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

NCT ID: NCT07056621

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 684 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-06-30

Brief 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.

Detailed 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, the investigators 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, the investigators 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.

Conditions

SLE - Systemic Lupus Erythematosus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Group A: Belimumab

Group A will consist of patients under treatment with belimumab.

No interventions assigned to this group

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

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).

No interventions assigned to this group

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

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).

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Research Foundation, Academy of Athens

OTHER

Sponsor Role: lead

Responsible Party

DIMITRIOS BOUMPAS

Professor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital 'Attikon'

Athens, Attica, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Dimitrios T. Boumpas, Professor in Medicine

Role: CONTACT

boumpasd@uoc.gr

00306937212025

Antonis Fanouriakis, Ass. Professor in Medicine

Role: CONTACT

afanour@med.uoa.gr

00306973016540

Facility Contacts

Dimitrios T Boumpas, Professor in Medicine

Role: primary

boumpasd@uoc.gr

00306937212025

References

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Fanouriakis A, Kostopoulou M, Andersen J, Aringer M, Arnaud L, Bae SC, Boletis J, Bruce IN, Cervera R, Doria A, Dorner T, Furie RA, Gladman DD, Houssiau FA, Ines LS, Jayne D, Kouloumas M, Kovacs L, Mok CC, Morand EF, Moroni G, Mosca M, Mucke J, Mukhtyar CB, Nagy G, Navarra S, Parodis I, Pego-Reigosa JM, Petri M, Pons-Estel BA, Schneider M, Smolen JS, Svenungsson E, Tanaka Y, Tektonidou MG, Teng YO, Tincani A, Vital EM, van Vollenhoven RF, Wincup C, Bertsias G, Boumpas DT. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024 Jan 2;83(1):15-29. doi: 10.1136/ard-2023-224762.

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Other Identifiers

224080

Identifier Type: -

Identifier Source: org_study_id