2009: A Year of Many Firsts in Efforts to Overcome Lupus

Achievements in Research, Education and Advocacy Cause for Celebration and Hope

The year 2009 will be remembered as a year of many firsts for lupus, including the first successful phase III clinical trial of a potential new treatment for lupus, the launch of the first-ever Ad Council public awareness campaign for lupus, and the first comprehensive report on the barriers to lupus drug development. And it appears there are no signs of any slowing of momentum as we enter the New Year.

Advances during 2009 in basic and clinical research on lupus hold promise for a greatly improved quality of life for the 1.5 million Americans and the more than five million individuals worldwide who are living with lupus. Two pivotal studies of BENLYSTA™ (belimumab) reached their primary endpoints that should enable the drug to become the first new treatment approved for lupus in more than a half-century. In addition, several studies published during 2009 provided new clues into the underlying causes of lupus and how the disease affects people of different genders, ages, races and ethnicities. In June, the Lewin Group issued a report commissioned by the Lupus Foundation of America (LFA) on barriers to lupus drug development. The report’s recommendations provide a roadmap to the further development and approval of a full arsenal of new, more tolerable and effective treatments for lupus.

Continued Growth in Awareness and Public Support for Lupus

Awareness of lupus further grew in 2009 with the launch in March by the Ad Council of a national public awareness campaign that targets individuals at greatest risk for development lupus. In addition, musicians Julian Lennon and James Scott Cook released a new digital single, “LUCY,” that helped to bring greater worldwide attention to lupus and generate funds to support lupus research.

The United States Congress expanded its support for lupus by greatly increasing funding for the National Lupus Patient Registry, and providing new funding for a national health provider education program to improve early diagnosis and treatment of lupus and reduce health disparities. In addition, Congress appropriated additional funding to support lupus research through the National Institutes of Health and the Department of Defense’s Peer Reviewed Medical Research Program.

These achievements were the result of the combined efforts of the Lupus Foundation of America and its national network of chapters and support groups, scientists and clinicians, industry representatives, congressional champions and leaders of federal agencies, countless lupus advocates and other volunteers, donors, and individuals with lupus and their families who have dedicated their energies to address this urgent health problem. While momentum had been building throughout the past decade, the historic events of 2009 provided solid evidence that we have entered a new era of discovery and hope in the search for the causes of and cure for lupus.

The LFA has compiled a list of ten significant accomplishments, including several firsts, in efforts to overcome lupus and its impact on individuals and families.

1. First Successful Completion of a Phase III Clinical Study of a potential New Treatment for Lupus

Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) announced positive results from BLISS-52 and BLISS-76, two large-scale phase III clinical trials of BENLYSTA™ (belimumab) for treating systemic lupus. Both trials succeeded in meeting their primary endpoints, which should make BENLYSTA eligible for approval by the U.S. Food and Drug Administration (FDA). Upon approval, BENLYSTA would be the first-ever treatment developed specifically for lupus, and the first new FDA-approved drug for lupus in more than 50 years.

2. Ad Council Launches its First-Ever National Public Awareness Campaign on Lupus

The Ad Council launched its first national multi-media public awareness campaign for lupus. Sponsored by the U.S. Department of Health and Human Services’ Office on Women’s Health (OWH), the campaign aimed to reach individuals most at risk for developing lupus — young women of childbearing age, especially African American, Asian, and Hispanic women. The Lupus Foundation of America was the Founding Partner with OWH on the campaign that is expected to generate $30 million annually in donated media exposure for lupus.

3. First Comprehensive Study to Address Barriers to Lupus Drug Development

The Lewin Group issued a report following a 9-month study commissioned by the LFA that included recommendations to overcome barriers that have obstructed lupus drug development. The LFA immediately began implementing the recommendations by launching the first-ever Collective Data Analysis Initiative (CDAI). The project will examine data from previous lupus clinical trials to learn the impact that background therapies may have had on trial outcomes and use that knowledge to improve the design of future trials of potential new therapies for lupus.

