Clinical trial NCT05624437: BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus
Official title: BElimumab corticoSteroids Sparing Treatment in Systemic Lupus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SLE (Systemic Lupus)
Lead sponsor: Centre Hospitalier de Niort
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.


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

Primary outcomes:
measure: number of patients whith low dose of steroids at six months after BELIMUMAB
timeFrame: at six months after BELIMUMAB
Secondary outcomes:
measure: number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB
timeFrame: 12, 18 and 24 months after BELIMUMAB
measure: cumulative dose of steroids at 6, 12, 18, 24 months
timeFrame: 6, 12, 18, 24 months
Other outcomes:
Locations:
city: Niort
country: France
facility: CH Niort
Study officials:
References: