Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus
Conditions: Systemic Lupus Erythematosus (SLE)
Sponsor: Sohag University

Protocol
 
 1
 
Sohag University              
    
 
Faculty of Medicine 
Department of Rheumatology & 
Rehabilitation 
 
Comparison of clinical and serological differences 
among juvenile, adult, and late-onset systemic lupus 
erythematosus 
 
Protocol 
Submitted for fulfillment for the requirement of the ’M.D.  
 Degree in Physical Medicine, Rheumatology and Rehabilitation 
 
By 
Alaa Mohamed Hemdan 
Assistant lecture of Physical Medicine, Rheumatology and 
Rehabilitation, Faculty of Medicine, Sohag University 
 
Supervised by 
Dr. Esam Mohamed Abu Al-
Fadl 
Professor of Physical Medicine, Rheumatology and Rehabilitation  
Faculty of Medicine, Sohag University 
 
 
 
Dr.Hanan Sayed Mohamed Abo 
Zaid 
 
Assistant Professor of Physical Medicine, Rheumatology and 
Rehabilitation Faculty of Medicine, Sohag University 
 
 
Faculty of Medicine 
Sohag University 
                                                      2022 

Protocol
 
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Introduction 
 
Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune 
disease with a highly variable presentation and course. It can affect 
virtually every organ of the body and many symptoms may be observed. 
Skin, musculoskeletal, hematologic, and serological involvement are 
most commonly observed. [1] Some patients show predominately 
hematologic, renal, or central nervous system manifestations. [2,3] 
 
            The presentation of SLE may be characterized by periods of 
remission and by chronic or acute relapses. Several factors, including age 
and ethnicity, can affect the course and severity of SLE and response to 
treatment varies by race, ethnicity, and age. Non-Caucasians tend to 
exhibit acute disease onset, more severe and numerous clinical 
manifestations , and higher disease activity.[4–10] Hispanics, African 
descendants and Asians exhibit more frequent renal, hematological, 
serosal , neuropsychiatric and immunological abnormalities.[5,7,11–14] 
Furthermore, response to treatment for lupus nephritis varies according to 
race and ethnicity.[15] Similarly, ethnicity can affect the nature and 
severity of SLE and its response to treatment: Age of onset also 
influences the clinical manifestations and severity of SLE. Approximately 
15–20% of SLE patients experience disease onset before to adulthood, 
and about 2–20% of all patients with SLE experience onset of SLE after 
age of 50.[16–18] 
 
Studies have reported that juvenile-onset SLE patients tend to have a 
more aggressive presentation and course, with higher rates of organ 
involvement and lower life expectancy than adult-onset SLE patients. 
[19–24] Late-onset SLE patients tend to have a more insidious onset of 

Protocol
 
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disease and tend to have less major organ involvement and more benign 
disease course. [25 ] However, they have a poorer prognosis than patients 
who developed SLE before the age of 50 years, because of the generally 
higher frequency of comorbid diseases and higher organ damage, due to 
aging and longer exposure to ‘‘classical’’ vascular risk factors.[17,26,27]. 
Aims of the Study: 
To compare clinical and serological differences among juvenile, adult, 
and late-onset systemic lupus erythematosus in a cohort of SLE patients 
in our hospital. 
Patients and Methods: 
Study design: 
This study is a cross-sectional study  
Setting: 
This study will be conducted from January 2023 to January 2024 in 
Rheumatology Department, Sohag University Hospital. All the SLE 
patients visiting our department will be included in the study if they are 
fulfilling the inclusion criteria. 
Inclusion criteria: 
1. Patients diagnosed as SLE according to SLICC 2012 or 
ACE/EULAR 2017 classification criteria. 
2. Age  (jSLE was defined as a diagnosis below the age of 18 years, 
and those diagnosed between 19 and 50 years of age were 
classified as aSLE (adult SLE),  while lSLE (late onset SLE)  
was defined as a diagnosis at more than 50 years of age). 
3. Patients with a disease duration of  more than 6 months 

