背景:在类风湿性关节炎的发展过程中,细胞因子白细胞介素-6发挥作用。称为olokizumab的白介素-6细胞因子特异性单克隆抗体直接靶向该细胞因子。OKZ的有效性和安全性正在通过这项荟萃分析进行评估。
方法:我查阅了所有已发表的关于Clinicaltrials.gov的随机对照研究,Scopus,WebofScience,科克伦,和PubMed。我使用Mantel-Haenszel和逆方差方法进行了这项研究。我使用偏倚风险工具2评估了纳入研究的偏倚。
结果:在本荟萃分析中,五项试验共2227名参与者,进行了检查。与安慰剂组相比,olokizumab组的美国风湿病学会20的发病率明显更高;RR=1.83,95%CI[1.69,1.99],P<0.00001。关于健康评估问卷-残疾指数的改进,olokizumab显著优于安慰剂组;MD=-0.28,95%CI[-0.32,-0.24],P<0.00001。治疗引起的不良事件发生率在olokizumab组明显高于安慰剂组;RR=1.10,95%CI[1.04,1.17],P=0.0006。此外,治疗引起的严重不良事件的发生率在olokizumab组和安慰剂组之间没有显着差异;RR=0.85,95%CI[0.60,1.20],P=0.35。
结论:类风湿性关节炎患者,olokizumab联合甲氨蝶呤的耐受性良好,比安慰剂联合甲氨蝶呤更有效.
In the development of rheumatoid arthritis, the cytokine interleukin-6 plays a role. An interleukin-6 cytokine-specific monoclonal antibody called olokizumab directly targets this cytokine. OKZ effectiveness and safety are being evaluated through this meta-analysis.
I looked up every published randomized controlled study on Clinicaltrials.gov, Scopus, Web of Science, Cochrane, and PubMed. I conducted the study using both the Mantel-Haenszel and inverse variance approaches. I evaluated bias in the included studies using the risk of bias tool 2.
In this meta-analysis, five trials totalling 2227 participants, were examined. In contrast to the placebo group, the olokizumab group had a significantly higher incidence of American College of Rheumatology 20; RR = 1.83, 95% CI [1.69, 1.99], P < 0.00001. Regarding Health Assessment Questionnaire-Disability Index improvement, olokizumab significantly outperformed the placebo group; MD = -0.28, 95% CI [-0.32, -0.24], P < 0.00001. The incidence of treatment-emergent adverse events was significantly higher in the olokizumab group than in the placebo group; RR = 1.10, 95% CI [1.04, 1.17], P = 0.0006. Furthermore, the incidence of treatment-emergent serious adverse events did not differ significantly between the olokizumab group and the placebo group; RR = 0.85, 95% CI [0.60, 1.20], P = 0.35.
In patients with rheumatoid arthritis, olokizumab combined methotrexate is well tolerated and more effective than placebo plus methotrexate.