Session Information
Date: Monday, October 22, 2018
Title: Systemic Lupus Erythematosus – Clinical Poster II: Biomarkers and Outcomes
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: Fatigue is one of the most frequent and disabling issues in systemic lupus erythematosus (SLE). It is, however, difficult to quantify. The Ad Hoc Committee on SLE Response Criteria for Fatigue in 2007 recommended use of the Krupp Fatigue Severity Scale (FSS). Since then, the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue score has also been validated in SLE. We performed a review of instruments used to measure fatigue in adult SLE patients from 2007 onward.
Methods: We used Medline and EMBase from 2008 to Oct. 2017 search terms to identify clinical trials and observational studies in adult SLE, where fatigue was an outcome. All English and French studies were reviewed to determine the fatigue measures used, and study results.
Results: 22 studies met our inclusion criteria. Eight fatigue scales were used. The most frequently used instruments were the Visual Analogue Scale (VAS) for fatigue (used in 32%), the FSS (32%) and the FACIT-Fatigue scale (14%). The FSS was used in the majority of clinical trials (5 of 12; 42%) with the remaining evenly divided between the two other scales. The VAS was used by the majority of observational studies (5 of 10; 50%), followed by the FSS (2 of 10; 20%). Fourteen of the 22 studies demonstrated a difference in fatigue levels in terms of statistical and clinically meaningfulness. Of the 8 studies which did not, 3 used the FFS, 3 used the VAS and 2 used other scales (MFI and BFI). All 3 studies using FACIT detected clinically and statistically significant differences.
Conclusion: The VAS, FSS and FACIT Fatigue scale were the most frequently used instruments to measure fatigue in adult SLE studies from 2008-2017. Several studies detected clinical important changes in fatigue with these instruments. If fatigue is considered a core data element of observational studies in SLE, this review may help inform choice of instruments.
Table 1: Fatigue scales used in studies of adults with systemic lupus (SLE)
|
Measure |
Description |
Psychometrically Validated in SLE(38) |
Minimal Clinically Important Difference (MCID) in SLE (39) |
|
Visual Analogue Scale (VAS) (40) |
Single 100mm line to measure fatigue |
No* |
Δ 10% |
|
Krupp Fatigue Severity Scale (FSS) (33) |
9-item questionnaire on impact of fatigue on specific types of functioning |
Yes |
Δ 9.7% |
|
Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale (5) |
13-item questionnaire on aspects of physical and mental fatigue and its impact on daily living over the past 7 days. |
Yes |
Δ 11.5% |
|
Multidimensional Assessment of Fatigue (MAF) (33) |
16 item scale that measures fatigue over the past week according to four dimensions: severity, distress, timing and its impact on daily living. |
No |
Δ 11.5% |
|
Multidimensional Fatigue Inventory (MFI) (41) |
20-item self-reported instrument that covers general, physical and mental fatigue as well as reduced motivation and activity. |
No |
Δ 14.3% |
|
Fatigue Assessment Scale (FAS) (42) |
Self-administered 10 item fatigue measure |
No |
N/A** |
|
Brief Fatigue Index/Inventory (BFI) (43) |
Multidimensional self-assessment tool which assesses severity of pain and fatigue in patients with chronic conditions |
Yes |
N/A** |
|
Vanderbilt Fatigue Severity VFS) (4) |
Consists of a fatigue subscale originally developed in Rheumatoid arthritis patients |
No |
N/A** |
* Validated in other populations, including chronic fatigue syndrome, and stroke.
