To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).
This is a single arm, 24 weeks, pilot trial. All patients will be treated with standard of care plus Belimumab (at a dose of 10 mg per kilogram of body weight) . The primary endpoint is the proportion of LLDAS in week 24.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Belimumab 10 mg/kg
Steroid(≤1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Peking Union Medical College hospital
Beijing, Dongcheng, China
LLDAS
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
Time frame: week 24
Serologies
Changes in titers of anti-DNA antibody levels
Time frame: week 12, week 24
Complement levels
Changes in measures of C3, C4
Time frame: week 12, week 24
Dynamics of immune cell subsets
T cell and B cell subsets
Time frame: week 12, week 24
Glucocorticoid tapering
A prednisone dose that was decreased≤ 7.5mg/d
Time frame: week 12, week 24
Remission
a clinical SLEDAI-2K of 0 (disregarding the serology, including anti-dsDNA and complements), Physician Global Assessment \<0.5 (0-3). The patient may be on antimalarials, low-dose glucocorticoids (prednisolone ≤5 mg/day), and/or stable immunosuppressives including biologics
Time frame: week 12, week 24
LLDAS
Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials
Time frame: week 12
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