Dr. James says this research lays a foundation for future studies to identify patients with ILE who shouldn’t be treated with high doses of prednisone or major immunosuppressive drugs if their disease isn’t likely to progress past two or three non-
organ-threatening SLE criteria.
“We think this is an interesting group of people to study so we can understand whether they have regulatory mechanisms in their immune system that can help stop the progression to full-blown systemic lupus. Or are there environmental factors, healthy lifestyle choices or things they have that helps protect them to keep them from transitioning [to lupus]?” says Dr. James.
Jill Buyon, MD, director of the Lupus Center at New York University Langone Medical Center in New York City, says the study encourages “us to think about the spectrum of the disease … what protects and what promotes it.” However, she prefers to avoid labels and instead focus on what specific symptoms or signs comprise the diagnosis.
“In this paper, the ‘I’ or ‘S’ is not the relevant adjective,” says Dr. Buyon. “It’s not about the label, but about the seriousness of the manifestation. That’s what we want to prevent.”
Rheumatologists must remember the classification criteria were developed for use in clinical trials, not as a diagnostic tool even though they are inadvertently used for that purpose, says Saira Sheikh, MD, director of Clinical Trials and the Rheumatology Lupus Clinic at the University of North Carolina, Chapel Hill, Thurston Arthritis Research Center.
“We need to be thoughtful of the care of the individual patient regardless of whether or not they meet the classification criteria for SLE. Classification criteria help identify homogenous patient sets for enrollment in clinical trials and can’t be applied across the board to the care of individual patients, especially because lupus is such a heterogeneous disease,” says Dr. Sheikh.
Karen Costenbader, MD, MPH, lupus program director at Brigham and Women’s Hospital in Boston, Mass., and a professor of medicine at Harvard Medical School, notes that some patients in the ILE group who were treated with major immunosuppressants may have been diagnosed with SLE without meeting the classification for it.
“It could be that some of those people, but not all, would develop into classified lupus,” says Dr. Costenbader, who co-wrote an editorial accompanying the study. “This type of study is trying to identify people who are at risk for developing lupus so we can find them earlier, we can study the pathogenesis of disease to see what’s happening early in the blood, in biomarkers and risk factors and genetics … so we can possibly prevent [disease escalation].”