by Leslie Hanrahan, LFA Vice President of Education and Research
Ask anyone with lupus and they will tell you what a flare is to and for them. Simply put, a flare can be seen as an increase in disease activity. And because no two cases of lupus are alike, you can bet that no 2 flares are either.
When looking to conduct a clinical trial and ultimately obtain FDA approval for an investigational treatment for people with any disease, the goal is to prove that the potential treatment being studied is safe and effective and works in a population of people who resemble each other in some way (and by resemble, I mean have some form of the same signs, symptoms and experiences with their disease). In order to prove this, there must be a goal the study is working toward (a study endpoint) or a positive change that can be measured when the investigational treatment is being used.
In lupus clinical trials, stopping the onset of a flare or extending the time between two flares can be and has been identified as study endpoints. However, the absence of a very specific definition of a lupus flare has made success in lupus studies difficult. Recognizing this as a barrier, the LFA spearheaded an international effort to find a uniform definition of a lupus flare that could be used as a standard definition when designing lupus clinical trials and working with flare as an outcome measure or endpoint. In 2006 the LFA convened an international panel of experts to discuss the issue and all agreed that a single, community accepted definition for flare is required as an underpinning necessary to measure outcome in a clinical trial.
From there, the LFA led an international consensus building exercise using a scientific method to reach agreement among the lupus key opinion leaders. A definition was created and agreed upon and was pre-published in the online version of the important peer review publication LUPUS. The printed version of the article is expected in the next 2-3 months.
So what does this monumental undertaking really mean? How does this impact me? For the past fifteen years, if not more, many trials of new investigational treatments for lupus have failed to show any benefit for the individual. Why? Well, one of the problems has been the difficulty in distinguishing minor disease changes from clinical significant flares of the disease. By providing a definition for a lupus flare that distinguished itself from minor symptoms, it will be possible to design clinical trials that are more likely to show effectiveness of a treatment.
Removing this barrier is an example of another way the LFA is working to advance the science and medicine of lupus!
Learn more about the LFA-Flare
Today's guest blog comes from Leslie Hanrahan, LFA Vice President of Education and Research. She was one of the lead authors of the LFA-FLARE.