LUNELORD: A Descriptive, Prospective Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and QoL of Patients With LUpus NEphritis and Long-term ORgan Damage
Conditions: Systemic Lupus Erythematosus
Sponsor: GlaxoSmithKline

 
Protocol 
Study ID:  216989
Official Title of Study: LUNELORD: A descriptive, prospective study to assess 
demographic, pharmacologic, biomarker, clinical features and QoL of patients with 
LUpus NEphritis and Long-term ORgan Damage  
NCT number: NCT04971590
Date of Document: 28-Jun-2021 (As part of signature on Page 4)

LUNELORD Study 
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GlaxoSmithKline group of 
companies
1 
NON-INTERVENTIONAL STUDY PROTOCOL
UNIQUE IDENTIFIER 
oneCDP: 216989 
TITLE 
LUNELORD: A descriptive, prospective study to assess 
demographic, pharmacologic, biomarker, clinical 
features and QoL of patients with LUpus NEphritis and 
Long-term ORgan Damage  
STUDY ACCOUNTABLE 
PERSON 
 
CONTRIBUTING 
AUTHORS 
 
Dr. 
 
Prof. 
 
 
 (Phoenix CRO) 
ASSET ID 
Belimumab 
GSK ASSET 
Belimumab (Benlysta®) 
INDICATION 
Lupus Nephritis, systemic lupus erythematosus 
PHASE OF 
DEVELOPMENT 
Not applicable 
REVISION CHRONOLOGY: 
Date 
Version 
Change(s) since last 
version 
01-03-2021
Original (version 1.0) 
N/A 
21-03-2021
Version 2.0 
Adjusted the protocol 
based on the comments 
received from PRC. The 
PRC comments and 
PPD
PPD
PPD
PPD
PPD

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companies
2 
revisions are provided on 
the portal.  
28-03-2021
Version 3.0 
1)
Added objective for
exploratory analysis of
physician profile and
treatment.
2)
Clarified second
secondary objective in
section 4.43 on how to
proceed with the analysis.
3)
In section 3.2.2 clarified
the routine laboratories
results that will be
collected in the
prospective and
retrospective.
28/06/2021 
Version 4.0 
1)
On page 1 the title on the
header should be written
-interventional
2)
For the protocol synopsis
on page 9 the correct title
descriptive, prospective
study to assess
demographic,
pharmacologic,
biomarker, clinical
features and QoL of
patients with LUpus
NEphritis and Long-term
3)
In Appendix 5 on page 48
the title should be
descriptive, prospective
study to assess
demographic,
pharmacologic,
biomarker, clinical
features and QoL of
patients with LUpus
NEphritis and Long-term
4)
Added clarification for
inclusion criteria.
Copyright 2021 the GlaxoSmithKline group of companies. All rights reserved. 
Unauthorised copying or use of this information is prohibited

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SPONSOR SIGNATORY 
Dr. Averyan Vasylyev 
Medical Director, Gulf 
Date 
INVESTIGATOR PROTOCOL AGREEMENT PAGE 
I confirm agreement to conduct the study in compliance with the protocol. 
I acknowledge that I am responsible for overall study conduct. I agree to personally 
conduct or supervise the described clinical study. 
I agree to ensure that all associates, colleagues and employees assisting in the conduct of 
the study are informed about their obligations. Mechanisms are in place to ensure that 
site staff receives the appropriate information throughout the study. 
Investigator Name: 
________________________________________________ 
Investigator Signature 
Date 
PPD

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TABLE OF CONTENTS 
PROTOCOL SUMMARY .................................................................................................. 8 
1.
BACKGROUND AND RATIONALE ........................................................................ 11 
1.1. 
Rationale ...................................................................................................... 12 
2.
OBJECTIVES .......................................................................................................... 13 
2.1. 
Primary Objective ......................................................................................... 13 
2.2. 
Secondary Objectives .................................................................................... 13 
3.
RESEARCH METHODOLOGY ................................................................................ 14 
3.1. 
Study Design ................................................................................................ 14 
3.1.1. 
Patient Identification Process and Eligibility Verification .................... 15 
3.1.2. 
Patient Consent and Patient Survey .................................................. 15 
3.1.3. 
Retrospective Medical Chart Review ................................................ 16 
3.1.4. 
Prospective Medical Chart Data Collection........................................ 16 
3.1.5. 
One-Time Physician Survey ............................................................ 16 
3.1.6. 
Medical Cost / HCRU ..................................................................... 16 
3.2. 
Data Source / Data Collection ......................................................................... 17 
3.2.1. 
Physician Practice Profile Form ....................................................... 17 
3.2.2. 
Retrospective Data Collection and Prospective Data Collection ........... 18 
3.2.3. 
Prospective Patient Survey: HRQoL ................................................. 21 
3.3. 
Study Population ........................................................................................... 21 
3.3.1. 
Eligibility Criteria .......................................................................... 22 
3.3.2. 
Sample Size / Power Calculations .................................................... 22 
4.
DATA ANALYSIS CONSIDERATIONS ................................................................... 25 
4.1. 
Analysis Population ....................................................................................... 25 
4.2. 
Protocol Deviation ........................................................................................ 25 
4.3. 
Interim Analysis ............................................................................................ 25 
4.4. 
Data Analyses ............................................................................................... 25 
4.4.1. 
General Considerations for Data Analysis ......................................... 25 
4.4.2. 
Primary Analysis ............................................................................ 25 
4.4.3. 
Secondary Analysis ........................................................................ 26 
4.5. 
Cost Evaluation ............................................................................................. 26 
4.6. 
Data Handling Conventions ............................................................................ 27 
4.7. 
Exploratory Analysis ..................................................................................... 27 
5.
LIMITATIONS ........................................................................................................ 27 
6.
STUDY CONDUCT, MANAGEMENT & ETHICS ..................................................... 28 
6.1. 
Ethical and Regulatory Submissions ................................................................ 28 
6.2. 
Patient Information ........................................................................................ 28 
6.3. 
Declaration of Informed Consent .................................................................... 29 
6.4. 
Legal Basis for Processing Individual Human Data ........................................... 29 
6.5. 
Adverse Event (AE), Pregnancy Exposure, and Incident Reporting ..................... 29 
6.6. 
Study Scientific Advisory Committee .............................................................. 30 

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7.
EXTERNAL INVOLVEMENT (THIRD PARTY SUPPLIER, EXTERNAL 
EXPERT/HCPS) ...................................................................................................... 30 
8. 
PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS .......... 31 
9. 
REFERENCES ......................................................................................................... 33 
10. APPENDIX 1: DATA TABLE ................................................................................... 36 
11. APPENDIX 2: SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE ACTIVITY 
INDEX 2000 (SLEDAI-2K) ....................................................................................... 38 
12. APPENDIX 3: 36-ITEM SHORT FORM HEALTH SURVEY (SF-36)  ENGLISH 
VERSION ............................................................................................................... 39 
13. APPENDIX 4: 36-ITEM SHORT FORM HEALTH SURVEY (SF-36)  ARABIC 
VERSION ............................................................................................................... 43 
14. APPENDIX 5: PHYSICAN PRACTICE PROFILE FORM ........................................... 50 

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ABBREVIATIONS
ACR 
American College of Rheumatology   
ADARRC 
Advanced Academic Rheumatology Review Course 
AE 
Adverse event 
anti-dsDNA   Antibody to double-stranded DNA test  
Anti-Rib 
Antibody to ribosomal P protein 
Anti-Scl-70 
Anti-topoisomerase I antibody 
anti-Sm   
Antibody smooth muscles  
anti-U1-RNP Anti-ribonucleoprotein  
ARA 
American Rheumatism Association 
ASE 
All subjects enrolled 
C3/C4 
Complement components 3 and 4 
CI 
Confidence interval 
CRO 
Clinical research organisation 
eCRF 
Electronic case report form 
eGFR 
Estimated glomerular filtration rate  
ESR 
Emirates Society for Rheumatology 
ERA-EDTA 
European Renal Association-European Dialysis and Transplant 
Association 
ESRD 
End-stage renal disease 
EULAR   
European League against Rheumatisms 
GFR 
Glomerular filtration rate  
GP1 
anti-beta 2 glycoprotein 1 
GPP 
Good Pharmacoepidemiology Practice 
GSK 
GlaxoSmithKline 
HCRU 
Healthcare resource utilisation 
HIV 
Human immunodeficiency virus 
HRQoL 
Health-related quality of life 
ICU 
Intensive care unit 
IEC 
Independent ethics committee 
IHD 
Individual human data 
IRB 
Institutional review board 
ISN/RPS 
International Society of Neurology and the Renal Pathology Society 
KAR 
Kuwait Association of Rheumatology 
LN 
Lupus nephritis 
MRI 
Magnetic resonance imaging 
NSAID 
Non-steroidal anti-inflammatory drug 
ORS 
Orthopaedic Research Society  
PPPF 
Physician practice profile form 
QoL 
Quality of life 
SAP 
Statistical analysis plan 
SDI 
SLICC/ACR damage index 
SELENA 
Safety of estrogens in lupus national assessment  
SF-36 
36-item short form health survey 
SLE 
Systemic lupus erythematosus 
SLEDAI 
Systemic lupus erythematosus disease activity index  

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SLEDAI-2K
Systemic lupus erythematosus disease activity index 2000
SLICC   
Systemic Lupus International Collaborative Clinics 
sPVP 
Specific pharmacovigilance plan 
TNF 
Tumour necrosis factor 
UPCR 
Urinary protein to creatinine ratio  
WHO 
World Health Organisation 
 
TRADEMARK INFORMATION 
Trademarks of the GlaxoSmithKline 
group of companies 
 
Trademarks not owned by the 
GlaxoSmithKline group of companies 
Belimumab (Benlysta®) 
 
36-Item Short Form Health Survey (SF-
36): used with the permission of RAND 
corporation 
 
SLEDAI-2K from Gladman DD, Ibañez 
D, Urowitz MB. Systemic lupus 
erythematosus disease activity index 
2000. J Rheumatol. 2002;29(2):288-91. 
PMID: 11838846. 
 
