Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients.
OBJECTIVE
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.
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.|The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).
Hiroto
H
Tsuboi
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Shinya
S
Hagiwara
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hiromitsu
H
Asashima
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hiroyuki
H
Takahashi
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Tomoya
T
Hirota
Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan.
Hisashi
H
Noma
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Department of Hematology and Immunology, Kanazawa Medical University, Kanazawa, Japan.|Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Hisanori
H
Umehara
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Atsushi
A
Kawakami
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Hideki
H
Nakamura
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Nishimoniya-city, Japan.
Hajime
H
Sano
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan.
Kazuo
K
Tsubota
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan.
Yoko
Y
Ogawa
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Department of Ophthalmology, School of Medicine, Tokyo Women's Medical University.
Etsuko
E
Takamura
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Department of Pathology, Tsurumi University School of Dental Medicine, Tsurumi, Japan.
Ichiro
I
Saito
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Department of Pharmacology, Nihon Pharmaceutical University.
Hiroko
H
Inoue
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Section of Oral and Maxillofacial Oncology, Division of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.
Seiji
S
Nakamura
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Section of Oral and Maxillofacial Oncology, Division of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.
Masafumi
M
Moriyama
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.
Tsutomu
T
Takeuchi
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Yoshiya
Y
Tanaka
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Shintaro
S
Hirata
The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).|Department of Rheumatology and Clinical Immunology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Tsuneyo
T
Mimori
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Isao
I
Matsumoto
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.|The Research Team for Autoimmune Diseases, The Research Program for Intractable Disease of the Ministry of Health, Labor and Welfare (MHLW).
Takayuki
T
Sumida
D000328:Adult; D003937:Diagnosis, Differential; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D012219:Rheumatology / Q000592:standards*; D012680:Sensitivity and Specificity; D012859:Sjogren's Syndrome / Q000145:classification / Q000175:diagnosis*; D011795:Surveys and Questionnaires; D014481:United States
Autoimmune Diseases; Epidemiology; Sjøgren's Syndrome