PHILADELPHIA -- The investigational monoclonal antibody belimumab (Benlysta) was safe and effective for patients with systemic lupus erythematosus in a Phase III trial, researchers reported.
After one year of treatment, belimumab reduced disease activity, flare rates, and use of prednisone, and increased the time to a first flare, according to Sandra Navarra, MD, of the University of Santo Tomas in Manila, Philippines, and colleagues.
The response rates at one year were significantly higher for patients taking 1 mg/kg of the drug (51.4%, P=0.013) and 10 mg/kg (57.6%, P=0.0006), compared with those taking placebo (43.6%).
Belimumab was generally well-tolerated, although there was a modest increase in serious or severe infusion reactions compared with placebo.
After one year of treatment, belimumab reduced disease activity, flare rates, and use of prednisone, and increased the time to a first flare, according to Sandra Navarra, MD, of the University of Santo Tomas in Manila, Philippines, and colleagues.
The response rates at one year were significantly higher for patients taking 1 mg/kg of the drug (51.4%, P=0.013) and 10 mg/kg (57.6%, P=0.0006), compared with those taking placebo (43.6%).
Belimumab was generally well-tolerated, although there was a modest increase in serious or severe infusion reactions compared with placebo.