Protocol
 
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Exclusion criteria: 
1. Patients with had other autoimmune diseases, such as rheumatoid 
arthritis, systemic sclerosis, mixed connective tissue disease , 
overlap syndrom or primary Sjogren’s syndrome ,but not 
secondary Sjogren’s syndrome or secondary antiphospholipid 
syndrome . 
2. Patients who are not willing to be involved in the study 
Methods: 
All patients will be subjected to the following: 
 
1. Thorough medical history of  the patients  
2. Full clinical examination including: 
a. General examination and vital signs. 
b. Complete rheumatological examination. 
c. SLE disease activity index SLEDAI (ref). 
d. SLICC damage index (ref). 
3. Routine investigations (complete blood picture, erythrocyte 
sedimentation rate and liver functions). 
4. Renal investigations: 
a. Kidney functions 
b. Urine analysis 
c. 24 hours protein in urine and/or A/C ratio 
d. Renal biopsy if indicated. 
5. ANA test. 
6. ANA profile for the most common 19 autoantibodies by 
immunoblot. 
 
 
 

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Ethical considerations: 
- The study will be approved by the local Scientific Ethical 
Committee of the Faculty of Medicine, Sohag University. 
- An informed written consent will be taken from all of the 
participants in the study after explaining the aim of the study. 
Statistical analysis: 
 Statistical package for social sciences (IBM-SPSS), version 24 
(May 2016); IBM- Chicago, USA will be used for statistical data 
analysis.  
 Data will be expressed as mean, standard deviation (SD), number 
and percentage. Mean and standard deviation will be used as 
descriptive value for quantitative data.  
 Student t test will be used to compare the means between two 
groups, and one-way analysis of variance (ANOVA) test will be 
used to compare means of more than two groups. Mann Whitney 
test will be used instead of Student t test when the data are non-
parametric. 
 Pearson Chi square test will be used to compare percentages of 
qualitative variables, and Fisher exact test will be used instead of 
ordinary chi square test in cases of non-parametric data.  
 Pearson correlation test will be used to compare two quantitative 
variables; and Spearman correlation test will be used instead if the 
data are non-parametric.  
 For all these tests, the level of significance (P-value) can be 
explained as: 
o No significance P > 0.05 
o Significance P < 0.05 
o High significance P < 0.001. 
 

Protocol
 
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References 
 
1 Von Feldt JM. Systemic lupus erythematosus. Recognizing its 
various 
presentations. Postgrad Med 1995; 97: 79, 83, 86 passim. 
2 Estes D, Christian CL. The natural history of systemic lupus 
erythematosus by prospective analysis. Medicine (Baltimore) 1971; 50: 
85–95. 
3 Fessler BJ, Boumpas DT. Severe major organ involvement in 
systemic 
lupus erythematosus. Diagnosis and management. Rheum Dis 
Clin North Am 1995; 21: 81–98. 
4 Borchers AT, Naguwa SM, Shoenfeld Y, Gershwin ME. The 
geoepidemiology of systemic lupus erythematosus. Autoimmun Rev 
2010; 9: A277–A287. 
5 Ferna´ ndez M, Alarco´ n GS, Calvo-Ale´n J, et al. A multiethnic, 
multicenter cohort of patients with systemic lupus erythematosus (SLE) 
as a model for the study of ethnic disparities in SLE. Arthritis 
Rheum 2007; 57: 576–584. 
6 Arbuckle MR, James JA, Dennis GJ, et al. Rapid clinical 
progression 
to diagnosis among African-American men with systemic lupus 
erythematosus. Lupus 2003; 12: 99–106. 
7 Alarco´ n GS, McGwin G Jr, Petri M, et al. Baseline characteristics 
of a multiethnic lupus cohort: PROFILE. Lupus 2002; 11: 95–101. 
8 Alarco´n GS, McGwin G Jr, Roseman JM, et al. Systemic lupus 
erythematosus in three ethnic groups. XIX. Natural history of the accrual 
of the American College of Rheumatology criteria prior to the 
occurrence 
of criteria diagnosis. Arthritis Rheum 2004; 51: 609–615. 
9 Alarco´ n GS, Calvo-Ale´n J, McGwin G Jr, et al. Systemic lupus 
erythematosus in a multiethnic cohort: LUMINA XXXV. 
Predictive factors of high disease activity over time. Ann Rheum 
Dis 2006; 65: 1168–1174. 
10 Alarco´ n GS, McGwin G Jr, Bartolucci AA, et al. Systemic lupus 
erythematosus in three ethnic groups. IX. Differences in damage 
accrual. Arthritis Rheum 2001; 44: 2797–2806. 
11 Uribe AG, Alarco´ n GS. Ethnic disparities in patients with 
systemic 
lupus erythematosus. Curr Rheumatol Rep 2003; 5: 364–369. 
12 Samanta A, Feehally J, Roy S, Nichol FE, Sheldon PJ, Walls J. 
High prevalence of systemic disease and mortality in Asian subjects 
with systemic lupus erythematosus. Ann Rheum Dis 1991; 50: 

