Session Information
Date: Sunday, November 8, 2015
Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session I
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Current validated disease assessment instruments (DAIs) in systemic lupus erythematosus (SLE) such as SLEDAI-2K and BILAG, require disease expertise and/or involve complex scoring systems, and are often impractical for use in daily clinical practice and hence are seldom used routinely in clinical practice. In an attempt to address this issue, several new simplified DAIs in SLE are in different stages of development, including SLE Activity Tracking Evaluation Tool (LAST; 14 items; includes medications, Physician Global Assessment (PhGA) 0-10 scale, Patient Global Assessment (0-10 scale), C3, C4 & anti-dsDNA lab measures), Clinical LAST (C-LAST; 11 items; similar to LAST, without lab measures), Total Lupus Activity Score (TLAS; 30 items; includes 15 physician clinical assessments and 15 patient self-assessment of lupus symptoms), and Simple Disease Assessment for People with Lupus Erythematosus (SIMPLE; 17 items; includes patient self-assessment of lupus symptoms, Lupus Impact Tracker, steroid medication, C3, C4 & proteinuria). The primary objective of this analysis is to assess the convergent validity of these various tools as well as PhGA indices in relation to SLEDAI-2K at baseline in a diverse sample of SLE patients in the US.
Methods: This is a prospective real-world observational cohort study of SLE patients receiving standard care at two academic and two private practice settings in the US. Consecutive patients meeting study criteria were screened within the study recruitment window. Physicians and patients are asked to complete their respective portions of the studied instruments at four different time points: baseline, 3 months, 6 months, and 12 months; PhGA:0-3 scale and SLEDAI-2K was completed for all patients; BILAG was assessed for patients at the academic sites; TLAS and SIMPLE for approx. 152 patients each; LAST & C-LAST algorithm for 169 patients each. Baseline data (presented here) was analyzed and Pearson correlation coefficients were calculated comparing mean SLEDAI-2K score to the individual DAI scores. Correlations with BILAG will be assessed in the longitudinal analysis in the future.
Results: A total of 201 SLE patients consented and enrolled in the study (mean age: 45 yrs; female: 91%; Black/African American (AA): 56%; Hispanic: 10%). At study entry (baseline), mean SLEDAI-2K score was 3.4 (range: 0-16); each of the DAIs (PhGA:0-10 scale, PhGA:0-3 scale, LAST, C-LAST, SIMPLE & TLAS) had a statistically significant positive correlation with the SLEDAI-2K, as shown in table-1. Analysis stratified by AA and non-AA status revealed similarly significant correlations between SLEDAI-2K and the other DAIs.
Conclusion: In the baseline cross-sectional analysis, each of the studied DAIs appeared to have convergent validity with the SLEDAI-2K. Further analyses with longitudinal data will assess additional metric properties of these instruments.
Table 1. DAI Scores and Correlations with SLEDAI-2K
|
Assessments |
n |
Median Score (IQR) |
Mean Score (SD; range) |
Pearson correlation with SLEDAI-2K r; p-value |
|
LAST (0=No activity – 100=High activity) |
169 |
23.0 (15.0-32.0) |
23.9 (13.0; 0-70.0) |
0.566; <0.0001 |
|
PhGA:0-10 scale (0=No activity – 10=High activity) |
168 |
2 (1-3) |
2.3 (1.9; 0–8) |
0.563; <0.0001 |
|
SIMPLE (0=No activity – 100=High activity) |
152 |
21.5 (15.1-27.8) |
23.2 (11.2; 6.2-68.5) |
0.560; <0.0001 |
|
PhGA:0-3 scale (0=No activity – 3=High activity) |
201 |
1 (N/A) |
0.9 (0.7; 0-3) |
0.553; <0.0001 |
|
C-LAST (0=No activity – 70=High activity) |
169 |
20.0 (12.5-27.5) |
20.3 (11.1; 0-50.0) |
0.450; <0.0001 |
|
TLAS (0=No activity – 120=High activity) |
153 |
56 (50-64) |
56.9 (10.8; 31.0-86.0) |
0.348; <0.0001 |
|
SLEDAI-2K (0=No activity – 105=High activity) |
199 |
2 (0-6) |
3.4 (3.2; 0-16) |
N/A |
To cite this abstract in AMA style:
Collins C, Chatham WW, Busch H, Gaylis NB, Hautamaki E, Narayanan S. Convergent Validity of New Disease Assessment Instruments in Systemic Lupus Erythematosus in Relation to Sledai-2K [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/convergent-validity-of-new-disease-assessment-instruments-in-systemic-lupus-erythematosus-in-relation-to-sledai-2k/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/convergent-validity-of-new-disease-assessment-instruments-in-systemic-lupus-erythematosus-in-relation-to-sledai-2k/