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.
OBJECTIVE
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.
Rheumatology Research Group, School of Immunity and Infection, College of Medical and Dental Sciences, The Medical School (East Wing), University of Birmingham, Birmingham B15 2TT, UK. csyee@ymail.com
Chee-Seng
CS
Yee
Vernon T
VT
Farewell
David A
DA
Isenberg
Bridget
B
Griffiths
Lee-Suan
LS
Teh
Ian N
IN
Bruce
Yasmeen
Y
Ahmad
Anisur
A
Rahman
Athiveeraramapandian
A
Prabu
Mohammed
M
Akil
Neil
N
McHugh
Christopher
C
Edwards
David
D
D'Cruz
Munther A
MA
Khamashta
Caroline
C
Gordon
D000328:Adult; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D018450:Disease Progression; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012372:ROC Curve; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D006113:United Kingdom
Epidemiology. 2005 Jan;16(1):73-81
15613948
J Rheumatol. 1998 Feb;25(2):277-84
9489819
J Rheumatol. 2004 Dec;31(12):2390-4
15570639
Arthritis Rheum. 1999 Jul;42(7):1354-60
10403262
Arthritis Rheum. 1989 Sep;32(9):1107-18
2775320
J Rheumatol. 2000 Feb;27(2):377-9
10685800
J Rheumatol. 1994 Aug;21(8):1468-71
7983648
Arthritis Rheum. 1982 Nov;25(11):1271-7
7138600
Arthritis Rheum. 2004 Nov;50(11):3418-26
15529383
J Rheumatol. 2000 Mar;27(3):664-70
10743805
J Rheumatol. 1992 Apr;19(4):608-11
1593583
Rheumatology (Oxford). 2009 Jun;48(6):691-5
19395542
J Rheumatol. 1992 Oct;19(10):1551-8
1464867
J Rheumatol. 1993 Apr;20(4):657-60
8496860
Arthritis Rheum. 2009 Sep 15;61(9):1143-51
19714615
Arthritis Rheum. 2007 Dec;56(12):4113-9
18050213
Biometrics. 2000 Jun;56(2):645-6
10877330
Arthritis Rheum. 1992 Jun;35(6):630-40
1599520
N Engl J Med. 2005 Dec 15;353(24):2550-8
16354891
Arthritis Rheum. 1991 Aug;34(8):937-44
1859487
Clin Chem. 1993 Apr;39(4):561-77
8472349
J Clin Epidemiol. 2002 May;55(5):488-97
12007552
J Rheumatol. 2000 Jun;27(6):1421-8
10852264
J Rheumatol. 1992 Jan;19(1):53-9
1556700
Ann Rheum Dis. 2008 Jun;67(6):873-6
17519277
Arthritis Rheum. 1997 Sep;40(9):1725
9324032
J Rheumatol. 2002 Feb;29(2):288-91
11838846
J Clin Epidemiol. 2000 May;53(5):459-68
10812317