Abstract：
The current therapy of Rheumatoid Arthritis (RA) is confronted with many challenges such as inadequate response, infection, and treatment failure.
The main objective was to assess the efficacy and safety of tocilizumab (TCZ) in subjects with RA using the available evidence from published randomized controlled trials.
The current systematic review was performed on nine randomized controlled trials from 2002 to 2016 for TCZ in subjects with rheumatoid arthritis. The primary outcomes were the clinical improvement in American College Rheumatology 20% (ACR20) or Disease Activity Score remission (DAS28), in addition to other outcomes such as ACR50 and ACR70 in the intention-to-treat population.
We have conducted a systematic review on nine randomized controlled trials, with 4129 [100%] enrolled, of which 3248 [78.7%] were on the intention-to-treat. 2147 (66.1%) were treated with TCZ and 1101 (33.9%) have had received placebo or methotrexate or other conventional Disease- Modifying Anti-rheumatic Drugs (cDMARD) or biologic Disease-Modifying Anti-rheumatic Drugs (bDMARDs). In subjects taking TCZ with or without concomitant methotrexate, compared to placebo, subjects treated with TCZ 4 or 8 mg/kg were substantially and statistically significantly more likely than placebo or methotrexate to achieve the ACR20 and/or DAS28. There were no statistically significant differences in serious adverse events such as serious infection; however, subjects on TCZ were more likely to have increased lipid profiles.
TCZ mono-therapy or in combination with methotrexate is valuable in diminishing rheumatoid arthritis disease activity and improving disability. Treatment with TCZ was associated with a significant surge in cholesterol levels but no serious adverse effects. Randomized clinical trials with safety as the primary outcome are warranted to report these safety issues.
The main objective was to assess the efficacy and safety of tocilizumab (TCZ) in subjects with RA using the available evidence from published randomized controlled trials.
The current systematic review was performed on nine randomized controlled trials from 2002 to 2016 for TCZ in subjects with rheumatoid arthritis. The primary outcomes were the clinical improvement in American College Rheumatology 20% (ACR20) or Disease Activity Score remission (DAS28), in addition to other outcomes such as ACR50 and ACR70 in the intention-to-treat population.
We have conducted a systematic review on nine randomized controlled trials, with 4129 [100%] enrolled, of which 3248 [78.7%] were on the intention-to-treat. 2147 (66.1%) were treated with TCZ and 1101 (33.9%) have had received placebo or methotrexate or other conventional Disease- Modifying Anti-rheumatic Drugs (cDMARD) or biologic Disease-Modifying Anti-rheumatic Drugs (bDMARDs). In subjects taking TCZ with or without concomitant methotrexate, compared to placebo, subjects treated with TCZ 4 or 8 mg/kg were substantially and statistically significantly more likely than placebo or methotrexate to achieve the ACR20 and/or DAS28. There were no statistically significant differences in serious adverse events such as serious infection; however, subjects on TCZ were more likely to have increased lipid profiles.
TCZ mono-therapy or in combination with methotrexate is valuable in diminishing rheumatoid arthritis disease activity and improving disability. Treatment with TCZ was associated with a significant surge in cholesterol levels but no serious adverse effects. Randomized clinical trials with safety as the primary outcome are warranted to report these safety issues.
摘要：
背景：当前治疗类风湿性关节炎（RA）面临许多挑战，例如反应不足，感染,治疗失败。
目的：主要目的是使用已发表的随机对照试验的现有证据评估托珠单抗（TCZ）在RA患者中的疗效和安全性。
方法：目前的系统评价是对2002年至2016年在类风湿关节炎受试者中进行的9项TCZ随机对照试验进行的。主要结果是美国大学风湿病学的临床改善20％（ACR20）或疾病活动评分缓解（DAS28），除了意向治疗人群的ACR50和ACR70等其他结局外.
结果：我们对9项随机对照试验进行了系统评价，4129[100%]注册，其中3248人[78.7%]接受意向治疗。2147（66.1％）接受了TCZ治疗，1101（33.9％）接受了安慰剂或甲氨蝶呤或其他常规缓解疾病的抗风湿药（cDMARD）或生物疾病改善抗风湿药（bDMARD）。在服用TCZ伴或不伴用甲氨蝶呤的受试者中，与安慰剂相比，与安慰剂或甲氨蝶呤相比,接受TCZ4或8mg/kg治疗的受试者获得ACR20和/或DAS28的可能性显著且具有统计学意义.在严重不良事件如严重感染方面没有统计学上的显著差异;然而,接受TCZ的受试者更有可能具有增加的血脂谱.
结论：TCZ单药治疗或与甲氨蝶呤联合治疗在降低类风湿性关节炎疾病活动性和改善残疾方面有价值。TCZ治疗与胆固醇水平的显著升高相关，但没有严重的不良反应。以安全性为主要结果的随机临床试验有必要报告这些安全性问题。
目的：主要目的是使用已发表的随机对照试验的现有证据评估托珠单抗（TCZ）在RA患者中的疗效和安全性。
方法：目前的系统评价是对2002年至2016年在类风湿关节炎受试者中进行的9项TCZ随机对照试验进行的。主要结果是美国大学风湿病学的临床改善20％（ACR20）或疾病活动评分缓解（DAS28），除了意向治疗人群的ACR50和ACR70等其他结局外.
结果：我们对9项随机对照试验进行了系统评价，4129[100%]注册，其中3248人[78.7%]接受意向治疗。2147（66.1％）接受了TCZ治疗，1101（33.9％）接受了安慰剂或甲氨蝶呤或其他常规缓解疾病的抗风湿药（cDMARD）或生物疾病改善抗风湿药（bDMARD）。在服用TCZ伴或不伴用甲氨蝶呤的受试者中，与安慰剂相比，与安慰剂或甲氨蝶呤相比,接受TCZ4或8mg/kg治疗的受试者获得ACR20和/或DAS28的可能性显著且具有统计学意义.在严重不良事件如严重感染方面没有统计学上的显著差异;然而,接受TCZ的受试者更有可能具有增加的血脂谱.
结论：TCZ单药治疗或与甲氨蝶呤联合治疗在降低类风湿性关节炎疾病活动性和改善残疾方面有价值。TCZ治疗与胆固醇水平的显著升高相关，但没有严重的不良反应。以安全性为主要结果的随机临床试验有必要报告这些安全性问题。
