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We read with interest the report by Whittall Garcia et al1 on ominosity, a proxy for the threatening role of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Systemic Lupus Erythematosus (SLE) Classification Criteria Score; in this article, the authors propose that a score of ≥20 predicts disease severity within 5 years of disease diagnosis. We would like to congratulate the authors for their novel approach in using these criteria as predictors. In their study, the authors included two cohorts: (1) a single-centre inception cohort that included 867 patients with SLE with a mean disease duration, from diagnosis to the first visit of 0.2 years in which they developed the concept, and (2) a validation cohort that included 807 patients from the multiethnic, multinational Systemic Lupus International Collaborating Clinics (SLICC) group cohort. They showed that achieving 20 or more points (threshold based on receiver operating characteristic (ROC) analysis) on the 2019 EULAR/ACR criteria at diagnosis was associated with a higher adjusted mean SLE Disease Activity Index 2000 scores, flares and the use of immunosuppressive drugs, while this threshold was also associated with having lower probability of achieving remission within the first 5 years after diagnosis.
Along the same lines, we have recently shown in the Lupus in Minority Populations: Nature versus Nurture (LUMINA) cohort that patients who did not achieve these criteria were more likely to accrue less damage.2 Likewise, we have studied 1047 patients from the Grupo Latino Americano De Estudio del Lupus (GLADEL) inception cohort and compared patients who achieved the EULAR/ACR criteria any time during follow-up to those who did not. In all, 68 patients never achieved these criteria; this group of patients was characterised by being older and having lower levels of disease activity and damage at enrolment than those who achieved these criteria. After performing univariable and multivariable negative binomial regression models (table 1) in which the adjustment model was based on a forward selection procedure, the damage score at last visit was 33% lower for those never achieving the criteria. Also, in the LUMINA and GLADEL cohorts, patients who were classified with the EULAR/ACR criteria earlier than with the 1982/1997 ACR criteria had a lower frequency of milder disease manifestations at baseline; taking these data together, it can be stated that these criteria may be useful in identifying a more severe SLE subset.3 4 These findings are also consistent with the data reported by Carneiro et al that a higher EULAR/ACR criteria score at the time of diagnosis was associated with a trend towards an increased occurrence of organ damage and higher rates of renal damage.5 In conclusion, taken all these studies together, these criteria could assist physicians in identifying a subset of patients with more severe disease, supporting the concept of ominosity (inauspicious); that is, there seems to be a subset or cluster of SLE patients that fulfil the new classification criteria earlier and with higher scores at diagnosis that present a greater likelihood of developing a more severe disease, which, in turn, associates with worse disease outcomes. Additional studies from different cohorts around the world are needed in order to validate the true impact and importance of this new concept in SLE.
LUMINA and GLADEL cohorts complied with the Declaration of Helsinki for Research in Humans, and the corresponding ethical approvals were obtained from the participating institutions.
Contributors All the authors contributed to the concept and writing of this letter.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
Provenance and peer review Not commissioned; internally peer reviewed.