ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2536

Lupus Impact Tracker Is Responsive To Changes In Physician Assessed Disease Status By Systemic Lupus Erythematosus Responder Index

Hervé Devilliers1,2, Mark Kosinski3, Cindy Garris4 and Meenakshi Jolly5, 1Clinical investigation and clinical epidemiology center (INSERM CIE01), Dijon, France, 2Internal medicine and systemic disease unit, Dijon University Hospital, Dijon, France, 3QualityMetric Inc, Lincoln, RI, 4US Health Outcomes, GlaxoSmithKline R&D, Research Triangle Park, NC, 5Rheumatology, Rush University Medical Center, Chicago, IL

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Systemic Lupus Erythematosus-Clinical Aspects III: Biomarkers, Quality of Life and Disease Indicators, Late Complications

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 test the responsiveness of the LIT 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, BILAG, SELENA-SLEDAI) were obtained three months apart. Responders according to modified SRI were 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 was calculated among SRI responders and non-responders by taking the average difference divided by the standard deviation of the differences between the paired measurements, and baseline LIT, respectively. Difference in the LIT variation was compared among SRI responders and non responders using Kruskall Walis test.

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. SRM and ES were -0.69 and -0.36 among SRI responders, -0.20 and -0.12 among non responders respectively. The mean LIT variation (SD) was -2.9 (14.4) and -7.9 (11.4) among non responder and responders, respectively (p=0.02). The mean difference in LIT variation between non-responders and responders was 5.0.

Conclusion: LIT was moderately responsive to changes in disease activity as assessed by SRI in patients with SLE in this study. The value of 5.0 seems to indicate a clinically important difference in LIT variation between two groups of patients

Disclosure:

H. Devilliers,

GlaxoSmithKline,

5;

M. Kosinski,
None;

C. Garris,

GlaxoSmithKline,

3,

GlaxoSmithKline,

1;

M. Jolly,

GSK,

5,

Medimmune,

5.

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