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The use of Systemic Lupus Erythematosus Disease Activity Index-2000 to define active disease and minimal clinically meaningful change based on data from a large cohort of systemic lupus erythematosus patients

The use of Systemic Lupus Erythematosus Disease Activity Index-2000 to define active disease and minimal clinically meaningful change based on data from a large cohort of systemic lupus erythematosus patients
The use of Systemic Lupus Erythematosus Disease Activity Index-2000 to define active disease and minimal clinically meaningful change based on data from a large cohort of systemic lupus erythematosus patients
Objectives: To examine SLEDAI-2000 cut-off scores for definition of active SLE and to determine the sensitivity to change of SLEDAI-2000 for the assessment of SLE disease activity and minimal clinically meaningful changes in score.

Methods: Data from two multi-centre studies were used in the analysis: in a cross-sectional and a longitudinal fashion. At every assessment, data were collected on SLEDAI-2000 and treatment. The cross-sectional analysis with receiver operating characteristic (ROC) curves was used to examine the appropriate SLEDAI-2000 score to define active disease and increase in therapy was the reference standard. In the longitudinal analysis, sensitivity to change of SLEDAI-2000 was assessed with multinomial logistic regression. ROC curves analysis was used to examine possible cut-points in score changes associated with change in therapy, and mean changes were estimated.

Results: In the cross-sectional analysis, the most appropriate cut-off scores for active disease were 3 or 4. In the longitudinal analysis, the best model for predicting treatment increase was with the change in SLEDAI-2000 score and the score from the previous visit as continuous variables. The use of cut-points was less predictive of treatment change than the use of continuous score. The mean difference in the change in SLEDAI-2000 scores, adjusted for prior score, between patients with treatment increase and those without was 2.64 (95% CI 2.16, 3.14).

Conclusions: An appropriate SLEDAI-2000 score to define active disease is 3 or 4. SLEDAI-2000 index is sensitive to change. The use of SLEDAI-2000 as a continuous outcome is recommended for comparative purposes.
SLEDAI-2000, SLE, sensitivity to change, disease activity, minimal clinically meaningful change
1462-0324
982-988
Yee, Chee-Seng
4bf73452-56d6-4e7e-b4a0-108df6e439a2
Farewell, Vernon T.
005669c0-7faf-44e6-82c6-d1679e650762
Isenberg, David A.
ede068d1-1953-4022-b894-b7aacf7d08f4
Griffiths, Bridget
832d47b3-c3f7-4aef-b44c-0c3ea14c12e6
Teh, Lee-Suan
c6c19ae8-bbc3-445b-85f4-d2e89cf85430
Bruce, Ian N.
1375900a-3ac1-4235-a573-abfd8c21c37d
Ahmad, Yasmeen
4e3ee2d0-c0de-4e6c-91dd-3b9f7886c744
Rahman, Anisur
cb88abd6-00b3-44da-87bf-a7772844dc86
Prabu, Athiveeraramapandian
f60265ed-6339-4613-b5ee-44ff1dc34377
Akil, Mohammed
701701a9-098d-48bc-9f2a-be6aa178c7a4
McHugh, Neil
8ba20383-0f65-43c4-bdd4-57f098f79110
Edwards, Christopher
dcb27fec-75ea-4575-a844-3588bcf14106
D'Cruz, David
75e7b96f-ef08-4deb-b137-db4880e40fc1
Khamashta, Munther A.
30a044e5-cc8f-4cae-a198-0b2c7154717a
Gordon, Caroline
26c12bd7-98a2-4614-827d-6016b6480e89
Yee, Chee-Seng
4bf73452-56d6-4e7e-b4a0-108df6e439a2
Farewell, Vernon T.
005669c0-7faf-44e6-82c6-d1679e650762
Isenberg, David A.
ede068d1-1953-4022-b894-b7aacf7d08f4
Griffiths, Bridget
832d47b3-c3f7-4aef-b44c-0c3ea14c12e6
Teh, Lee-Suan
c6c19ae8-bbc3-445b-85f4-d2e89cf85430
Bruce, Ian N.
1375900a-3ac1-4235-a573-abfd8c21c37d
Ahmad, Yasmeen
4e3ee2d0-c0de-4e6c-91dd-3b9f7886c744
Rahman, Anisur
cb88abd6-00b3-44da-87bf-a7772844dc86
Prabu, Athiveeraramapandian
f60265ed-6339-4613-b5ee-44ff1dc34377
Akil, Mohammed
701701a9-098d-48bc-9f2a-be6aa178c7a4
McHugh, Neil
8ba20383-0f65-43c4-bdd4-57f098f79110
Edwards, Christopher
dcb27fec-75ea-4575-a844-3588bcf14106
D'Cruz, David
75e7b96f-ef08-4deb-b137-db4880e40fc1
Khamashta, Munther A.
30a044e5-cc8f-4cae-a198-0b2c7154717a
Gordon, Caroline
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Yee, Chee-Seng, Farewell, Vernon T., Isenberg, David A., Griffiths, Bridget, Teh, Lee-Suan, Bruce, Ian N., Ahmad, Yasmeen, Rahman, Anisur, Prabu, Athiveeraramapandian, Akil, Mohammed, McHugh, Neil, Edwards, Christopher, D'Cruz, David, Khamashta, Munther A. and Gordon, Caroline (2011) The use of Systemic Lupus Erythematosus Disease Activity Index-2000 to define active disease and minimal clinically meaningful change based on data from a large cohort of systemic lupus erythematosus patients. Rheumatology, 50 (5), 982-988. (doi:10.1093/rheumatology/keq376). (PMID:21245073)

