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 EULAR Annual European Congress of Rheumatology, being held in Berlin, Germany from June 6 to June 9, 2012. A total of seven abstracts – all posters – have been accepted for presentation, five clinical trial data abstracts and two health economics and outcomes research (HEOR) abstracts.
Belimumab is the first in a drug class known as BLyS-specific inhibitors. Belimumab 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. Belimumab has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of belimumab is not recommended in these situations. Belimumab is currently administered as a one-hour intravenous infusion given at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
In Europe, belimumab was approved by the European Commission on July 13, 2011. It is indicated as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g., positive anti-dsDNA and low complement), despite standard therapy. The summary of product characteristics (SmPC) lists patient groups which have not been studied with belimumab, including severe active CNS lupus and severe active lupus nephritis. Use of belimumab is therefore not recommended to treat these conditions. Caution should be exercised if belimumab is co-administered with other B-cell targeted therapy or intravenous cyclophosphamide, as it has not been studied in combination with these agents.
The clinical abstracts examine the impact of BENLYSTA on patients with SLE, including its efficacy and safety, its early clinical improvement and its impact in patients also being treated with mycophenolate mofetil and/or corticosteroids. In addition, predictors of moderate-to-severe SLE flares were evaluated from the placebo groups in the phase 3 BLISS trials. The HEOR analyses explore the prevalence of SLE in Europe as well as the impact of lupus on healthcare utilization following early diagnosis versus late diagnosis.