BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus

Completed

• Conditions: SLE (Systemic Lupus)

• Registration Number: NCT05624437
• Lead Sponsor: Centre Hospitalier de Niort

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-19
• Primary Completion: 2021-11-19
• Study First Submitted: 2021-11-29
• Study Completion: 2022-08-31
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-17
• Last Update Submitted: 2022-11-17
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of patients whith low dose of steroids at six months after BELIMUMAB	at six months after BELIMUMAB	number of patients whith low dose of steroids at six months after BELIMUMAB

Secondary Outcome Measures

Name	Time	Method
number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB	12, 18 and 24 months after BELIMUMAB	number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB
cumulative dose of steroids at 6, 12, 18, 24 months	6, 12, 18, 24 months	cumulative dose of steroids at 6, 12, 18, 24 months

Trial Locations

Locations (1)

CH Niort; 🇫🇷 Niort, France