BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus (BESST)

BElimumab corticoSteroids Sparing Treatment in Systemic Lupus

BELIMUMAB, anti-BLyS human monoclonal antibody, is the first immunotherapy used for the treatment of systemic lupus erythematosus (SLE) which was licensed in 2011 in France.

Currently, Belimumab is reimbursed for the treatment of active SLEwith autoantibody-positive after intolerant or initial failure of first-line traitment (anti malaria, non-steroidal anti-inflammatory drugs, glucocorticoids and/ou immunomodulatory agents).

EUropean League Against Rheumatism (EULAR) suggest the following terminology of "low dose" when steroids are less than 7.5 mg/day (prednisone equivalent) because this dose range is often used for maintenance therapy for many rheumatic diseases requiring glucocorticoids and it is relatively few adverse effects.

In patients with SLE, a significant proportion of the damage could be attributed to corticosteroid therapy, and this damage accumulated over time.

Thanks to randomised and subgroups trials, post-hoc analysis , BELIMUMAB seems to be interesting in the maintain of lowest possible dose of glucocorticoids. However, these studies were not design with this aim, so it is impossible to conclude.

Thus, BELIMUMAB seems to be very interesting treatment to redcuce glucocorticoids level.

We conduce a multicentric French study in real-life settings, to assess the ability of belimumab to achieve low-dose of steroids.

Study Overview

• Status: Completed
• Conditions: SLE (Systemic Lupus)
• Intervention / Treatment: Other: data record

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• France
  • Niort, France, 79021
    • CH Niort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

person aged ≥ 18 years

• with SLE according to ACR/EULAR criteria 2019
• started treatment by BELIMUMAB between 13 / July / 2011 to 13 / July / 2020
• following in an hospital center in Poitiers, La Rochelle, Rochefort, Niort, Angoulême, Nantes, Rennes, Tours, Angers
• affiliate or beneficiary of a social security scheme

Description

Inclusion Criteria:

• person aged ≥ 18 years
• with SLE according to ACR/EULAR criteria 2019
• started treatment by BELIMUMAB between 13 / July / 2011 to 13 / July / 2020
• following in an hospital center in Poitiers, La Rochelle, Rochefort, Niort, Angoulême, Nantes, Rennes, Tours, Angers
• affiliate or beneficiary of a social security scheme

Exclusion Criteria:

• Persons Under guardianship or curatorship or without civil law
• Pregnant and breastfeeding
• Persons who refused to participate
• Patients who stoppped BELIMUMAB before 6 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients whith low dose of steroids at six months after BELIMUMAB	number of patients whith low dose of steroids at six months after BELIMUMAB	at six months after BELIMUMAB

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB	number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB	12, 18 and 24 months after BELIMUMAB
cumulative dose of steroids at 6, 12, 18, 24 months	cumulative dose of steroids at 6, 12, 18, 24 months	6, 12, 18, 24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Niort

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CHNiort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No