A definition for lupus flares was created through a global consensus.
A definition for lupus flares was created through a consensus of 120 lupus experts from 11 countries, the pharmaceutical and biotechnology industries, and federal agencies.
The Lupus Foundation of America spearheaded a four-year worldwide initiative. 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.
“This definition addresses several controversial issues about how we look at flares of disease, which may have been interfering with the accuracy of how we evaluate new treatments”
For the past 15 years, many trials of new investigational medicines for lupus have failed to show significant benefits for patients. A consistent and meaningful definition for a lupus flare is critical to evaluating the effectiveness of treatment over time. The new definition may help enable more precise outcome measures for future studies, such as the number of flares or the time between flares. The event may positively impact the quality and scientific basis of clinical trials, which are required by the FDA to demonstrate the effectiveness of any new therapy before it can be approved for general use in patients.
The consensus definition is: A flare is a measurable increase in disease activity in one or more organ systems involving new or worse clinical signs and symptoms and/or lab measurements. It must be considered clinically significant by the assessor and usually there would be at least consideration of a change or an increase in treatment.
“This definition addresses several controversial issues about how we look at flares of disease, which may have been interfering with the accuracy of how we evaluate new treatments,” Joan T. Merrill, MD, head of the Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, and LFA Medical Director, said, in a press release.
A paper describing the definition and the consensus process is now available online and will be published in the March or April issue of the medical journal Lupus. LFA-FLARE has high face validity and now is ready for validation in clinical studies. The Systemic Lupus International Collaborating Clinics (SLICC), an international consortium of lupus doctors, is evaluating this definition as a basis for modified outcome measurements of flare to provide an improved scientific basis for clinical trials.
Source: The Lupus Foundation of American
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