SLE patients experienced a significantly greater response to treatment with Benlysta (belimumab) 200mg administered via subcutaneous injection plus standard of care (SoC), compared to placebo plus SoC.- GSK

GSK has announced data at the Annual European Congress of Rheumatology (EULAR 2016) showing that patients with highly active systemic lupus erythematosus (SLE) experienced a significantly greater response to treatment with Benlysta (belimumab) 200mg administered via subcutaneous injection plus standard of care (SoC), compared to placebo plus SoC. High SLE disease activity is associated with symptom flares and a range of organ manifestations in lupus patients. The pre-specified analysis reviewed a subset of patients from the overall BLISS-SC Phase III pivotal study of belimumab subcutaneous formulation. This high disease activity sample is reflective of the licensed population for Benlysta intravenous formulation in the European Union.

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.

On secondary endpoints, patients in the Benlysta group showed a 62% reduction in their risk of experiencing a severe flare compared to those in the placebo group; 14.1 percent and 31.5 percent (respectively) had a severe flare during the course of the study. Also, in those receiving more than 7.5mg/day of prednisone, 20.7 percent of patients in the Benlysta group were able to reduce their steroid dose by 25 percent or more, compared with 11.4 percent of those in the placebo group, though this difference was not deemed statistically significant (p=0.0844).