Assessment of individual therapeutic responses provides valuable information concerning treatment benefits in individual patients. We evaluated individual therapeutic responses as determined by the Disease Activity Score-28 joints critical difference for improvement (DAS28-dcrit) in rheumatoid arthritis (RA) patients treated with intravenous tocilizumab or comparator anti-tumor necrosis factor (TNF) agents. The previously published DAS28-dcrit value [DAS28 decrease (improvement) ≥ 1.8] was retrospectively applied to data from two studies of tocilizumab in RA, the 52-week ACT-iON observational study and the 24-week ADACTA randomized study. Data were compared within (not between) studies. DAS28 was calculated with erythrocyte sedimentation rate as the inflammatory marker. