GSK Announces Systemic Lupus Erythematosus Trial Results

GlaxoSmithKline (GSK) and Human Genome Sciences have announced secondary endpoints from BLISS-76, the second of two pivotal Phase 3 trials of Benlysta (belimumab) in seropositive patients with systemic lupus erythematosus (SLE).

At Week 76 in the BLISS-76 study, belimumab plus standard of care showed higher response rates compared with placebo plus standard of care as measured by the SLE Responder Index; however, this secondary endpoint did not reach statistical significance. Study results also showed that belimumab continued to be generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups.

The data from the study were previously analyzed after 52 weeks in accord with the study protocol, in support of a potential biologics license application in the US and marketing authorization applications in Europe and other regions.

The primary efficacy endpoints in both pivotal Phase 3 studies of belimumab, BLISS-52 and BLISS-76, were the patient response rates at Week 52 as measured by the SLE Responder Index. BLISS-76 then continued for an additional 24 weeks.