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490–492. 
13 Thumboo J, Uramoto K, O’Fallon WM, et al. A comparative 
study of the clinical manifestations of systemic lupus erythematosus 
in Caucasians in Rochester, Minnesota, and Chinese in 
Singapore, from 1980 to 1992. Arthritis Rheum 2001; 45: 494–500. 
14 Richman IB, Taylor KE, Chung SA, et al. European genetic 
ancestry 
is associated with a decreased risk of lupus nephritis. Arthritis 
Rheum 2012; 64: 3374–3382. 
15 Isenberg D, Appel GB, Contreras G, et al. Influence of 
race/ethnicity 
on response to lupus nephritis treatment: The ALMS study. 
Rheumatology 2010; 49: 128–140. 
16 Tucker LB, Uribe AG, Ferna´ ndez M, et al. Adolescent onset of 
lupus results in more aggressive disease and worse outcomes: 
Results of a nested matched case-control study within LUMINA, 
a multiethnic US cohort (LUMINA LVII). Lupus 2008; 17: 
314–322. 
17 Boddaert J, Huong DL, Amoura Z, Wechsler B, Godeau P, Piette 
JC. Late-onset systemic lupus erythematosus: A personal series of 
47 patients and pooled analysis of 714 cases in the literature. 
Medicine (Baltimore) 2004; 83: 348–359. 
18 Klein-Gitelman M, Reiff A, Silverman ED. Systemic lupus 
erythematosus in childhood. Rheum Dis Clin North Am 2002; 28: 
561–577, vi–vii. 
19 Carren˜o L, Lo´ pez-Longo FJ, Monteagudo I, et al. Immunological 
and clinical differences between juvenile and adult onset of systemic 
lupus erythematosus. Lupus 1999; 8: 287–292. 
20 Descloux E, Durieu I, Cochat P, et al. Influence of age at disease 
onset 
in 
the 
outcome 
of 
paediatric 
systemic 
lupus 
erythematosusRheumatology (Oxford) 2009; 48: 779–784. 
21 Faco MM, Leone C, Campos LM, Febroˆ nio MV, Marques HH, 
Silva CA. Risk factors associated with the death of patients 
hospitalized 
for juvenile systemic lupus erythematosus. Braz J Med Biol 
Res 2007; 40: 993–1002. 
22 Hoffman IE, Lauwerys BR, De Keyser F, et al. Juvenile-onset 
systemic lupus erythematosus: Different clinical and serological 
pattern than adult-onset systemic lupus erythematosus. Ann 
Rheum Dis 2009; 68: 412–415. 
23 Hersh AO, Trupin L, Yazdany J, et al. Childhood-onset disease as 
a predictor of mortality in an adult cohort of patients with systemic 
lupus erythematosus. Arthritis Care Res (Hoboken) 2010; 62: 

