of systemic lupus erythematosus in Egyptian patients: the impact of
disease activity on the quality of life
Sliem1,&, Gamal Tawfik1, Khalil A Khalil1,
of Internal Medicine, Faculty of Medicine, Suez Canal University, Egypt
of internal medicine, Faculty of Medicine, Suez Canal University, Ismailia,
Post-code 41522. Tel. 002-064-2381410, Egypt
lupus erythematosus (SLE) is a chronic autoimmune disease affecting almost all
organ systems. It is characterized by exacerbations (or flares) of disease
activity and disease damages. Measures of disease activity include; SLE disease
activity index (SLEDAI) , British Isles Lupus Assessment
Group (BILAG) disease activity index  and SLE Activity
Measure (SLAM) 
in addition to disease activity and damages, other important consequences of
the disease include changes in Quality of Life (QoL) affecting employment and
social functioning. Therefore, in an effort to improve assessment of outcomes
in SLE, the outcome measures in rheumatology clinical trials group has
recommended that trials of SLE include outcome measures of QoL, adverse events
and economic costs, in addition to measures of disease activity and damages .
term health related QoL (HRQoL) refers to those aspects of life which are
affected by health e.g. functional status, and excludes other determinants of
QoL e.g.: income, job security or living conditions .
Measuring of HRQoL provides patients with an opportunity to participate more
fully in their treatment and ultimately facilitate better communication with
the multi-disciplinary team of health professionals involved in their care . In addition to more objective clinical indicators of
disease, measurement of HRQoL, allows for a more comprehensive assessment and
in some cases may prove to be a more sensitive indicator of treatment response
than measures of disease activity or damages [4,5].
most commonly used measure of HRQoL is the short form (SF)-36. The SF-36 is a
generic, 36-item self-report questionnaire. It was designed to be used in a
variety of conditions, populations, and settings. The SF-36 has been shown to
be a valid and reliable instrument in SLE and has been used in numerous studies
in SLE .
order to evaluate QoL in rural and urban areas in Lebanon, the SF-36 health
survey was adapted into Arabic . In Egypt, reliability
of an Arabic version of the SF 36-Item health survey and its equivalence to the
US-English version was performed by Abdul-Mohsin et al. .
the basis of the hypothesis (SLE is a disease characterized by a variety
of clinical manifestation with changes of its activity over time, and the
quality of life of SLE patients during disease activity is low), the present
study was designed with four objectives: 1) Studying the clinical
and biochemical pattern of SLE in Egyptian patients; 2) Assess different
aspects of quality of life in terms of physical, mental, psychological and
social aspects; 3) Assess disease activity using SLEDI score; 4) Assess factors
affecting quality of life including disease activity and renal involvement that
were confirmed by previous records of kidney pathology.
present study was conducted as a descriptive case control study on 59 of SLE patients
who registered at SLE special outpatient clinic in the Suez Canal University
Hospital from January 2008 to April 2009. All fulfilled the Criteria of
Classification of the American College of Rheumatology (ACR) for diagnosis of
healthy adults matched for age and gender were considered as a control group.
They were defined by self-report and confirmed by physician observations. The
control group was added to be compared with SLE group regarding QoL assessment.
sample size was calculated according to the following equation :
2 X PQ/D2: Where: N= number of subjects. Za = the value of standard normal distribution
for type I error probability for the sided test and equals 1.96; P=prevalence
of poor QoL of SLE patients=81%. Q=1-P, D2=the accuracy of estimate= 0.01.