 

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PROTOCOL SUMMARY
Title 
LUNELORD: A descriptive,  prospective study to assess demographic, pharmacologic, 
biomarker, clinical features and QoL of patients with LUpus NEphritis and Long-term 
ORgan Damage 
Rationale 
Systemic lupus erythematosus (SLE) is a potentially serious, chronic, autoimmune disease, 
which can affect multiple organs of the body, including the kidneys (lupus nephritis). The 
high variability and its unpredictable course (flaring/remission), combined with a lack of 
indicated and integrated treatments, induce a high unmet need within the patient population. 
Reliable data on LN-related care patterns and resource utilisation in 5 countries in Arabian 
Gulf (UAE, Kuwait, Qatar, Bahrain, and Oman) region are currently unavailable.  
The expected key outcomes of this study will be: 
 Description of clinical characteristics, demographics, and health-related quality of life 
(HRQoL) of LN patients.  
 
-world
healthcare resource utilisation (HCRU) 
associated with LN in the Gulf countries: Bahrain, Kuwait, Oman, Qatar, and United Arab 
Emirates. 
The information collected may be used for scientific communication among the 
expert/physician community and payers with the aim to enhance medical care of lupus 
nephritis. The study protoco
-world
patients in the Gulf countries. 
Study 
Objectives 
 Primary: Describe demographics, clinical characteristics, comorbidities, treatments and 
HRQoL of LN patients across 5 Gulf countries. 
 Secondary: 
o Describe refractory LN cases, involving rituximab, and to assess changes in 
serological markers of disease activity (including autoantibodies and complement 
levels) over the treatment period.  
o Assess the association between clinical factors, biomarkers, treatment and renal 
remission. 
o Assess impact of LN on HRQoL over a one-year period after diagnosis or enrolment.  
o Describe LN HCRU and direct medical cost, associated with LN management across 
5 Gulf countries over a one-year period. 
o Exploring the difference in treatment patterns by physician profile (physicians in 
private versus public hospitals). 
Study 
Design 
This is a multicentre prospective study with a patient-completed survey and retrospective 
chart review component. 
This study will enrol approximately 200 patients with clinician diagnosed LN cases.  
 
 to identify 
 preliminary selection criteria. Identified 
patients who are potentially eligible will be contacted by trained site staff via phone, or 
approached onsite 
 
enrolment timelines. When approaching the patient, site staff will review the main study 
informed consent form (ICF) with patients, explain the study purpose and design, which 
will include a prospective survey as well as a one-time retrospective data abstraction from 
their medical chart. Additionally, site staff will answer any questions patients may have 
about the study. Patients will be asked to confirm their consent to participate in the study 
by signing the informed consent.  
 
 A retrospective phase to collect data from diagnosis or up to one year before enrolment, 
and  
 A prospective arm consisting of 5 visits as per routine care of a LN patient:  
o 
Visit 1: enrolment  
o 
Visit 2: 3-month follow-up after Visit 1  
o 
Visit 3: 6-month follow-up after Visit 1 
o 
Visit 4: 9-month follow-up after Visit 1 

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o 
Visit 5: last 12-month follow-up visit after Visit 1 
Study 
Population 
 Inclusion criteria: 
o 
age of 18 years 
o 
Clinician diagnosed LN patient per 
 discretion  
o 
At least one visit to the investigational centre, recorded in medical documentation, 
during the past (12) twelve months prior to enrolment date 
o 
Literacy in English or Arabic allowing to fully comprehend the written informed 
consent and study-specific patient reported questionnaires 
o 
Written informed consent by the patient 
 Exclusion criteria: 
o 
Incomplete medical records to be able to assess the disease severity or absence of 
any of the following renal laboratory results from the medical record within the last 
(12) twelve months: 
o 
Urinary protein to creatinine ratio (UPCR) or 24-hour proteinuria or urine 
sediment (activity) 
o 
Serum creatinine or estimated glomerular filtration rate (eGFR); or 
measured glomerular filtration rate (GFR), if eGFR is not available 
o 
Current or medical history of: 
o 
Congenital or acquired immunodeficiency  
o 
Malignancy in active treatment phase 
o 
Acute viral infection, such as HIV infection, requiring hospitalisation 
Study 
Duration 
 Retrospective arm: medical chart review from diagnosis or up until 12 months prior to 
enrolment  
 Prospective arm: 12 months after enrolment 
Data 
Collection 
 Retrospective data collection - medical chart review from diagnosis or up till 12 
months prior to enrolment  
o 
Basic patient demographic characteristics (gender, race/ethnicity, BMI, date of first 
SLE manifestation, date at SLE diagnosis, date at first LN manifestation, date at 
LN diagnosis, date at last visit in 2020) 
o 
LN/SLE treatment medications, including starting dose, current dose, date of 
treatment start and end, dose at cessation and reasons for medication choice 
(medications limited to NSAIDs, antimalarials, corticosteroids, 
immunosuppressants/cytotoxics and biologics) 
o 
LN treatment history (most recent induction regimen, number of prior treatment 
failures/relapse(s) [if any], ESRD, and dialysis [current/past and type], listed for 
transplant/prior transplant conducted) 
o 
Most recent LN classification including class and histological activity/chronicity 
based on most recent biopsy (International Society of Neurology and the Renal 
Pathology Society [ISN/RPS] or World Health Organisation [WHO] classification) 
o 
LN clinical manifestations 
o 
Comorbidities (such as antiphospholipid syndrome/thrombotic microangiopathy, 
obesity, cardiovascular disease, diabetes) 
o 
Renal laboratory assessments (such as UPCR or 24-hour proteinuria or urine 
sediment [activity], serum creatinine, and eGFR or measured GFR, if eGFR is not 
available) 
o 
Most recent serological findings (such as anti-phospholipid antibodies 
[anticardiolipin, anti-beta 2 glycoprotein 1 [GP1] and lupus anticoagulant], anti-
C1q, low-complement [C3/C4] and positive anti-double-stranded-deoxyribonucleic 
acid [anti-dsDNA]) 
o 
Other laboratory tests (haematology, liver function tests, lipid profile, and plasma 
albumin) 
o 
Active non-renal clinical manifestations of SLE (such as mucocutaneous, central 
nervous system, constitutional, cardiopulmonary, gastrointestinal, 
hematologic, musculoskeletal, vasculitis)  
o 
Most recent total Systemic Lupus Erythematosus Disease Activity Index 
(SLEDAI), such as SLEDAI or SLEDAI-2K 

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o 
Renal remission defined as proteinuria of <0.7 g/d or <0.5g/d or per 
 
discretion  
 Prospective data collection from enrolment or diagnosis of LN (0, 3, 6, 9, 12 months) 
o 
HRQoL using 36-Item Short Form Health Survey (SF-36) at enrolment (Visit 1) 
and at 12 months of follow-up (Visit 5) 
o 
Clinical manifestations at period start with clinical improvement/ worsening 
assessment at period end 
o 
Changes in disease activity assessment tools used 
o 
Any cases presented with refractory LN (defined as inefficacy of 
cyclophosphamide, use of rituximab, splenectomy, or inefficacy of 
immunosuppressives (methotrexate, leflunomide, abatacept, anti-TNF, 
azathioprine, mycophenolate mofetil, and/or mycophenolic acid) 
o 
Renal remission identified (defined as proteinuria of <0.7 g/d or <0.5g/d or per 
 discretion) 
o 
Biopsies requested  
o 
Changes linked to the primary treatment of the disease 
o 
Renal laboratory assessments (such as UPCR or 24-hour proteinuria or urine 
sediment [activity], serum creatinine and eGFR or GFR, if eGFR is not available) 
o 
Most recent serological findings (such as anti-phospholipid antibodies 
[anticardiolipin, GP1 and lupus anticoagulant], anti-C1q, low complement 
[C3/C4] and positive anti-dsDNA) 
o 
Other laboratory tests (haematology, liver function tests, lipid profile, and plasma 
albumin) 
o 
HCRU (number of laboratory tests, number of dialyses and use of imaging 
techniques, ICU hospitalisations/hospitalisations, outpatient visits) 
Statistical 
Methods 
Continuous numeric variables will be summarised using the mean, ±standard deviation, 
median, interquartile range, minimum and maximum. Categorical variables will be 
summarised using frequency distributions. 
 Primary objective: summary statistics will be used to describe patient profile, 
demographic features, clinical manifestations, comorbidities, severity, treatments and 
HRQoL of LN patients across 5 Gulf countries. 
 Secondary objective 1: summary statistics will be used to describe refractory LN cases 
and the independent t-test or Wilcoxon signed rank test along with repeated measures 
analysis will be used to test for changes in serological markers of disease activity at one 
year and over the treatment period. Changes in categorical variables at one-year period 
  
 Secondary objective 2: univariate and multivariate logistic regression with renal 
remission as the dependent variable and clinical factors and treatment as the independent 
variables. Odds ratios and 95% confidence intervals (CIs) will be presented.  
 Secondary objective 3: paired t-test on the HRQoL scores at enrolment and at one year, 
or Wilcoxon signed rank test for non-normal distribution. Repeated measures will be 
used to assess changes over time. 
 Secondary objective 4: for each country, the average HCRU and direct medical cost 
will be estimated along with its 95%CI. 
 Secondary objective 5: Exploratory analysis of the differences between physician 
profile and treatment. 
Sample Size 
and Power 
Calculations
200 patients, a statistical test will ensure the sample size calculation is powered to 
generate the data. The sample size calculation was computed by PASS® version 2019. 

