2007 was a year of significant achievement in the fight against lupus, an unpredictable and potentially fatal disease that affects more than 1.5 million Americans and at least five million individuals worldwide. Public and private funding for lupus research greatly expanded, and new efforts were initiated to bring greater public awareness to lupus and its often devastating consequences.
Promising new targets for treatment were presented at major scientific conferences this past year as links between the laboratory and the clinic began to emerge. Most notably, several pharmaceutical companies are targeting an inflammatory pathway that has in recent years been recognized as critical in lupus, in hopes of developing new drug candidates.
The largest sources of funding for research on lupus – the federal government and the pharmaceutical and biotechnology industries – each boosted their support during the past year.
The U.S. Congress tripled funding for lupus epidemiological research funded through the Centers for Disease Control and Prevention (CDC) by providing $3.1 million to expand the National Lupus Patient Registry. In addition, the National Institutes of Health (NIH) awarded a $5 million grant to establish a new Center of Research Translation on lupus, and the Department of Defense (DoD) Peer Reviewed Medical Research Program (PRMRP) also awarded millions of dollars to support additional lupus research studies.
Private funding for lupus research also rose dramatically in 2007, as evidenced by the nearly two dozen clinical research studies conducted by pharmaceutical and biotechnology companies to test potential new, safe, and effective treatments for lupus. This progress in lupus research and development provided growing enthusiasm among people with lupus and their physicians that new options are on the horizon. The outlook brightened this year when several pharmaceutical and biotechnology companies announced encouraging results of their clinical studies.
The Lupus Foundation of America (LFA) in 2007 greatly expanded its own lupus medical research program, "Bringing Down the Barriers," due in part to a partnership with the Wallace H. Coulter Foundation, which has a special interest in lupus in children and in men, and in mid- to late-state translational research. With the addition of $2 million from the LFA and its chapters over the past year, the LFA has to date awarded nearly $20 million in grants to approximately 400 investigators at 100 academic and scientific institutions nationwide. Other private lupus foundations and organizations have also provided funding for lupus research.
Lupus awareness received a giant boost this year when the Advertising Council, which has created some of our most endearing pop culture icons – including Smokey the Bear, McGruff the Crime Dog, and the Crash Test Dummies – began work on a three-year, $3 million national lupus public awareness campaign. The initiative is sponsored by the U.S. Department of Health and Human Services Office on Women’s Health (OWH), in partnership with the LFA. When launched in 2008, the campaign will generate $30-$50 million annually in free media placements, and is expected to reach more than 100 million adults in the U.S. with life-saving information about lupus.
2007 will be remembered as a watershed year for lupus, during which decades of effort to address key gaps in the understanding of lupus and bring down scientific barriers began to pay dividends. These developments have resulted in building optimism and new hope for a better quality of life for people with lupus and their families who struggle daily with the life-diminishing and life-threatening consequences of the chronic autoimmune disease.
The Lupus Foundation of America has compiled a list of ten important advances in research and education that occurred during 2007. They are as follows:
1. U.S. Congress Expands Funding for Lupus Epidemiological Research and Education Programs
The Omnibus Appropriations Bill which funds the federal government for 2008 includes $3.122 million for the Centers for Disease Control and Prevention (CDC) to continue and expand the National Lupus Patient Registry, as part of a broader national epidemiological study on lupus. The Registry will provide data for the first ever comprehensive national study to determine the true incidence and prevalence of lupus in the United States, as well as measure the burden of the disease. The legislation also reinforces Congress’ commitment to support lupus public awareness and professional education programs funded through the U.S. Department of Health and Human Services Office on Women’s Health.
2. NIAMS-NIH Provides $5 Million to Establish Center of Research Translation (CORT) on Lupus at University of Texas Southwestern Medical Center and Baylor University
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS-NIH) in 2007 awarded $5 million to fund a new Center of Research Translation (CORT). These centers are designed to bring together basic and clinical research to help translate basic discoveries into new drugs, treatments, and diagnostic tests. The Center for Research Translation at the University of Texas Southwestern Medical Center in Dallas and the Baylor Institute of Immunology Research will study mouse models of lupus to identify the genetic background of developmental stages of the disease. The research is based on previous studies that have identified two major steps leading to lupus in mice, and is aimed at identifying similar stages in the development of lupus in humans.
3. NIAMS-NIH Issues Comprehensive Roadmap for “Future Directions of Lupus Research”
In the fall of 2007, the National Institutes of Health issued a comprehensive plan to guide future efforts for research on lupus. The plan document was developed with input from leading scientific experts from the lupus research community and beyond. The plan focuses on five major areas of research, including: disease etiology; innate immunity, acquired immunity and inflammation; target organ damage; pediatric lupus, special populations, and health services research; and diagnosis and treatment.
