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| |  Belimumab Reduces Disease Exacerbations in Patients With Lupus: Presented at ACR By Ed Susman BOSTON, MA -- November 12, 2007 -- Researchers said that the biological agent belimumab significantly reduced the risk that a patient with active systemic lupus erythematosus would suffer a disease flare-up over 2.5 years of treatment. The results of a phase 2 study, presented here on November 8 at the 71st annual meeting of the American College of Rheumatology (ACR), also showed patients generally sensitive to medication found belimumab to be well tolerated. "Systemic lupus erythematosus is a chronic disease, and patients need new therapies that provide durable efficacy with a favorable safety profile," said Michelle A. Petri, MD, Professor of Rheumatology, Johns Hopkins University, Baltimore, Maryland. The results showed that the significant clinical benefit observed for belimumab in patients with serologically active systemic lupus erythematosus at 52 weeks appears to be sustained through 2.5 years. Phase 3 studies are ongoing. Dr. Petri reported the phase 2 study goals were to evaluate safety and tolerability of belimumab over an extended period. It was compared with current standard treatment for lupus. The researchers enrolled 449 individuals with active lupus and randomly assigned them to receive placebo or doses of belimumab at 1 mg/kg, 4 mg/kg, or 10 mg/kg administered intravenously over a 52-week period in addition to standard treatment. "We found that belimumab normalized immunoglobulinG, reduced auto-antibodies and immunoglobulin isotypes, while increasing complement over 2.5 years of therapy," Dr. Petri said. "These objective changes demonstrate long-term biological activity that supports the clinical use of belimumab in active systemic lupus erythematosus." After 52 weeks, 345 patients chose to participate in an optional 24-week extension phase of the study, during which all patients received belimumab. At week 76, 296 patients chose to remain on treatment in an open-label, long-term continuation phase of the phase 2 trial, in which all patients are receiving belimumab 10 mg/kg. As of October 1, 2007, 244 patients remained on belimumab treatment in the continuation study. Among the findings at 52 weeks was that 46% of the belimumab patients registered no change in their Physician's Global Assessment compared with 29% of the patients on placebo. That difference reached statistical significance at the P <.01 level, Dr. Petri reported.
[Presentation title: Progressive Normalization of Autoantibody, Immunoglobulin, and Complement Levels Over 2.5 Years of Belimumab (Fully Human Monoclonal Antibody to BLyS) Therapy in Systemic Lupus Erythematosus (SLE) Patients. Abstract 426]
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