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Comparison of ESSDAI and ClinESSDAI in potential optimisation of trial outcomes in primary Sjögren's syndrome: Examination of data from the UK Primary Sjögren's Syndrome Registry

Lookup NU author(s): Professor Fai Ng, Dr Katherine James, Dr Bridget Griffiths, Dr David Coady, Dr Steven Young-Min, Dr Francesca Barone, Andrew Carr, Suzy Edgar, Professor Marco Carrozzo, Professor Francisco Figueiredo, Heather Foggo, Dr Colin Gillespie, Vicki Hindmarsh, Dr Dennis Lendrem, Dr Iain Macleod, Sheryl Mitchell, Dr Jessica Tarn, Kit Muir, Dr Elizabeth Kidd

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


Abstract

OBJECTIVES: To assess the use of the Clinical EULAR Sjogren's Syndrome Disease Activity Index (ClinESSDAI), a version of the ESSDAI without the biological domain, for assessing potential eligibility and outcomes for clinical trials in patients with primary Sjogren's syndrome (pSS), according to the new ACR-EULAR classification criteria, from the UK Primary Sjogren's Syndrome Registry (UKPSSR). METHODS: A total of 665 patients from the UKPSSR cohort were analysed at their time of inclusion in the registry. ESSDAI and ClinESSDAI were calculated for each patient. RESULTS: For different disease activity index cut-off values, more potentially eligible participants were found when ClinESSDAI was used than with ESSDAI. The distribution of patients according to defined disease activity levels did not differ statistically (chi2 p = 0.57) between ESSDAI and ClinESSDAI for moderate disease activity (score ≥5 and <14; ESSDAI 36.4%; ClinESSDA 36.5%) or high diseaseactivity (score ≥14; ESSDAI 5.4%; ClinESSDAI 6.8%). We did not find significant differences between the indexes in terms of activity levels for individual domains, with the exception of the articular domain. We found a good level of agreement between both indexes, and a positive correlation between lymphadenopathy and glandular domains with the use of either index and with different cut-off values. With the use of ClinESSDAI, the minimal clinically important improvement value was more often achievable with a one grade improvement of a single domain than with ESSDAI. We observed similar results when using the new ACR-EULAR classification criteria or the previously used American-European Consensus Group (AECG) classification criteria for pSS. CONCLUSIONS: In the UKPSSR population, the use of ClinESSDAI instead of ESSDAI did not lead to significant changes in score distribution, potential eligibility or outcome measurement in trials, or in routine care when immunological tests are not available. These results need to be confirmed in other cohorts and with longitudinal data.


Publication metadata

Author(s): Dumusc A, Ng W-F, James K, Griffiths B, Price E, Pease CT, Emery P, Lanyon P, Jones A, Bombardieri M, Sutcliffe N, Pitzalis C, Gupta M, McLaren J, Cooper A, Giles I, Isenberg D, Saravanan V, Coady D, Dasgupta B, McHugh N, Young-Min S, Moots RJ, Gendi N, Akil M, Barone F, Fisher BA, Rauz S, Richards A, Bowman SJ, Frankland H, Mediana A, Chadravarty K, Lamabadusuriya S, Adeniba R, Hamburger J, Higham J, Poveda-Galego A, Logan J, Mulherin D, Andrews J, McManus A, Booth A, Regan M, Dimitroulas T, Kadiki L, Kaur D, Kitas G, Lloyd M, Moore L, Gordon E, Lawson C, Hunter J, Stirton L, Ortiz G, Clunie G, Rose G, Cuckow S, Knight S, Symmons D, Jones B, Carr A, Edgar S, Carrozzo M, Figueiredo F, Foggo H, Gillespie C, Hindmarsh V, Lendrem D, Macleod I, Mitchell S, Tarn J, Muir A, White P, Pugmire S, Watkins M, Field A, Kaye S, Mewar D, Medcalf P, Tomlinson P, Whiteside D, Pauling J, James J, Olaitan N, McDermott J, Godia O, Kidd E, Palmer L, Katsande V, Long P, Chandra U, MacKay K, Fedele S, Ferenkeh-Koroma A, Marconnell H, Porter S, Brailsford S, Allcoat P

Publication type: Article

Publication status: Published

Journal: Swiss Medical Weekly

Year: 2018

Volume: 148

Online publication date: 07/02/2018

Acceptance date: 02/04/2016

Date deposited: 02/03/2018

ISSN (electronic): 1424-3997

Publisher: EMH Swiss Medical Publishers Ltd.

URL: https://doi.org/10.4414/smw.2018.14588

DOI: 10.4414/smw.2018.14588


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