The Clinical Study On The Efficacy And Safety Of Denosumab In The Treatment Of Bone Erosion In Rheumatoid Arthritis

Objective: Systematic evaluation of the efficacy and safety of denosumab in the treatment of bone erosion in rheumatoid arthritis(RA)through Meta-analysis and clinical control study.Methods: The Pub Med,EMbase,Web of Science,The Cochrane Library,CNKI,Wan Fang Data,and VIP databases were searched to collect randomized controlled trials(RCTs)of denosumab in the treatment of rheumatoid arthritis.Two reviewers independently screened literature,extracted data,and assessed the risk of bias of the included studies.Meta-analysis was then performed using Rev Man 5.4 software.Subsequently,we selected 34 RA patients with bone erosion admitted to the Department of Rheumatology and Immunology,the Second Hospital of Lanzhou University from July 2021 to August 2022 as the research objects.We followed up them for 6 months.Among them 17 patients were treated with denosumab and 17 patients were treated with risephosphate sodium.The changes of disease activity index(tender joint counts,swollen joint counts,C-reaction protein(CRP),erythrocyte sedimentation rate(ESR),Disease Activity Score-28(DAS28),health assessment questionnaire disability index(HAQ-DI))and bone destruction-related index(lumbar bone mineral density(BMD),femoral neck BMD,total hip joint BMD,modified total Sharp score(m TSS),Sharp erosion score(ES),Sharp joint stenosis score(JSNS))were compared between the two groups before and 6 months after treatment to evaluate the curative effect.Compare the adverse reactions,blood routine test,liver and kidney function changes of the two groups before and after treatment to evaluate the safety of the drug.SPSS25.0 software was used for statistical analysis.Results: Meta analysis: A total of 7 RCTs including 2346 patients were included.The results of meta-analysis showed that administering 60 mg densuzumab every 6months(Q6M)was superior to placebo in increasing the BMD of the lumbar spine,the hip,the femoral neck,and improving the m TSS.Administering 60 mg denosumab every 3 months(Q3M)and 60 mg Q6M were both superior to the placebo group at improving the ES;in addition,the 60 mg Q3M group was superior to the 60 mg Q6M group.There was no significant difference between denosumab and the placebo in improving the JSNS,the American College of Rheumatology 20%,50%,or 70%responses(ACR20/50/70),HAQ-DI or DAS28.In terms of safety,there was no significant difference between denosumab and the placebo group.The clinical control study: After treatment,tender joint counts,swollen joint counts,CRP,ESR,DAS28 and HAQ-DI of the two groups were significantly lower than those before treatment(P < 0.05);There was no significant difference between denosumab group and risephosphate sodium group(P > 0.05).The m TSS,ES and JSNS of the two groups after treatment were significantly higher than those before treatment(P < 0.05).The changes of m TSS and ES in denosumab group were significantly lower than those in risephosphate sodium group(P < 0.05).The BMD of lumbar spine and femoral neck after treatment in denosumab group were significantly higher than those before treatment(P < 0.05).The BMD of total hip joint was not improved after treatment(P > 0.05).The lumbar spine BMD,femoral neck BMD,and total hip BMD after treatment in the risephosphate sodium group were not improved compared with those before treatment(P > 0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P > 0.05).Conclusions: Denosumab can significantly improve the BMD of lumbar spine,hip joint and femoral neck in RA patients,delay the progression of bone erosion without increasing adverse reactions,but has no significant therapeutic effect on disease activity in RA patients.