influenza IgG levels in patients receiving on-study influenza vaccination in BLISS-76.

Standard Therapy + PlaceboStandard Therapy + Belimumab 1 mg/kgStandard Therapy + Belimumab 10 mg/kg
2007–8 vaccine, n ††10137
  Solomon Island 1,2,3: mean IgG % change pre- to postvaccination (SE)1774.6 (1240.0)791.1 (474.4)318.1 (118.5)
    Median300.0300.0300.0
    No. with antibody titer > 1:10/no. without titer > 1:10 prevaccination (%)0/01/1 (100)0/0
    No. with antibody titer > 1:10/no. with titer > 1:10 prevaccination (%)10/10 (100)12/12 (100)7/7 (100)
  Wisconsin 1,2,3: mean IgG % change pre- to postvaccination (SE)8410.8 (7816.5)692.1 (419.2)94.9 (42.4)
    Median158.7217.533.3
    No. with antibody titer > 1:10/no. without titer > 1:10 prevaccination (%)0/01/1 (100)0/0
    No. with antibody titer > 1:10/no. with titer > 1:10 prevaccination (%)10/10 (100)12/12 (100)7/7 (100)
  Malaysia 1,2,3: mean IgG % change pre- to postvaccination (SE)326.7 (145.3)131.2 (40.4)3749.9 (3626.2)
    Median183.5100.0100.0
  No. with antibody titer > 1:10/no. without titer > 1:10 prevaccination (%)0/0NA/11/1 (100)
    No. with antibody titer > 1:10/no. with titer > 1:10 prevaccination (%)10/10 (100)12/12 (100)6/6 (100)
2008–9 vaccine, n ††162414
  Brisbane-10 1,2,3: mean IgG % change pre- to postvaccination (SE)1445.8 (420.7)225.4 (72.0)*610.6 (216.8)
    Median744.5100.0258.7
    No. with antibody titer > 1:10/no. without titer > 1:10 prevaccination (%)4/4 (100)5/6 (83)1/1 (100)
    No. with antibody titer > 1:10/no. with titer > 1:10 prevaccination (%)12/12 (100)18/18 (100)13/13 (100)
  Brisbane-59 1,2,3: mean IgG % change pre- to postvaccination (%)818.9 (388.8)318.7 (134.0)219.1 (139.6)*
    Median258.7100.018.5
    No. with antibody titer > 1:10/no. without titer > 1:10 prevaccination (%)3/3 (100)5/8 (62.5)1/1 (100)
    No. with antibody titer > 1:10/no. with titer 1:10 prevaccination (%)> 13/13 (100)16/16 (100)13/13 (100)
  Florida: mean IgG % change pre- to postvaccination (SE)896.6 (417.9)301.0 (129.4)282.3 (121.0)
    Median125.9100.0100.0
    No. with antibody titer > 1:10/no. without titer > 1:10 prevaccination (%)1/1 (100)1/1 (100)0/0
    No. with antibody titer > 1:10/no. with titer > 1:10 prevaccination (%)15/15 (100)23/23 (100)14/14 (100)
  • * p < 0.01;

  • p < 0.05.

  • †† Numbers of patients with data available. The p values for comparison of proportions of patients maintaining antibody levels ≥ LLOQ or achieving adequate response levels are from Fisher’s exact test for belimumab vs placebo; p values for comparison of changes in antibody levels are from Wilcoxon rank-sum test for belimumab vs. placebo. IgG: immunoglobulin G; NA: not available; SE: standard error. LLOQ: lower limit of quantitation.