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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiomedical Research Foundation, Academy of Athens

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Patients with incomplete medical records or missing key variables

Patients with concomitant autoimmune disorders (excluding thyroid disease)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

684 Participants
are grouped into 3 trial groups