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Abstract Number: 877

Modification of the  Classification Criteria for Primary Sjögren Syndrome: An International Vignette Survey

Sandrine Jousse-Joulin1, Florence Gatineau2, Chiara Baldini3, Alan N. Baer4, Francesca Barone5, Hendrika Bootsma6, Simon Bowman7, Pilar Brito Zeron8, Divi Cornec9, Thomas Doerner10, Salvatore De Vita11, Benjamin Fisher12, Daniel S. Hammenfors13, Malin V. Jonsson14, Xavier Mariette15, Vera Milic16, Hideki Nakamura17, Wan-Fai Ng18, Emmanuel Nowak2, Manuel Ralos-Casals19, Astrid Rasmussen20, Raphaèle Seror21, Caroline Shiboski22, Takashi Nakamura23, Arjan Vissink24, Alain Saraux25 and Valérie Devauchelle-Pensec1, 1Rheumatology, Brest university medical school, EA 2216, UBO and CHU de la Cavale Blanche,, Brest, France, 2INSERM CIC 1412, Brest Medical University Hospital, Brest, France, 3Internal Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy, 4Medicine (Rheumatology), Johns Hopkins University School of Medicine, Baltimore, MD, 5Institute of Inflammation and Ageing (IIA), University of Birmingham, Birmingham, United Kingdom, 6Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands, 7Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK, Birmingham, United Kingdom, 8Autoimmune Diseases Unit, Department of Internal Medicine, Hospital CIMA-Sanitas, Barcelona, Spain, 9CHU Brest, Brest, France, 10Charité Universitätmedizin Berlin and DRFZ, Berlin, Germany, 11Rheumatology Clinic, Academic Hospital S. M. della Misericordia, Medical Area Department, University of Udine, Italy, Udine, Italy, 12Rheumatology Research Group, University of Birmingham, Birmingham, United Kingdom, 13Broegelmann Research Laboratory, Department of Clinical Science, University of Bergen, Bergen, Norway, Bergen, Norway, 14Section for Oral and Maxillofacial Radiology, Department of Clinical Dentistry, University of Bergen, Bergen, Norway, Bergen, Norway, 15Université Paris Sud, Paris, France, 16Institute of Rheumatology, School of Medicine, University of Belgrade, Belgrade, Serbia, 17Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan, 18Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom, 19Department of Medicine, University of Barcelona, Barcelone, Spain, 20Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, 21Assistance Publique-Hôpitaux de Paris (APHP), Hôpitaux universitaires Paris Sud, Université Paris Sud, kremlin bicetre, France, 22Department of Orofacial Sciences, School of Dentistry, University of California, San Francisco, CA, 23Department of Radiology and Cancer Biology, Nagasaki University School of Dentistry, Nagasaki, Japan, 24Department of Oral and Maxillofacial Surgery, University of Groningen, University Medical Center Groningen, Groningen, Netherlands, 25Rheumatology Department, Rheumatology Department, CHU de la Cavale Blanche, Brest, France, Brest Cedex, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: classification criteria, Diagnostic criteria, salivary gland and ultrasonography, Sjogren's syndrome

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Session Information

Date: Sunday, November 5, 2017

Title: Sjögren's Syndrome I: Clinical Assessment and Trial Outcomes

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose:

The common classification criteria sets of primary Sjogren syndrome, did not considered the ultrasonography (US) of the major salivary glands as a useful item. However, it is well known that US can increase the performance of these two sets.

UTOPIA study (ultrasonography to diagnose and classify pSS) was an international vignette survey undertaken to determine the accuracy of salivary gland ultrasonography (SGUS) and to add it as a new item in the AECG-2002 and new ACR/EULAR-2017 classification criteria.