4. Department of Defense Provides Millions of Dollars for Lupus Research
The Department of Defense (DoD) Congressionally Directed Peer Reviewed Medical Research Program (PRMRP) awarded three new grants in 2007, bringing the total support for lupus research through the PRMRP to $5 million for important studies on lupus and lupus biomarkers. Because lupus is a complicated disease, biomarkers (useful blood tests) are needed to help predict which individuals are candidates for different treatments, how best to dose such treatments, and how to predict and detect side effects.
5. Pharmaceutical and Biotechnology Companies Increase Their Investment in Lupus Drug Development
During 2007, nearly two dozen clinical studies were underway on potential new, safe, and effective treatments for lupus. The companies actively recruiting clinical trial participants or conducting clinical studies during 2007 include Human Genome Sciences, Inc. (LymphoStatB™); Bristol-Myers Squib (Orencia®); Genentech, Biogen-Idec, and Roche (Rituxan®); MedImmune (MEDI-545); La Jolla Pharmaceutical Company (Riquent™); Merck, Serono, and Zymogenetics (atacicept); Genelabs Technologies (Prestara™); UCB (epratuzumab); and Aspreva Pharmaceuticals and Roche (CellCept®). These studies offer hope to people with lupus, their physicians, and family members that a better quality of life is within reach.
6. New Uses for Existing Drugs Show Promise in Treating Lupus
Preliminary data from a clinical study of the organ transplant anti-rejection drug CellCept (mycophenolate mofetil) showed that the drug achieved results that were equivalent to those achieved with intravenous cyclophosphamide (IVC), a toxic chemotherapy which has been used to treat people with lupus kidney disease (lupus nephritis) since the 1970s. Studies also have shown that CellCept is better tolerated than IVC, providing people with lupus and their physicians a safer alternative. Several studies also showed promising results for the cancer drug, Rituxan (rituximab) for treating central nervous system involvement in lupus and lupus-related kidney disease.
7. The Wallace H. Coulter Foundation Partners with LFA to Fund New Areas of Lupus Research
The LFA launched a series of bold new research initiatives during 2007 in the areas of mid-to-late stage translational research, lupus in children and adolelescents, and lupus in men. Funds for these initiatives were generously granted to the LFA through the Wallace H. Coulter Foundation in memory of Michael Jon Barlin, who passed away in 2006 at age 24 after a long battle with lupus. The LFA also supported studies in adult stem cell transplantation as a treatment for lupus in people with severe manifestations of the disease, research related to cardiovascular disease in women and African Americans with lupus, novel pilot projects which apply new and innovative approaches to advance lupus research, and initiatives to identify and validate lupus biomarkers.
8. Public-Private Collaborations to Improve Treatment of Lupus
In response to Food and Drug Administration (FDA) guidelines for new drug development in lupus, the LFA during 2007 engaged the international community of lupus specialist physicians to determine widely accepted definitions of mild, moderate, or severe lupus disease flares (changes in disease activity). The LFA organized three committees to adapt existing disease activity measures to the measurements of lupus flares. The LFA also took additional steps during 2007 to validate lupus biomarkers, a project which it has supported for the past three years. The LFA, the Gulfstream Company, and IBM collaborated to begin creation of a central database to compare blood samples from people with lupus with carefully collected clinical information about each person. To date, nine sites have received computer equipment from IBM to allow clinical information to be linked to these samples from within a central repository. The information will then be made available to international researchers. During 2007 the first data were being entered into this database.
9. Public Awareness of Lupus Will Grow Dramatically through Advertising Council Campaign
In partnership with the LFA, the Advertising Council and the U.S. Department of Health and Human Services Office on Women’s Health (OWH) entered into an agreement with an internationally recognized advertising agency to produce a national lupus awareness campaign that will include public service announcements on radio and television stations, in newspapers and magazines, on buses, subways, and billboards, as well as on the Internet.
10. Educational Opportunities for All People Affected by Lupus Expand in 2007
The LFA’s expanded Website, lupus.org, attracted more than three million visitors this past year. In all, more than 80,000 people viewed 17 live Webchats on a wide range of topics, featuring leading experts on lupus in men, lupus in children, participation in lupus clinical trials, and specific types of organ involvement. The LFA also presented its education program for people with lupus and their families, Lupus Now®: State of the Art Approaches from the Experts, in 10 more cities, reaching an additional 2,500 individuals in 2007, with two programs presented entirely in Spanish. Also during 2007, the LFA published three issues of its award-winning national magazine, Lupus Now, completely rewrote and redesigned all of its written education brochures, and further expanded its comprehensive library of fact sheets for specific audiences.