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1.
BACKGROUND AND RATIONALE
Systemic lupus erythematosus (SLE or lupus) is a complex and severe rheumatic disease with 
exceedingly diverse clinical manifestations, including renal manifestations. Renal involvement is 
a frequent aspect of SLE, as 40 75% of SLE patients develop lupus nephritis (LN), most often 
within five years of the disease onset (1), although some patients do develop this complication 
later (2). 
The risk of developing LN is higher among men, young people, and people of non-European 
ancestry (3). This risk varies significantly between different regions of the world and different 
races and ethnicities. For example, black and Hispanic SLE patients develop LN earlier, and have 
worse outcomes than white patients with SLE, including death and end-stage renal disease 
(ESRD) (4). As for Arab SLE patients, LN seems to be common and occurring in 37 69% of 
SLE patients in the Arab dominated groups, particularly among those from Saudi Arabia, and in 
50% of the exclusively Arab group (1). Also, LN is more common in patients with anti-dsDNA 
and it is less frequent in those with positivity for rheumatoid factor and discoid manifestations 
(2).  
LN is recognised as a major cause of morbidity, mortality, health expenditure, and impaired 
quality of life (QoL) in patients with SLE (1). However, an early diagnosis and treatment are 
associated with a better prognosis (2). In many patients, LN ends in chronic kidney disease or 
ESRD despite potent anti-inflammatory and immunosuppressive therapies (4). Also, patients with 
LN have a higher standardised mortality ratio (6 6.8 versus 2.4) and die earlier than SLE patients 
without LN (4). Importantly, 10-year survival improves from 46% to 95% if disease remission 
can be achieved (4). Despite the improvements in care, LN patients often suffer long-term 
morbidity that can adversely affect their QoL and ability to work (5), resulting in substantial direct 
and indirect costs. Patients with flares incur higher direct and indirect costs as compared to those 
without flares. Flares in major organs such as kidneys increase disease costs much more than 
other organ flares. The high costs associated with LN flare may be reduced by treatments that 
effectively control disease activity and prevent major organ flares (6,7). Thus, due to both direct 
and indirect costs, LN leads to a very high burden of disease. Improvement in disease activity and 
physical health, and prevention of organ damage, may reduce direct and indirect costs in SLE and 
LN (6,7,8,9,10,11). 
LN can be asymptomatic 
 (detected by routine renal biopsy), or presenting with trace 
proteinuria or active urinary sediments (microscopic haematuria, pyuria or cellular casts), or with 
serious proteinuria (nephrotic syndrome) and acute nephritic syndrome with rapid progression to 
acute renal failure (5). LN evaluation consists of assessing serum creatinine level, urine dipstick 
testing, and urine sediment examination (3). Many patients will have findings suggestive of LN 
at the initial diagnosis of SLE, and patients with SLE should undergo screening for LN at 
diagnosis, at least yearly thereafter, and any time there is concern for a lupus flare (3). 
Furthermore, renal biopsy is the gold standard diagnosis and histological classification of LN 
(3,5). A complete staining pattern for LN consists of finding positive staining for immunoglobulin 
(Ig) G, A, and M with C1q, C3, and C4 (5). Moreover, patients with LN that is refractory to 
treatment should be evaluated for other possible causes for the persistence of proteinuria or 
deterioration in renal function. These include the nephrotoxic side effects of medications (such 
as the calcineurin inhibitors and nonsteroidal anti-inflammatory drugs [NSAIDs]), renal vein 
thrombosis, infections, over diuresis, and poorly controlled hypertension. Treatment compliance 

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should be checked. To help guide further treatment decisions, a repeat renal biopsy should be 
considered in patients with persistently active serological markers (5,12). Indeed, a second biopsy 
provides information on: 1) the histological transformation of LN classes; 2) the degree of 
residual activity in the kidneys; and 3) the extent of chronic irreversible changes and their 
progression since the initiation of immunosuppressive treatment (5). 
To help physicians in diagnosis and care management, new guidelines and recommendations for 
the management of LN have been proposed by the European League Against Rheumatism 
(EULAR) and European Renal Association-European Dialysis and Transplant Association (ERA-
EDTA) in 2020 (12). Beside the EULAR recommendations, other parameters may be considered 
such as: patient education, coexisting morbidities, fibromyalgia, stress reduction, and many organ 
specific complications and aspects of SLE (e.g. autoimmune haemolytic anaemia, and screening 
for pulmonary hypertension) (13). Patients are usually followed up by rheumatologists and 
nephrologists in hospital-based physicians in specialised SLE centres (14). 
As for the treatment of LN, it depends on disease severity and risk for progressive kidney damage 
(3). A conservative treatment is used for the non-proliferative forms of LN (class II and V with 
sub-nephrotic range proteinuria and normal glomerular filtration rate), with treatment focused on 
blood pressure control with renin-angiotensin system blockade and immunomodulation with 
antimalarials (e.g. hydroxychloroquine) (3). As for immunosuppressive agents, these are used as 
needed to treat extrarenal manifestations only. In addition to antimalarials and renin-angiotensin 
system blockade, proliferative forms of LN (class III, IV, or III/IV+V) and class V with nephrotic 
syndrome are treated with systemic immunosuppression combined with high-dose corticosteroids 
to suppress inflammation and control autoimmunity (3). This induction phase of treatment 
generally lasts 3 6 months and is followed by a prolonged, but less intense maintenance phase, 
often lasting years. It is not clear when maintenance therapy can be withdrawn. A repeat kidney 
biopsy showing histologic remission during maintenance in LN patients who have achieved 
complete clinical remission, or who have stable but persistent proteinuria, may help in making a 
decision to taper off therapy (4). During the maintenance phase, immunosuppressive/cytotoxic 
agents are continued but de-escalated slowly over time to limit risk for LN flares. Biological 
drugs developed more recently show interesting beneficial effects in LN (4). They decrease the 
level of B lymphocytes which contributes to the decrease in autoantibodies known to play the 
central role in disease activity and consequently decrease the global inflammation level (15).  
There is a paucity of data in the Gulf countries on LN care management (treatment strategies, 
healthcare pathways, healthcare resource utilisation [HCRU] and costs), especially in moderate 
and severe cases. In this context, GSK has decided to carry out an observational study mainly to 
characterise LN patients in 5 Gulf countries who may benefit from early intervention. Also, in 
order to have an accurate estimation of the costs of LN care management. This study aims at 
 
 
1.1. 
Rationale 
SLE is a potentially serious, chronic, autoimmune disease, which can affect multiple organs of 
the body, including the kidneys (LN). The high variability and its unpredictable course 
(flaring/remission), combined with a lack of indicated and integrated treatments, induce a high 

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unmet need within the patient population. Reliable data on SLE- and LN-related care patterns and 
resource utilisation in the Gulf region are currently unavailable.  
The expected key outcomes of this study will be: 
 
Description of clinical characteristics, demographics, treatment and health-related quality 
of life (HRQoL) of LN patients.  
 
-world
region. 
for 
developing a scientific communication plan for Gulf. It can also be used for clinical research, for 
health planners, for clinical management and education/information for patients/ healthcare 
-
of LN patients in the Gulf countries.  
 
2. 
OBJECTIVES 
2.1. 
Primary Objective 
Describe patient profile, demographic features, clinical manifestations, comorbidities, severity, 
treatments and HRQoL of LN patients over one-year period across 5 Gulf countries (UAE, Qatar, 
Bahrain, Kuwait and Oman). 
 
2.2. 
Secondary Objectives 
1. Describe refractory LN cases, involving rituximab, and to assess changes in serological 
markers of disease activity (including anti-nuclear antibody, anti-dsDNA antibody and 
complement levels) over the treatment period. 
2. Assess the association between clinical factors, biomarkers, treatment and renal 
remission. 
3. Assess impact of LN on HRQoL over a one-year period after diagnosis or enrolment. 
4. Describe LN HCRU and direct medical cost, associated with LN management across 5 
Gulf countries over a one-year period. 
5. Exploring the difference in treatment patterns by physician profile (physicians in private 
versus public hospitals).  
 

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3.
RESEARCH METHODOLOGY
3.1. 
Study Design 
The LUNELORD study is a multicentre prospective study compromising of a patient-completed 
survey and retrospective chart review (Figure 1). 
This study will enrol approximately 200 patients with clinician diagnosed LN cases from 5 
different countries in the Gulf (UAE, Bahrain, Qatar, Kuwait and Oman). Enrolment is planned 
to last for 6 months from June 2021 till November 2021. 
Each site is planned to enrol around 16 patients, with the aim to have around 50% of the patients 
with renal remission and 50% with no renal remission to ensure the study meets the sample size 
and power assumptions provided below. The recruitment will not be competitive among 
participating sites for optimal representation of the study population. Since rheumatologists 
usually play a leading role in the disease management in multidisciplinary setting, clinical sites 
will predominantly be selected from this clinical specialty. Treatment of flares/ exacerbations/ 
organ manifestations, recommended by other specialists than rheumatologists / immunologists 
(for example nephrologists), will be considered and registered during the study by the 
investigators. 
Centres from the private and public sectors will be chosen based on their ability to fulfil the 
objectives of the study and the ability to enter data onto the electronic case report form (eCRF). 
The country regulation will not impact the selection criteria of the centre or patient recruitment; 
major sites in each participating country will be selected and are representative of most patients. 
All nationalities have also been included as well. Given the ethnic diversity of the region study 
investigators will ensure to include all ethnicities. Prior to the selection of the sites, feasibility of 
study in all clinical sites and pilot eCRF will be tested and trainings will be conducted. 
GSK study team will choose sites, representing major lupus treatment centres in respective 
countries, based on availability of sufficient potentially eligible patient population, their 
competency and experience to conduct research, their ability to fulfil the objectives of the study, 
ability to enter the data onto the eCRF. Prior to selection feasibility all clinical sites and pilot 
eCRF will be tested and trainings will be conducted.  

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Figure 1. Study schematics. 
 
