GSK announced publication of a new long-term analysis showing that patients with moderate-to-severe systemic lupus erythematosus (SLE) treated with Benlysta (belimumab) plus standard of care (SoC) over five years experienced low rates of organ damage progression, regardless of their baseline level of damage. Patients with SLE are at risk of irreversible organ damage which will accrue over time and is associated with increased risk of death.
Results from this analysis of two pooled, open-label, continuation studies published in Lupus, showed that for the primary endpoint (change in SLICC Damage Index [SDI] from baseline, a validated score to quantify organ damage, at study years 5-6), 85.1 percent patients had no change in organ damage and the mean change in SDI from baseline was 0.2 (0.48, n=403). In patients without organ damage at baseline, 87.6 percent had no change in SDI and the mean change was 0.2 (0.44, n=241). In patients with organ damage at baseline, 81.5 percent had no change in SDI and the mean change was 0.2 (0.53, n=162).The overall probability of patients maintaining their SDI score was 0.83 (95 percent confidence interval [CI]: 0.79, 0.86) and the median time to first worsening was 677 days (n=117).
Professor Ian Bruce, University of Manchester, UK, said: “This is the first analysis to investigate Benlysta’s long-term effect on organ damage. Whilst this is an open-label continuation study, the results are very encouraging and suggest that use of more targeted therapies may slow progression of irreversible long-term damage for lupus patients. Further studies to examine this question further would be warranted.”
The long-term safety observed in the analysis was consistent with the known safety profile of Benlysta. The majority (96.5 percent) of patients in the modified intent-to-treat population (MITT) experienced an adverse event (AE) any time post baseline. The incidence of AEs decreased from 87.4 percent to 52.7 percent during the study. 313 (31.4 percent) patients experienced a serious AE. Overall, 433 (43.4 percent) patients experienced a drug-related AE. The most commonly reported drug-related AEs were infections/infestations (282, 28.3 percent) and gastrointestinal disorders (139, 13.9 percent).Opportunistic infections were reported in 23 (2.3 percent) patients, four cases of which were serious, and herpes zoster infection was reported for 87 (8.7 percent) patients, seven cases of which were serious. 11 deaths occurred during the study period and three additional deaths occurred after study exit.
This data is an interim analysis of two open-label, non-randomised, uncontrolled extension studies with no placebo (SoC) data for comparison.
Filed Under: Drug Discovery