Guest Blog: Why Define a Lupus Flare?

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.

Lupus Foundation of America Achieves International Consensus on Definition of a Lupus Flare

The Lupus Foundation of America (LFA) spearheaded a four-year worldwide initiative with more than 120 lupus experts from 11 countries, the pharmaceutical and biotechnology industries, and federal agencies, which resulted in the first-ever global definition of a lupus flare. The development of Lupus Foundation of America Flare Definition (LFA-Flare) helps to overcome long-standing barriers to the development of new, safe, and more tolerable treatments for lupus.

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80 International Lupus Experts Met to Address Gaps in Clinical Research to Speed Approval of New Treatments

Research scientists and physicians – including scientific thought leaders from university centers, pharmaceutical and biotechnology industries, the National Institutes of Health, U.S. Food and Drug Administration, and other government agencies – addressed two important gaps impeding approval of new treatments for the autoimmune disease lupus during the Lupus Foundation of America’s (LFA) 2nd International Flare Conference June 5 and 6 in suburban Washington, DC. These experts discussed modifications to tools used to monitor disease progression and how lupus patients respond to treatment. They also worked to develop a consensus definition of a lupus flare, which is an increase in disease activity.

It has been difficult to define a lupus flare because the disease manifests itself in diverse ways in different people, affects multiple organ systems, and can increase and decrease in severity from one day to another. Accurately and consistently measuring a flare is crucial to monitoring progression of the disease in patients and to evaluating the effectiveness of treatment over time.

“This effort is part of the LFA’s strategy aimed at bringing down barriers that have obstructed progress on research and to advance the science of lupus,” said Sandra Raymond, LFA President & CEO. “The fact that no new drug therapies have been approved for lupus in more than four decades underscores the need to address issues and answer questions that have impeded the successful outcome of clinical trials of new, safe and effective therapies for the disease.”

Without new approved drugs specifically for lupus, physicians must rely on therapies borrowed from other diseases. Many are highly toxic, causing side effects that can be worse than the primary disease. The LFA is working to bridge gaps in lupus research to stimulate additional public and private investment in the development and approval of new lupus treatments.

Keeping a Lupus Flare at Bay

Doctors have identified healthy habits that can help you avoid triggering a lupus flare.

• Always take your medication as prescribed.
  
  
• Keep your doctor's appointments even if you are feeling well.
  
  
• Avoid taking sulfa drugs (sulfonomides) that are used to treat infections such as bronchitis and urinary tract infections.
  
  
• Limit your exposure to sunlight; apply sunscreen before going outside during the day, and wear sun-protective clothing and a wide-brimmed hat.
  
  
• Reduce your risk of infections.
  
  
• Get plenty of rest.
  
  
• Do not smoke.