By Liz Meszaros
PHILADELPHIA -- October 22, 2009 -- Belimumab significantly reduced disease activity in patients with systemic lupus erythematosus (SLE), with reductions in flare rates, severity of flares, and prednisone usage and increases in time to first flare, according to a study presented here at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).
Sandra Navarra, MD, University of Santo Tomas, St. Luke's Medical Center, Manila, Philippines, presented the results from the international, double-blind, placebo-controlled, 52-week Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS)-52 here on October 20.
Seropositive patients with SLE (n = 865) were randomised to treatment with belimumab 1 or 10 mg/kg or to placebo plus standard of care (therapy with prednisone and immunosuppressives).
Response rates to the SLE Responder Index, which was the primary endpoint of the trial, were 51.4% in the group treated with the 1-mg/kg dose (P = .013) and 57.6% in the group treated with 10 mg/kg (P = .0006), compared with 43.6% in the placebo group.
The secondary endpoints of the study were Physicians' Global Assessment (PGA) scores, prednisone usage, and time to first flare.
Improvements were seen in PGA scores at week 24 (-29.5 in the 1-mg/kg group, P = .034; -36.8 in the 10-mg/kg group, P < .0001; -22.4 in placebo).
Prednisone usage was reduced in both active treatment groups compared with placebo. Prednisone reduction from >7.5 mg/day by 25% from baseline or to <=7.5 mg/day during weeks 40-52 was seen in 20.6% of patients in the 1-mg/kg group (P = .025), 18.6% of those in the 10-mg/kg group (P = .053), and 12.0% in the placebo group.
Increases in median time to first flare as assessed by the Safety of Estrogens in Lupus Erythematosus-National Assessment SLE Disease Activity Index (SELENA-SLEDAI) Flare Index were seen by week 12 of active treatment, with a rate of 70.5% (126 days) in the 1-mg/kg group, 70.7% (119 days) in the 10-mg/kg group, and 80.1% (84 days) in the placebo group.
"BLISS-52 met its primary efficacy endpoint. Belimumab reduced SLE disease activity, reduced SLE flare rates, and delayed time to first SLE flare. It demonstrated also a steroid-sparing effect and improved PGA at week 4," said Dr. Navarra.
Dr. Navarra also noted that "reductions in severe flares began to be evident as early as week 12 for both belimumab groups."
Rates of serious adverse events, mortality, and laboratory abnormalities were comparable between all groups. Severe adverse events occurred in 12.5% of the group treated with 1 mg/kg, 11.4% in those treated with 10 mg/kg, and 11.8% in those treated with placebo. Severe infusion reactions were slightly greater with belimumab than with placebo.
[Presentation title: Belimumab, a BlyS-Specific Inhibitor, Reduced Disease Activity, Flares and Prednisone Use in Patients With Active SLE: Efficacy and Safety Results From the Phase 3 BLISS-52 Study. Abstract LB1]
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