A Cochrane review [Abstract] 1 included 6 studies with a total of 2 917 subjects (age range 22 to 80 years). Study duration ranged from 84 days to 76 weeks. More participants on belimumab 10 mg/kg showed at least a 4-point improvement (reduction) in SELENA-SLEDAI score, a validated SLE disease activity index (RR 1.33, 95% CI 1.22 to 1.45; 4 studies, n=2 666) compared to placebo (NNTB 8, 95% CI 6 to 11).There was probably little or no difference between groups in change in health-related quality of life (HRQOL), assessed by Short Form-36 Physical Component Summary score improvement (range 0 to 100) (MD 1.6 points, 95% CI 0.30 to 2.90; 2 studies, n=801). A higher proportion of participants on belimumab reduced their glucocorticoid dose by at least 50% compared to placebo (RR 1.59, 95% CI 1.17 to 2.15; 2 studies, n=537; NNTB 9, 95% CI 5 to 28).
The proportion of participants experiencing harm did not differ between the groups: one or more serious adverse event (RR 0.87, 95% CI: 0.68 to 1.11; 5 studies, n=2 890); one or more serious infection (RR 1.01, 95% CI: 0.66 to 1.54; 4 studies, n=2 185); and withdrawals due to adverse events (RR 0.82, 95% CI: 0.63 to 1.07; 5 studies, n=2 890). Mortality was rare, and did not differ between belimumab and placebo (Peto OR 1.15, 95% CI 0.41 to 3.25; 6 studies, n=2 917).
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