Human Genome Sciences Reports Phase 2 Results for LymphoStat-B(TM) (Belimumab) In Patients With Rheumatoid Arthritis

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the results of a Phase 2 clinical trial of LymphoStat-B(TM) (belimumab) in patients with rheumatoid arthritis show that LymphoStat-B met the primary efficacy and safety endpoints, and demonstrate that it is safe and well tolerated, biologically active, and reduces rheumatoid arthritis disease activity at a level of statistical significance. The results were reported in San Diego at the 69th Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP). (Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO ) An oral presentation entitled "Belimumab, a Fully Human Monoclonal Antibody to B-Lymphocyte Stimulator (BLyS(TM)), Combined with Standard of Care Therapy Reduces the Signs and Symptoms of Rheumatoid Arthritis in a Heterogeneous Subject Population" presented data on 283 patients who participated in the Phase 2 study.(1) The double-blind, placebo-controlled, multi-center clinical trial was designed to evaluate the safety, optimal dosing and efficacy of LymphoStat-B in patients with active moderate-to-severe rheumatoid arthritis who had failed prior treatment(s).(2-3) Study participants had failed an average (mean) of more than 2.2 disease-modifying anti-rheumatic drugs (DMARDS). Approximately 38% of study participants had failed at least one TNF-alpha inhibitor. The study was conducted in the United States and Poland. Patients were randomized to receive one of three different doses (1, 4 or 10 mg/kg) of LymphoStat-B or placebo administered intravenously over a 24-week treatment period, in addition to standard-of-care therapy. All patients in the study were dosed on Days 0, 14 and 28, and then every 28 days for the remainder of the 24 weeks. All patients received concurrent standard-of-care therapy, including up to two DMARDS and less than or up to 10 mg/day of prednisone. Approximately 73% of study participants were receiving background methotrexate therapy. Efficacy was evaluated according to the American College of Rheumatology (ACR) criteria for defining clinical improvement in rheumatoid arthritis patients. The primary efficacy endpoint for the LymphoStat-B Phase 2 study was the rate of ACR 20(4) response at Week 24 (i.e., the percentage of patients who achieved at least 20% improvement on the ACR-specified measures of disease activity).(5) Secondary biological endpoints, as well as safety, were also evaluated. Patients treated with LymphoStat-B showed statistically significant improvement in the primary efficacy endpoint versus the placebo group. The rate of improvement in ACR 20 response at Week 24 was 35% in the 1-mg/kg active-treatment group, and 29% in all active-treatment groups combined -- significantly higher than the 16% rate of improvement observed for the placebo group (p=0.0097 and p=0.021, respectively).(6) In addition, trends toward a drug benefit were observed in the 4-mg/kg treatment group (25% ACR 20 response, p=0.17) and in the 10-mg/kg treatment group (28% ACR 20 response, p=0.08). Results show that LymphoStat-B was well tolerated with no clinically significant differences from placebo in adverse events, serious adverse events or laboratory abnormalities. Clinically significant infusion reactions were rare. Human Genome Sciences will continue to collect data from the current Phase 2 trial of LymphoStat-B in patients with rheumatoid arthritis through an ongoing optional extension protocol. An oral presentation entitled "Belimumab, a Novel Fully Human Monoclonal Antibody to B-Lymphocyte Stimulator (BLyS), Selectively Modulates B-Cell Subpopulations and Immunoglobulins in a Heterogeneous Rheumatoid Arthritis Subject Population" described the correlation of circulating BLyS levels with rheumatoid arthritis (RA) disease activity at baseline, and the effect of LymphoStat-B (belimumab) on B-cell subpopulations in subjects with moderate- to-severe RA in a 24-week Phase 2, double-blind, placebo-controlled, multi- center clinical trial.(7) The results demonstrate that LymphoStat-B produced statistically significant reductions (all active-treatment groups combined versus placebo) of 20% or more in the following B cell subsets: CD 20+ B cells (p=0.0001), CD19+ B cells (p=0.0001), naive B cells (p

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