3.1.1. 
Patient Identification Process and Eligibility Verification 
Staff at participating sites will consecutively 
pre-
identify 
might be 
considered eligible to participate in the study. Identified patients who are potentially eligible will 
be contacted over the phone or 
within the study enrolment timelines. When contacting the patient, site staff will review the main 
study informed consent form (ICF) with each patient to explain the study design, which will 
include a two-time prospective patient survey, prospective data abstraction from medical charts 
for a period of a year, as well as a one-time retrospective data abstraction from their medical 
chart. Additionally, site staff will answer any questions patients may have at this time about the 
study. Patients will be asked to confirm study interest verbally. 
Site staff will maintain a master list of patients invited to participate in the study (screening log) 
to assess the correspondence of the sample to the general population of potentially eligible LN 
patients at the site. 
 
3.1.2. 
Patient Consent and Patient Survey 
Eligible patients who provide verbal consent will receive a written informed consent form and 
asked to review and sign following the discussion of the study with the site staff and all queries 
resolved. Upon signing of the consent form the patient will be asked to complete the first patient 
survey during their first routine care visit after signing of the consent form. The second patient 
survey will be completed approximately 12 months after the completion of the first survey. In 
routine care, this would typically be Visit 5 from the enrolment period. 
 

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3.1.3.
Retrospective Medical Chart Review
Site staff will perform a one-time data abstraction from the medical charts of patients who sign 
the consent form and complete the first patient survey. Available data in the charts as part of usual 
care from diagnosis, or up to (12) twelve months prior to enrolment will be abstracted (as outlined 
in Section 3.2.2). Data abstracted will be recorded directly in the eCRF. 
 
3.1.4. 
Prospective Medical Chart Data Collection 
Site staff will be asked to abstract data from medical charts of patients who have completed the 
first patient survey. Data will be abstracted after each patient visit based on their routine care 
visits. Data abstracted will be recorded directly in the eCRF. A typical LN patient visits the 
physician every 3 months. In total there will be 5 visits (Figure 1).  
a. Visit 1: Enrolment visit  
b. Visit 2: 3-month follow-up after Visit 1  
c. Visit 3: 6-month follow-up after Visit 1 
d. Visit 4: 9-month follow-up after Visit 1 
e. Visit 5: last 12-month follow-up visit after Visit 1 
We will aim for the data collection visits to be near the 3,6,9,12-month time points, however, 
since this is a real-world evidence study the frequencies of visits may vary from one patient to 
another. Therefore, we will take the closest available visit to our study time points. If a patient 
misses a visit, we will analyse based on available data and assume clinical status did not change. 
This would allow to minimise the influence of the study procedures on the typical schedule of 
patient and associated healthcare resource utilisation. 
 
3.1.5. 
One-Time Physician Survey 
A brief, one-time physician survey will be used to collect site-level data on overall practice, 
population of patients with LN, and LN-related treatment patterns. Sites will be asked to complete 
and return the survey prior to the last subject last visit date (Appendix 5. Physician Practice Form). 
 
3.1.6. 
Medical Cost / HCRU 
Site staff will be asked to perform abstraction of data on HCRU from the medical charts of 
patients who sign the consent form and complete the first patient survey. Other data will be 
collected at enrolment and prospectively. These include number of laboratory tests, number of 
dialyses and use of imaging techniques, hospitalisations in the intensive care unit 
(ICU)/hospitalisations. Data abstracted will also be recorded directly in the eCRF. 

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Data related to the unitary cost of individual healthcare resources will be collected retrospectively 
at the end of prospective observation. The source of the cost information will be collected for 
each country separately. For each country, the payer perspective shall be taken (Ministry of 
Health or the tender price for the relevant payer). 
The type of unitary costs will be divided for each country in laboratory tests, biopsy and imaging, 
medical costs, medical visits costs and hospitalisation costs. More details will be further 
developed in the statistical analysis plan (SAP).  
The cost of illness shall be stratified by disease activity (SELDAI-2K). 
The prices will be taken by the end of the year for each country/institution for each resource; if 
any price modification has occurred during the year, an average price will be considered for the 
related resource. 
Inflation will not be considered since the study period is only for one year. 
 
 
3.2. 
Data Source / Data Collection 
Data collection will occur by physician abstraction of patient medical chart data onto the study 
eCRFs which were developed by GSK and the clinical research organisation (CRO). All data 
instruments are field-tested prior to initiation of data collection. 
 
3.2.1. 
Physician Practice Profile Form 
After being screened for study eligibility and successfully recruited, each physician will be 
assigned a unique identifier, and the PPPF will be completed. This form will be used to gather 
specific physician practice information including: 
1) Clinical practice and investigator profile 
2) Practice setting (community-based, hospital-based or other) 
3) Practice type (solo; single specialty group or multi-specialty group with number of 
rheumatologists quantified) 
4) Years in practice  
5) Estimated currently managed total patients and SLE and LN patients 
6) 
 
 

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3.2.2.
Retrospective Data Collection and Prospective Data Collection
Participating physicians will assign a unique identifier to each patient selected for inclusion in 
the study. This identifier will be used to facilitate follow-up on data queries and data entry 
validation. The date of chart data abstraction will be tracked separately by the eCRF vendor. 
Retrospective data collection - medical chart review from diagnosis or up till 12 months 
prior to enrolment 
collected in the patient eCRF, from diagnosis, or up to (12) twelve months prior to enrolment 
(Appendix 1). 
The patients routine repeated laboratory results will be taken closest to the protocol defined visits 
0, 3, 6, 9 and 12. Retrospective data will be collected for both routine laboratory visits and other 
parameters (i.e. renal biopsies if available). All such additional tests and assessments will be taken 
for the calculation for the HCRU and associated direct medical costs.  
Data include but are not limited to: 
1) Basic patient demographic characteristics: 
a. Gender 
b. Race/ethnicity 
c. BMI 
d. Date at first SLE manifestation 
e. Date at SLE diagnosis  
f. Date at first LN manifestation 
g. Date at LN diagnosis  
h. Date at last visit in 2020 
2) LN/SLE 
treatment 
medications 
(medications 
limited 
to 
NSAIDs, 
antimalarials, corticosteroids, immunosuppressants/cytotoxic and biologics): 
a. Starting dose, current dose, date of treatment start and end, dose at cessation and reasons 
for medication choice 
3) LN treatment history: 
a. Most recent induction regimen and number of prior treatment failures/relapse(s), if any 
b. End-stage renal disease (ESRD), and dialysis 

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c. Date of ESRD diagnosis 
d. Type and date of dialysis (current/past) 
e. Listed for transplant/prior transplant conducted (date of transplant) 
4) Most recent LN classification: 
a. Class and histological activity/chronicity based on most recent biopsy (International 
Society of Neurology and the Renal Pathology Society [ISN/RPS] or World Health 
Organisation [WHO] classification) 
5) LN clinical manifestations 
6) Comorbidities (such as, but not limiting with antiphospholipid syndrome/thrombotic 
microangiopathy, obesity, cardiovascular disease, and diabetes) 
7) Laboratory tests: 
a. Haematology: white blood cell count (x109/L]), haemoglobin (g/dL), platelet count 
(x109/L), erythrocyte sedimentation rate (mm/hour), C-reactive protein (mg/L) 
b. Liver function tests 
c. Lipid profile 
d. Plasma albumin 
e. Most recent serological findings such as: antiphospholipid antibody tests (anticardiolipin, 
anti-beta 2 glycoprotein 1 [GP1] and lupus anticoagulant), antiC1q, low-complement 
(C3/C4), positive anti-double-stranded deoxyribonucleic acid (anti-dsDNA) (IU/mL), 
anti-U1-RNP, anti-Sm antibody, anti-Rib, and anti-Scl-70 
f. Renal assessments, such as urinary protein to creatinine ratio (UPCR) or 24-hour 
proteinuria (mg/24-hr) or urine sediment (activity), serum creatinine (mg/dL), and 
estimated glomerular filtration rate (eGFR) or measured glomerular filtration rate (GFR) 
(if eGFR is not available) with date of assessment 
8) Active non-renal clinical manifestations of SLE (such as mucocutaneous, central nervous 
system, constitutional, cardiopulmonary, gastrointestinal, hematologic, musculoskeletal, and 
vasculitis) 
a. 
Type and date of resolution, if applicable 
9) Most recent total Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), such as 
SLEDAI or SLEDAI-2K (16), Appendix 2 
10) Renal remission: defined as proteinuria of <0.7 g/d or <0.5g/d or at 
 discretion  
11) Renal biopsy: 

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a. Activity index 
b. Chronicity index 
c. Number of glomeruli 
Prospective data collection from enrolment (0, 3, 6, 9, 12 months) 
Variables include but are not limited to (Appendix 1): 
1) Non-renal and renal clinical manifestations at period start with clinical improvement/ 
worsening assessment at period end 
2) Changes in disease activity assessment tools used (such as SLEDAI-2K) 
3) Refractory SLE: defined as inefficacy of cyclophosphamide, use of rituximab, splenectomy, 
-TNF, 
azathioprine, mycophenolate mofetil, and/or mycophenolic acid) 
4) Renal remission: defined as proteinuria of <0.7 g/d or <0.5g/d or at physician discretion  
5) Renal biopsy: 
a. Activity index 
b. Chronicity index 
c. Number of glomeruli 
6) Changes linked to the primary treatment of the disease: 
a. Adjustment of the dose by 20% or more, and 
b. Change happening for longer than 1 month, or 
c. Change or addition in the type or group of medication (immunosuppressants, biologics, 
anti-malarial, and steroids) 
7) Laboratory tests: 
a. Haematology: white blood cell count (x109/L]), haemoglobin (g/dL), platelet count 
(x109/L), erythrocyte sedimentation rate (mm/hour), C-reactive protein (mg/L) 
b. Liver function tests 
c. Lipid profile 
d. Plasma albumin 

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e. Most recent serological findings such as: antiphospholipid antibody tests (anticardiolipin, 
GP1 and lupus anticoagulant), antiC1q, low-complement (C3/C4), positive anti-dsDNA 
(IU/mL), anti-U1-RNP, anti-Sm antibody, anti-Rib, and anti-Scl-70 
f. Renal assessments, such as UPCR or 24-hour proteinuria (mg/24-hr) or urine sediment 
(activity), serum creatinine (mg/dL), and eGFR or measured GFR (if eGFR is not 
available) with date of assessment 
8) HCRU (number of laboratory tests, number of dialyses and use of imaging techniques, ICU 
hospitalisations/hospitalisations, outpatient visits) 
 
3.2.3. 
Prospective Patient Survey: HRQoL 
The 36-Item Short Form Health Survey (SF-36) has been selected as a standard tool, utilized in 
past studies in patients with lupus nephritis and is widely used in both clinical and real-world 
research. The tool is comprehensive and recognized by multiple experts in rheumatology as the 
optimal validate tool to measure quality of life in clinical practice. 
The 36-Item Short Form Health Survey (SF-36) is a 36-item QoL questionnaire covering 8 health 
domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical 
health problems (4 items), role limitations due to personal or emotional problems (4 items), 
emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general 
health perceptions (5 items). The questionnaire is available in Arabic and English versions. The 
average time to complete the questionnaire is 5 to 10 minutes. 
Each patient will complete an SF-36 form (17) at enrolment (Visit 1) and at the last visit (Visit 
5). It will be completed by the patient in Arabic, or in English in case he/she does not understand 
Arabic. Once completed, the site staff will enter data in the eCRF. 
Scores for each domain range from 0 to 100, with a higher score defining a more favourable 
health state (Appendix 3 and Appendix 4). 
 