4. First-Ever Consensus Definition of Lupus Flares Reached by 120 International Lupus Experts

The LFA addressed a significant barrier to advancing the science and medicine of lupus by securing consensus on a definition of lupus flares. The Lupus Foundation of America Flare Definition (LFA-FLARE) was developed through a rigorous three-year process that involved more than 120 global lupus experts. Once validated, the LFA-FLARE is likely to be used mainly as a primary or secondary outcome for clinical trials, to assist in establishing entry criteria for certain clinical trial designs, and may be useful for managing lupus.

5. Scientists Gain Clues on the Underlying Causes and Triggers for Lupus

Researchers identified a gene linked to lupus, interleukin-1 receptor-associated kinase 1 (IRAK1). Its location on the X chromosome may help explain why females are 10 times more susceptible to the disease than males. Scientists also found that people whose vitamin D tests showed low levels of the nutrient had higher levels of lupus antibodies. The study suggests that a vitamin D deficiency could serve as a catalyst to developing lupus in people who are genetically predisposed to the disease.

6. Congress Funds New and Continuing Lupus Research

In 2009, Congress provided $4 million to support the National Lupus Patient Registry, as part of a broader national epidemiological study on lupus, and $1 million for a national health provider education program to improve early diagnosis and treatment of lupus and reduce health disparities. Congress also continued to support lupus research through the Department of Defense’s Peer Reviewed Medical Research Program, which last year provided an additional $1.4 million for a study of lupus biomarkers.

7. New Companies Entered the Lupus Market and New Studies Planned to Develop More Tolerable and Effective Treatments for Lupus

Pharmaceutical and biotechnology companies continued to expand efforts during 2009 to develop and test potential new treatments for lupus. UCB and Immunomedics announced positive phase IIb study results for epratuzumab, ImmuPharma released promising findings from a final phase IIb study of Lupuzor™, and Genentech presented encouraging data from a phase I study of rontalizumab. In addition, approximately twenty clinical studies were underway at the end of 2009 to test possible new therapies for lupus.

8. LFA Awards New Research Funding to Address Issues Critical to Lupus Patients

The LFA awarded new funding for research grants to address issues of critical importance for people with lupus, including the management of the disease in children and teens, improving health outcomes, the underlying genetic causes of male lupus, facilitating greater accuracy in the diagnosis of lupus, and the development of new, safe, and effective treatments. In addition, the LFA awarded five student fellowships to foster an interest in lupus research, and renewed funding for the Lupus Biomarkers Clinical Consortium, a collaborative initiative that seeks to identify biomarkers that hold promise to facilitate the diagnosis and treatment of lupus. In all, the LFA supported the work of 13 lupus investigators in 2009.

9. A Growing Number of Lupus Studies Presented at World’s Largest Scientific Meeting for Rheumatologists

Building momentum for scientific discovery in lupus was evident when more than 260 abstracts of research studies related to lupus were presented during the 75th Annual Scientific Meeting of the American College of Rheumatology in Philadelphia during October. The LFA produced video highlights of more than 20 significant studies. The videos are available at www.lupus.org/acr. During the conference, LFA officials also met with the Foundation’s medical and corporate advisors to discuss the future direction of research on lupus and to review recommendations from an important new report on barriers to lupus drug development.

10. Lupus Enters Popular Culture and Awareness Increases as LFA Expands its Presence on the Net

As part of its Patient Voices series, The New York Times website featured the stories of people from across the country who are affected by lupus. The LFA further expanded its presence on YouTube, Facebook and Twitter to engage a new online audience in advocacy and public awareness. To highlight the need for safer, more tolerable, and effective medications, the LFA launched Band Together for Lupus, that asks people to wear an LFA purple wristband until there is a medication approved by the FDA specifically for lupus. Musicians Julian Lennon and James Scott Cook released the digital single, “LUCY,” with proceeds going to support lupus research, generating more than a quarter million views to LFA’s YouTube page.

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