December 12, 2017
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ACR/EULAR criteria for Sjögren’s syndrome offers higher sensitivity, lower specificity

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The 2016 American College of Rheumatology-European League Against Rheumatism classification criteria for the diagnosis of primary Sjögren’s syndrome has a significantly higher sensitivity, and lower specificity, than the three other sets of criteria currently available, according to research published in Annals of the Rheumatic Disease.

The study, conducted by researchers from the University of Tsukuba, in Japan, and the Japanese Ministry of Health, Labor and Welfare, compared the new American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria with the 1999 revised Japanese Ministry of Health criteria (JPN), the 2002 American-European Consensus Group classification criteria (AECG) and the 2012 ACR classification criteria (ACR).

The 2016 ACR/EULAR criteria classification criteria for primary Sjögren’s syndrome offered a significantly higher sensitivity, and lower specificity, than the three other criteria now available.
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“Comparison of the four sets of criteria shows certain differences in the adopted items. In addition to the adopted items, the purpose of these criteria sets also differs,” Hiroto Tsuboi, MD, PhD, an associate professor at the University of Tsukuba, and the other researchers wrote. “Importantly, the JPN criteria were formulated for the diagnosis of [Sjögren’s syndrome (SS)] as the diagnostic criteria, while other three sets of criteria (the ACR/EULAR, AECG and ACR criteria) were formulated for research purposes as the classification criteria.”

To compare the performance of the ACR/EULAR criteria with the JPN, AECG and ACR criteria for diagnosing SS in Japanese patients, the researchers followed up with 499 patients who had, or were suspected to have, primary Sjögren’s syndrome (pSS) at 10 hospitals in June 2012.

All patients had been assessed by all four criteria of the JPN model — pathology, oral, ocular, anti-SS-A/SS-B antibodies, the researchers said. They added that the clinical diagnosis by the physician in charge was determined to be the “gold standard.”

According to the researchers, the physician in charge diagnosed 302 of the patients with pSS, and ruled it out in the remaining 197 cases. The sensitivity of the ACR/EULAR criteria in the diagnosis of pSS was recorded as 95.4%, compared to 82.1% for the JPN criteria, 89.4% for AECG and 79.1% for ACR. Meanwhile, the specificity of the ACR/EULAR criteria was 72.1%, compared with 90.9% for the JPN criteria, 84.3% for AECG and 84.8% for ACR. The differences of sensitivities and specificities between the ACR/EULAR and other three sets of criteria were statistically significant (P < .001), the researchers said. Among the 302 patients with pSS, 8 cases satisfied only the ACR/EULAR criteria.

“In conclusion, although this study has certain limitations, the results showed that the ACR/EULAR criteria have higher sensitivity and lower specificity in the diagnosis of pSS, compared with the JPN, AECG and ACR criteria,” Tsuboi and colleagues wrote. “Furthermore, the degree of agreement of the ACR/EULAR criteria with the other three sets of criteria for the diagnosis and denial of pSS was low.”  by Jason Laday

Disclosure: The authors report no relevant financial disclosures.