Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that several abstracts related to BENLYSTA® (belimumab) and systemic lupus erythematosus (SLE) will be presented at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals, being held in Chicago, IL from November 4 to November 9, 2011. A total of 13 abstracts - three oral presentations and 10 posters - have been accepted for presentation; seven in the Annual Scientific Sessions and six in the Health Economics Outcomes Research (HEOR) sessions.
BENLYSTA is the first in a class of drugs called BLyS-specific inhibitors. BENLYSTA was approved by the U.S. Food and Drug Administration (FDA) on March 9, 2011 for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. Limitations of use: The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of belimumab is therefore not recommended in these situations.
The scientific analyses examine the impact of BENLYSTA on patients with SLE, including its efficacy, safety profile and effect on specific organ systems. The HEOR analyses explore the manifestations of the disease and outcome predictors as well as the impact of lupus on healthcare utilization and work productivity
ANNUAL SCIENTIFIC SESSIONS
Tuesday, November 8
Dooley, M. et. al., Abstract #2472: Effect of Belimumab Treatment on Renal Outcome: Results from BLISS-52/BLISS-76
Time/Location: 3:15 p.m. - 3:30 p.m., McCormick Place Convention Center: W 183 A
Time/Location for all: 9 a.m. - 6 p.m., McCormick Place Convention Center, Poster Hall
Sunday, November 6
Manzi, S. et. al., Abstract #602: Post Hoc British Isles Lupus Assessment Group Index Mucocutaneous Organ Domain Item Analysis of Systemic Lupus Erythematosus Patients Treated in Phase 3 Belimumab Clinical Trials
Merrill, J.T. et. al., Abstract #584: Sustained Disease Improvement and Safety Profile over the 1500 Patient-Year Experience (Six years) With Belimumab in Patients with SLE
Wallace, D.J. et. al., Abstract #578: Safety Profile of Belimumab, a B-Lymphocyte Stimulator-Specific Inhibitor, in Phase 2 and 3 Clinical trials in Patients with Active SLE
Monday, November 7
Furie, R.A. et. al., Abstract #1367: Clinical and Laboratory Correlates in Responders (by the SLE Responder Index) in Phase 3 Belimumab Clinical Trials
Strand, V. et. al., Abstract #1369: Responders in the Phase 3 Belimumab Clinical Trials in Patients with SLE Reported Improvements in Fatigue and Health-Related Quality of Life at Week 52