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Abstract
Background Belimumab and low dose IL2 (Ld-IL2) has been identified effective in the treatment of systemic lupus erythematosus (SLE). However, the application of combined therapy for SLE has not been documented in the real-life clinical setting. This study aims to determine the efficacy and safety of belimumab plus Ld-IL2 in patients with SLE.
Methods A randomized clinical trial was designed as SLE patients regularly received 10 mg/kg belimumab (n=10), 1 million IU Ld-IL2 (n=10) and combined utilization (n=10). Notably, belimumab was intravenously administered once a month for 48 weeks. Ld-IL2 was injected subcutaneously every other day to week 12, subsequently once a week to week 24 as one cycle and then treated for another cycle to week 48. During the therapy, we evaluated clinical parameters every three months and detected immunological variants monthly.
Results Data showed that the serum IgG, anti-dsDNA and AnuA levels witnessed a substantial decline at week 48 after Belimumab combined with Ld-IL2 treatment (figure 1A, C and D, P<0.05) while C3 experienced a great improvement (figure 1B, P<0.001). The addition of Ld-IL2 did not increase the incidence of adverse events. As compared to control groups, taking Ld-IL2 as a supplementary strategy dramatically suppressed naïve B cells and plasma cells after T-B combined therapy (figure 2A and B, P<0.05). Ld-IL2 upregulated the effect of belimumab on memory B cells and regulatory B (Breg) cells (figure 2C and D, P<0.05). B suppression alone conferred no function to T cells as IL2 and IL17 revealed no changes in combined therapy (figure 2E and F), while Treg cells showed an increasing trend followed by a decrease in Tfh cells (figure 2G and H).
Conclusions Ld-IL2 synthesis with Belimumab regulated the immune balance in patients with SLE without increasing the risk for severe advents. We provide the novel insights into the favorable effect of the combined therapy in clinical practice.
The decline in clinical activity after combined treatment
Combined treatment improved the distribution of circulating T and B cell subsets in SLE patients
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