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Original article

Vol. 148 No. 0506 (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

  • Alexandre Dumusc
  • Wan-Fai Ng
  • Katherine James
  • Bridget Griffiths
  • Elizabeth Price
  • Colin T. 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
  • Neil McHugh
  • Steven Young-Min
  • Robert J. Moots
  • Nagui Gendi
  • Mohammed Akil
  • Francesca Barone
  • Benjamin A. Fisher
  • Saaeha Rauz
  • Andrea Richards
  • Simon J. Bowman
  • on behalf of the UK primary Sjögren’s Syndrome Registry
DOI
https://doi.org/10.4414/smw.2018.14588
Cite this as:
Swiss Med Wkly. 2018;148:w14588
Published
07.02.2018

Summary

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.

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