3.3. 
Study Population 
Study participants are patients with lupus nephritis as defined by physician per patient hospital 
records prior to the enrolment visit or at diagnosis. Retrospective data of patients with diagnosed 
LN who made at least one centre visit during 12 months prior to the enrolment visit or at diagnosis 
of LN who fulfil inclusion/exclusion criteria will be abstracted from chart records. The data will 
be consecutively extracted from paper or electronic records were available. Based on our sample 
size assumptions and power calculations the study population will aim to recruit 50% of patients 
with renal remission and 50% of patients with no renal remission at the time of enrolment.  

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3.3.1.
Eligibility Criteria
Patient selection and eligibility for the study at the time of baseline enrolment were determined 
by the following inclusion/exclusion criteria. 
3.3.1.1. 
Inclusion Criteria 
For inclusion into the study, all the following inclusion criteria must be fulfilled by the patients: 
1) 
age of 18 years 
2) Clinician diagnosed LN patient 
3) At least one visit to the investigational centre during 12 months prior to the baseline visit, 
recorded in medical documentation 
4) Literacy in English or Arabic allowing to fully comprehend the written informed consent and 
study-specific patient reported questionnaires 
5) Written informed consent by the patient 
 
 
3.3.1.2. 
Exclusion Criteria 
Patients are not eligible for inclusion if they fulfil the following non-inclusion criteria: 
1) Incomplete medical records to be able to assess the disease severity or absence of any of the 
following renal laboratory results from the medical record within the last (12) twelve months:  
a. UPCR or 24-hour proteinuria or urine sediment (activity) 
b. Serum creatinine or eGFR; or measured GFR, if eGFR is not available 
2) Current or medical history of: 
a. Congenital or acquired immunodeficiency 
b. Malignancy in active treatment phase  
c. Acute viral infection, such as  HIV infection, requiring hospitalisation  
 
3.3.2. 
Sample Size / Power Calculations 
As other similar research recruited a sample size ranging between 200 and 300 patients (18,19) 
the decision was made to proceed with 200 sample size in this research. This sample size would 
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constraints the maximum number of participants allocated for the study has been determined as 
200.  
Based on the sample size determination using 
 and assuming the total SLE 
population in Gulf countries is 5,600 patients, while 40% of SLE patients manifest with lupus 
nephritis (LN), the entire LN population size was estimated as 2,240 patients disease onset (1). 
The margin of error (significance level), denoting the allowed probability of committing an error 
in selecting a small representative of the population, is 0.067 for the 93% of confidence that the 
data are going to be reflective of the entire LN population, given the assumptions of 200 LN 
patients, required to achieve this significance level (20).  
Significance of the adverse factors, impacting the data accuracy and completeness, will be 
assessed during the data acquisition and may result in respective adjustments to the sample size. 
In addition, taking into account our secondary hypothesis on the association between clinical 
factors, biomarkers, treatment and renal remission, a sample size of 200 observations (of which 
65% are in not in renal remission=0 and 35% are in renal remission=1) achieves 80% power at a 
0.050 significance level to detect a change in Prob(Y=1) from the baseline value of 0.200 to 0.385 
(Table 1). This change corresponds to an odds ratio of 2.508. 
 
 

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Table 1. Tests for the odds ratio in logistic regression with one binary X and other Xs  
(Wald Test) (21) 
Numeric Results 
 
 
 
Pcnt N 
 
 
Odds 
R 
Power 
N 
X=1 
P0 
P1 
Ratio 
Squared 
Alpha 
Beta 
0.80000 
200 
35 
0.200 
0.385 
2.508 
0.000 
0.050 
0.20000 
0.80000 
200 
35 
0.200 
0.409 
2.770 
0.200 
0.050 
0.20000 
0.80000 
200 
35 
0.200 
0.444 
3.199 
0.400 
0.050 
0.20000 
0.80000 
200 
35 
0.200 
0.504 
4.065 
0.600 
0.050 
0.20000 
0.80000 
200 
35 
0.200 
0.643 
7.200 
0.800 
0.050 
0.20000 
0.90000 
200 
35 
0.200 
0.418 
2.871 
0.000 
0.050 
0.10000 
0.90000 
200 
35 
0.200 
0.446 
3.216 
0.200 
0.050 
0.10000 
0.90000 
200 
35 
0.200 
0.487 
3.791 
0.400 
0.050 
0.10000 
0.90000 
200 
35 
0.200 
0.555 
4.985 
0.600 
0.050 
0.10000 
0.90000 
200 
35 
0.200 
0.707 
9.644 
0.800 
0.050 
0.10000 
0.80000 
200 
35 
0.300 
0.501 
2.342 
0.000 
0.050 
0.20000 
0.80000 
200 
35 
0.300 
0.525 
2.582 
0.200 
0.050 
0.20000 
0.80000 
200 
35 
0.300 
0.561 
2.981 
0.400 
0.050 
0.20000 
0.80000 
200 
35 
0.300 
0.620 
3.808 
0.600 
0.050 
0.20000 
0.80000 
200 
35 
0.300 
0.752 
7.094 
0.800 
0.050 
0.20000 
0.90000 
200 
35 
0.300 
0.533 
2.666 
0.000 
0.050 
0.10000 
0.90000 
200 
35 
0.300 
0.561 
2.984 
0.200 
0.050 
0.10000 
0.90000 
200 
35 
0.300 
0.602 
3.524 
0.400 
0.050 
0.10000 
0.90000 
200 
35 
0.300 
0.668 
4.685 
0.600 
0.050 
0.10000 
0.90000 
200 
35 
0.300 
0.808 
9.836 
0.800 
0.050 
0.10000 
0.80000 
200 
35 
0.400 
0.606 
2.308 
0.000 
0.050 
0.20000 
0.80000 
200 
35 
0.400 
0.630 
2.554 
0.200 
0.050 
0.20000 
0.80000 
200 
35 
0.400 
0.665 
2.972 
0.400 
0.050 
0.20000 
0.80000 
200 
35 
0.400 
0.721 
3.877 
0.600 
0.050 
0.20000 
0.80000 
200 
35 
0.400 
0.843 
8.080 
0.800 
0.050 
0.20000 
0.90000 
200 
35 
0.400 
0.637 
2.634 
0.000 
0.050 
0.10000 
0.90000 
200 
35 
0.400 
0.664 
2.965 
0.200 
0.050 
0.10000 
0.90000 
200 
35 
0.400 
0.703 
3.543 
0.400 
0.050 
0.10000 
0.90000 
200 
35 
0.400 
0.764 
4.859 
0.600 
0.050 
0.10000 
0.90000 
200 
35 
0.400 
0.891 
12.225 
0.800 
0.050 
0.10000 
 
Report Definitions 
Power is the probability of rejecting a false null hypothesis. It should be close to one. N is the 
size of the sample drawn from the population. Pcnt N X=1 is the percentage of the population in 
which X = 1. P0 is the response probability at the mean of X. P1 is the response probability when 
X is increased to one standard deviation above the mean. Odds Ratio is the odds ratio when P1 is 
on top. That is, it is [P1/(1-P1)]/[P0/(1-P0)]. R-Squared is the R2 achieved when X is regressed 
on the other independent variables in the regression. Alpha is the probability of rejecting a true 
null hypothesis. Beta is the probability of accepting a false null hypothesis (21). 
The sample size calculation was computed by PASS® version 2019. 
 

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4.
DATA ANALYSIS CONSIDERATIONS 
4.1. 
Analysis Population 
a
who meet the inclusion or exclusion criteria 
 
4.2. 
Protocol Deviation 
No per-protocol population is included in this study. 
Any protocol deviations will be documented and tracked by the study team. Any lost to follow 
up will not be replaced if it happens after the third month of recruitment. All efforts will be done 
by the investigator to reach out to the patient who is lost to follow up. Analysis of data associated 
with visits will happen according to data analysis planned, expect for HCRU.  
The number of patients who do not meet the inclusion and exclusion criteria will be reported. 
 
4.3. 
Interim Analysis 
No interim analysis is planned for this study. 
 
4.4. 
Data Analyses 
4.4.1. 
General Considerations for Data Analysis 
Variables will be summarised using the mean±standard deviation along with the median, 
interquartile range, smallest and largest observations for continuous numeric variables such as 
age, body weight at SLE diagnosis, and HRQoL. For categorical variables such as gender, race, 
and current diagnosis, frequency distributions (basically the frequency and percentage in each 
category) will be used. 
 
4.4.2. 
Primary Analysis 
The primary objective is to describe patient profile, demographic features, clinical manifestations, 
comorbidities, severity, treatments and HRQoL of LN patients across 5 Gulf countries. The 
analysis of the primary objective will be carried out on the ASE population and includes using 
summary statistics as described above in Section 4.4.1. General Considerations for Data Analysis 
at each time point the variables are collected. 
 

