Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study

Summary

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.

Eligibility

Inclusion Criteria:

* 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
* Physician Global Assessment (PGA) visual analogue score \> 1

Exclusion Criteria:

* Patients with incomplete medical records or missing key variables
* Patients with concomitant autoimmune disorders (excluding thyroid disease)

Conditions2

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