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1152–1159. 
24 Moss KE, Ioannou Y, Sultan SM, Haq I, Isenberg DA. Outcome 
of a cohort of 300 patients with systemic lupus erythematosus 
attending a dedicated clinic for over two decades. Ann Rheum 
Dis 2002; 61: 409–413. 
25 Formiga F, Moga I, Pac M, Mitjavila F, Rivera A, Pujol R. Mild 
presentation of systemic lupus erythematosus in elderly patients 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol
 
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انًهخص انعزبي 
 
 
( انزئجخ انحًشاء انجٓبصٚخSLE
 ) ْٕ يشع يُبػٙ رارٙ غٛش يزجبَظ يغ
 االػشاع ٔدٔسح يزغٛشح نهغبٚخ. ًٚكٍ أٌ ٚؤثش ػهٗ كم ػؼٕ يٍ أػؼبء انجغى
 رقشٚجًب ًٔٚكٍ يالحظخ انؼذٚذ يٍ األػشاع. ٚزى يالحظخ يثال فٙ انجهذ ٔانؼؼالد
[ .انٓٛكهٛخ ٔانذيٕٚخ ٔانًظهٛخ ثشكم شبئغ1
 ] ثؼغ انًشػٗ ٚظٓشٌٔ فٙ انغبنت
[ .٘اػشاع  ديٕٚخ أٔ كهٕٚخ أٔ انجٓبص انؼظجٙ انًشكض3،2
]
 
 
  
  
 قذ ٚزًٛض انًغبس انًشػٗ  نًشع انزئجخ انحًشاء ثفزشاد شفبء ٔاَزكبعبد
 يضيُخ أٔ حبدح. ًٚكٍ أٌ رؤثش ػذح ػٕايم ، ثًب فٙ رنك انؼًش ٔانؼشق ، ػهٗ ؽجٛؼخ
 .ٔشذح يشع انزئجخ انحًشاء ، كًب رخزهف االعزجبثخ نهؼالج حغت انؼشق ٔانؼًش
 ، ًٚٛم غٛش انقٕقبصٍٚٛ إنٗ انظٕٓس ثًشع حبد ٔيظبْش ّٛيشػ ، أكثش حذح ٔرؼذدًا
[ .َٔشبؽًب أػهٗ نهًشع4
-
11
 ٌٕٕٚٛ] ُٚظٓش رٔٔ األطٕل األعجبَٛخ ٔاألفبسقخ ٔاٜع
 اػزالل كهًٕٚب ٔديًٕٚب ٔيظهًٛب ٔػظجًٛب ٔيُبػًٛب أكثش رٕارشًا. ػالٔح ػهٗ رنك ، رخزهف
االعزجبثخ نؼالج انزٓبة انكهٛخ انزئجٙ ٔفقًب نهؼشق. ٔثبنًثم ، ًٚكٍ أ ٌ ٚؤثش انؼشق
 ػهٗ ؽجٛؼخ ٔشذح يشع انزئجخ انحًشاء ٔاعزجبثزّ نهؼالج: ٚؤثش عٍ انجذاٚخ أٚؼًب
 ػهٗ انًظبْش ّٛانًشػ ٍٔشذح يشع انزئجخ انحًشاء. ٚؼبَٙ يب ٚقشة ي11
-
31
 ٪
 ٙيٍ يشػٗ انزئجخ انحًشاء يٍ ظٕٓس انًشع قجم عٍ انجهٕؽ ، ٔحٕان3
-
31
 ٍ ي٪
جًٛغ انًشػٗ انزٍٚ ٚؼبٌَٕ يٍ يشع 
 انزئجخ انحًشاء ٚؼبٌَٕ يٍ ظٕٓس انًشع
 ٍثؼذ ع11
[ .
11
-
11
]
 
