The LUNET Project: Developing the Italian Systemic Erythematous Lupus Network
Abstract
1. Introduction
- Planning and conducting epidemiological studies to evaluate the incidence and prevalence rates of different clinical manifestations of SLE, and to evaluate short- and long-term outcomes, including survival rates and organ dysfunction, injury, and failure
- Promoting multicenter studies that will compare different patient subgroups based on clinical phenotypes and organ involvement, to attain insights regarding disease expression and progression
- Describing the profile of patients with lupus nephritis in the national population, to improve guidelines on its systematic and standardized assessment.
- Evaluating the presence of central and peripheral nervous system involvement in the national population of patients with SLE, assessing the type, frequency, and severity of neurological symptoms and objective signs, as well as the instrumental techniques used in clinical practice (e.g., Magnetic Resonance Imaging (MRI)
- Assessing biomarker data to support early diagnosis and guide treatment choices
- Improving screening techniques for early identification of organ damage in SLE patients
- Improving early treatment strategies
- Tracking adherence and response to therapy
- Evaluating the short- and long-term real-life effectiveness and safety of old and novel drugs approved for SLE, overall and in groups of patients with specific phenotypes
- Assessing SLE patients’ quality of life according to clinical phenotype and treatment approach
- Assessing how socioeconomic status impacts patients’ access to healthcare and absenteeism in relation to the disease and various therapeutic approaches
- Evaluating how different therapeutic strategies impact hospitalization
- Assessing the influence of old and novel therapies on fertility, pregnancy, and breastfeeding
- Monitoring cardiovascular risk in SLE patients by evaluating the associated comorbidities, prospective development of cardiovascular events, and biomarker levels (e.g., fasting blood glucose, hemoglobin A1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides and pro-BNP)
- Evaluating bone metabolism in patients with SLE through assessment of laboratory measurements (e.g., vitamin D, calcium, phosphorus, calciuria, and phosphaturia) and instrumental assessments, such as dual-energy X-ray absorptiometry (DEXA) scans
- Monitoring the causes of death among SLE patients
2. Materials and Methods
2.1. Registry Design and Governance
2.2. Oversight
2.3. Patients
2.4. Database
- Inclusion criteria
- Patient details
- Occupation
- Medical history
- Comorbidities
- Clinical manifestations, including symptoms and signs of organ involvement at disease onset and subsequent follow-up, course of the disease, and number of disease flares per year
- Autoantibodies profile, including positivity of ANA, anti-dsDNA, anti-Sm, anti-Ro/SSA, anti-La/SSB, anti-centromere, anti-Scl70, anti-RNA polymerase III, anti-RNA polymerase I, anti-U3 RNP/fibrillarin, Jo1, anti-histone, anti-CCP, rheumatoid factor, ANCA-MPO, ANCA-PR3, myositis antibodies (i.e., anti-Mi2, anti-PL7, anti-PL12, anti-OJ, EJ, SRP, anti-MDA5, Anti-NXP2, and TIF1-gamma), and other anti-nuclear antibodies.
- Laboratory measurements: white blood cells (cells/mm3), red blood cells (cells/mm3), hemoglobin (g/dL), platelets (cells/mm3), lymphocytes (cells/mm3), neutrophils (cells/mm3), C-reactive protein (mg/dL), erythrocyte sedimentation rate value (mm/h), C3 (mg/dL), C4 (mg/dL), creatine kinase (mg/dL), NT-proBNP (pg/mL), BNP (pg/mL), total cholesterol (mg/dL), low density lipoprotein (mg/dL), high density lipoprotein (mg/dL), triglycerides (mg/dL), fasting blood glucose (mg/dL), glycated hemoglobin (mmol/mol, %), AST (U/L), ALT (U/L), GGT (U/L), eGFR (mL/min/1.73 mq), azotemia (mg/dL), serum creatinine (mg/dL), urine protein creatinine ratio (mg/g), urine sediment analysis (physical, chemical and microscopic analysis of urine), 24 h urine protein test (mg/day), vitamin D (mg/dL), calcium (mg/dL), phosphorus (mg/dL), calciuria (mg/24 h specimen), and phosphaturia (mg/24 h specimen)
- Functional/instrumental assessments: electrocardiography, echocardiography, kidney biopsy, musculoskeletal ultrasound and MRI, brain MRI, cerebrospinal fluid analysis, dual-energy X-ray absorptiometry (DEXA) scans
- SLE medication therapy details, including category, therapy name, current, start date, stop date, precise dose, dose unit, drug side effects, reason for change in therapy, and others
- Women’s reproductive health information, including the number of pregnancies, miscarriages, live births, congenital abnormalities, complications during pregnancy, administration of drugs before and during pregnancy, breastfeeding duration, administration of drugs before and during breastfeeding, and use of any contraceptive measures
2.5. Pharmacovigilance
2.6. Statistical Analysis
2.7. Electronic Database, Data Management, and Confidentiality
2.8. Ethics
3. Discussion
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Mormile, I.; Brussino, L.; Canonica, G.W.; Cortini, F.; Costantino, M.T.; Dagna, L.; Del Giacco, S.; Della Casa, F.; Di Gioacchino, M.; Emmi, G.; et al. The LUNET Project: Developing the Italian Systemic Erythematous Lupus Network. J. Clin. Med. 2025, 14, 6197. https://doi.org/10.3390/jcm14176197
Mormile I, Brussino L, Canonica GW, Cortini F, Costantino MT, Dagna L, Del Giacco S, Della Casa F, Di Gioacchino M, Emmi G, et al. The LUNET Project: Developing the Italian Systemic Erythematous Lupus Network. Journal of Clinical Medicine. 2025; 14(17):6197. https://doi.org/10.3390/jcm14176197
Chicago/Turabian StyleMormile, Ilaria, Luisa Brussino, Giorgio Walter Canonica, Francesca Cortini, Maria Teresa Costantino, Lorenzo Dagna, Stefano Del Giacco, Francesca Della Casa, Mario Di Gioacchino, Giacomo Emmi, and et al. 2025. "The LUNET Project: Developing the Italian Systemic Erythematous Lupus Network" Journal of Clinical Medicine 14, no. 17: 6197. https://doi.org/10.3390/jcm14176197
APA StyleMormile, I., Brussino, L., Canonica, G. W., Cortini, F., Costantino, M. T., Dagna, L., Del Giacco, S., Della Casa, F., Di Gioacchino, M., Emmi, G., Moroncini, G., Negrini, S., Pacella, D., Parronchi, P., Patella, V., Rossi, F. W., Sirena, C., Triggiani, M., Vacca, A., & de Paulis, A. (2025). The LUNET Project: Developing the Italian Systemic Erythematous Lupus Network. Journal of Clinical Medicine, 14(17), 6197. https://doi.org/10.3390/jcm14176197