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

NCT07056621 | Recruiting

• 1 other identifier: 224080
• Study Type: observational
• Target: 684
• Locations: 1 country
• Sites: 1

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.

Conditions

SLE - Systemic Lupus Erythematosus

Keywords

SLE; belimumab; bilag

Outcome Measures

Primary Outcomes (1)

• Bilag A flare

  Major organ systemic lupus erythematosus manifestations as defined by the BILAG (British Isles Lupus Assessment Group) index (BILAG A flare)

  From enrollment to the end of treatment (expected follow-up duration 1-4 years).

Secondary Outcomes (1)

• SLICC/ACR Damage Index

  From enrollment to the end of treatment (expected follow-up duration 1-4 years).

Study Arms (3)

Group A: Belimumab

Group A will consist of patients under treatment with belimumab.

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).

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult systemic lupus erythematosus patients, receiving belimumab (Arm A) or standard-of-care treatment (Arms B and C).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Biomedical Research Foundation, Academy of Athens: lead

Study Sites (1)

University Hospital 'Attikon'

Athens, Attica, 12462, Greece

RECRUITING

Related Publications (6)

• Fanouriakis A, Adamichou C, Koutsoviti S, Panopoulos S, Staveri C, Klagou A, Tsalapaki C, Pantazi L, Konsta S, Mavragani CP, Dimopoulou D, Ntali S, Katsikas G, Boki KA, Vassilopoulos D, Konstantopoulou P, Liossis SN, Elezoglou A, Tektonidou M, Sidiropoulos P, Erden A, Sfikakis PP, Bertsias G, Boumpas DT. Low disease activity-irrespective of serologic status at baseline-associated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: A real-life observational study. Semin Arthritis Rheum. 2018 Dec;48(3):467-474. doi: 10.1016/j.semarthrit.2018.02.014. Epub 2018 Feb 23.

  PMID: 29555348 BACKGROUND

• Nikoloudaki M, Nikolopoulos D, Koutsoviti S, Flouri I, Kapsala N, Repa A, Katsimbri P, Theotikos E, Pitsigavdaki S, Pateromichelaki K, Bertsias A, Elezoglou A, Sidiropoulos P, Fanouriakis A, Boumpas D, Bertsias G. Clinical response trajectories and drug persistence in systemic lupus erythematosus patients on belimumab treatment: A real-life, multicentre observational study. Front Immunol. 2023 Jan 4;13:1074044. doi: 10.3389/fimmu.2022.1074044. eCollection 2022.

  PMID: 36685524 BACKGROUND

• Iaccarino L, Bettio S, Reggia R, Zen M, Frassi M, Andreoli L, Gatto M, Piantoni S, Nalotto L, Franceschini F, Larosa M, Fredi M, Punzi L, Tincani A, Doria A. Effects of Belimumab on Flare Rate and Expected Damage Progression in Patients With Active Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2017 Jan;69(1):115-123. doi: 10.1002/acr.22971. Epub 2016 Nov 18.

  PMID: 27390293 BACKGROUND

• Bartels C, Bell C, Rosenthal A, Shinki K, Bridges A. Decline in rheumatoid vasculitis prevalence among US veterans: a retrospective cross-sectional study. Arthritis Rheum. 2009 Sep;60(9):2553-7. doi: 10.1002/art.24775.

  PMID: 19714622 BACKGROUND

• van Vollenhoven R, Askanase AD, Bomback AS, Bruce IN, Carroll A, Dall'Era M, Daniels M, Levy RA, Schwarting A, Quasny HA, Urowitz MB, Zhao MH, Furie R. Conceptual framework for defining disease modification in systemic lupus erythematosus: a call for formal criteria. Lupus Sci Med. 2022 Mar;9(1):e000634. doi: 10.1136/lupus-2021-000634.

  PMID: 35346982 BACKGROUND

• 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.

  PMID: 37827694 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Dimitrios T. Boumpas, Professor in Medicine

CONTACT

00306937212025; boumpasd@uoc.gr

Antonis Fanouriakis, Ass. Professor in Medicine

CONTACT

00306973016540; afanour@med.uoa.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Medicine

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)