LFA Flare Definition
Until recently, the lack of a universally accepted definition of a lupus flare has been a barrier to drug development in lupus.
In its 2005 Guidance to Industry, the U.S. Food and Drug Administration (FDA) documented the reduction in lupus flares and increase in time to lupus flare—as appropriate measures to evaluate potential new lupus treatments. Before a standard definition of a flare existed, lupus clinical trials used varying definitions, none of which were universally or consistently accepted. The lack of a consistent definition made it very difficult to evaluate how effective a new treatment was over time.
The First Global Definition of a Lupus Flare A Valuable Tool to Accelerate Drug Development
The Lupus Foundation of America responded by spearheading a four-year, worldwide initiative to develop the very first universally accepted definition of a lupus flare. The initiative joined the expertise of more than 120 lupus thought leaders across 11 countries, leaders within pharmaceutical and biotechnology industries and representatives from key U.S. federal agencies.
In December 2010, the journal LUPUS published the Lupus Foundation of America Flare Definition (LFA-Flare). Since then, researchers worldwide have relied on the LFA-Flare Definition in research studies, availing the potential to achieve more meaningful results
The Lupus Foundation of America Flare Definition (LFA-Flare) helps researchers overcome a significant and long-standing barrier to the development of new, safe, and more tolerable treatments for lupus.
Reviewed August 2013