GSK has reported long-term efficacy analysis of organ damage with Benlysta (belimumab) combined with standard of care (SoC) in patients suffering from active systemic lupus erythematosus (SLE).
Patients with the chronic autoimmune disease are at-risk of irreversible organ damage, resulting in increased risk of death.
Benlysta is a human monoclonal antibody being developed to specifically bind to and inhibit BLyS.
Results showed that subjects administered with belimumab had significantly less organ damage compared to SoC alone over five years.
The study compared the BLISS-76 US long-term extension study, involving 259 patients received the combination therapy, with the Toronto Lupus Cohort (TLC) of 706 subjects treated with SoC alone.
Observed during the first year, the pattern of significantly lower organ damage progression was found to continue every year of the analysis through year five.
It was further shown that in subjects whose organ damage levels increased, the year-to-year progression magnitude decreased, when compared with SoC alone.
Study lead author and University of Toronto Medicine professor Dr Murray Urowitz said: “These findings support results from a previous analysis of the BLISS long-term extension studies, published last year.
“The results are encouraging and indicate the potential impact of belimumab on organ damage progression in patients living with this chronic condition.”
The long-term efficacy study analysed the primary endpoint of mean change in SLICC Damage Index (SDI) score from baseline to year five in a total of 198 patients.
Secondary endpoints of the study were time to first SDI worsening, total SDI score at yearly intervals, SLEDAI score and steroid use.
The safety profile of belimumab demonstrated in the BLISS-76 long-term extension study was found to be consistent with that observed in the overall BLISS clinical trial programme.