The purpose of this study was to explore the clinical and immunological efficacy of belimumab plus low dose IL-2 in systemic lupus erythematosus.
Given that belimumab and low dose interleukin-2 (IL-2) have been widespreadly applied in the treatment of systemic lupus erythematosus (SLE), this study designed a randomised, single center, prospective study to investigate the effects and safety of combined utilization of belimumab and low dose IL-2. SLE patients were allocated in each group randomly (n=10) and regularly administered belimumab (10mg/kg) with or without IL-2 (1 million IU). Then, we evaluated the improvement of clinical and laboratory indexes and monitored the changes of immune cell subsets and cytokines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Belimumab was intravenously administrated at a dose of 10mg/kg once a month for at least 24 weeks.
Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, China
RECRUITINGImmunological responses of B cell subsets
A significant reduction of active B cell subsets including naive B cells and transitional B cells after different interventions. P values below 0.05 are considered statistically significant in this study.
Time frame: Week 24
Proportion of SLE Responder Index (SRI)4 response
SLE Responder Index (SRI)4 responders had ≥4-point reduction in safety of estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index(SELENA-SLEDAI) score
Time frame: Week 12 and 24
Prednisone dose
The improvement in prednisone dose experienced a mean corticosteroid dose reduction of ≥25% mg/day at baseline to ≤7.5 mg/day.
Time frame: Week 12 and 24
Immunoglobulin change from baseline
Serum samples were collected at indicated time-points for analysis of immunoglobulins: Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). Baseline is defined as the Day 0 visit from parent studies.
Time frame: Week 12 and 24
Autoantibody change from baseline
Blood samples were collected at indicated time-points for analysis of autoantibodies like anti-double stranded deoxyribonucleic Acid(dsDNA), antinuclear antibody (ANA). Baseline is defined as the Day 0 visit from parent studies.
Time frame: Week 12 and 24
Change of complement C3 and C4 Levels from baseline
Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies.
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Time frame: Week 12 and 24
Safety and tolerability of the treatment
The incidence of adverse events, disease activity and clinical laboratory data throughout the study were accessed.
Time frame: Up to Week 24