| Objective.To investigate the efficacy and safety of belimumab(BEL)in the treatment of newly diagnosed and relapsing/refractory active lupus nephritis(LN),observe the changes in disease activity indicators and immunological indicators in patients with LN,and summarize the experience of BEL treatment in our center.Methods.Patients with active LN who were hospitalized in our department from March 2020 to October 2021 and treated with BEL were included.The patients’baseline data were collected,including gender,age,course of SLE and LN,time and pathological diagnosis of renal biopsy,clinical manifestations and autoantibodies before BEL treatment,and medication history.At the same time,biochemical and immunological indicators at week 0,4,12,and 24 were collected,including 24-hour proteinuria,white blood cell count,platelet count,serum creatinine(SCr),estimated glomerular filtration rate(eGFR),anti-dsDNA antibodies,erythrocyte sedimentation rate(ESR),complement C3,C4,and SLEDAI-2K.The absolute count of lymphocyte subsets and IgG were also collected before each infusion.Renal responses and adverse events(AE)during the treatment were recorded.Meanwhile,SPSS 26.0 and Graphpad Prism 9.0 were used for statistical analysis,including the changes in disease activity indicators and immunological indicators.The group comparison results summarize the clinical characteristics of patients with a rapid response at week 4 or with complete remission(CR)at week 24.Results.(1)A total of 15 patients including 14 females were included,with a baseline age of 33.33±10.47 years.10 patients with a course of 5.95±4.15 years had relapsing/refractory LN.Pathological diagnosis of all the 8 patients who accepted renal biopsy 6 months before BEL treatment were active proliferative LN.(2)The obvious renal response was observed in 66.7%(10/15)of all the patients 4 weeks after the first BEL infusion,and the total remission rate(TRR)and complete remission rate(CRR)continued to rise.At week 24,the TRR reached 80%(12/15),and the CRR was 60%(9/15).In addition,the CRR was 80%(4/5)in newly diagnosed patients and 50%(5/10)in relapsing/refractory patients at week 24.(3)At week 24,the median 24-hour proteinuria decreased from 1.65g/24h to 0.13g/24h(P<0.001),and the median SLEDAI-2K decreased from 14 to 4(P<0.001);the anti-dsDNA antibodies and ESR decreased,while C3,C4,and serum albumin increased significantly.The mean daily doses of glucocorticoid were gradually reduced from 19.47mg to 9.07mg(P=0.007),and the final doses were less than 10mg in 8 patients.Compared to baseline,the median IgG levels were reduced from 9.92g/L to 8.01g/L(P=0.225),the median count of CD19+B cells were reduced from 164.4 cells/uL to 82.9 cells/uL(P<0.001),and the median count of CD16/56+NK cells were increased from 44.46 cells/uL to 189.8 cells/uL(P<0.001)at week 24 in patients with renal remission.(4)Compared between two groups,the baseline C3 and C4 levels were lower(P<0.05)in patients who achieved renal remission at week 4;the baseline ESR,SCr of CR were lower(P<0.05),while the baseline eGFR,CD19+B cell count and TRR at week 12 were higher(P<0.05)in patients who achieved CR at week 24.(5)In terms of safety,there were 5 AEs occurred in 4 patients,including 2 cases of upper respiratory tract infection,1 case of pneumonia,1 case of abnormal liver function and 1 case of abnormal uterine bleeding.No serious AE such as death occurred.Conclusion.(1)BEL has a significant effect on patients with newly diagnosed or relapsing/refractory active LN,which can rapidly reduce proteinuria and disease activity,and reduce the doses of a basic glucocorticoid.(2)BEL may act more quickly in patients with lower baseline complement levels;and may be more effective in patients with milder kidney injury and higher baseline CD19+B cell count.Otherwise,the renal remission at week 12 may correlate with CR at week 24.(3)Monitoring immunological indicators during the use of BEL may prevent infection and better predict efficacy.(4)BEL has a low incidence of AE which indicates high safety. |
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