Session Information
Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies
Session Type: Abstract Submissions (ACR)
Background/Purpose
With improving survival in SLE patients, patient-reported health-related quality of life (HRQoL) has become an important outcome. The LupusQoL is a disease-specific patient-derived HRQoL measure with good psychometric properties. The aim of the UK multi-centre LupusQoL Sensitivity Study is to assess whether the LupusQoL is sensitive to change when disease activity improves or deteriorates.
Methods
Patients with SLE (≥ 4 1997 ACR criteria), experiencing a flare (new A or B by BILAG-2004 Index) & requiring an increase in treatment (either prednisolone ≥ 20mg daily, introduction of methotrexate, parenteral steroids, cyclophosphamide &/or biologics) were recruited from 9 UK centres. Assessments were undertaken at baseline & monthly for 9 months after initiation of therapy & included BILAG-2004 disease activity index & the LupusQoL with 8 domains (physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, fatigue) and scores ranging from 0 (worst) to 100 (best HRQoL). Changes in disease activity are defined (see Table – first column) as deterioration: major & minor and improvement: major & minor. Changes in LupusQoL domain scores when disease activity improved, deteriorated or was unchanged between consecutive time-points are reported as mean changes, with 95% confidence intervals (CI) constructed using robust standard errors to account for repeated patient assessments.
Results
Mean (SD) age was 40.9 (12.8) & duration since diagnosis was 9.3 (8.1) years for the 101 patients recruited; 94% females, 62.6% white Caucasians, 15.2% south Asians, 8.1% black Caribbean, 4% black Africans, 5% mixed, 1% Chinese. At baseline mean (SD) BILAG2004 score was 16.4 (8.1); all mean LupusQoL domain scores were < 52. LupusQoL physical health, pain & fatigue domain scores increased when BILAG improved (overall, major & minor). Physical health and pain domain scores decreased when there was a major BILAG deterioration but changes with a minor BILAG deterioration were small and non-significant. The effects of improvements & deterioration in BILAG on the LupusQoL domain scores were smaller or not present (Table).
|
|
Mean changes in LupusQoL Domain Scores (95% Confidence Intervals) between monthly visits |
|||||||
|
BILAG change category (Total npat=100; nobs=724) |
Physical health |
Pain |
Planning |
Intimate relationships |
Burden to others |
Emotional health |
Body Image |
Fatigue |
|
Major & Minor Deterioration (npat=73 ;nobs=160) |
-0.8 (-3.0 to 1.4) |
-2.4 (-5.9 to 1.1) |
-1.2 (-3.8 to 1.4) |
2.6 (-1.3 to 6.5) |
2.3 (-0.6 to 5.2) |
-1.1 (-3.5 to 1.3) |
0.5 (-2.2 to 3.2) |
-1.0 (-3.5 to 1.5) |
|
Major deterioration (any system to A from B/C/D &/or any 2Bs from C/D) (npat=32; nobs=43) |
-4.9 (-9.4 to -0.4) |
-6.9 (-12.9 to -0.8) |
-3.0 (-8.2 to 2.1) |
4.3 (-6.6 to 15.2) |
1.4 (-4.6 to 7.5) |
-2.8 (-7.7 to 2.2) |
-4.1 (-8.7 to 0.5) |
-2.4 (-7.6 to 2.7) |
|
Minor deterioration (one B from C/D & no new As) (npat=63; nobs=117) |
0.7 (-1.6 to 2.9) |
-0.8 (-4.6 to 3.0) |
-0.5 (-3.6 to 2.6) |
2.0 (-1.5 to 5.5) |
2.7 (-0.6 to 5.9) |
-0.5 (-3.3 to 2.3) |
2.2 (-1.0 to 5.4) |
-0.5 (-3.3 to 2.4) |
|
Major & Minor Improvement (npat=97 ;nobs=199)
|
4.0 (1.9 to 6.1) |
7.7 (4.8 to 10.5) |
2.6 (0.1 to 5.1) |
2.4 (-1.2 to 6.0) |
2.4 (-0.1 to 4.8) |
3.1 (0.8 to 5.4) |
3.1 (0.1 to 6.1) |
4.1 (1.7 to 6.5) |
|
Major improvement (all As to B/C/D &/or all Bs to C/D) (npat=93; nobs=162) |
3.8 (1.3 to 6.3) |
7.4 (4.2 to 10.5) |
1.8 (-0.9 to 4.6) |
2.6 (-1.6 to 6.7) |
1.8 (-0.9 to 4.5) |
2.7 (0.0 to 5.3) |
3.4 (0.2 to 6.6) |
3.3 (0.6 to 5.9) |
|
Minor improvement (all As to B/C/D, some Bs to C/D but 1 persistent B) (npat24=; nobs=37) |
5.0 (0.6 to 9.3) |
8.8 (2.2 to 15.5) |
5.9 (-1.9 to 13.7) |
1.8 (-4.4 to 7.9) |
4.9 (-2.1 to 11.9) |
5.0 (-0.3 to 10.4) |
2.1 (-4.5 to 8.6) |
7.8 (2.1 to 13.4) |
|
Persistent active disease (all As or ≥ 2Bs unchanged) (npat=57;nobs=127) |
-0.9 (-2.7 to 0.9) |
-0.9 (-3.6 to 1.7) |
0.0 (-1.9 to 1.8) |
-2.5 (-6.3 to 1.3) |
-1.2 (-4.0 to 1.6) |
0.3 (-1.7 to 2.3) |
0.6 (-2.0 to 3.2) |
2.0 (-0.7 to 4.7) |
|
Persistent inactive disease (all systems remaining C/D) (npat=65;nobs=238) |
1.6 (0.6 to 2.7) |
2.0 (0.5 to 3.5) |
2.5 (0.9 to 4.0) |
1.8 (-0.8 to 4.5) |
4.1 (2.2 to 6.0) |
2.3 (1.1 to 3.5) |
0.2 (-1.2 to 1.5) |
1.7 (0.2 to 3.2) |
Conclusion
Improvement and deterioration of LupusQoL domain scores for physical health, pain & fatigue domain scores was seen in patients with significant changes in disease activity over 1 month. Sensitivity to change of other LupusQoL domains in relation to changes of disease activity may need to be evaluated over a longer interval as the more emotive type of response to the disease & its consequences may be latent and therefore not evident at monthly intervals.
Disclosure:
K. McElhone,
None;
J. Burnell,
None;
C. Sutton,
None;
J. Abbott,
None;
P. Lanyon,
None;
A. Rahman,
None;
C. S. Yee,
None;
M. Akil,
None;
Y. Ahmad,
None;
I. Bruce,
None;
C. Gordon,
GlaxoSmithKline, MedImmune, Merck Serono, Paraxel and UCB Pharma,
5;
L. S. Teh,
Roche Pharmaceuticals,
8.
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