SAN DIEGO, CA—A much smaller increase in the total corticosteroid dose was seen in the belimumab treatment arm than standard therapy alone for patients with systemic lupus erythematosus (SLE), reported study investigators at the 2013 ACR/ARHP Annual Meeting.
Corticosteroids are frequently administered as standard therapy in patients with SLE.
Ronald F. van Vollenhoven, MD, PhD, from the Karolinska Institute, Stockholm, Sweden, and colleagues examined the effects of belimumab on total corticosteroid dose across 52 weeks of treatment in two randomized trials, BLISS-52 and BLISS-76.
Data from these two trials were pooled and study investigators compared patients treated with corticosteroids at baseline that were randomized to receive belimumab 10mg/kg with standard therapy or placebo (standard therapy). A conservative steroid taper was imposed by each protocol.
The primary endpoint was the cumulative change from baseline (average dose over prior 7 days) in corticosteroid dose (prednisone or an equivalent) through Week 52. Also, cumulative dose reductions and increases and change from baseline in average daily corticosteroid dose were examined.
At baseline, 478 patients received belimumab 10mg/kg and 488 patients received placebo. The mean SELENA Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score was 9.8 (3.8 standard deviation [SD]) and mean corticosteroid dose (prednisone or an equivalent) was 12.5mg/day (8.2 SD).
The mean of all cumulative decreases in corticosteroid dose was 741mg for belimumab 10mg/kg and 542mg for placebo (P=0.017). The mean of all cumulative increases in corticosteroid dose was 1272mg for belimumab and 1458mg for placebo (P<0.001). The mean cumulative change from baseline in corticosteroid dose was 531mg for belimumab vs. 916mg for placebo (P <0.001), and the mean change from baseline in average daily corticosteroid dose was 1.46mg for belimumab vs. 2.51mg for placebo (P<0.001).
Dr. van Vollenhoven noted, “Although there was an increase in total corticosteroid dose in both arms over the duration of the trial, this increase was significantly smaller in patients who received belimumab 10mg/kg plus standard therapy compared with standard therapy alone after one year of treatment.” Adverse events were comparable among treatment groups.