BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus

NCT ID: NCT05624437

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-19
• Study Completion Date: 2022-08-31

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.

Conditions

SLE (Systemic Lupus)

Study Design

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

Interventions

data record

data record

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

Centre Hospitalier de Niort

OTHER

Sponsor Role: lead

Responsible Party

Perier

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CH Niort

Niort, , France

Countries

France

Other Identifiers

CHNiort

Identifier Type: -

Identifier Source: org_study_id