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4.4.3.
Secondary Analysis
The first secondary objective is to describe refractory LN cases, involving rituximab, and to assess 
changes in serological markers of disease activity (including anti-nuclear antibody, anti-dsDNA 
antibody and complement levels) over the treatment period. This will be achieved by first using 
summary statistics as per the general consideration of data analysis section at each time point. To 
assess one-year changes in numeric variables, the paired t-test or Wilcoxon signed rank test will 
be used while the McN
 will be used for changes in categorical variables. In addition, 
repeated measures analysis will be used to look at changes over the whole time period. 
The second secondary objective is to assess the association between clinical factors (disease 
activity), biomarkers (inflammatory markers and hematological markers), treatment (type and 
duration of therapy) and renal remission. The variables included in the model will be taken from 
the measures closest to the time of enrolment. For continuous variables, the nonparametric 
Wilcoxon test will be used for assessing differences between the patients who attained renal 
remission verses patients who did not attain renal remission, while the chi-square test will be 
used for dichotomized variables. Statistically significant factors will be included in the 
multivariate logistic regression models with renal remission as the dependent variable. Odds 
ratio and corresponding 95% confidence intervals (CIs) will be presented. 
 
The third secondary objective is to assess impact of LN on HRQoL over a one-year period after 
diagnosis or enrolment. This will be achieved by looking at changes in the SF-36 physical and 
mental components, and the total score at one year using the paired t-test or Wilcoxon signed 
rank test for non-normal distribution. Changes over all the time period will be assessed using 
repeated measures analysis. 
The fourth secondary objective is to estimate HCRU and direct medical cost, associated with LN 
management across 5 Gulf countries over a one-year period. This will be carried out as per Section 
4.5. Cost Evaluation. Generating an estimate for the average HCRU and direct medical cost and 
creating the 95% CIs for those will be carried out for each country. 
The number and proportion of patients with missing data will be presented. Listwise missing will 
be used during data analysis. All data analyses will be done using IBM-SPSS (version 26, 
Armonk NY). A p-value of 0.05 or less will be considered statistically significant. 
 
4.5. 
Cost Evaluation  
Direct medical costs of LN management will be assessed per country based on laboratory 
analyses, medication and duration of hospitalisation during 2020. 
In each country cost analysis will be determined by considerations outlined in the SAP of the 
study.  
Direct costs will be calculated for each patient on annual basis.  

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The annual direct medical cost will be calculated considering resources used and unitary costs at 
local level, in local currencies and United States Dollars. Direct medical cost evaluation 
considerations are outlined in the study SAP. 
To compute total cost, the direct cost components listed in Appendix 1 will be summed. 
Major cost drivers associated with LN management will be identified by multivariate adjusted 
models. 
The relevance of health status, disease severity, disease activity, symptoms and organs involved, 
disease duration since diagnosis, number of flares endured, age/severity at disease onset, 
treatments used, etc as predictor variables will be established. Multiple linear regression analysis 
will be used to determine the best model.  
Details about model specifications, parameter estimation and assumption validity will be outlined 
in the study SAP. 
 
4.6. 
Data Handling Conventions 
Details about the methods of handling missing data and the analysis methods will be documented 
in a separate SAP. 
4.7. 
Exploratory Analysis  
Supplementary exploratory data will be analysed regarding 
 (public versus 
private) and treatment of patients.   
5. 
LIMITATIONS 
Study limitations are as follows: 
 In routine practice, limited retrospective clinical SLE/LN data are available in the 
participating countries. Doctors in routine practice often do not indicate SLE and LN activity 
scores (SELENA-SLEDAI, SLEDAI-2K) in medical documentation. Lack of data to perform 
the full SLE activity scales completion will not limit inclusion of patients. Investigator will 
capture data of SLE and LN activity scales optionally, if possible. 
 HCRU and costs: 
o Relevant data will be collected in local currency, as US$ and local currency are 
used based on a fixed annual rate. 
o In order to map the costs at Governmental hospitals, these hospitals will be asked 
to list the costs of their services and to describe consultation fees of their salaried 
healthcare practitioners. 
o Assumptions should also be made on out-of-pocket expenses that are not recorded. 

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 The participating centres will be selected based on the feasibility of providing adequate 
data. Given regional variations in LN risk factors and in healthcare provision (including 
access to specialised SLE/LN centres) within the participating countries, the data should 
only be extrapolated to general populations with caution.  
 Since the number of patients to be recruited from each country is not prefixed, analyses 
by countries from where the number of patients recruited is very small will lack precision.  
 Sample size of the patient population in the study may not allow to generalize the data 
and perform comparisons between countries and some stratified analyses. However, the 
data from this research will be extremely important to inform future research of lupus 
nephritis in larger populations. 
 
6. 
STUDY CONDUCT, MANAGEMENT & ETHICS  
6.1. 
Ethical and Regulatory Submissions 
This study protocol and any amendments will be submitted to a properly constituted IEC/ IRB 
and/or Regulatory Authorities, in agreement with applicable regulatory requirements, for formal 
approval of the study conduct. A copy of these approvals will be submitted to GSK before 
initiation of the study and each centre will keep a copy of these documents. 
Changes to the study protocol must be made in the form of an amendment that has the prior 
written approval of GSK and  as applicable  of the appropriate IEC/IRB and regulatory 
authority.  
The study will be performed according to the legal requirements of the national law(s) of the 
participating countries considering the principles of Good Pharmacoepidemiological Practice 
(GPP; 22) and the ethical principles that guided development of the Declaration of Helsinki. 
 
6.2. 
Patient Information 
The patient and/or - if applicable - legally acceptable representative will be informed about the 
study according to the requirements of the GPP and the legal requirements of the country in which 
the patient is recruited.  
The study, its objectives, possible benefits and risks, and its consequences will be verbally 
explained to the patient and/or his/her legally acceptable representative. Moreover, the patient 
and/or legally acceptable representative is/are provided with written information about the study. 
Enough time will be allowed for the information to be read and for questions to be asked. The 
patient and/or legally acceptable representative must be told that refusal to participate in the study 
does not cause any disadvantages to their treatment; similarly, withdrawal of written informed 
consent is possible at any time, without stating a reason and without prejudice to further medical 
management.  

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Patients and/or legally acceptable representative should be informed and should agree that 
medical data may be reviewed by authorised persons during monitoring and during an audit or an 
inspection by the appointed regulatory authority or ethics committee, but that personal data will 
be treated with absolute confidentiality.  
The 
 and/or le
s written informed consent will be filed at 
 
 
6.3. 
Declaration of Informed Consent 
The patient and/or - if applicable - legally acceptable representative must give written consent to 
participate in the study by signing and personally dating the informed consent form. Informed 
consent to the proposed data handling and to data inspection must also be documented in written 
form. Written informed consent must be obtained from each patient or legally acceptable 
representative before any study-related procedures are performed. A duplicate of the signed and 
dated written informed consent form must be handed over to the patient and/or  if applicable - 
legally acceptable representative. 
 
6.4. 
Legal Basis for Processing Individual Human Data 
The authors confirm that study data are Individual Human Data (IHD) not owned by GSK, but 
and/or the terms and conditions of use of the data source and will it comply with any specified 
prohibitions of use. 
 
6.5. 
Adverse Event (AE), Pregnancy Exposure, and Incident Reporting 
All serious and non-serious AEs, pregnancy exposures, or incidents related to any GSK products 
will be collected and reported by Investigators as described in the study-specific 
pharmacovigilance plan (sPVP) reviewed by GSK Pharmacovigilance accordingly. This plan will 
include the following elements to ensure a comprehensive approach to safety event collection and 
reporting:  
 CRO pharmacovigilance training 
 Investigator and site staff pharmacovigilance training  
 Safety-specific roles 
 AEs, pregnancy exposures, and incidents collection and reporting processes 
 AE, pregnancy exposure, and incident collection forms 

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 Frequency of data review 
 Reporting process and timelines 
 Interim reports 
 Reconciliation process 
 Study-specific PVP monitoring process 
 Provision of final study report 
 
6.6. 
Study Scientific Advisory Committee 
This study is developed and governed under the guidance of a scientific advisory committee, 
composed of academic members experienced in SLE research and clinical practice (maximum 2 
from each country) and 2 methodologists. 
Its role will be:  
 To review and provide credible scientific input for the essential study documents (protocol, 
CRF, SAP etc.); 
 To review and comment on the study results;  
 To review and provide input on the study report; 
 To review and provide input into the data dissemination plan for the study results; 
 To provide input into the selection of manuscript(s) authors as per ICMJE 
recommendations; 
 To participate in medical writing and lead potential publications from the study results; 
 To appoint an external audit, if considered necessary; 
 To communicate results both internationally and locally upon explicit written approval from 
the study sponsor prior to such data disclosure in the public domain. 
7. 
EXTERNAL INVOLVEMENT (THIRD PARTY SUPPLIER, 
EXTERNAL EXPERT/HCPS) 
Quality control and Quality Assurance  
This study will be conducted according to GSK SOP52213 (Conducting Quality Control 
Review of Study Results generated using Existing Data in VEO and USVEO).  

