GSK has announced positive efficacy and safety data from a pivotal study of patients with systemic lupus erythematosus (SLE) in Northeast Asia (Japan, China and South Korea).
Presented at the 2016 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting, the data showed that Benlysta® achieved the primary and all four pre-specified secondary endpoints with statistical significance. The information obtained will be used to submit files for the regulatory approval of belimumab in Japan and China in the next few months.
For the primary efficacy endpoint (SLE Responder Index at Week 52), significantly more of the patients on belimumab 10mg/kg administered intravenously (54%) achieved reduced disease activity compared to those on placebo (40%).
The benefits of belimumab were also seen for all the secondary endpoints in the study. The key secondary endpoint relating to average steroid reduction in patients with baseline dose of >7.5mg/day prednisone was significant, favouring belimumab. In addition, 56% of patients on belimumab achieved a ≥4 point reduction in SS at Week 52 (versus 42% on placebo). 33% of belimumab patients achieved an SRI7 response rate (versus 23% on placebo); and the belimumab group had a 50% lower risk of experiencing a severe flare versus placebo, as measured by the Severe Flare Index.
The safety profile of belimumab observed in the study was consistent with that observed in previous IV and subcutaneous belimumab studies, with the overall incidence of adverse events being similar in both the belimumab (75%) versus placebo (76%) groups.
David Roth, Project Lead for Benlysta at GSK, said: “Based on this data and subsequent regulatory submissions, we hope to be able to make Benlysta available to more patients living with lupus in this region.”