This will be a combined retrospective and prospective cohort study, that will evaluate the incidence of de novo Systemic Lupus Erythematosus major organ manifestations (defined as BILAG A flares) in patients receiving belimumab (Arm A) and compare it to 2 standard-of-care groups (SoC) (Arm B: patients on SoC; Arm C: patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece).
The investigators will utilize survival analysis methods (Kaplan-Meier survival curves and Cox regression) and mixed effects longitudinal analyses. Additionally, the investigators will employ propensity score matching and/or inverse probability of treatment weighting, to create balanced cohorts and reduce bias.
Systemic lupus erythematosus classification according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria
Age ≥ 18 years old
Time of follow-up ≥ 6 months
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4
Patients with incomplete medical records or missing key variables
Patients with concomitant autoimmune disorders (excluding thyroid disease)
Adult systemic lupus erythematosus patients, receiving belimumab (Arm A) or standard-of-care treatment (Arms B and C).
Cohort
Other
Not listed
Bilag A flare
Major organ systemic lupus erythematosus manifestations as defined by the BILAG (British Isles Lupus Assessment Group) index (BILAG A flare)
SLICC/ACR Damage Index
Systemic Lupus International Collaborating Clinics, ACR/American College of Rheumatology (SLICC/ACR) Damage Index (SDI)
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