Record type: Article

Abstract

Objectives: To examine SLEDAI-2000 cut-off scores for definition of active SLE and to determine the sensitivity to change of SLEDAI-2000 for the assessment of SLE disease activity and minimal clinically meaningful changes in score.

Methods: Data from two multi-centre studies were used in the analysis: in a cross-sectional and a longitudinal fashion. At every assessment, data were collected on SLEDAI-2000 and treatment. The cross-sectional analysis with receiver operating characteristic (ROC) curves was used to examine the appropriate SLEDAI-2000 score to define active disease and increase in therapy was the reference standard. In the longitudinal analysis, sensitivity to change of SLEDAI-2000 was assessed with multinomial logistic regression. ROC curves analysis was used to examine possible cut-points in score changes associated with change in therapy, and mean changes were estimated.

Results: In the cross-sectional analysis, the most appropriate cut-off scores for active disease were 3 or 4. In the longitudinal analysis, the best model for predicting treatment increase was with the change in SLEDAI-2000 score and the score from the previous visit as continuous variables. The use of cut-points was less predictive of treatment change than the use of continuous score. The mean difference in the change in SLEDAI-2000 scores, adjusted for prior score, between patients with treatment increase and those without was 2.64 (95% CI 2.16, 3.14).

Conclusions: An appropriate SLEDAI-2000 score to define active disease is 3 or 4. SLEDAI-2000 index is sensitive to change. The use of SLEDAI-2000 as a continuous outcome is recommended for comparative purposes.

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More information

e-pub ahead of print date: 18 January 2011
Published date: May 2011
Keywords: SLEDAI-2000, SLE, sensitivity to change, disease activity, minimal clinically meaningful change
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 338211
URI: http://eprints.soton.ac.uk/id/eprint/338211
ISSN: 1462-0324
PURE UUID: 62ec89a1-e33a-4546-aea9-0ced70f7be47

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Date deposited: 11 May 2012 15:37
Last modified: 14 Mar 2024 11:02

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Contributors

Author: Chee-Seng Yee
Author: Vernon T. Farewell
Author: David A. Isenberg
Author: Bridget Griffiths
Author: Lee-Suan Teh
Author: Ian N. Bruce
Author: Yasmeen Ahmad
Author: Anisur Rahman
Author: Athiveeraramapandian Prabu
Author: Mohammed Akil
Author: Neil McHugh
Author: David D'Cruz
Author: Munther A. Khamashta
Author: Caroline Gordon

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