Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two–Week Randomized, Double-Blind, Placebo-Controlled Study

In patients with moderate-to-severe SLE, the SLE Responder Index response rate at week 52 was higher in patients who received subcutaneous belimumab (200mg weekly) than in those who received placebo (61.4% vs. 48.4%; OR 1.68 [95% CI 1.25–2.25]; P=0.0006).

An intravenously administered formulation of belimumab (Benlysta) is licensed in the UK as an add-on therapy in adult patients with active, autoantibody-positive SLE with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy.

A liquid formulation of belimumab for subcutaneous administration has been developed and the current study (BLISS-SC) sought to evaluate its efficacy and safety when administered via a prefilled syringe. The authors say that their findings support fixed dosing with 200mg weekly, and that the more convenient treatment regimen may make it a more viable treatment option for some patients.

An application seeking approval of the subcutaneous formulation of belimumab, which included the results of this study, has been filed in the EU.