Methods: Twenty four experts in primary Sjogren, from 20 countries participated in the study (22 Europeans from 13 countries, two North Americans and two Japanese). They evaluated on an internet-secure relational database, 512 realistics vignettes, randomly assigned, abstracted from 150 patients of an Italian cohort (CB). Each vignettes contained items of the classification criteria and sections on ‘history’ (duration of the symptoms, gender, age), clinical symptoms (dry mouth or eyes and systemic manifestations) and results of the SGUS evaluation. Each expert has to consider the diagnosis of pSS as absent, unlikely, likely or present for 64 vignettes. Each vignette was evaluated by 3 experts. The diagnosis of pSS (the gold standard) was obtained when 2/3 considered it as likely or present. Univariate and multivariate analysis were performed to evaluate the association of US to the diagnosis of pSS. Data were secondly verified on an independent French cohort (DiapSS cohort).

Results: The univariate and multivariate analysis confirmed that both classification criteria and SGUS were independently associated with the diagnosis of pSS (p<0.001). Disease duration, OSS and ocular dryness were not associated with the diagnosis of pSS. When adding US to the AECG-2002 criteria, the sensitivity (Se) and specificity (Sp) were respectively of 91 % and 83 % and of 98% and 80% if we add US. For the ACR/EULAR 2017 criteria, (with a global score of 4), the Se and Sp were respectively of 90 % and 84 % and of 95% and 82% if we add US. Results were quite similar in the independent French DiapSS. The SE and Sp of the ACR/EULAR 2017 were 87.5 and 84.5% and of 92.5 and 82 % with US. If we considered each items of the vignettes separately to build a new weighted score, only 6 variables were selected by logistic regression analysis: presence of anti-SSA (weight:4), focus score (weight:4), SGUS (weight:2), Schirmer’s test (weight:1), dry eye (weight:1) and salivary fow rate (weight:1). According to ROC curve analysis, a score of ≥5 had 96% Se and 84% Sp, compared with 90% Se and 84% Sp for the ACR/EULAR 2017 Criteria. The corrected C statistic (AUC) for the new weighted score was 0.98.

Conclusion:

Adding US item to both AECG and ACR/EULAR 2017 classification criteria increased Se but did not change Sp. The modified scores are easy to use especially the ACR/EULAR 2017.


Disclosure: S. Jousse-Joulin, None; F. Gatineau, None; C. Baldini, None; A. N. Baer, None; F. Barone, None; H. Bootsma, None; S. Bowman, I have consulted in the field of Sjogren's for: AstraZeneca/Meddimmune, BMS, Celgene, Eli Lilly, Glenmark, GSK, MTPharma, Novartis, Ono, Takeda, UCB, xtlbio). Roche provided Rituximab for the TRACTISS Study, 5; P. Brito Zeron, None; D. Cornec, None; T. Doerner, None; S. De Vita, None; B. Fisher, Novartis, Roche, Virtualscopics, 5; D. S. Hammenfors, None; M. V. Jonsson, None; X. Mariette, None; V. Milic, None; H. Nakamura, None; W. F. Ng, None; E. Nowak, None; M. Ralos-Casals, None; A. Rasmussen, None; R. Seror, None; C. Shiboski, None; T. Nakamura, None; A. Vissink, None; A. Saraux, None; V. Devauchelle-Pensec, Roche-Chugai provided me tocilizumab for the SEMAPHORER study, 2.

To cite this abstract in AMA style:

Jousse-Joulin S, Gatineau F, Baldini C, Baer AN, Barone F, Bootsma H, Bowman S, Brito Zeron P, Cornec D, Doerner T, De Vita S, Fisher B, Hammenfors DS, Jonsson MV, Mariette X, Milic V, Nakamura H, Ng WF, Nowak E, Ralos-Casals M, Rasmussen A, Seror R, Shiboski C, Nakamura T, Vissink A, Saraux A, Devauchelle-Pensec V. Modification of the  Classification Criteria for Primary Sjögren Syndrome: An International Vignette Survey [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/modification-of-the-classification-criteria-for-primary-sjogren-syndrome-an-international-vignette-survey/. Accessed .
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