 
ٌأفبدد انذساعبد أٌ يشػٗ انزئجخ انحًشاء فٙ ثذاٚخ األحذاس ًٚٛهٌٕ إنٗ أ 
 ٚكٌٕ نذٚٓى ػشع ٔدٔسح أكثش ػذٔاَٛخ ، يغ اسرفبع يؼذالد يشبسكخ األػؼبء
 ٔاَخفبع يزٕعؾ
انؼًش انًزٕقغ يٍ يشػٗ انزئجخ انحًشاء ػُذ انجبن[ .ٍٛغ11
-
34
 ]
 ًٚٛم يشػٗ انزئجخ انحًبيٛخ انًجًٕػٛخ انًزأخشح إنٗ ظٕٓس انًشع ثشكم أكثش
خذاػًب ًٔٚٛهٌٕ إنٗ يشبسكخ أػؼبء سئٛغٛخ أقم ٔيغبس يشػٙ
 
[ .أكثش حًٛذح31
 ]

Protocol
 
 
11
 
 ٔيغ رنك ، فئٌ رٕقؼبد عٛش انًشع نذٚٓى أػؼف يٍ انًشػٗ انزٍٚ أطٛجٕا
 ، ٍٛثًشع انزئجخ انحًشاء قجم عٍ انخًغ ثغجت انزكشاس األػهٗ نأليشاع انًشػٛخ
انًظبحجخ ٔرهف األػؼبء ثشكم أكجش ، ثغجت انشٛخٕخخ ٔانزؼشع 
 نفزشح أؽٕل
[ "نًخبؽش األٔػٛخ انذيٕٚخ "انزقهٛذٚخ12،31
،
32
.]
 
 
:أهذاف انذراست 
 
 انًقبسَخ ٍٛث
انفشٔق االّٚكهُٛكب 
 ّٛٔانًؼًه 
ٍٛث 
 يشع 
 انزئجخ
انحًشاء 
 ػُذ
 األؽفبل ، ٔانجبنغٍٛ ، ٔانزئجخّٛانحًشاءانًُبػ انجٓبصٚخ انًزأخشح 
ٙف يجًٕػخ 
ٍي 
ٗيشػ انزئجخ انحًشاء 
ٙف يغزشفبَب. 
 
انًزضى وطزق انبحث:
 
 
:تصًيى انذراست 
 
ْزِ انذساعخ ػجبسح ػٍ دساعخ يقطؼٛخ 
 
انضىابظ:
 
 
 ٍعزجشٖ ْزِ انذساعخ فٙ انفزشح ي
ُٚبٚش 
3132
 
 ٗإنُٚٚب ش3134
 
 فٙ قغى
أيشاع انشٔيبرٛضو ثًغزشفٗ جبيؼخ عْٕبج عٛزى ػى جًٛغ يشػٗ
 
 انزئجّ انحًشاء
ٍٚانز 
ٌٔٚضٔس قغًُب 
ٙف انذساعخ إرا كبَٕا 
ٌٕٚغزٕف يؼبٚٛش 
ًٍٛانزؼ. . 
 
:يعاييز االشتًال 
 
1.
 
 انًشػٗ انزٍٚ رى رشخٛظٓى ػهٗ أَٓى يشػٗ انزئجّ انحًشاء ٔفقًب
نًؼبٚٛشرظُٛف  
3113
. 
3.
 
 انؼًش (رى رؼشٚف رئجّ حًشاء فٗ االؽفبل ٍػهٗ أَّ رشخٛض أقم ي11
 
 ػبيًب ، ثًُٛب رى رظُٛف ٍٛاألشخبص انزٍٚ رى رشخٛظٓى ث11
 
 ٔ
11
 
 ػبيًب

Protocol
 
 
11
 
ػهٗ أَٓى 
 ٍٛرئجّ حًشاء فٗ انجبنغ ، ٔرى رؼشٚف ٍرئجّ حًشاء فٗ كجبس انغ
 ٍػهٗ أَّ رشخٛض ػُذ أكثش ي11
 
.)ػبيًب 
 
2.
 
