Despite the fact that five million people worldwide are afflicted with lupus, the general public is not very well informed about the nature of this disease.
Lupus is a chronic, often debilitating inflammatory disease that occurs when the body’s immune system malfunctions and attacks its own tissues and organs.In lupus and certain other autoimmune diseases, increased amount of B-lymphocyte stimulator (BlyS) is believed to contribute to the production of autoantibodies (antibodies that attack and destroy the body’s own healthy tissues). The presence of autoantibodies in lupus patients appears to correspond with the severity of the illness. The symptoms of lupus may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders.
Figure drawing by Flemish anatomist Andreas Vesalius (1514-1564)
Lupus generally affects women. The ratio of affliction is 10 females to one male. It commonly affects Asian, Hispanic and African-American women. Women who have the highest chance of acquiring lupus are those who are within the ages of 18 to 50. Lupus is a multi-system lifetime disease, which has no permanent cure yet, but can be put on check through special treatments. There is still no scientific finding on the direct cause of lupus therefore it cannot be prevented.
In recognition of the seriousness of the threat that lupus poses, President Gloria Arroyo on December 17, 2007 signed Proclamation 1435 declaring the first week of February every year as “Lupus Advocacy Week.” A part of the proclamation reads, “People with lupus are more likely than the general population to be hospitalized [32 percent in 1 year] and unable to work [66 percent compared to 38 percent non-participation work rate in general population] because of their illness.” Pertaining to the high cost of treatment, the proclamation says, “Lupus poses an enormous drain on the personal, family, and community resources, which translates not only to personal and family economic losses but also to a significant loss of productivity among these patients who should otherwise be in the most productive years of their lives.”
The options for lupus treatment are quite limited and there has been no new treatment approved by regulatory authorities for the disease in more than 50 years. But promising developments occurred in lupus research lately. Human Genome Sciences Inc. and GlaxoSmithKline PLC announced recently that the drug
Benlysta (belimumab, formerly LymphoStat-B) showed positive results in BLISS-52, the first of two pivotal
Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the said studies, the results showed that Benlysta, plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone.
Dr. Sandra Navarra, an associate professor of rheumatology and clinical immunology at the University of Santo Tomas Faculty of Medicine and Surgery, says, “Given the limitations of available therapies, there is a great need for well tolerated and effective treatments for lupus. We are very encouraged by the findings of BLISS-52, and look forward to presenting these results later in the year. We also look forward to the results of BLISS-76 later this year.” Navarra is a member of the steering committee for the BLISS-52 study and was the lead author for the BLISS-52 manuscript.
Benlysta is an investigational antibody drug that specifically recognizes and inhibits the biological activity of BLyS. Pre-clinical and clinical studies suggest that Benlysta can reduce autoantibody levels in patients with SLE.
On how soon the new drug will be available in the market, H. Thomas Watkins, president and chief executive officer of Human Genome Sciences, says, “The BLISS-52 results demonstrated that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus.
Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. Benlysta is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of Benlysta, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010.”