Session Information
Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies
Session Type: Abstract Submissions (ACR)
Background/Purpose: Lupus Impact Tracker (LIT) is a 10-item patient reported outcome tool to measure the impact of Systemic Lupus Erythematosus (SLE) or its treatment on patients’ daily lives. The transformed scores range from 0-100, where higher scores denote greater impact. The tool is responsive to self-reported changes in SLE health status over time. Herein, we compare the responsiveness of the LIT and LupusQoL (34 items) to changes in disease activity as judged by SLE responder index (SRI).
Methods: Adult SLE patients were prospectively recruited from 20 North American Rheumatology clinics for the LIT study- an observational, non-interventional prospective multi center study conducted across the US and Canada. Data (Demographics, LIT, LupusQoL, BILAG, SELENA-SLEDAI) were obtained three months apart. Modified SRI was defined as (1) a decrease in SELENA-SLEDAI (4 points), (2) No new BILAG A and not more than 1 new B and (3) No increase in Physician Global Assessment (PGA). Latter definition was used as our PGA variable was categorical (0/1/2/3). Standardized response mean (SRM) and effect size (ES) for LIT and LupusQoL domains were calculated among SRI responders and non-responders by taking the average difference divided by the standard deviation of the differences between the paired measurements at baseline and 3 month visit LIT scores. Kruskall Walis test was used to compare the SRM among SRI responders (R) and non responders (NR).
Results: 325 patients participated (90% Female); 53% Whites, 33% Black and 17% Hispanic. Mean (SD) age and SELENA-SLEDAI at baseline were 42.3 (16.2 ) yrs and 4.3 (3.8), respectively. Mean (SD) LIT score at baseline was 39.4 (22.9). SRI data was available for 295 (40 R and 255 NR) at the 3 month timepoint. LIT SRM (ES) was -0.69 (-0.36) and -0.20 (-0.12) among SRI responders and non-responders respectively, (p=0.02).
For LupusQoL, SRM (ES) for Physical health and Pain domains were 0.42 (0.23) and 0.65 (0.44) respectively.
Conclusion: 10 item LIT was modestly responsive to changes in disease activity as assessed by SRI in patients with SLE in this study Two domains (11 items) of LupusQoL showed responsiveness to SRI . Inclusion of the these tools in clinical care and clinical trials may provide further insight into its responsiveness.
|
|
Responders (n=40) |
Non-responders (n=255) |
p-value |
||||||||
|
|
Mean variation |
SRM |
95% CI |
ES |
95% CI |
Mean variation |
SRM |
95% CI |
ES |
95% CI |
|
|
LIT |
– 7.9 |
-0.68 |
[-1.05;-0.28] |
-0.36 |
[-0.54;-0.16] |
-2.9 |
-0.19 |
[-0.32;-0.06] |
-0,12 |
[-0.2;-0.04] |
0.023 |
|
LupusQoL domains |
|
|
|
|
|
|
|
|
|
|
|
|
Physical health |
+ 5.7 |
+ 0.42 |
[0.07;0.74] |
+ 0.23 |
[0.04;0.41] |
+ 0.5 |
+ 0.03 |
[-0.09;0.15] |
+ 0.02 |
[-0.05;0.09] |
0.042 |
|
Pain |
+ 12.6 |
+ 0.65 |
[0.36;0.91] |
+ 0.44 |
[0.19;0.66] |
+ 1.6 |
+ 0.08 |
[-0.04;0.20] |
+ 0.06 |
[-0.03;0.13] |
0.002 |
|
Planning |
+ 3.5 |
+ 0.18 |
[-0.16;0.50] |
+ 0.13 |
[-0.10;0.37] |
+ 1.2 |
+ 0.07 |
[-0.06;0.19] |
+ 0.04 |
[-0.03;0.12] |
NS |
|
Intimate Relationship |
– 0.7 |
– 0.06 |
[-0.41;0.27] |
– 0.05 |
[-0.32;0.24] |
+ 0.4 |
+0.02 |
[-0.09;0.08] |
+0.01 |
[-0.16;0.14] |
NS |
|
Burden to others |
+ 6.0 |
+ 0.24 |
[-0.05;0.55] |
+ 0.20 |
[-0.05;0.44] |
+ 3.9 |
+ 0.18 |
[0.04-0.31] |
+ 0.12 |
[0.04-0.21] |
NS |
|
Emotional health |
+ 4.5 |
+ 0.38 |
[0.07;0.68] |
+ 0.17 |
[0.03;0.32] |
+ 0.3 |
+ 0.01 |
[-0.11;0.14] |
+ 0.01 |
[-0.09;0.11] |
NS |
|
Body image |
+ 4.7 |
+ 0.29 |
|
+ 0.15 |
|
+ 2.7 |
+ 0.13 |
|
+ 0.09 |
|
NS |
|
Fatigue |
+ 3.5 |
+ 0.26 |
[-0.07;0.56] |
+ 0.16 |
[-0.05;0.36] |
+ 2.5 |
+0.13 |
[0.01;0.25] |
+ 0.09 |
[0.01;0.17] |
NS |
Disclosure:
H. Devilliers,
None;
N. Annapureddy,
None;
W. Sequeira,
None;
J. A. Block,
None;
M. Jolly,
None.
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