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
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), accord...
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SMW supporting association (Trägerverein Swiss Medical Weekly SMW)
2018-02-01
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| Series: | Swiss Medical Weekly |
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| Online Access: | https://www.smw.ch/index.php/smw/article/view/2444 |
| _version_ | 1826996720332963840 |
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| author | 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 Swiss Medical Weekly |
| author_facet | 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 Swiss Medical Weekly |
| author_sort | Alexandre Dumusc |
| collection | DOAJ |
| description |
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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| first_indexed | 2024-04-11T12:12:01Z |
| format | Article |
| id | doaj.art-af11e023dbb742e2835f1b6a0799460b |
| institution | Directory Open Access Journal |
| issn | 1424-3997 |
| language | English |
| last_indexed | 2025-02-18T09:50:10Z |
| publishDate | 2018-02-01 |
| publisher | SMW supporting association (Trägerverein Swiss Medical Weekly SMW) |
| record_format | Article |
| series | Swiss Medical Weekly |
| spelling | doaj.art-af11e023dbb742e2835f1b6a0799460b2024-11-02T11:53:28ZengSMW supporting association (Trägerverein Swiss Medical Weekly SMW)Swiss Medical Weekly1424-39972018-02-01148050610.4414/smw.2018.14588Comparison 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 RegistryAlexandre Dumusc0Wan-Fai Ng1Katherine James2Bridget Griffiths3Elizabeth Price4Colin T. Pease5Paul Emery6Peter Lanyon7Adrian Jones8Michele BombardieriNurhan SutcliffeCostantino PitzalisMonica Gupta9John McLaren10Annie Cooper11Ian Giles12David Isenberg13Vadivelu Saravanan14David Coady15Bhaskar Dasgupta16Neil McHugh17Steven Young-Min18Robert J. Moots19Nagui Gendi20Mohammed Akil21Francesca Barone22Benjamin A. Fisher23Saaeha Rauz24Andrea Richards25Simon J. Bowman26Swiss Medical Weekly27University Hospital Lausanne, Switzerland; University Hospitals Birmingham NHS Foundation Trust, Birmingham, United KingdomNewcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom; Musculoskeletal Research Group, Institute of Cellular Medicine and Newcastle NIHR Biomedical Research Centre for Ageing and Chronic Diseases, Newcastle University, Newcastle upon Tyne, United KingdomInterdisciplinary Computing and Complex BioSystems research group, School of Computing Science, Newcastle University, Newcastle upon Tyne, United KingdomNewcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United KingdomGreat Western Hospitals NHS Foundation Trust, Swindon, United KingdomLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, United KingdomNottingham University Hospital, Nottingham, United KingdomNottingham University Hospital, Nottingham, United KingdomNottingham University Hospital, Nottingham, United KingdomGartnavel General Hospital, Glasgow, United KingdomNHS Fife, Whyteman's Brae Hospital, Kirkcaldy, United KingdomRoyal Hampshire County Hospital, Winchester, United KingdomUniversity College London Hospitals NHS Foundation Trust, London, United KingdomUniversity College London Hospitals NHS Foundation Trust, London, United KingdomQueen Elizabeth Hospital, Gateshead, United KingdomSunderland Royal Hospital, Sunderland, UKSouthend University Hospital, Southend, United KingdomRoyal National Hospital for Rheumatic Diseases, Bath, United KingdomPortsmouth Hospitals NHS Trust, Portsmouth, United KingdomAintree University Hospitals, Liverpool, United KingdomBasildon Hospital, Basildon, United KingdomRoyal Hallamshire Hospital, Sheffield, United KingdomUniversity of Birmingham, Birmingham, United KingdomUniversity of Birmingham, Birmingham, United KingdomUniversity of Birmingham, Birmingham, United KingdomBirmingham Dental Hospital, Birmingham, United KingdomUniversity Hospitals Birmingham NHS Foundation Trust, Birmingham, United KingdomOther collaborators in the UKPSSR are listed in appendix 1 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. https://www.smw.ch/index.php/smw/article/view/2444Sjögren’sclinical trialeligibilityregistryoutcomeClinESSDAI |
| spellingShingle | 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 Swiss Medical Weekly 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 Sjögren’s clinical trial eligibility registry outcome ClinESSDAI |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | comparison of essdai and clinessdai in potential optimisation of trial outcomes in primary sjogren s syndrome examination of data from the uk primary sjogren s syndrome registry |
| topic | Sjögren’s clinical trial eligibility registry outcome ClinESSDAI |
| url | https://www.smw.ch/index.php/smw/article/view/2444 |
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