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Extended report
Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients
  1. Hiroto Tsuboi1,2,
  2. Shinya Hagiwara1,
  3. Hiromitsu Asashima1,
  4. Hiroyuki Takahashi1,
  5. Tomoya Hirota1,
  6. Hisashi Noma3,
  7. Hisanori Umehara2,4,5,
  8. Atsushi Kawakami2,6,
  9. Hideki Nakamura2,6,
  10. Hajime Sano2,7,
  11. Kazuo Tsubota2,8,
  12. Yoko Ogawa2,8,
  13. Etsuko Takamura2,9,
  14. Ichiro Saito2,10,
  15. Hiroko Inoue2,11,
  16. Seiji Nakamura2,12,
  17. Masafumi Moriyama2,12,
  18. Tsutomu Takeuchi2,13,
  19. Yoshiya Tanaka2,14,
  20. Shintaro Hirata2,14,
  21. Tsuneyo Mimori2,5,
  22. Isao Matsumoto1,
  23. Takayuki Sumida1,2
  1. 1Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
  2. 2The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW)
  3. 3Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan
  4. 4Department of Hematology and Immunology, Kanazawa Medical University, Kanazawa, Japan
  5. 5Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan
  6. 6Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
  7. 7Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Nishimoniya-city, Japan
  8. 8Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan
  9. 9Department of Ophthalmology, School of Medicine, Tokyo Women's Medical University
  10. 10Department of Pathology, Tsurumi University School of Dental Medicine, Tsurumi, Japan
  11. 11Department of Pharmacology, Nihon Pharmaceutical University
  12. 12Section of Oral and Maxillofacial Oncology, Division of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University, Fukuoka, Japan
  13. 13Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan
  14. 14The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
  1. Correspondence to Professor Takayuki Sumida, Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba-city, Ibaraki 305-8575, Japan; tsumida{at}md.tsukuba.ac.jp

Abstract

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.

  • Sjøgren's Syndrome
  • Autoimmune Diseases
  • Epidemiology

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