GSK has announced the results of the first study assessing levels of organ damage in patients with active systemic lupus erythematosus (SLE) treated with Benlysta (belimumab) plus standard of care (SoC), versus SoC alone.
Patients with SLE are at risk of irreversible organ damage, which can accrue over time and is associated with increased risk of death.
The data being presented at the 2017 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting shows that patients treated with belimumab plus SoC had significantly less organ damage over five years compared to those on SoC alone.
The propensity score (PS) matched study compared patients treated with belimumab plus SoC from the BLISS-76 US long-term extension study versus patients treated with SoC alone in the Toronto Lupus Cohort (TLC), a population of SLE patients with similar clinical characteristics to those in the BLISS pivotal studies for belimumab. Propensity Score is a composite value that allows clinically similar patients to be compared.
Results demonstrated that patients treated with belimumab plus SoC had significantly less SLE-related organ damage progression (0.44 smaller unit increase in SDI score), compared to patients in the TLC receiving SoC (p=0.001). This pattern of significantly lower organ damage progression started in the first year and continued every year of the analysis (through Year 5). Patients receiving belimumab plus SoC were 61% less likely to progress to a higher SDI score over any given year of follow-up, compared to SoC patients (p<0.001). Among patients whose levels of organ damage did increase, the magnitude of year-to-year progression also reduced compared to those on SoC alone (p=0.006).
The results of the study were validated using an alternative method of analysis, based on inverse PS weighting, which showed similar results for the change in SDI score from baseline to Year 5 for belimumab plus SoC versus SoC alone.
The safety profile observed in the BLISS-76 long-term extension study was consistent with that observed in the overall BLISS clinical trial programme for belimumab.
Dr. Murray Urowitz, Professor of Medicine, University of Toronto and lead author on the study said: “Having an appropriate SLE comparator arm has enabled us to make the first formal evaluation of long-term belimumab treatment versus standard therapy alone. The results are encouraging and indicate the potential impact of belimumab on organ damage progression in patients living with this chronic condition.”