Outcomes of patients with systemic lupus erythematosus treated with belimumab: a post hoc efficacy analysis of five phase III clinical trials by British Isles Lupus Assessment Group-based Combined Lupus Assessment criteria.

A highly significant difference was observed in the pooled population (1.47 (1.25–1.72); p<0.001; adjusted for trial variance).

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By contrast, in the subgroups of patients with SLEDAI-2K<10 at baseline ( figure 2C ; online supplemental table S3 ), patients negative for anti-dsDNA at baseline ( figure 2E ; online supplemental table S5 ) and patients negative for anti-dsDNA and normal/high C3 and C4 levels at baseline ( figure 2G ; online supplemental table S7 ), the differences between belimumab and placebo in BICLA response frequencies did not reach statistical significance.

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