Clinical Data
Results showed that patients with highly active SLE (low C3/C4 complement and positive anti-double-stranded DNA) treated with belimumab administered subcutaneously plus SoC (belimumab group) had significantly greater reductions in disease activity as measured by the primary efficacy endpoint SRI4 (Systemic Lupus Responder Index) at Week 52, compared to placebo plus SoC (placebo group) (64.6% compared to 47.2%, p=0.0014). These findings are consistent with those observed in the pivotal Phase III BLISS clinical trial programme for belimumab administered intravenously.For the pre-specified secondary endpoints, patients in the belimumab group showed a 62% reduction in their risk of experiencing a severe flare compared to those in the placebo group (Hazard Ratio = 0.38, p<0.0001). 14.1% of patients in the belimumab group had a severe flare during the course of the study compared to 31.5% in the placebo group. In patients receiving more than 7.5mg/day of prednisone (n=234), 20.7% of patients in the belimumab group were able to reduce their steroid dose by 25% or more to <7.5mg/day during Weeks 40-52, compared with 11.4% of those in the placebo group, but this was not statistically significant (p=0.0844).