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

Alexandre Dumusc, Wan-Fai Ng, Katherine James, Bridget Griffiths, Elizabeth Price, Colin Pease, Paul Emery, Peter Lanyon, Adrian Jones, Michele Bombardieri, Nurhan Sutcliffe, Costantino Pitzalis, Monica Gupta, John McLaren, Annie Cooper, Ian Giles, David Isenberg, Vadivelu Saravanan, David Coady, Bhaskar Dasgupta & 10 others Neil McHugh, Steven Young-Min, Robert Moots, Nagui Gendi, Mohammed Akil, Francesca Barone, Benjamin Fisher, Saaeha Rauz, Andrea Richards, Simon Bowman

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Abstract

OBJECTIVES: To assess the use of the Clinical EULAR Sjögren'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 Sjögren's syndrome (pSS), according to the new ACR-EULAR classification criteria, from the UK Primary Sjögren'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 disease activity (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.

LanguageEnglish
Pagesw14588
JournalSwiss Medical Weekly
Volume148
DOIs
StatusE-pub ahead of print - 7 Feb 2018

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Sjogren's Syndrome
Registries
Immunologic Tests
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Clinical Trials

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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. / Dumusc, Alexandre; Ng, Wan-Fai; James, Katherine; Griffiths, Bridget; Price, Elizabeth; Pease, Colin; Emery, Paul; Lanyon, Peter; Jones, Adrian; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; Gupta, Monica; McLaren, John; Cooper, Annie; Giles, Ian; Isenberg, David; Saravanan, Vadivelu; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Barone, Francesca; Fisher, Benjamin; Rauz, Saaeha; Richards, Andrea; Bowman, Simon.

In: Swiss Medical Weekly, Vol. 148, 07.02.2018, p. w14588.

Research output: Contribution to journalArticle

Dumusc, A, Ng, W-F, James, K, Griffiths, B, Price, E, Pease, C, 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, R, Gendi, N, Akil, M, Barone, F, Fisher, B, Rauz, S, Richards, A & Bowman, S 2018, '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', Swiss Medical Weekly, vol. 148, pp. w14588. https://doi.org/10.4414/smw.2018.14588
Dumusc, Alexandre ; Ng, Wan-Fai ; James, Katherine ; Griffiths, Bridget ; Price, Elizabeth ; Pease, Colin ; Emery, Paul ; Lanyon, Peter ; Jones, Adrian ; Bombardieri, Michele ; Sutcliffe, Nurhan ; Pitzalis, Costantino ; Gupta, Monica ; McLaren, John ; Cooper, Annie ; Giles, Ian ; Isenberg, David ; Saravanan, Vadivelu ; Coady, David ; Dasgupta, Bhaskar ; McHugh, Neil ; Young-Min, Steven ; Moots, Robert ; Gendi, Nagui ; Akil, Mohammed ; Barone, Francesca ; Fisher, Benjamin ; Rauz, Saaeha ; Richards, Andrea ; Bowman, Simon. / 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. In: Swiss Medical Weekly. 2018 ; Vol. 148. pp. w14588.
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abstract = "OBJECTIVES: To assess the use of the Clinical EULAR Sj{\"o}gren'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 Sj{\"o}gren's syndrome (pSS), according to the new ACR-EULAR classification criteria, from the UK Primary Sj{\"o}gren'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 disease activity (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.",
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TY - JOUR

T1 - Comparison of ESSDAI and ClinESSDAI in potential optimisation of trial outcomes in primary Sjögren's syndrome

T2 - Swiss Medical Weekly

AU - Dumusc, Alexandre

AU - Ng, Wan-Fai

AU - James, Katherine

AU - Griffiths, Bridget

AU - Price, Elizabeth

AU - Pease, Colin

AU - Emery, Paul

AU - Lanyon, Peter

AU - Jones, Adrian

AU - Bombardieri, Michele

AU - Sutcliffe, Nurhan

AU - Pitzalis, Costantino

AU - Gupta, Monica

AU - McLaren, John

AU - Cooper, Annie

AU - Giles, Ian

AU - Isenberg, David

AU - Saravanan, Vadivelu

AU - Coady, David

AU - Dasgupta, Bhaskar

AU - McHugh, Neil

AU - Young-Min, Steven

AU - Moots, Robert

AU - Gendi, Nagui

AU - Akil, Mohammed

AU - Barone, Francesca

AU - Fisher, Benjamin

AU - Rauz, Saaeha

AU - Richards, Andrea

AU - Bowman, Simon

PY - 2018/2/7

Y1 - 2018/2/7

N2 - OBJECTIVES: To assess the use of the Clinical EULAR Sjögren'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 Sjögren's syndrome (pSS), according to the new ACR-EULAR classification criteria, from the UK Primary Sjögren'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 disease activity (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.

AB - OBJECTIVES: To assess the use of the Clinical EULAR Sjögren'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 Sjögren's syndrome (pSS), according to the new ACR-EULAR classification criteria, from the UK Primary Sjögren'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 disease activity (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.

KW - Journal Article

U2 - 10.4414/smw.2018.14588

DO - 10.4414/smw.2018.14588

M3 - Article

VL - 148

SP - w14588

JO - Swiss Medical Weekly

JF - Swiss Medical Weekly

SN - 1424-7860

ER -