According to the calculations, the sample size was estimated at 59 patients.
the time of HRQoL assessment, all patients were subjected to the following: 1)
Complete medical history and clinical examination, 2) Outcome measures and
assessment questionnaires: Disease activity was measured by SLEDAI score and
measure of QoL was done by Medical Outcomes Study SF-36, which is a generic
measure that is applicable in a variety of conditions, including SLE.
disease activity using SLEDAI
has 24 descriptors representing 9 organ systems affected by SLE. For every
organ, score points are calculated. Points are based on a "weighted"
index for lupus disease activity with 8 points for central nervous system and
vascular system; 4 points for renal and musculoskeletal systems; 2 points for
serosal, dermal and immunologic systems; 1 point for constitutional and
hematological. The points were assigned if the descriptor is present at the
time of the patient visit or within the preceding 10 days [1,12]. SLEDAI score = Sum of score points of 24
descriptors with minimum score = 0 and maximum score = 105. SLEDAI score
grading: no, mild, moderate, and severe activities.
the quality of life using SF-36 Health Survey questionnaire
Arabic  and the English 
versions were used. The questionnaire included eight subscales (physical and
social functioning, role limitations due to physical and emotional problems,
mental health, energy/vitality, pain and general health perception) that can be
summarized into two component scores; physical and mental component summary
investigation included complete blood picture and urine analysis. Kidney
function tests, anti-nuclear antibodies (ANA), and anti-ds DNA antibodies
(ELISA) were also performed.
reports of kidney Biopsy
kidney biopsies were reviewed for all patients to estimate renal involvement
and to determine the extent and severity of renal disease. Reports of biopsies
were taken to be correlated with QoL of the patients. According to
International Society of Nephrology – Renal Pathology Society Classification of
Lupus Nephritis (2003), patients were classified into 6 classes: class I
(minimal), class II (mesangial), class III (focal), class IV (diffuse), class V
(membranous), and class VI (advanced sclerosis) [14,15].
consent was obtained from all the adults. The aim and the value of the work
were explained in a simplified manner for them. There was no harm inflicted on
them. On the contrary, all had benefited from follow-up and the final results
of the study. The study was approved by the ethical committee of faculty of
medicine, Suez Canal University.
data were analyzed using parametric tests and presented in terms of mean,
standard deviation (SD) of the mean and percentages. Statistical analysis was
done using SPSS Ver. 11. Student-t, correlation coefficient, and Chi-square
tests were used to evaluate the results. P value was set at <0.05 for
statistically significant results and <0.0001 for highly significant
of 59 SLE patients, 56 were females (94.9%) and 3 patients (5.1%) were
males. The age ranged from 16 to 42 years with a mean of 28.6±6.6 years.
The mean disease duration was 5.6±3.4 years. There were no differences between
cases and controls for demographic characteristic items (table 1).
clinical and biochemical findings (table 2), malar rash was presented in 91.5%
of the patients, photosensitivity was presented in 83.1% and discoid rash was
presented in 20.3%. Eighty five percent (85%) of the patients were presented
with mucosal ulcers. Arthritis was present in 52.5% of the SLE patients, while
serositis (cardiopulmonary involvements) was present in 44.1% of them. 10.2% of
the patients had had persistent proteinuria >0.5 grams/day or greater than
3+, 23.7% had cellular casts, and 54.2% had both proteinuria and urinary casts.
About 51% of the patients had anemia, 55.9% had leucopenia and 33.9% had
thrombocytopenia. 73% had elevated DNA and 6.8% had positive both anti-DNA and
to SLEDAI score 51% of the SLE population in our study had mild activity and
27.2% had moderate to severe activity. No activity was present in 13%, while
16% had from moderate to severe activity.
renal pathology classification of lupus nephritis, 12% of the patients had
class I, 5.1% had class II, 57.6% had class III, 20.3% class IV and 5.1% had
Table 3 shows the main domains of QoL measured by SF-36 in SLE patients compared to
control. All domains of SF-36 including general health, physical functions,
physical limitations, energy/fatigue, emotional well-being, pain, social
functions, and health changes were lower in the SLE patients compared with
control except emotional limitations.
Table 4 shows that all domains of SF-36 including general health, physical functions,
physical limitations, emotional limitations, energy/fatigue, emotional
well-being, pain, social functions, and health changes were negatively
correlated with grades of disease activity as detected by SLEDAI.
