Human Genome Sciences's Lupus Drug Shows Positive Mid-Stage Trial Results
ROCKVILLE, Md., June 14 -- Human Genome Sciences, Inc. today announced the presentation of Phase 2 trial data demonstrating that LymphoStat-B® (belimumab) significantly reduced disease activity across multiple clinical measures, was well tolerated and improved quality of life in patients with active systemic lupus erythematosus (SLE). The 52-week and 76-week results of the Phase 2 study were the subject of an oral presentation today in Barcelona at the annual congress of the European League Against Rheumatism (EULAR).
"A number of clinical measures used in the Phase 2 study demonstrate that LymphoStat-B produced significant improvements in disease activity in patients with serologically active SLE," said Ellen Ginzler, M.D., Professor of Medicine and Chief of Rheumatology at the Downstate Medical Center, State University of New York (SUNY) in Brooklyn. "At Week 52, we saw significant reductions in SLE disease activity as measured by the SELENA SLEDAI and BILAG indices and the Physician's Global Assessment, as well as the patient response rate chosen as the primary efficacy endpoint of the Phase 3 trials. Continued improvements were observed from Week 52 through Week 76 in the 24-week extension phase of the trial."
Dr. Ginzler noted that reductions observed in activated B cells and anti- dsDNA autoantibodies, as well as the improvements observed in health-related quality of life, were associated with therapeutic response. No increase in infections or infectious events was observed over time. "We look forward to continuing the evaluation of LymphoStat-B as a potential treatment for SLE in the Phase 3 trials that are now underway," she said.
Of the patients who completed 52 weeks of treatment in this randomized, double-blind, placebo-controlled Phase 2 trial, 96% (351/364) elected to enter the 24-week open-label extension phase of the trial, and 92% (321/351) of those who entered completed it. Of those completing the extension phase, 78% (250/321) continue to receive LymphoStat-B in a long-term continuation study. The trial began in October 2003.
"We are encouraged that nearly all of the patients who completed the 52- week Phase 2 study chose to continue treatment in the 24-week extension phase," said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research -- Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences. "Many of these patients began treatment more than three years ago and continue on treatment today. This provides us with a substantial body of data on the long-term effects of LymphoStat-B."
About the Phase 2 Trial Results
The primary objectives of the Phase 2 study were to evaluate the safety, tolerability and efficacy of LymphoStat-B plus standard of care, versus placebo plus standard of care. A total of 449 patients with active SLE were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. In the extension phase, all placebo patients received LymphoStat-B at a dose of 10 mg/kg, while patients in the LymphoStat-B 10 mg/kg treatment arm continued on the 10 mg/kg dose, and patients in the 1 mg/kg and 4 mg/kg LymphoStat-B treatment arms were offered the choice of continuing on the same dose or receiving LymphoStat-B at a dose of 10 mg/kg.
In June 2006, HGS reported the 52-week data from the Phase 2 trial of LymphoStat-B in patients with SLE. The 52-week results demonstrated that LymphoStat-B significantly reduced disease activity versus placebo in patients with serologically active SLE, exhibited clinically relevant biological activity, and appeared safe and well tolerated. Frequency and severity of adverse events were similar to placebo, with no increase at higher doses. Among the Phase 2 study findings was a significantly improved response rate among serologically active patients at Week 52, as defined by an improvement in SELENA SLEDAI score of 4 points or greater, no new BILAG A flare and no more than one new BILAG B flare, and no worsening in Physician's Global Assessment (46% for LymphoStat-B versus 29% for placebo, p7.5 mg/day) (p