| Background:Systemic lupus erythematosus(SLE)involves multisystem throughout the body.The precise pathogenesis of SLE has not been fully elucidated,and there are still many problems in treatment.Belimumab can be specifically combined with B-cell activating factor(BAFF)to exert therapeutic effects,and has been applied in clinical practice.The efficacy of belimumab in the treatment of SLE varies greatly among different patient populations,and the effectiveness and safety of the application in Chinese patients still need to be further verified.Real-world study(RWS)is based on real-world data generated in clinical practice to research the etiology,diagnosis,treatment,prognosis and other issues of diseases.The design of RWS is closely related to clinical practice,among which therapeutic studies are non-randomized treatment regimens selected in clinical conditions based on patients’conditions and medication willingness.Compared with randomized controlled trials(RCTS),RWS have no strict restrictions on subjects,methods,process and other factors,and the results have guiding significance for clinical practice.Objective:To evaluate the effectiveness and safety of belimumab in clinical practice and provide valuable reference for clinical treatment and medication.Methods:It is a retrospective study.The case data of SLE patients treated from January 2020 to December 2021 were selected according to inclusion and exclusion criteria.These patients were divided into two groups,including the group receiving routine treatment plus belimumab and the group receiving routine treatment only.After matching for age,sex,course of disease,routine treatment and duration of routine treatment prior to enrollment.The changes of blood test indexes and disease activity score indexes of patients in the two groups were analyzed to evaluate the effectiveness,including erythrocyte sedimentation rate(ESR),double-stranded DNA(dsDNA)antibody levels,complement C3 and C4,immunoglobulin(Ig)G,IgA and IgM levels and SLE Responder Index 4(SRI-4)response rate.At the same time,adverse reactions during medication were recorded to evaluate the safety.Changes in urinary protein levels in patients with Lupus Nephritis(LN)were analyzed to assess the clinical efficacy of patients with LN.The initial use of belimumab was baseline for the belimumab group and the time point of inclusion was baseline for the routine treatment group.The duration of inclusion was 24 weeks and changes in laboratory and disease activity scores were assessed every 4 weeks.Results:1.Finally,102 SLE patients were enrolled in each group,and there was no significant difference between the two groups in age,sex,disease course,conventional treatment regimen and duration at baseline.2.Effectiveness evaluation:(1)ESR,anti-dsDNA antibody,immunoglobulin(IgG,IgA,IgM)and complement(C3,C4)levels were significantly different during 24 weeks in the belimumab group from 4 weeks after the addition of belimumab;Only ESR,anti-dsDNA antibody and complement(C3,C4)levels were significantly different in routine treatment group,while immunoglobulin levels(IgG,IgA,IgM)had no significant difference.ESR,anti-dsDNA antibody,IgG,IgA and complement(C3,C4)levels were significantly different between the two groups.(2)At 24 weeks,the SRI-4 response rate in the belimumab group was significantly higher than that in the routine treatment group.At 24 weeks,the SRI-4 response rate in the two groups was 51.2%and 38.7%,respectively.(3)At 24 weeks,the changes of urinary protein levels,including the ratio of urinary total protein creatinine and urinary albumin creatinine,in patients with LN showed significant differences from 8 weeks after the addition of belimumab.There was no significant difference in the changes of urinary protein levels in the routine treatment group.3.Safety evaluation:(1)In the belimumab group,4 patients(3.92%)had mild infusion reaction during application,and 2 patients(1.96%)had infectious adverse events during treatment,which improved after corresponding treatment.Patients with adverse reactions did not stop treatment,did not adjust the drug dose and continued treatment,and did not have subsequent discomfort symptoms.There were no serious infusion reactions and hypersensitivity reactions.(2)In the routine treatment group,7 patients(6.86%)showed gastrointestinal adverse reactions,and 5 patients(4.90%)showed infectious adverse events during treatment,which improved after corresponding treatment.No adverse events such as tuberculosis,tumor and bone marrow suppression were found in both groups within 24 weeks.Conclusion:1.Belimumab can improve some blood test indicators of SLE patients,and overall improve the disease activity status of SLE patients.2.Belimumab can improve the degree of kidney injury in patients with LN to a certain extent.3.Compared with the routine treatment regimen,belimumab has a faster onset and a greater advantage in the treatment of SLE.4.The safety of intravenous belimumab in the treatment of SLE is good.5.As a supplement to the routine treatment regimen,belimumab has good efficacy and safety in the treatment of SLE. |
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