Performance of the 2016 ACR-EULAR classification criteria for primary Sjogren’s syndrome in a Korean cohort
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This study compared the performance of the newly proposed 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria to the 2002 American–European Consensus Group (AECG) and 2012 ACR classification criteria for primary Sjogren’s syndrome (pSS) in well-characterized Korean patients. Patients with pSS from 12 university-affiliated hospitals in Korea were enrolled from October 2013 to January 2017. Clinical and laboratory data were reviewed. For the validation set, patients who underwent evaluation tests to rule out pSS at Seoul St. Mary’s hospital from November 2016 to December 2017 were analyzed. Baseline registry data were available in 458 patients, and 328 patients had sufficient data to determine the fulfillment of each criteria set. All three sets of criteria were met by 307 patients (93.6%). The newly proposed 2016 ACR/EULAR criteria were met by 325 patients (99.1%). The 2002 AECG and 2012 ACR criteria were met by 325 (99.1%) and 310 patients (94.5%), respectively. In a validation cohort consisting of 161 patients with pSS-related symptoms/signs, the sensitivity and specificity of the 2016 ACR/EULAR criteria were 100% [95% confidence interval (CI), 96.11–100.00] and 81.8% [95% CI, 76.15–94.26], respectively. Agreement between the 2016 criteria and 2012 or 2002 criteria was high (Cohen’s kappa 0.736 and 0.769, respectively). The newly proposed 2016 ACR/EULAR criteria were met by most patients diagnosed with pSS according to previous criteria and showed higher sensitivity and lower specificity compared with both previous criteria sets.
KeywordsClassification criteria Sjogren’s syndrome
This study was supported by a grant of the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (HI13C0016).
JL and SHP contributed to the study design, data collection, data analysis, interpretation of the results, and preparation of the manuscript. JHK, JWK, YKS, SSL, JYC, SCS, HSK, HRK, JMK, SRK, HOK, KS, CHL, SHC, SKK, and JHJ contributed to data collection. All the authors read and approved the final manuscript.
Compliance with ethical standards
Conflict of interest
Jennifer Lee, Jung Hee Koh, Ji-Won Kim, Yoon-Kyoung Sung, Shin-Seok Lee, Jung Yoon Choe, Seung-Cheol Shim, Hyun-Sook Kim, Hae-Rim Kim, Ji-Min Kim, Sung Ryul Kwon, Hyun-Ok Kim, Kichul Shin, Chang Hoon Lee, So-Hyang Chung, Seung-Ki Kwok, Ji Hyeon Ju, and Sung-Hwan Park declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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