Background In rheumatoid arthritis (RA) trials, inclusion of patients on background treatment with glucocorticoids (GCs) might impact efficacy and safety outcomes. Objectives To determine if inclusion of patients on background GC use influenced efficacy and safety outcomes of RA randomised clinical trials on initiation of tocilizumab (TCZ) or adalimumab (ADA) or methotrexate (MTX) monotherapy. Methods Data of four double-blind RA randomised controlled trials (AMBITION, ACT-RAY, ADACTA and FUNCTION) with in total four TCZ, one ADA and two MTX monotherapy arms were analysed. Analyses of covariance of changes from baseline to week 24 in efficacy endpoints and radiographic progression up to week 104 were performed, correcting for relevant covariates. Incidence rates of serious adverse events (SAEs) were assessed. Results No statistically significant differences were found in efficacy parameters between background GC users and non-GC users, except for less radiographic progression associated with GC usage in one MTX arm. SAE rates were not statistically significantly different between GC users and non-GC users in the treatment arms. Conclusion No effect of including patients on background GC treatment on efficacy and safety trial outcomes was found, with the exception of reduced radiological joint damage in one MTX arm.

中文翻译：

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在托珠单抗或阿达木单抗或甲氨蝶呤单药治疗的类风湿性关节炎临床试验中，同时招募正在进行糖皮质激素治疗的患者对疗效和安全性试验结果的影响

背景 在类风湿性关节炎 (RA) 试验中，将患者纳入糖皮质激素 (GC) 背景治疗可能会影响疗效和安全性结果。目的 确定在背景 GC 使用中纳入患者是否会影响 RA 随机临床试验在开始托珠单抗 (TCZ) 或阿达木单抗 (ADA) 或甲氨蝶呤 (MTX) 单药治疗时的疗效和安全性结果。方法 分析了四个双盲 RA 随机对照试验（AMBITION、ACT-RAY、ADACTA 和 FUNCTION）的数据，这些试验共有四个 TCZ、一个 ADA 和两个 MTX 单药治疗组。对从基线到第 24 周的疗效终点和放射学进展到第 104 周的变化进行协方差分析，校正相关协变量。评估了严重不良事件 (SAE) 的发生率。结果 背景 GC 用户和非 GC 用户之间的功效参数没有发现统计学上的显着差异，除了在一个 MTX 组中与 GC 使用相关的放射学进展较少。治疗组中 GC 用户和非 GC 用户之间的 SAE 发生率在统计学上没有显着差异。结论 没有发现将患者纳入背景 GC 治疗对疗效和安全性试验结果的影响，除了在一个 MTX 组中减少放射学关节损伤。