Systemic Lupus Erythematosus
Conditions
Keywords
SLE, LLDAS, survival
Brief summary
This study aims to prospectively follow patients diagnosed with Systemic Lupus Erythematosus (SLE) at Peking University People's Hospital, assessing long-term outcomes such as disease activity, organ involvement, survival, and quality of life. Findings will support individualized patient management and contribute to understanding disease progression in the Chinese population.
Detailed description
This single-center, prospective observational cohort study aims to evaluate the long-term clinical outcomes of patients diagnosed with SLE at Peking University People's Hospital. SLE is a chronic, heterogeneous autoimmune disease that can lead to cumulative organ damage, impaired quality of life, and premature mortality. Although disease control has improved with the advent of immunosuppressive therapies, predicting long-term outcomes remains a challenge. The study will enroll adult SLE patients and follow them for a period of up to 10 years. Data will be collected at regular intervals, including clinical assessments, laboratory findings, treatment history, and patient-reported outcomes. A particular focus will be placed on measuring disease activity using validated indices such as the SLE Disease Activity Index (SLEDAI) and on evaluating the achievement and maintenance of Lupus Low Disease Activity State (LLDAS). LLDAS is a validated treat-to-target goal associated with reduced damage accrual and improved prognosis. It will be assessed at each follow-up visit based on established criteria, including low disease activity (SLEDAI-2K ≤4 with no major organ activity), no new disease activity, low-dose glucocorticoid use (prednisone ≤7.5 mg/day or equivalent), and stable standard immunosuppressants. The frequency, duration, and determinants of achieving and sustaining LLDAS over time will be analyzed as a key outcome, alongside major organ involvement, flare rates, survival, and quality of life. This study will provide real-world data on long-term disease trajectories in a Chinese tertiary hospital population and offer insights into predictors of favorable outcomes, guiding personalized disease management strategies and supporting the implementation of treat-to-target approaches in clinical practice.
Interventions
None listed
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients must meet at least one of the following classification criteria for Systemic Lupus Erythematosus (SLE): The 1997 American College of Rheumatology (ACR) Revised Classification Criteria; The 2012 Systemic Lupus International Collaborating Clinics (SLICC) Classification Criteria; The 2019 EULAR/ACR Classification Criteria for SLE. All patients must be over the age of 18 and competent to provide written consent.
Exclusion criteria
* Patients less than 18 years of age and patients who are unable to consent are excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving and Sustaining Lupus Low Disease Activity State (LLDAS) | Approximately 5-10 years | LLDAS is defined according to the Asia Pacific Lupus Collaboration (APLC) criteria as meeting all of the following at a study visit: SLEDAI-2K ≤4 with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, etc.) No new features of lupus disease activity compared to the previous assessment Physician Global Assessment (PGA) ≤1 (on a 0-3 scale) Prednisone (or equivalent) dose ≤7.5 mg/day Use of standard maintenance immunosuppressive drugs only |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ Damage Accrual Measured by the SLICC/ACR Damage Index (SDI) | Annually over a 10-year follow-up period | Organ damage will be assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). SDI ranges from 0 to 47, with higher scores indicating more severe, irreversible organ damage accrued since the onset of SLE. A score of 0 indicates no damage, while each additional point reflects cumulative damage in different organ systems. |
| Lupus-Related Mortality Rate | Approximately 5-10 years | Number and proportion of deaths directly attributable to SLE or its complications (e.g., infection, renal failure, cardiovascular events). |
| Glucocorticoid-Sparing Effect | Assessed at each follow-up visit (up to 10 years) | Proportion of patients achieving and maintaining prednisone (or equivalent) ≤7.5 mg/day without disease flare. Also evaluating cumulative steroid dose over time. |
Countries
China
Contacts
Primary ContactHaihong Yao, MD
Outcome results
None listed