ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2551

Validation of EULAR Primary Sjögren’s Syndrome Disease Activity and Patient Indexes

Raphaèle Seror1, Elke Theander2, Johan G. Brun3, Manel Ramos-Casals4, Valeria Valim5, Thomas Dorner6, Xavier Mariette7, Hendrika Bootsma8, Athanasios G. Tzioufas9, Roser Solans-Laqué10, Jacques-Eric Gottenberg11, Eric Hachulla12, Wan-Fai NG13, Stefano Bombardieri14, Roberto Gerli15, Takayuki Sumida16, Alain Saraux17, Matija Tomsic18, Roberto Caporali19, Roberta Priori20, Kathy Moser Sivils21, A.a. Kruize22, Cristina F. Vollenweider23, Claudio Vitali24 and Simon J. Bowman25, 1Rheumatology, Bicetre university hospital, LE Kremlin-Bicetre, France, 2Dept of Rheumatology, Skane University Hospital, Lund University, Malmö, Sweden, 3Department of Rheumatology, Haukeland University Hospital, Bergen, Norway, 4Laboratorio de Enfermedades Autoinmunes Josep Font, Hospital Clínic, Barcelona, Spain, 5Clínica Médica - Reumatologia, Universidade Federal do Espírito Santo, Vitória, Brazil, 6Department of Medicine/Rheumatology and Clinical Immunology and German Rheumatism Research Centre Berlin (DRFZ), Charité University Medicine Berlin, Berlin, Germany, 7Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France, 8Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, Netherlands, 9Pathophysiology, School of Medicine, National University of Athens, Athens, Greece, 10Internal Medicine, Senior Consultant, Barcelona, Spain, 11Rheumatology, Strasbourg University Hospital, Strasbourg, France, 12Department of Internal Medicine, Claude Huriez University Hospital, Lille, France, 13Departement of rheumatology, New-Castle University Hospital,, Departement of rheumatology, New-Castle University Hospital, UK, Newcastle, England, 14Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy, 15Rheumatology Unit, University of Perugia, Perugia, Italy, 16Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba City, Japan, 17Department of rheumatology and unit of immunology (EA 2216), Université Brest Occidentale, Brest, France, 18Department of Rheumatology, University Medical Centre Ljubjana, Ljubljana, Slovenia, 19Division of Rheumatology, IRCCSPoliclinico S. Matteo Foundation, Pavia, Italy, 20Department of Internal Medicine and Medical Specialties, Sapienza University, Rome, Italy, 21Oklahoma Medical Research Foundation, Oklahoma City, OK, 22Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands, 23Rheumatology, German Hospital, Buenos Aires, Argentina, 24Casa di Cura di Lecco, Lecco, Italy, 25Department of Rheumatology, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Sjögren's Syndrome II - Clinical

Session Type: Abstract Submissions (ACR)

Background/Purpose: To validate the EULAR scores for assessment of primary Sjögren’s Syndrome (SS): the EULAR SS Disease Activity Index (ESSDAI), the EULAR SS Patient Reported Index (ESSPRI).  

Methods: Prospective international validation study with 2 visits: baseline and 6 months. At each physicians completed ESSDAI, SS disease activity index (SSDAI), Sjögren’s Systemic Clinical Activity Index (SCAI) and physician global assessment (PhGA); and patients completed ESSPRI, Sicca Symptoms Inventory (SSI), Profile of Fatigue and Discomfort (PROFAD) and patient global assessment (PGA). Construct validity (using correlations with gold standard), responsiveness (using standardized response mean [SRM]) and reliability (intraclass correlation coefficient [ICC]) were evaluated and compared between each scores.

Results: 395 patients (96% women, mean age 55.4 ± 13.7 years, 79% with anti-SSA and/or anti-SSB antibodies) from 15 countries have been included. At enrollment, 145 (37%) and 251 (64%) had, respectively, current or either current or past systemic manifestations. EULAR scores had higher correlation with gold standard than other scores (ESSDAI with PhGA: rho=0.59; ESSRPI with PGA: rho=0.70). Correlations between patient and systemic scores were very low (rho ranging from 0.07 to 0.29). All systemic scores had similar large responsiveness in improved patients. Responsiveness of patients scores was low in patient experiencing improvement of their symptoms but was significantly higher for ESSPRI compared to SSI and PROFAD (p=0.006 and 0.049 for SRM comparisons) Reliability was assessed in a subgroup of 47 and 62 patients, for systemic and patients scores, respectively. Reliability was very good for all scores.

Conclusion:

ESSDAI and ESSPRI had good construct validity, better than other scores. All scores were reliable. Systemic scores were sensitive to change in patient whose disease activity improves. Patient scores had a small sensitivity to change. However, ESSPRI was significantly better than SSI and PROFAD. The poor correlation between systemic and patients scores confirms that these 2 components are different and should be evaluated separately.

 

Disclosure:

R. Seror,
None;

E. Theander,
None;

J. G. Brun,
None;

M. Ramos-Casals,
None;

V. Valim,
None;

T. Dorner,
None;

X. Mariette,
None;

H. Bootsma,
None;

A. G. Tzioufas,
None;

R. Solans-Laqué,
None;

J. E. Gottenberg,
None;

E. Hachulla,
None;

W. F. NG,
None;

S. Bombardieri,
None;

R. Gerli,
None;

T. Sumida,
None;

A. Saraux,
None;

M. Tomsic,
None;

R. Caporali,
None;

R. Priori,
None;

K. Moser Sivils,
None;

A. A. Kruize,
None;

C. F. Vollenweider,
None;

C. Vitali,
None;

S. J. Bowman,
None.

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