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8. 
PLANS FOR DISSEMINATING AND COMMUNICATING 
STUDY RESULTS 
A report will be generated at the end of the study. GSK will provide the competent authority and 
IEC/IRB with a summary of the study report within 6 months after the end of the study, where 
required. 
Where required by applicable regulatory requirements, an investigator signatory will be identified 
for the approval of the study report. The investigator will be provided reasonable access to 
statistical tables, figures, and relevant reports and will have the opportunity to review the 
complete study results at a GSK site or other mutually agreeable location. 
GSK will also provide the investigator with the full summary of the study results. The investigator 
is encouraged to share the summary results with the study subjects, as appropriate.  
Neither the complete report nor any part of the study report may be used without the approval of 
GSK. 
Publication plan to support the dissemination of study results will be developed to seek 
publication of the research results (primary manuscript) in the indexed peer-reviewed scientific 
literature within 18 months of LSLV. Secondary manuscripts and congress abstracts, posters and 
oral presentations will provide important scientific knowledge around the study methodology, 
design, additional analyses of study data, country-specific data analysis and findings, arising from 
this research and provide additional scientific insight and/or release important new data into the 
public domain. 
For all publication authors will follow authorship criteria of the ICMJE or, if more stringent, the 
criteria of the target journals. 
Oral presentation and associated abstract on the primary and key secondary outcomes from the 
study will be aimed for the disclosure at the international (e.g. EULAR or ACR) or regional (e.g., 
ADARRC, ESR, KAR, ORS) congresses. 
Primary manuscript primary and key secondary outcomes from the study will be aimed for the 
publication in Lupus or equivalent scientific journals (e.g., Journal of Rheumatology, Current 
Opinion in Rheumatology, or Journal of Clinical Rheumatology). 
Secondary manuscripts with country-specific data analysis and findings, arising from this 
research will be aimed for publication in similar scientific journals. 
Study data around HCRU and direct medical cost, associated with LN management across 5 Gulf 
countries will be aimed for dissemination at respective leading Middle East and North Africa 
conferences for Health Economics and Outcomes Research or Public Health (e.g. ISPOR, Public 
Health Conference Dubai), followed by the publication in local or regional Health Economics 
and Outcomes Research journals (e.g. Journal of Medical Economics). 

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Each investigator is obligated to keep data pertaining to the study confidential. He/she must 
receive an explicit written approval from the study sponsor before any study data are published. 
The study protocol will be disclosed at the GSK study register and other study registries.  

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9.
REFERENCES

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1  Al Attia HM. Lupus nephritis among arabs - differences with other races; emphasis on 
clinicopathological and serological perspectives. Saudi J Kidney Dis Transpl. 
2000;11(3):370 80. PMID: 18209329 
2  Delfino J, Dos Santos TAFG, Skare TL. Comparison of lupus patients with early and late 
onset nephritis: a study in 71 patients from a single referral center. Adv Rheumatol. 
2020;60(1):5. doi: 10.1186/s42358-019-0105-5 
3  Parikh SV, Almaani S, Brodsky S, Rovin BH. Update on lupus nephritis: core curriculum 
2020. Am J Kidney Dis. 2020;76(2):265 81. Published online March 24, 2020. doi: 10.1053/ 
j.ajkd.2019.10.017 
4  Almaani S, Meara A, Rovin BH. Update on lupus nephritis. Clin J Am Soc Nephrol. 
2017;12(5):82 35. doi: 10.2215/CJN.05780616 
5  Mok CC. Understanding lupus nephritis: diagnosis, management, and treatment options. Int 
J Womens Health. 2012;4:213 22. doi: 10.2147/IJWH.S28034 
6  Zhu TY, Tam LS, Lee VW, Lee KK, Li EK. The impact of flare on disease costs of patients 
with systemic lupus erythematosus. Arthritis Rheum. 2009;61(9):1159 67. doi: 
10.1002/art.24725 
7  Carls G, Li T, Panopalis P, et al. Direct and indirect costs to employers of patients with 
systemic lupus erythematosus with and without nephritis. J Occup Environ Med. 
2009;51(1):66 79. doi: 10.1097/JOM.0b013e31818a405a 
8  Sutcliffe N, Clarke AE, Taylor R, Frost C, Isenberg DA. Total costs and predictors of costs 
in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2001;40(1):37 47. 
doi: 10.1093/rheumatology/40.1.37 
9  Huscher D, Merkesdal S, Thiele K, et al. Cost of illness in rheumatoid arthritis, ankylosing 
spondylitis, psoriatic arthritis and systemic lupus erythematosus in Germany. Ann Rheum 
Dis. 2006;65(9):1175 83. doi: 10.1136/ard.2005.046367 
10  Wilson EC, Jayne DR, Dellow E, Fordham RJ. The cost-effectiveness of mycophenolate 
mofetil as firstline therapy in active lupus nephritis. Rheumatology. 2007;46(7):1096 101. 
doi: 10.1093/rheumatology/kem054 
11  Clarke AE, Panopalis P, Petri M, et al. SLE patients with renal damage incur higher health 
care costs. Rheumatology (Oxford). 2008;47(3):329 33. doi: 10.1093/rheumatology/kem373 
12  Fanouriakis A, Kostopoulou M, Cheema K, et al. 2019 update of the joint European League 
Against Rheumatism and European Renal Association European Dialysis and Transplant 
Association (EULAR/ERA EDTA) recommendations for the management of lupus 
nephritis [published online March 27, 2020]. Ann Rheum Dis. doi: 10.1136/annrheumdis-
2020-216924  
 
 

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13  Wallace DJ. New European Recommendations (European League against Rheumatism 2008) 
for the management of Lupus Erythematosus: American perspective. Pol Arch Med Wewn. 
2008;118 (7-8):402 3. PMID: 18714734 
14  Mok CC. Who should treat lupus nephritis: rheumatologists or nephrologists?. Nat Rev 
Nephrol0 2008;4:E1. doi: 10.1038/ncpneph0654 
15  Panopalis P, Clarke AE. Systemic lupus erythematosus: clinical manifestations, treatment and 
economics. Expert Rev Pharmacoeconomics Outcomes Res. 2006;6(5):563 75. doi: 
10.1586/14737167.6.5.563 
16  Gladman DD, Ibañez D, Urowitz MB. Systemic lupus erythematosus disease activity index 
2000. J Rheumatol. 2002;29(2):288 91. PMID: 11838846 
17  Saris-Baglama RN, Dewey CJ, Chisholm GB, et al. 
software 4.0. Lincoln, RI: QualityMetric Incorporated, 2010, p. 138. 
18  Davidson JE, Fu Q, Ji B, Rao S, Roth D, Magder LS, Petri M. Renal remission status and 
longterm renal survival in patients with lupus nephritis: a retrospective cohort analysis. J 
Rheumatol. 2018;45(5):671 7. doi: 10.3899/jrheum.161554. Epub 2018 Mar 1. PMID: 
29496892; PMCID: PMC5932209. 
19  Moroni G, Quaglini S, Radice A, et al. The value of a panel of autoantibodies for predicting 
the activity of lupus nephritis at time of renal biopsy. J Immunol Res. 2015;2015:106904. 
doi:10.1155/2015/106904 
20  Kim M, Merrill JT, Wang C, et al. SLE clinical trials: impact of missing data on estimating 
treatment effects. Lupus Sci Med. 2019;6(1):e000348. doi: 10.1136/lupus-2019-000348 
21 Hsieh FY, Block DA, Larsen MD. A simple method of sample size calculation for linear and 
logistic regression. Statistics in Medicine.1998;17:1623 34. 
22  Public Policy Committee, International Society of Pharmacoepidemiology. Guidelines for 
good pharmacoepidemiology practice (GPP). Pharmacoepidemiol Drug Saf. 2016;25(1):2
10. doi: 10.1002/pds.3891 

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10. 
APPENDIX 1: DATA TABLE  
Variables 
Retro-
spective 
Enrolment* 
(Visit 1) 
Pro-
spective 
Demographics 
 
 
 
  Gender 
 
x 
 
  Race/ethnicity 
 
x 
 
  BMI 
 
x 
 
  Date at first SLE manifestation 
 
x 
 
  Date at SLE diagnosis  
 
x 
 
  Date at first LN manifestation 
 
X 
 
  Date at LN diagnosis  
 
X 
 
  Date at last visit in 2020 
 
X 
 
  Comorbidities 
 
X 
 
SLE Characteristics 
 
 
 
  SLEDAI-2K 
x 
 
x 
  Refractory SLE 
 
 
x 
Lupus Nephritis Characteristics 
 
 
 
  LN Pathological type (Class I-V) 
x 
 
x 
Active Non-Renal Clinical Manifestations of SLE 
 
 
 
  Mucocutaneous 
x 
 
x 
  Central nervous system 
x 
 
x 
  Constitutional 
x 
 
x 
  Cardiopulmonary 
x 
 
x 
  Gastrointestinal 
x 
 
x 
  Hematologic 
x 
 
x 
  Musculoskeletal 
x 
 
x 
  Vasculitis 
x 
 
x 
 LN Clinical Manifestations  
 
 
 
  Arthritis 
x 
 
x 
  Arthralgia 
x 
 
x 
  Photosensitisation 
x 
 
x 
  Skin rash 
x 
 
x 
  Malar rash  
x 
 
x 
  Neuropsychiatric disorders 
x 
 
x 
  Oral ulcer 
x 
 
x 
  Haematological abnormality 
x 
 
x 
  Serositis 
x 
 
x 
  Anti-dsDNA 
x 
 
x 
  Anti-U1-RNP 
x 
 
x 
  Anti-Sm 
x 
 
x 
  Anti-Rib 
x 
 
x 
  Anti-Scl-70 
x 
 
x 
  Lupus anticoagulant 
x 
 
x 
  Antiphospholipid  
x 
 
x 
  Anti-cardiolipin  
x 
 
x 
  C3/C4 
x 
 
x 
Laboratory Tests  
 
 
 
  White blood cell 
x 
 
x 
  Haemoglobin 
x 
 
x 
  Platelet count 
x 
 
x 
  Erythrocyte sedimentation rate 
x 
 
x 

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Variables 
Retro-
spective 
Enrolment* 
(Visit 1) 
Pro-
spective 
  C-reactive protein 
x 
 
x 
  Serum creatinine 
x 
 
x 
  24-proteinuria 
x 
 
x 
  Urinary protein to creatinine ratio 
x 
 
x 
  Urine sediment 
x 
 
x 
  eGFR  
x 
 
x 
  Measured glomerular filtration rate (if eGFR is not 
available) 
x 
 
x 
  Liver function tests 
x 
 
x 
  Lipid profile 
x 
 
x 
  Plasma albumin 
x 
 
x 
  Renal remission  
x 
 
x 
 Renal Biopsy  
 
 
 
  Activity index 
x 
 
x 
  Chronicity index 
x 
 
x 
  Number of glomeruli 
x 
 
x 
Treatment  
 
 
 
  Oral glucocorticoids  
x 
 
x 
  Daily dose of methylprednisolone 
x 
 
x 
  Daily dose of prednisolone 
x 
 
x 
  Antimalarial drugs 
x 
 
x 
  Immunosuppressants/cytotoxic 
x 
 
x 
  NSAIDs 
x 
 
x 
  Biological therapy 
x 
 
x 
Quality of Life 
 
 
 
  SF-36 
 
x 
x 
Healthcare Resources/ Medical Costs 
 
 
 
  Immunological tests  
 
 
x 
  Haematology tests 
 
 
x 
  Blood chemistry tests 
 
 
x 
  Urine analysis: creatinine 
 
 
x 
  Other fluid analysis  
 
 
x 
  Kidney biopsy  
 
 
x 
  Dialysis  
 
 
x 
  Imaging tests  
 
 
x 
  MRI 
 
 
x 
  Computer tomography 
 
 
x 
  Ultrasound 
 
 
x 
  X-ray  
 
 
x 
 Hospitalisations  
 
 
x 
 ICU hospitalisations 
 
 
x 
 Outpatient visits  
 
 
x 
 Other 
 
 
x 
*Enrolment or diagnosis of LN  
Note: Data will be collected only if available.  