Table 5 shows the mean score of each domains of QoL measured by SF-36 according to
renal pathology classification of lupus nephritis in SLE patients. All domains
of SF-36 including general health, emotional limitations, physical limitations,
energy/fatigue, emotional well-being, pain, social functions, and health
changes were lower in class IV-V the SLE patients compared with other classes
except physical functions.
Table 6 shows the correlation between QoL score measured by SF-36 and activity score
measured by SLEDAI in SLE patients. The correlation was assessed through
Pearson correlation. There are significant correlations between general health,
pain and social functions domains in QoL score and activity score measured by
SLEDAI in SLE patients.
the evaluation of patients with SLE it is important to measure not only disease
activity (which is potentially reversible with treatment) and damage (which is permanent
and can be due to the disease or treatment) but also the patients’ perspective.
This is because the disease is likely to have a significant impact on the
physical, social and psychological aspects of the patient health and QoL .
present clinical and biochemical data had revealed that, mucocutaneous and
hematological manifestations were present in most of the patients, while
arthralgia was present in half of them. Many variations were seen in other
studies. Ch et al studied 1082 SLE patients; 70% of the patients were
characterized predominantly by mucocutaneous manifestations .
Sultan et al reported, out of 305 SLE patients, 2.5% only had hematological
disorders . In the cohort study of Alarcon et al., the
first ACR criteria fulfilled were arthritis (34.5%) and photosensitivity
(18.2%) . In the Sultanate of Oman, Abdwani et al
followed 50 children with lupus; the initial manifestations were arthritis or
arthralgia (76%), cutaneous (70%), hematological (68%), and renal (64%) . Additionally, Nazarinia et al found that out of 410
patients in Iran, 78% had hematological disorders and 38% had serositis . Wallace and Tumlin, documented that 78% of SLE patients
had anemia, and 30% had thrombocytopenia . These
variations may be due to different sample sizes, different patients' ages,
variable diseases durations, unreported recent or mild cases, and seasonal,
regional or racial variations.
SLE is a disease with great impact on all aspects of health status. QoL is
increasingly being recognized as an important aspect of chronic diseases. Its
measurement has traditionally relied on the use of generic or disease-specific
questionnaires. Generic questionnaires were developed for general use and may
be used in a variety of diseases and populations. They allow for comparison
with other groups and conditions and allow measurement of dysfunction for
individuals experiencing more than one condition. Therefore, general health
instruments have been shown to be valid for measuring QoL in SLE patients. In
contrast, disease-specific questionnaires are designed to measure outcomes in a
specific disease . Only recently have disease-specific
instruments been developed for use in SLE and these are not yet widely used .
our study, we observed a progressive decrease in all SF-36 scores. These
progressive changes in HRQoL could be due to several factors, such as SLE
progression along the years, continuously coping with a chronic illness, and
practical management items that may be required (frequent medical visits,
laboratory examinations, etc.). Other possible explanations are that, most of
our SLE patients were young adults females, and in ages at which physical,
psychological and social stability had not yet been reached. The disease
started at a crucial time in their lives when they were trying to establish
relationships, start families and launch careers. As a result, patients
experienced a wide range of physical, psychological and social problems.
addition, all domains of SF-36 including general health, physical functions,
physical limitations, emotional limitations, energy/fatigue, emotional
well-being, pain, social functions, and health changes were correlated with
disease activity as detected by SLEDAI.
M et al. found similar results. SF-36 scores were correlated with BILAG and
SLEDAI scores, suggesting divergent construct validity of the SF-36 meaning it
offered an independent assessment of the impact of SLE .
Also, Thumboo et al. reported that improvements in SF-36 scores correlate with
decreases in disease activity and damage. Decrements in SF-36 scores reflect
end stage renal disease and immunosuppressive use .
