Patients who fail to meet 2019 EULAR/ACR lupus criteria amass less damage
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Among participants of a multiethnic lupus cohort recruited using the 1982/1997 American College of Rheumatology criteria, those who failed to achieve the new 2019 EULAR/ACR criteria accrued less damage than those who did, according to data published in Arthritis Care & Research.
“This is the first study to report the impact of achieving — or not — the EULAR/ACR criteria on damage accrual,” Manuel F. Ugarte-Gil, MD, MSc, of the Guillermo Almenara Irigoyen National Hospital, in Lima, Peru, told Healio Rheumatology. “Several groups have evaluated whether these criteria were more sensitive than the previous one or not. However, it is also important to know if those patients classified with these criteria will have the same prognosis as those who will not.”
To examine the differences in outcomes among patients who achieved the 2019 EULAR/ACR SLE criteria and those who did not, Ugarte-Gil and colleagues studied data from the U.S. LUMINA (Lupus in Minorities: Nature vs nurture) cohort. In that study, SLE was defined using the 1982/1997 ACR classification criteria, and disease duration could have been up to 5 years at cohort entry. For their own study, Ugarte-Gil and colleagues included 640 LUMINA participants, and compared those who achieved the 2019 criteria at any time during the follow-up with those who did not.
Predefined outcomes included the last Systemic Lupus International Collaborating Clinics (SLICC)/ACR damage index (SDI) and survival. Possible confounders included were age, sex, race or ethnicity, poverty, disease duration at baseline, baseline disease activity, baseline SDI, and any antimalarial, glucocorticoid and immunosuppressive drugs use at baseline. The researchers performed univariable and multivariable negative binomial regression models, with adjustment models based on a forward selection process.
According to the researchers, 98 of the 640 included participants achieved the 2019 EULAR/ACR criteria for SLE. There was no difference in mean baseline SDI among the patients who did not achieve the criteria, compared with those who did. However, the mean SDI at last visit was lower among patients who never achieved the 2019 criteria, at 1.2 ± 1.7, compared with 2 ± 2.3 among those who did met the criteria (P = .0004). In the final adjusted model, the SDI score at last visit was 31% lower among those who failed to meet the criteria (P = .0077).
“Patients who achieved these criteria accrued more damage than those who did not, even though those who did not achieve the criteria were classified as having SLE with the 1982/1997 ACR criteria,” Ugarte-Gil said. “Patients who did not achieve the EULAR/ACR criteria could have a milder form of the disease. Potentially, these criteria may be useful in predicting prognosis and not only to classify patients earlier or not.”
Perspective
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Alan L. Epstein, MD
This study demonstrates that, in this multiethnic cohort, not achieving the 2019 EULAR/ACR classification criteria is associated with a better outcome. The researchers found was that there was statistically less organ damage in the patients who did not satisfy the 2019 criteria. These new criteria, originally developed for the purpose of study enrollment, might also be useful as a way to predict a worse prognosis in patients with systemic lupus erythematosus.
To best understand this study and its results, three key features of the study need to be reviewed. First, the study examined the LUMINA cohort, the result of a collaborative effort between the University of Alabama, the University of Texas at Houston, and the University of Puerto Rico, that began in 1994. The purpose of the original study was to determine the causes for the different outcomes observed in ethnic minorities when compared to the Caucasian majority. A multitude of papers have been generated from this cohort, beyond what can be addressed here.
The second feature of the study that needs to be discussed are the new 2019 EULAR/ACR classification criteria. SLE, as we know, is a complex disease. Classification criteria are essential in defining relatively homogeneous groups of patients for inclusion in research studies. The 1982 ACR classification criteria and their 1997 revision have been used worldwide. However, since 1997, considerable advancements in the understanding of the disease have led to the development of the 2012 SLICC criteria.
The new EULAR/ACR criteria are quite different in a number of ways from the prior ACR criteria and SLICC criteria. They were developed to improve the sensitivity and specificity of previously published criteria, especially in patients with early disease. The first difference with the new criteria is that a positive ANA is a required entry criterion. The new system uses weighted criteria (clinical and immunologic) to produce a measure of the relative probability that a patient can be classified as having SLE. The criteria were carefully defined to improve reliability and precision.
The third significant feature of the study is that, in recent years, much more attention has been paid to organ damage in patients with SLE; this is typically measured using the SLICC/ACR damage index (SDI). We know that 33% to 50% of patients experience organ damage within 5 years: Are we able to predict which patients will suffer organ damage? Telltale features associated with increased organ damage include flares (regardless of severity), disease activity, male sex, older age at onset, ethnicity, income, glucocorticoid use, among others. We are also beginning to examine the ability of treatments to reduce organ damage, not just control disease activity/flares.
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