Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Patients with systemic lupus erythematosus (SLE) frequently receive corticosteroids (CS) as standard therapy. We examined the effects of belimumab on CS dose across 52 weeks of treatment in two randomized, controlled trials.
Methods: Data from BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) were pooled (GSK 200317). Patients treated with CS at baseline and randomized to receive belimumab 10 mg/kg plus standard therapy or placebo (standard therapy) were compared. A conservative steroid taper was imposed by each protocol. The primary endpoint was the cumulative change from baseline (average dose over the prior 7 days) in CS dose (prednisone or equivalent) through week 52. Rank analysis of covariance (ANCOVA) was applied. Cumulative dose reductions and increases, and change from baseline in average daily CS dose were examined. Adverse events (AE) were summarized.
Results: At baseline, 966 (Total N=1125, 86%) subjects received CS therapy: 478 belimumab 10 mg/kg, 488 placebo. Most subjects were female (n=910, 94%); mean age was 37.1 (11.5 SD) years, mean SELENA SLEDAI score was 9.8 (3.8 SD) and mean CS dose (prednisone or equivalent) was 12.5 (8.2 SD) mg/day. Baseline parameters for subjects treated with CS were similar between treatment groups. The mean of all cumulative decreases in CS dose was 741 mg for belimumab 10 mg/kg and 542 mg for placebo (p=0.017). The mean of all cumulative increases in CS dose was 1272 mg for belimumab and 1458 mg for placebo (p<0.001). The mean cumulative change from baseline in CS dose was 531 mg for belimumab compared with 916 mg for placebo (p <0.001). The mean change from baseline in average daily CS dose was 1.46 mg for belimumab and 2.51 mg for placebo (p <0.001). The most commonly reported AE among those subjects receiving CS at baseline was headache for both belimumab and placebo groups.
Conclusion: Although there was an increase in total CS dose in both arms over the duration of the trial, this increase was significantly smaller in patients who received belimumab 10 mg/kg plus standard therapy compared with standard therapy alone after one year of treatment. Adverse events for patients treated with CS were comparable among treatment groups.
Disclosure:
R. F. van Vollenhoven,
AbbVie Inc, BMS, GlaxoSmithKline, Lilly, Merck. Pfizer, Roche, UCB,
2,
AbbVie Inc, BMS, GlaxoSmithKline, Lilly, Merck. Pfizer, Roche, UCB,
5;
M. Petri,
GlaxoSmithKline,
2,
GlaxoSmithKline,
5;
D. J. Wallace,
Abbott Immunology Pharmaceuticals,
5,
Abbott Immunology Pharmaceuticals,
8,
GlaxoSmithKline,
5,
GlaxoSmithKline,
8,
Pfizer Inc,
5,
Amgen,
5,
UCB,
5;
D. Roth,
GlaxoSmithKline,
1,
GlaxoSmithKline,
3;
C. T. Molta,
GlaxoSmithKline,
3,
GlaxoSmithKline,
1;
A. Hammer,
GlaxoSmithKline,
1,
GlaxoSmithKline,
3;
T. Tang,
GlaxoSmithKline,
3;
A. Thompson,
GlaxoSmithKline,
1,
GlaxoSmithKline,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/corticosteroid-use-across-52-weeks-of-belimumab-therapy-in-patients-with-systemic-lupus-erythematosus-combined-analyses-from-the-bliss-trials/