Kidney Diseases, Lupus Nephritis, Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Immune-Inflammation Index SII, Systemic Inflammation Response Index SIRI, Lupus Nephritis Biomarkers
Brief summary
This prospective observational study aims to evaluate the prognostic utility of the Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) as novel inflammatory biomarkers for monitoring disease activity and predicting renal progression, flares, and outcomes in patients with lupus nephritis.
Detailed description
Lupus nephritis (LN) is a common and serious manifestation of systemic lupus erythematosus (SLE) that can lead to progressive renal damage and end-stage renal disease. Current assessment of disease activity and prognosis relies mainly on proteinuria, serum creatinine, estimated glomerular filtration rate (eGFR), and kidney biopsy, which is invasive and not always feasible for repeated monitoring. Simple blood count-derived inflammatory indices, such as the Systemic Immune-Inflammation Index (SII) and the Systemic Inflammation Response Index (SIRI), have recently emerged as potential biomarkers of systemic inflammation. These indices are inexpensive, readily available, and may reflect disease activity and renal risk in lupus nephritis. However, their prognostic value remains incompletely established, particularly in prospective settings. This prospective observational study will evaluate the ability of SII and SIRI to monitor disease activity and predict renal flares and outcomes in patients with lupus nephritis over a 12-month follow-up period.
Interventions
None listed
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria * Confirmed lupus nephritis according to ISN/RPS classification
Exclusion criteria
* Active infection, sepsis, or other concurrent inflammatory or autoimmune conditions * Malignancy or hematologic disorders affecting blood cell counts * Pregnancy * Use of medications significantly affecting blood counts (such as recent chemotherapy or G-CSF) * Incomplete medical records or anticipated loss to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of SII and SIRI with disease activity | Baseline, 6 months, and 12 months | Correlation between Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) levels with disease activity assessed by SLEDAI-2K and Renal SLEDAI scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association of SII and SIRI with renal function parameters | Baseline, 6 months, and 12 months | Association between SII and SIRI levels and renal function parameters including serum creatinine, eGFR, and proteinuria. |
| Predictive value of SII and SIRI for renal flares | 12 months | Ability of baseline and follow-up SII and SIRI values to predict the occurrence of renal flares |
| Association of SII and SIRI with clinical outcomes | 12 months | Relationship between SII and SIRI levels and short-term clinical outcomes including renal remission or disease progression. |
Contacts
CONTACTAbobakr A bakr, Resident
Outcome results
None listed