Various degrees of correlation between SLE disease activity and HR QoL were
documented by some authors. In a cross-sectional analysis, Fortin PR et al.
found that SLAM-R, correlated with most subscales of the SF-36. In a
longitudinal analysis, both disease activity instruments (SLAM-R and SLEDAI)
were associated with changes in the SF-36 . Sutcliffe
N et al. found that higher disease activity correlated with worse physical and
emotional function, pain, and general health .
et al. used the World Health Organization Quality of Life-Bref (WHOQoL-Bref) to
evaluate the relationship between disease activity and health status in the
Indian subcontinent. The WHOQoL-Bref includes an environment domain, which the
authors wanted to capture. They found that physical and psychological QoL are
impaired with active lupus, whereas social and environmental QoL do not
correlate with disease activity . Simone et al
reported that patients with SLE and active renal disease concurrently
experience a slightly poorer QoL than those without renal disease, especially
in the physical domains . Lai et al found that
low-grade inflammation as reflected by low serum albumin and hemoglobin
concentrations were associated with impaired HRQOL in patients with SLE,
independent of other socio-demographic and clinical variables .
Study by Strand et al showed that, the impact of SLE was evident - with decrements
in HRQoL similar to those reported by patients with inflammatory arthritis,
chronic congestive heart failure and post myocardial infarction despite
differing disease activity and baseline disease .
a cross-country comparison, Panopalis et al. (2005) evaluated the Short Form-36
General Health Survey (SF-36) scores done annually over 4 years in 231 patients
from Canada, 269 from the United States, and 215 from the United Kingdom. They
found that the physical and mental well-being components did not differ
significantly between countries . Whether the equivocal
results on the relationship with disease activity and quality of life measures
will be resolved with more uniform use of activity and health status indices
remains to be seen. Larger studies including cohorts from diverse geographic
regions are also needed for comparisons to better understand lupus variability.
addition, we reported that the QoL of SLE patients as measured by SF-36 was
poorer than healthy control in all domains except emotional limitations. Both
physical and mental component summary scores of the SF-36 were reduced in our
studied patients compared with controls. In SLE great variability in all the
subscales was observed. Significant correlations between physical and mental
components and different subscales were observed in patients but not in
controls. In SLE, HRQoL tended to worsen with age. Higher disease activity and
damage were associated with significantly lower HRQoL and worsening of SLE
leads to a further decline. The same observations were detected by Rinaldi et
al. They examined HRQoL in Italian patients with SLE and compared it with that
of healthy people and investigated relationships among different dimensions and
subscales of a generic health status measure . They
used SF-36 as we do and it was applied in a cohort of 126 consecutive SLE
patients and 96 healthy controls. Current results were also in agreement with
other studies in different patients age groups [33,34].
of SLE studied patients were characterized predominantly by mucocutaneous and
hematological manifestations. The QoL of SLE patients with renal involvement as
measured by SF-36 was poorer than healthy control in all domains except
emotional limitations. There are significant negative correlations between
general health, pain and social functions domains in QoL score and activity
score measured by SLEDAI in SLE patients. Physicians should focus on QoL and
how to improve it in relation to bio-psychosocial approach, (health education
regarding the negative impact of disease activity on the patients is required).
The results of quality of life studies help physicians understand and give
better support to SLE patients beside rapid meticulous control of disease
activity. Further researches on the factors affecting QoL in SLE patients,
including drugs are required.
Table 1: The socio-demographic characteristics of case and control groups
Table 2: Clinical and laboratory findings in studied SLE population
Table 3: Main domains of QoL measured by SF-36 in SLE patients
Table 4: Mean score of each domains of QoL measured by SF-36 according to grades of
disease activity measured by SLEDAI in SLE patients
Table 5: Mean score of each domains of QoL measured by SF-36 according to renal
pathology classification of lupus nephritis in SLE patients
Table 6: Correlations between QoL score measured by SF-36 and activity score measured
by SLEDAI in SLE patients
study concept, statistical analysis, manuscript writing and review. GT: study
design, manuscript writing and review. KK: study concept, editing and review.
NI: data collection and statistical analysis.
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