Does Belimumab Modify the Natural History of SLE? A Propensity Scorematched, Real- World, Basket Study

Biomedical Research Foundation, Academy of Athens

Status: Enrolling

Conditions: SLE - Systemic Lupus Erythematosus

Study type: Observational

Funder types: Other

Identifiers

NCT07056621

224080

Details and patient eligibility

About

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).

We will utilize survival analysis methods (Kaplan-Meier survival curves and Cox regression) and mixed effects longitudinal analyses. Additionally, we will employ propensity score matching and/or inverse probability of treatment weighting, to create balanced cohorts and reduce bias.

Full description

Belimumab (BEL) has been used for the treatment of SLE for over 10 years, with clear evidence for a beneficial effect in reduction of disease activity and frequency of flares, as well as prevention of damage accrual.

Whether BEL may also result in prevention of incident, major organ involvement in patients with SLE is less clear. A recent post-hoc analysis of the BLISS trials suggested that BEL (although at the low, rather than standard-dose) reduced the rate of de novo renal flares (defined by BILAG) compared to standard-of-care but real-life data are scarce. Importantly, data on the ability of belimumab to decrease major neuropsychiatric events in SLE such as strokes, seizures and cognitive dysfunction or other severe manifestations such as severe hematologic or cardiopulmonary disease is not known.

To this end, we propose a propensity score-matched, real-world, with the use of longitudinal data from large patient cohorts and time-to-event analyses. Given the non-experimental setting of this study, we will also employ propensity score matching (PSM), to create balanced cohorts of BEL-treated and non-BEL-treated patients and reduce bias in estimating treatment efficacy.

The study will consist of 3 arms, as follows: Arm A: patients on treatment with belimumab; Arm B: patients on standard-of-care (SoC) treatment from May 1st 2014 onwards; Arm C: a historical cohort of patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece.

Enrollment: 684 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

684 participants in 3 patient groups

Group A: Belimumab

Description:

Group A will consist of patients under treatment with belimumab.

Group B: Standard-of-care (follow-up after May 1st 2014)

Description:

Group B will consist of patients on standar-of-care SLE treatment, who were followed-up after May 1st 2014 (the first date where belimumab was available in Greece).

Group C: Standar-of-care (follow-up before May 1st 2014)

Description:

Group C will consist of a historical cohort of patients under standar-of-care, followed-up before May 1st 2014 (the first date where belimumab was available in Greece).