**N/A= not available
Table 2: Summary of Clinical Trials with Fatigue as an Outcome in SLE
|
Authors |
Data collection/ publication |
Scale |
Intervention |
N |
Findings |
Country |
|
Greco et al.(15) |
2004-2006 |
FSS |
Acupuncture versus minimal needling |
24 |
No difference detected |
USA |
|
Strand et al. (9) |
2007-2010 |
FACIT |
Belimumab or placebo |
1684 |
Clinically significant improvement * |
Multicenter |
|
Hartkamp et al. (14) |
Published 2009 |
MFI |
Dehydroepiandrosterone versus placebo |
60 |
No difference detected |
Netherlands |
|
Uppal et al. (8) |
Published 2009 |
VAS |
Standard therapy +/- infliximab |
27 |
No difference detected |
Kuwait |
|
Lai et al. (12) |
2009-2011 |
FAS |
Placebo versus escalating doses of N-acetylcysteine |
36 |
Statistically significant improvement |
USA |
|
Merrill et al. (7) |
Published 2010 |
VAS |
Abatacept versus placebo |
175 |
Clinically significant improvement * |
Multicenter |
|
Petri et al. (10) |
2010-2012 |
FACIT |
Blisibimod or placebo |
547 |
Clinically significant improvement * |
USA & Brazil |
|
Davies et al. (18) |
Published 2012 |
FSS |
Low glycemic index (GI ) diet and low-calorie (LC) diet versus placebo |
23 |
Clinically significant improvement with GI diet*, but only statistically significant improvement with LC diet (did not meet MCID) |
UK |
|
Avaux et al. (17) |
2012-2013 |
FSS |
Exercise versus controls |
45 |
Clinically significant improvement * |
Belgium |
|
Merrill et al. (11) |
2011-2014 |
BFI |
Tabalumab vs. placebo |
1124 |
No difference detected |
Multicenter |
|
Bogdanovic et al. (16) |
Published 2015 |
FSS |
Aerobic and isotonic exercise |
60 |
Clinically significant improvement * |
Serbia |
|
Arriens et al. (13) |
Published 2015 |
FSS |
Fish oil versus placebo |
50 |
No difference |
USA |
*Met minimal clinically important difference (MCID)
Table 3: Summary of Observational Studies Reporting Fatigue as an Outcome in SLE
|
Authors |
Data collection/ publication |
Scale |
Predictor (independent) variable |
N |
Results |
Country |
|
Petri et al. (26) |
2003-2004 |
FSS |
Depression |
160 |
Clinically significant association * |
USA |
|
Ruiz-Irastorza et al. (20) |
2008 |
VAS |
Vitamin D levels |
80 |
No difference detected |
Spain |
|
Fischin et al. (28) |
2009 |
VFS |
Pain, coping and catastrophizing |
447 |
Statistically significant association (MCID not available) |
Germany |
|
Fragoso et al. (24) |
2009-2010 |
VAS |
Vitamin D levels |
142 |
No difference detected |
Brazil |
|
Kasitanon et al. (25) |
2009-2011 |
FACIT |
Sleep disturbances |
56 |
Clinically significant association * |
Thailand |
|
Stockton et al. (23) |
Published 2012 |
FSS |
Vitamin D levels |
45 |
No difference detected |
Australia |
|
Waldheim et al. (27) |
Published 2013 |
MAF |
Pain severity |
175 |
Statistically significant association (MCID not available) |
Sweden |
|
Salman-Monte et al. (21) |
2012-2014 |
VAS |
Vitamin D deficiency & insufficiency |
102 |
Clinically significant association* between increased fatigue & low vitamin D |
Spain |
|
Parodis et al. (19) |
2011-2015 |
VAS |
Belimumab |
58 |
Clinically significant improvement* |
Sweden & France |
|
Abaza et al. (22) |
Published 2016 |
VAS |
Vitamin D levels |
90 |
Clinically significant association* between increased fatigue & low vitamin D |
Egypt |
*Met minimal clinically important difference (MCID)
To cite this abstract in AMA style:
Barbacki A, Petri M, Avina-Zubieta JA, Alarcón GS, Bernatsky S. Fatigue Measurements in Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/fatigue-measurements-in-systemic-lupus-erythematosus/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/fatigue-measurements-in-systemic-lupus-erythematosus/