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news.Human Genome Sciences and GlaxoSmithKline (GSK) have commenced the dosing in BLISS-SC, a Phase 3 trial intended to assess the efficacy, safety and tolerability of Benlysta (belimumab) in systemic lupus erythematosus (SLE) patients.
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Belimumab belongs to a class of drugs known as BLyS-specific inhibitors.
The multi-center, international, randomized, double-blind, placebo-controlled, 52-week study will investigate use of belimumab administered subcutaneously (SC) once-weekly to autoantibody-positive adults with active systemic lupus erythematosus (SLE).
The primary efficacy endpoint of BLISS-SC is response rate at Week 52, as measured by the SLE Responder Index (SRI).
The company is likely to announce the initial results in the second half of 2014.
Once the data of the study receives approval by regulatory authorities, belimumab could be made available in a subcutaneous formulation.