Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis

GlaxoSmithKline193 enrolled

Overview

This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates \[UAE\], Qatar, Bahrain, Kuwait and Oman).

Study Type

OBSERVATIONAL

Enrollment

193

Conditions

Systemic Lupus Erythematosus

Interventions

Participant completed surveyOTHER

Participants will be required to complete the participant survey.

Medical chart reviewOTHER

Data will be collected from medical charts of participants.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * More than or equal to 18 years of age * Clinician diagnosed LN participants. * At least one visit to the investigational center during 12 months prior to the baseline visit, recorded in medical documentation. * Literacy in English or Arabic allowing to fully comprehend the written informed consent and study-specific patient reported questionnaires. Exclusion Criteria: * 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 twelve months: a. Urinary protein to creatinine ratio (UPCR) or 24-hour proteinuria or urine sediment (activity). b. Serum creatinine or estimated glomerular filtration rate (eGFR); or measured glomerular filtration rate (GFR), if eGFR is not available. * Current or medical history of: a. Congenital or acquired immunodeficiency. b. Malignancy in active treatment phase. c. Acute viral infection, such as human immunodeficiency virus (HIV) infection, requiring hospitalization.

Locations (6)

GSK Investigational Site

Shweikh, Kuwait

GSK Investigational Site

Bawshar, Oman

GSK Investigational Site

Alrayyan, Qatar

GSK Investigational Site

Abu Dhabi, United Arab Emirates

Outcomes

Primary Outcomes

Number of Participants Categorized by Demographic Characteristics

Number of participants categorized by demographic characteristics including - health insurance coverage (yes, no), employment status (full time, part-time, housewife, not working, other, retired, self-employment), cigarette smoking status (current smoker, ex-smoker, non-smoker, unknown) and alcohol consumption (current, former, never, unknown) has been presented.

Time frame: At Baseline (Day 1)

Number of Participants With Active Clinical Manifestations of Lupus Nephritis

The active clinical manifestations included pedal edema, serositis, hair loss, decreased urine output, malar rash, discoid rash, photosensitive rash, joint pain/arthritis, hypertension, oral ulcer, seizure, psychosis, proteinuria, microscopic hematuria, anemia, thrombocytopenia, renal failure, leukopenia, other (autoimmune hepatitis, raised Serum creatinine with estimated glomerular filtration rate \[eGFR\] 59 milliliters per minute \[ml/min\]/1.73 meter square \[m\^2\]). Participants may have more than 1 active clinical manifestations of Lupus Nephritis.

Time frame: Up to 12 months

Number of Participants With Comorbidities

Participants with comorbidities (such as antiphospholipid syndrome/thrombotic microangiopathy, obesity, cardiovascular disease, diabetes) observed since the date of first diagnosis of lupus nephritis has been presented.

Time frame: Up to 12 months

Number of Participants With Severe Lupus Nephritis

Severe lupus nephritis was defined as participants with Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score greater than or equal to (\>=) 10. SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity.

Time frame: Up to 12 months

Number of Participants Categorized by Treatments for Lupus Nephritis

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Participants With Refractory Lupus Nephritis

Refractory systemic lupus nephritis was defined as inefficacy of cyclophosphamide, use of rituximab, splenectomy, or inefficacy of \>=2 immunosuppressives (methotrexate, leflunomide, abatacept, anti-tumor necrosis factor \[anti-TNF\], azathioprine, mycophenolate mofetil, and/or mycophenolic acid).

Time frame: Up to 12 months

Number of Participants With Abnormal Findings for Serological Markers

Number of participants with abnormal findings for serological markers (including anti-nuclear antibody, anti-double-stranded deoxyribonucleic acid \[dsDNA\] antibody and complement levels \[C3, C4\]) has been presented. Abnormal values were determined by the investigator.

Time frame: At 3, 6, 9 and 12 months

Number of Participants With Renal Remission That Were Associated With Clinical Factors, Biomarkers, and Treatments

Renal remission was defined as proteinuria of \<0.7 grams per day (g/d) or \<0.5g/d or at physicians' discretion. Number of participants with renal remission that were associated with clinical factors, biomarkers, and treatments has been presented.

Time frame: Up to 12 months

Percent Change From Baseline in SF-36 Scores for Each Health Domain:Physical Functioning, Pain, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problem, Emotional Well-being, Social Functioning, Energy/Fatigue and General Health

The 36-Item Short Form Health Survey (SF-36) is a 36-item HRQoL questionnaire covering 8 health domains: physical functioning, pain, role limitations due to physical health, role limitations due to emotional problems, emotional well-being, social functioning, energy/fatigue, and general Health. The individual question items are first summed for each item under the various sections. Then, those domain scores were weighted to a scale ranging between 0 to 100, where higher score represents better health. Baseline was considered as Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value (at 12 months). Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100. Percent change from Baseline values of individual domain scores have been presented.

Time frame: Baseline (Day 1) and at 12 months

Number of Participants With Hospitalizations and Intensive Care Unit (ICU) Hospitalizations

Number of participants with hospitalizations and ICU hospitalizations has been presented.

Time frame: Up to 12 months

Direct Medical Costs Associated With Lupus Nephritis Management

The direct medical costs of hospitalization and ICU hospitalization per participant associated with lupus nephritis management in United States dollars (USD) of United Arab Emirates (UAE), Kuwait, Qatar, and Oman were analyzed. Costs are described in local currency of each country and converted in USD dollars using the average exchange rate for each local currency versus USD in 2023. Direct medical costs associated with lupus nephritis management have been reported as USD.

Time frame: Up to 12 months

Number of Participants With Treatment for Lupus Nephritis by Sector (Public or Private Sector)

Number of participants with treatments for lupus nephritis (Prednisone, Chloroquine, Hydroxychloroquine, Azathioprine, Belimumab, Tacrolimus, Cyclosporine A, Voclosporin, Cyclophosphamide, Mycophenolate mofetil, Methotrexate, Rituximab) among physicians in the public and private sectors, respectively has been presented. Data has been presented per treatment received either in public sector or private sector up to 12 months. Participants may have received more than 1 treatment.

Time frame: Up to 12 months