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| |  Investigational Lupus Drug Belimumab Improves Patient Symptoms NEW YORK -- July 21, 2009 -- Belimumab (Benlysta), an investigational human monoclonal antibody drug that specifically recognises and inhibits the biological activity of B-lymphocyte stimulator (BLyS), met the primary endpoint in the first of 2 pivotal phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). Belimumab, the first in a new class of drugs called BLyS-specific inhibitors, is the first drug for the treatment of SLE to reach an advanced stage of clinical development in years. No new drug for lupus has been approved by regulatory authorities in more than 50 years. In the multicentre, randomised, controlled BLISS-52 study, patients with SLE were randomised to belimumab 10 mg/kg (n = 290), belimumab 1 mg/kg (n = 288), or placebo (n = 287). Belimumab is administered intravenously on days 0, 14, and 28, then every 28 days thereafter for the duration of the study. All patients also received standard care. The results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at week 52, compared with standard of care alone: 57.6% for belimumab 10 mg/kg (P = .0006) and 51.7% for belimumab 1 mg/kg (P = .011), versus 43.6% for placebo. Based on an intention-to-treat (ITT) analysis, belimumab met its primary efficacy endpoint of superiority versus placebo at week 52. “The BLISS-52 results demonstrated that [belimumab] has the potential to become the first new approved drug in decades for people living with systemic lupus,” said H. Thomas Watkins, Human Genome Sciences, Inc, (HGS), Rockville, Maryland. “Given the limited treatment options currently available, patients would benefit greatly from potential new treatments.” Patient response was defined by an improvement in Safety of Estrogens in Lupus Erythematosus National Assessment / Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) score of >=4 points, no clinically significant British Isles Lupus Assessment Group (BILAG) worsening, and no clinically significant worsening in Physician’s Global Assessment. “Of note,” said Watkins, “a greater percentage of patients receiving [belimumab] achieved a clinically meaningful reduction in steroid dose.” Patients treated with belimumab had their average prednisone dose reduced by at least 25% from baseline to 7.5 mg/day or less during the last 12 weeks of study (P = .053 for 10 mg/kg and P = .025 for 1 mg/kg belimumab, respectively vs placebo). “We are delighted to report that the efficacy of treatment with [belimumab] plus standard of care was superior in this study to that of placebo plus standard of care, while the safety profile was comparable overall to placebo,” said David C. Stump, MD, Research and Development, HGS. “[Belimumab] met the primary endpoint in this phase 3 study at a robust level of statistical significance.” Adverse event rates were comparable between belimumab and placebo treatment groups. Serious infections were reported in 5.9% of patients on placebo and 6.1% of patients on belimumab. The most common adverse events were headache, arthralgia, upper respiratory tract infections, urinary tract infection, and influenza, and were also comparable between belimumab and placebo treatment groups. No malignancies were reported. Sandra V. Navarra, MD, University of Santo Tomas, Manila, The Philippines, said, “Given the limitations of available therapies, there is a great need for well tolerated and effective treatments for lupus.” A second phase 3 trial, BLISS-76, is underway to confirm the findings of BLISS-52.
SOURCE: Human Genome Sciences, Inc, and GlaxoSmithKline PLC
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