Trial Outcomes & Findings for Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis (NCT NCT04971590)

This was a multicenter prospective study. A total of 193 participants were enrolled in the study.

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

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.

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.

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.

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.

Number of participants categorized by treatments for lupus nephritis including prednisone, chloroquine, hydroxychloroquine, azathioprine, belimumab, tacrolimus, cyclosporine, voclosporin, cyclophosphamide, mycophenolate mofetil, methotrexate, and rituximab has been presented. Participants may have received more than 1 treatment for lupus nephritis.

The 36-Item Short Form Health Survey (SF-36) is a 36-item Health-Related Quality of Life (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. Individual domain scores have been presented.

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).

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.

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.

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.

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

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.

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.