Global Lupus Experts Gather For Historic Meeting -- Urgent And Unmet Needs Of Individuals With Lupus Dominate Agenda

Main Category: Lupus
Article Date: 08 Jun 2009 - 6:00 PDT

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The Lupus Foundation of America (LFA) convened an Expert Panel June 1-2 to address the urgent and unmet need for the development and approval of new, safe, effective, and tolerable medications for people with lupus. It has been more than 50 years since the U.S. Food and Drug Administration (FDA) approved a new drug specifically to treat lupus. Discussions during the two-day meeting in Washington, DC focused on how to better conduct studies of potential new lupus treatments, including clinical endpoints, diagnostic tools, background medications, and clinical trial design.

This historic gathering of 70 lupus thought leaders from around the world, representing academia, biotechnology and pharmaceutical industries, and government, is part of a comprehensive initiative entitled A New 21st Century Approach to Lupus Healthcare, launched by the LFA to advance the science and medicine of lupus. This initiative includes research, education, and policy programs aimed at addressing the multi-dimensional needs of individuals with lupus.

During the meeting, the LFA reported on the progress of its three-year study which has now resulted in an international consensus on a definition of lupus flares and proposed flare indices for instruments used to measure disease activity in clinical trials. The definition has been lacking and is necessary in order to measure the effectiveness of potential new therapies for lupus.

Scientific challenges are not the only issues that affect the ability of individuals with lupus to receive affordable, accessible health care. The LFA also announced several initiatives related to drug reimbursement, including the launch of a major study of policies in private and public health plans for future lupus drugs. A separate project will examine reimbursement issues that affect the use of off-label medications currently used to treat lupus.

The Expert Panel meeting concluded with agreement on several key outcomes. Among them was the request and agreement that LFA lead a collaboration with industry representatives to share and mine data gathered from past studies to determine possible trends in drug development, and to use the collective lessons to better construct future studies of new lupus treatments.

Other results of the meeting will be released in a report to be issued later this summer. The report will summarize discussions from the Expert Panel meeting and outline strategies to begin a new era in healthcare for all people with lupus. The report will include a research agenda specific to advancing the development and approval of new, safe, effective, and tolerable treatments for the disease. People with lupus and the physicians who care for them are sure to benefit from the collaboration of this interdisciplinary group of experts to bring down the barriers to lupus drug development.

In related news, data from studies of two potential lupus drugs will be released later this year. While the results of these trials hold great promise, at this time the outcomes cannot be predicted. Therefore, the work that is being done collectively in the scientific community, government, and industry will be needed to ensure an improved quality of life for the estimated 1.5 million Americans and at least five million individuals worldwide living with lupus.

About Lupus

Lupus is a chronic autoimmune disease that is the result of an unbalanced immune system which can become destructive to any major organ or tissue in the body. Lupus is unpredictable and potentially fatal, yet no satisfactory treatment or cure exists. Its health consequences may include heart attacks, strokes, seizures, or sudden organ failure.

Source
Lupus Foundation of America