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11. 
APPENDIX 2: SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE 
ACTIVITY INDEX 2000 (SLEDAI-2K) 
 

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12. 
APPENDIX 3: 36-ITEM SHORT FORM HEALTH SURVEY (SF-36)  
ENGLISH VERSION 
Choose one option for each questionnaire item 
1. In general, would you say your health is: 
1 - Excellent 
2 - Very good 
3 - Good 
4 - Fair 
5  Poor 
 
2. Compared to one year ago, how would you rate your health in general now? 
1 - Much better now than one year ago 
2 - Somewhat better now than one year ago 
3 - About the same 
4 - Somewhat worse now than one year ago 
5 - Much worse now than one year ago 
 
The following items are about activities you might do during a typical day. Does your health now limit you in these 
activities? If so, how much? 
 
Yes, limited a 
lot 
Yes, limited a 
little 
No, not 
limited at all 
3. Vigorous activities, such as running, lifting heavy objects, 
participating in strenuous sports 
 1 
 2 
 3 
4. Moderate activities, such as moving a table, pushing a vacuum 
cleaner, bowling, or playing golf 
 1 
 2 
 3 
5. Lifting or carrying groceries 
 1 
 2 
 3 
6. Climbing several flights of stairs 
 1 
 2 
 3 
7. Climbing one flight of stairs 
 1 
 2 
 3 
8. Bending, kneeling, or stooping 
 1 
 2 
 3 
9. Walking more than a mile 
 1 
 2 
 3 
10. Walking several blocks 
 1 
 2 
 3 
11. Walking one block 
 1 
 2 
 3 
12. Bathing or dressing yourself 
 1 
 2 
 3 

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During the past 4 weeks, have you had any of the following problems with your work or other regular daily 
activities as a result of your physical health? 
Yes 
No
13. Cut down the amount of time you spent on work or other activities 
 1
 2
14. Accomplished less than you would like 
 1
 2
15. Were limited in the kind of work or other activities 
 1
 2
16. Had difficulty performing the work or other activities (for example, it took extra 
effort) 
 1
 2
 
During the past 4 weeks, have you had any of the following problems with your work or other regular daily 
activities as a result of any emotional problems (such as feeling depressed or anxious)? 
 
Yes  
No 
17. Cut down the amount of time you spent on work or other activities 
 1 
 2 
18. Accomplished less than you would like 
 1 
 2 
19. Didn't do work or other activities as carefully as usual 
 1 
 2 
 
20. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your 
normal social activities with family, friends, neighbors, or groups? 
1 - Not at all 
2 - Slightly 
3 - Moderately 
4 - Quite a bit 
5  Extremely 
 
21. How much bodily pain have you had during the past 4 weeks? 
1 - None 
2 - Very mild 
3 - Mild 
4 - Moderate 
5 - Severe 
6 - Very severe 
 
 
 

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22. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the 
home and housework)? 
1 - Not at all 
2 - A little bit 
3 - Moderately 
4 - Quite a bit 
5  Extremely 
These questions are about how you feel and how things have been with you during the past 4 weeks. For each 
question, please give the one answer that comes closest to the way you have been feeling. 
 
All of 
the 
time 
Most of 
the 
time 
A good 
bit of 
the 
time 
Some 
of the 
time 
A little 
of the 
time 
None 
of the 
time 
23. Did you feel full of pep? 
 1 
 2 
 3 
 4 
 5 
 6 
24. Have you been a very nervous person? 
 1 
 2 
 3 
 4 
 5 
 6 
25. Have you felt so down in the dumps that nothing 
could cheer you up? 
 1 
 2 
 3 
 4 
 5 
 6 
26. Have you felt calm and peaceful? 
 1 
 2 
 3 
 4 
 5 
 6 
27. Did you have a lot of energy? 
 1 
 2 
 3 
 4 
 5 
 6 
28. Have you felt downhearted and blue? 
 1 
 2 
 3 
 4 
 5 
 6 
29. Did you feel worn out? 
 1 
 2 
 3 
 4 
 5 
 6 
30. Have you been a happy person? 
 1 
 2 
 3 
 4 
 5 
 6 
31. Did you feel tired? 
 1 
 2 
 3 
 4 
 5 
 6 
32. During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with 
your social activities (like visiting with friends, relatives, etc.)? 
1 - All of the time 
2 - Most of the time 
3 - Some of the time 
4 - A little of the time 
5 - None of the time 
How TRUE or FALSE is each of the following statements for you? 
 
Definitely 
true 
Mostly 
true 
Don't 
know 
Mostly 
false 
Definitely 
false 
33. I seem to get sick a little easier than other people 
 1 
 2 
 3 
 4 
 5 
34. I am as healthy as anybody I know 
 1 
 2 
 3 
 4 
 5 
35. I expect my health to get worse 
 1 
 2 
 3 
 4 
 5 
36. My health is excellent 
 1 
 2 
 3 
 4 
 5 

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13. 
APPENDIX 4: 36-ITEM SHORT FORM HEALTH SURVEY (SF-36)  
ARABIC VERSION 
 
PPD

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PPD

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PPD

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PPD

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PPD

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PPD

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PPD

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14.
APPENDIX 5: PHYSICAN PRACTICE PROFILE FORM
PHYSICIAN PRACTICE 
PROFILE FORM 
 
 
 
 
 
 
LUNELORD: A descriptive, prospective study to evaluate demographic, pharmacologic, biomarker, QoL, 
and clinical features of patients with SLE, LUpus NEphritis, refractory SLE and Long term ORgan Damage
 
 
SPONSOR: 
 
GlaxoSmithKline 
Al Sufouh 2 - Dubai  United Arab Emirates 
 
 
VENDOR/COLLABORATOR: 
 
Phoenix Clinical Research 
 
 
 
COORDINATING INVESTIGATOR: 
 
XX 
 
 
 

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Clinical Practice and Investigator Profile 
 
 
 
1. 
Years in practice: ___ ___   
 
 
2. 
Estimated currently managed total patients             ___ ___ ___ ___  
 
 
3. 
Estimated currently managed SLE patients             ___ ___ ___ ___  
 
 
4. 
Estimated currently managed LN patients               ___ ___ ___ ___  
 
 
5. 
Consultation fees                                                      ___ ___ ___ ___  
 
 
6. 
Estimated burden of disease severity on SLE patients:  
 
 
 
 
Health-related burden 
 Low 
 Moderate 
 High 
 
Cost-related burden 
 Low 
 Moderate 
 High 
 
Healthcare utilisation-related burden 
 Low 
 Moderate 
 High 
8. 
 
 Total 
 Partial 
 None 
 
Practice Setting 
 
 
No 
Yes 
1. 
Community-based 
2. 
Hospital-based 
3. 
If other, please specify: 
________________________________ 
 
 
 
Practice Type 
 
No 
Yes 
1. 
Solo 
2. 
Single specialty group 
3. 
Multi-specialty group including a quantified number of rheumatologists 
 
 
 
 
Disease Assessment tools/Laboratory Tests for SLE/LN Patient Monitoring 
 
No 
Yes 
1. 
Disease activity assessment 
 
 

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The European Consensus Lupus Activity Measurements, Systemic Lupus Activity Measure 
Revised (SLAM-R) 
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
 
 
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI
 
 
The British Isles Lupus Assessment Group Index (BILAG) 
 
 
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI 
 
 
Systemic Lupus International Collaborating Clinics/American College of Rheumatology 
Damage Index (SLICC/ACR DI) score 
 
 
Systemic Lupus Activity Questionnaire for Population Studies (SLAQ)
 
 
European Consensus Lupus Activity Measurement (ECLAM) 
 
 
Other, please specify: ______________________________ 
 
 
 
 

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2.
Laboratory assessment
2.1 
Hematology 
 
 
White blood cell count 
 
 
Hemoglobin count 
 
 
Platelet count 
 
 
Erythrocyte sedimentation rate 
 
 
C-reactive protein 
 
 
2.2 
Renal function  
 
 
serum creatinine 
 
 
estimated 24-hour urinary protein 
 
 
spot protein/creatinine ratio 
 
 
2.3 
Complement protein system components 
 
 
C3 
 
 
C4 
 
 
2.4 
Immunology  
 
 
Anti-dsDNA test 
 
 
ANA 
 
 
Anti-Sm antibody 
 
 
2.5 
Antiphospholipid (APL) antibody tests 
 
 
lupus anticoagulant (LAC) 
 
 
anticardiolipin (ACL) antibodies 
 
 
anti-
-glycoprotein I antibodies