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EULAR, ACR offer new classification criteria for lupus
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SAN DIEGO — The European League Against Rheumatism and the American College of Rheumatology have presented a draft of their new classification criteria for systemic lupus erythematosus, which researchers said provides greater specificity and sensitivity, and will more accurately identify patients for clinical trials.
“We have defined a system of criteria, which produces a measure of the relative probability that a particular case, with a combination of clinical symptoms or features, has systemic lupus erythematosus,” Sindhu Johnson, MD, PhD, director of the Toronto Scleroderma Program at the University of Toronto, and co-chair of the 12-member steering committee developing the new criteria, said during a press conference at the 2017 ACR Annual Meeting.
“The differential weight more accurately reflects our current understanding of the disease,” she said. “Although systemic lupus erythematosus has many manifestations, some influence whether we would classify an individual more than other manifestations — such as fever vs. kidney involvement.”
According to Johnson, there are several issues with the current set of classification criteria that necessitated the push for a new approach. The standards for developed classification criteria over the past 10 to 15 years have changed, which has led to the presence of potential biases that may reduce their validity and reliability, she said. In addition, according to the ACR, investigative groups in the past have favored one set of criteria over another, making it difficult to compare study results. Johnson also noted that none of the existing sets of criteria have been able to adequately identify patients in the early stages of the disease.
To address this, the two groups collaborated 4 years ago to improve criteria that reflect the current understanding of the disease, and that could be used by the global rheumatology community. The four-phase drafting process featured input from experts as well as data from more than 2,200 patients and 150 investigators from the ACR and EULAR. Members of the committee also included patient perspectives.
According to Johnson, the new draft criteria, which are still in the open consultation process, begin with an entry requirement of an antinuclear-antibody titer of 1:80, by HEp-2 immunofluorescence. If the patient possesses that, the research will then consider additive criteria, which fall into either clinical or immunological domains. The clinical domains include fever, skin manifestations, arthritis, neurologic symptoms and serositis, as well as hematologic and kidney domains, Johnson said. Among the immunological domains are complement proteins and lupus-specific autoantibodies.
Within each domain is a collection of sub-criteria, and each criterion is organized from lowest weight to highest weight, Johnson said.
“Within any one domain, you may only count the criteria with the highest score,” she added. “If the subject has a score of 10 or more, they may be classified as systemic lupus erythematosus.”
According to Johnson, the ACR and EULAR recently presented the draft to steering committee and expert panel members for feedback. Following a revision process, the final validation of the criteria is expected to be presented at the EULAR Annual Meeting in June.
“We have been presenting the work to date to steering committee and expert panel members who have been participating over the last number of years, to get their feedback on whether they are happy with what we have produced,” Johnson said. “... This open consultative process will continue for the next 2 weeks, so if anyone has comments or feedback for us, we would ask them to reach out to either myself, or to Dr. Martin Aringer, who is the EULAR co-chair for this project, or to any of the steering committee members.”
Reference:
Johnson S. “Presentation of the new SLE classification criteria.” Presented at the American College of Rheumatology Annual Meeting, Nov. 4, 2017; San Diego, California.
Disclosure: Johnson reports no relevant financial disclosures.