PT - JOURNAL ARTICLE AU - Hiroto Tsuboi AU - Shinya Hagiwara AU - Hiromitsu Asashima AU - Hiroyuki Takahashi AU - Tomoya Hirota AU - Hisashi Noma AU - Hisanori Umehara AU - Atsushi Kawakami AU - Hideki Nakamura AU - Hajime Sano AU - Kazuo Tsubota AU - Yoko Ogawa AU - Etsuko Takamura AU - Ichiro Saito AU - Hiroko Inoue AU - Seiji Nakamura AU - Masafumi Moriyama AU - Tsutomu Takeuchi AU - Yoshiya Tanaka AU - Shintaro Hirata AU - Tsuneyo Mimori AU - Isao Matsumoto AU - Takayuki Sumida TI - Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients AID - 10.1136/annrheumdis-2016-210758 DP - 2017 Dec 01 TA - Annals of the Rheumatic Diseases PG - 1980--1985 VI - 76 IP - 12 4099 - http://ard.bmj.com/content/76/12/1980.short 4100 - http://ard.bmj.com/content/76/12/1980.full SO - Ann Rheum Dis2017 Dec 01; 76 AB - Objectives To compare the performance of the new 2016 American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) classification criteria for primary Sjögren's syndrome (SS) with 1999 revised Japanese Ministry of Health criteria for diagnosis of SS (JPN), 2002 American-European Consensus Group classification criteria for SS (AECG) and 2012 ACR classification criteria for SS (ACR) in Japanese patients.Methods The study subjects were 499 patients with primary SS (pSS) or suspected pSS who were followed up in June 2012 at 10 hospitals in Japan. All patients had been assessed for all four criteria of JPN (pathology, oral, ocular, anti-SS-A/SS-B antibodies). The clinical diagnosis by the physician in charge was set as the ‘gold standard’.Results pSS was diagnosed in 302 patients and ruled out in 197 patients by the physician in charge. The sensitivity of the ACR-EULAR criteria in the diagnosis of pSS (95.4%) was higher than those of the JPN, AECG and ACR (82.1%, 89.4% and 79.1%, respectively), while the specificity of the ACR-EULAR (72.1%) was lower than those of the three sets (90.9%, 84.3% and 84.8%, respectively). The differences of sensitivities and specificities between the ACR-EULAR and other three sets of criteria were statistically significant (p<0.001). Eight out of 302 patients with pSS and 11 cases out of 197 non-pSS cases satisfied only the ACR-EULAR criteria, compared with none of the other three sets.Conclusions The ACR-EULAR criteria had significantly higher sensitivity and lower specificity in diagnosis of pSS, compared with the currently available three sets of criteria.