Vol.23 No.2

Original Article

Validation of different sets of criteria for the diagnosis of Sjögren’s syndrome in Japanese patients

Authors

Hiroto Tsuboi1,12 , Shinya Hagiwara1 , Hiromitsu Asashima1 , Hisanori Umehara12,2 , Atsushi Kawakami12,3 , Hideki Nakamura12,3 , Hajime Sano12,4 , Kazuo Tsubota12,5 , Yoko Ogawa12,5 , Etsuko Takamura12,6 , Ichiro Saito12,7 , Hiroko Inoue12,7, Seiji Nakamura12,8, Masafumi Moriyama12,8, Tsutomu Takeuchi12,9, Yoshiya Tanaka10,12, Shintaro Hirata10,12, Tsuneyo Mimori 11,12, Isao Matsumoto1, Takayuki Sumida1,12

  • Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
  • Department of Hematology and Immunology, Kanazawa Medical University, Kanazawa, Japan
  • Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
  • Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan
  • Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan
  • Department of Ophthalmology, Tokyo Women’s Medical University, School of Medicine, Tokyo, Japan
  • Department of Pathology, Tsurumi University School of Dental Medicine, Yokohama, Kanagawa, Japan
  • Section of Oral and Maxillofacial Oncology, Division of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University, Fukuoka, Japan
  • Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan
  • The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
  • Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan
  • The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW), Tokyo, Japan
Received:

8 November 2012

Accepted:

5 December 2012

Published online:

28 December 2012

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Abstract

Objective To validate the revised Japanese Ministry of Health criteria for the diagnosis of Sjögren’s syndrome (SS) (JPN) (1999), The American-European Consensus Group classification criteria for SS (AECG) (2002), and American College of Rheumatology classification criteria for SS (ACR) (2012).
Methods The study subjects were 694 patients with SS or suspected SS who were followed-up in June 2012 at ten hospitals that form part of the Research Team for Autoimmune Diseases, The Research Program for Intractable Disease by the Ministry of Health, Labor and Welfare (MHLW). All patients had been checked for all four criteria of the JPN (pathology, oral, ocular, anti-SS-A/SS-B antibodies). We studied the clinical diagnosis made by the physician in charge and the satisfaction of the above criteria.
Results Of the 694 patients, 499 patients did not have other connective tissue diseases (CTDs). SS was diagnosed in 476 patients (primary SS in 302, secondary SS in 174), whereas non-SS was diagnosed in 218 patients (without other CTDs in 197, with other CTDs in 21) by the physician in charge. The sensitivities of JPN, AECG, and ACR in the diagnosis of all forms of SS (both primary and secondary SS) were 79.6, 78.6, and 77.5 %, respectively, with respective specificities of 90.4, 90.4, and 83.5 %. The sensitivities of the same systems in the diagnosis of primary SS were 82.1, 83.1, and 79.1 %, respectively, with specificities of 90.9, 90.9, and 84.8 %, respectively. The sensitivities of the same systems in the diagnosis of secondary SS were 75.3, 70.7, and 74.7 %, respectively, with specificities of 85.7, 85.7, and 71.4 %, respectively.
Conclusion The sensitivity of JPN to all forms of SS and secondary SS, the sensitivity of AECG to primary SS, and the specificities of JPN and AECG for all forms of SS, primary SS, and secondary SS were highest in the diagnosis of SS in Japanese patients. These results indicate that the JPN criteria for the diagnosis of SS in Japanese patients are superior to ACR and AECG.

Key words

Sjögren’s syndrome - Criteria