Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients

Hiroto Tsuboi, Shinya Hagiwara, Hiromitsu Asashima, Hiroyuki Takahashi, Tomoya Hirota, Hisashi Noma, Hisanori Umehara, Atsushi Kawakami, Hideki Nakamura, Hajime Sano, Kazuo Tsubota, Yoko Ogawa, Etsuko Takamura, Ichiro Saito, Hiroko Inoue, Seiji Nakamura, Masafumi Moriyama, Tsutomu Takeuchi, Yoshiya Tanaka, Shintaro HirataTsuneyo Mimori, Isao Matsumoto, Takayuki Sumida

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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.

Original languageEnglish
Pages (from-to)1980-1985
Number of pages6
JournalAnnals of the Rheumatic Diseases
Volume76
Issue number12
DOIs
Publication statusPublished - Dec 1 2017

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Rheumatology
Rheumatic Diseases
Oral Pathology
Physicians
Sensitivity and Specificity
Pathology
Japan
Health
Antibodies

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

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Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients. / Tsuboi, Hiroto; Hagiwara, Shinya; Asashima, Hiromitsu; Takahashi, Hiroyuki; Hirota, Tomoya; Noma, Hisashi; Umehara, Hisanori; Kawakami, Atsushi; Nakamura, Hideki; Sano, Hajime; Tsubota, Kazuo; Ogawa, Yoko; Takamura, Etsuko; Saito, Ichiro; Inoue, Hiroko; Nakamura, Seiji; Moriyama, Masafumi; Takeuchi, Tsutomu; Tanaka, Yoshiya; Hirata, Shintaro; Mimori, Tsuneyo; Matsumoto, Isao; Sumida, Takayuki.

In: Annals of the Rheumatic Diseases, Vol. 76, No. 12, 01.12.2017, p. 1980-1985.

Research output: Contribution to journalArticle

Tsuboi, H, Hagiwara, S, Asashima, H, Takahashi, H, Hirota, T, Noma, H, Umehara, H, Kawakami, A, Nakamura, H, Sano, H, Tsubota, K, Ogawa, Y, Takamura, E, Saito, I, Inoue, H, Nakamura, S, Moriyama, M, Takeuchi, T, Tanaka, Y, Hirata, S, Mimori, T, Matsumoto, I & Sumida, T 2017, 'Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients', Annals of the Rheumatic Diseases, vol. 76, no. 12, pp. 1980-1985. https://doi.org/10.1136/annrheumdis-2016-210758
Tsuboi, Hiroto ; Hagiwara, Shinya ; Asashima, Hiromitsu ; Takahashi, Hiroyuki ; Hirota, Tomoya ; Noma, Hisashi ; Umehara, Hisanori ; Kawakami, Atsushi ; Nakamura, Hideki ; Sano, Hajime ; Tsubota, Kazuo ; Ogawa, Yoko ; Takamura, Etsuko ; Saito, Ichiro ; Inoue, Hiroko ; Nakamura, Seiji ; Moriyama, Masafumi ; Takeuchi, Tsutomu ; Tanaka, Yoshiya ; Hirata, Shintaro ; Mimori, Tsuneyo ; Matsumoto, Isao ; Sumida, Takayuki. / Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients. In: Annals of the Rheumatic Diseases. 2017 ; Vol. 76, No. 12. pp. 1980-1985.
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title = "Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sj{\"o}gren's syndrome with other sets of criteria in Japanese patients",
abstract = "Objectives To compare the performance of the new 2016 American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) classification criteria for primary Sj{\"o}gren'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.",
author = "Hiroto Tsuboi and Shinya Hagiwara and Hiromitsu Asashima and Hiroyuki Takahashi and Tomoya Hirota and Hisashi Noma and Hisanori Umehara and Atsushi Kawakami and Hideki Nakamura and Hajime Sano and Kazuo Tsubota and Yoko Ogawa and Etsuko Takamura and Ichiro Saito and Hiroko Inoue and Seiji Nakamura and Masafumi Moriyama and Tsutomu Takeuchi and Yoshiya Tanaka and Shintaro Hirata and Tsuneyo Mimori and Isao Matsumoto and Takayuki Sumida",
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T1 - Comparison of performance of the 2016 ACR-EULAR classification criteria for primary Sjögren's syndrome with other sets of criteria in Japanese patients

AU - Tsuboi, Hiroto

AU - Hagiwara, Shinya

AU - Asashima, Hiromitsu

AU - Takahashi, Hiroyuki

AU - Hirota, Tomoya

AU - Noma, Hisashi

AU - Umehara, Hisanori

AU - Kawakami, Atsushi

AU - Nakamura, Hideki

AU - Sano, Hajime

AU - Tsubota, Kazuo

AU - Ogawa, Yoko

AU - Takamura, Etsuko

AU - Saito, Ichiro

AU - Inoue, Hiroko

AU - Nakamura, Seiji

AU - Moriyama, Masafumi

AU - Takeuchi, Tsutomu

AU - Tanaka, Yoshiya

AU - Hirata, Shintaro

AU - Mimori, Tsuneyo

AU - Matsumoto, Isao

AU - Sumida, Takayuki

PY - 2017/12/1

Y1 - 2017/12/1

N2 - 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.

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.

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