ٍانًشػٗ انزٍٚ ٚؼبٌَٕ ي 
 ٍانًشع يذح رضٚذ ػ1 أشٓش. 
 
:يعاييز االستبعاد 
 
1.
 
 انًشػٗ انزٍٚ ٚؼبٌَٕ يٍ أيشاع انًُبػخ انزارٛخ األخشٖ ، يثم انزٓبة
 ٌانًفبطم انشٔيبرٕٚذ٘ ، أٔ انزظهت انجٓبص٘ ، أٔ يزالصيخ عجٕجش
 األٔنٛخ ، ٔنكٍ نٛظ يزالصيخ عجٕجشٌ انثبَٕٚخ أٔ يزالصيخ أػذاد انشحٕو
 انفٕعفٕسٚخ
انثبَٕٚخ. 
3.
  
ٗانًشػ 
ٍٚانز ال 
ٌٕٚشغج 
ٙف انًشبسكخ 
ٙف انذساعخ 
 
وسىف يخضع جًيع انًزضى وحاالث انًزاقبت نًا يهي:
 
 
1
. انزبسٚخ 
ٙانطج انشبيم 
ٍي 
ٗانًشػ 
2
. انفحض 
ٙاالكهُٛٛك ثًب 
ٙف رنك:
 
1
- انفحض انؼبو 
2
- انفحض 
ٙانشٔيبرٛضي 
3
. 
 انزحبنٛم انشٔرُٛٛخ (طٕسح انذو كبيهخ، ٔيؼذل انزشعٛت، ٔظبئف
انكجذ ٔظبئف 
.)ٗانكه 
4
. قٛبط يؼبداد األَٕٚخ. 
 
اإلعتبار األخالقي:
 
o
 ٚزى انحظٕل 
ٗػه يٕافقخ خطٛخ 
ٍي انًشٚغ ثؼذ ششح ْذف دساعزُب. 
o
 عٛزى اػزًبد ثشٔرٕكٕل انذساعخ 
ٍي قجم انهجُخ األخالقٛخ انًحهٛخ 
ٍي كهٛخ 
عْٕبج نهطت. 
 

Protocol
 
 
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جايعت سىهاج 
كهيت انطب 
قسى انزوياتيشو وانتأهيم 
 
 
 
ُانًقارَت بيٍ انفزوق االكهي
كي يه وانًعًهيه  بيٍ يزض  انذئبت انحًزاء
عُذ األطفال ، وانبانغيٍ ، وانذئبت انحًزاءانًُاعيه انجهاسيت انًتأخزة 
 
بزوتىكىل 
 رٕؽئخ نهحظٕل ػهٗ دسجخ
ا ِنذكزٕسا 
 ٙف
انطت انطجٛؼٙ ٔانشٔيبرٛضو ٔانزأْٛم 
 
:ٍيقذيت ي 
ٌط. االء يحًذ حًذا 
 يذسط يغبػذ
ثقغى انشٔيبرٛضو ٔانزأْٛم 
 كهٛخ انطت– جبيؼخ عْٕبج 
 
 :رحذ إششاف 
 .د
عصاو يحًذ أبى انفضم 
أعزبر ثقغى 
 انشٔيبرٛضو ٔانزأْٛم 
 كهٛخ انطت– 
 جبيؼخ
عْٕبج 
 .د ٌحُا سيذ يحًذ
ابى سيذ 
اعزب
ر يغبػذ ثقغى انشٔيبرٛضو ٔانزأْٛم 
 كهٛخ انطت– 
 جبيؼخ
عْٕبج 
 
كهيت انطب 
جايعت سىهاج 
0200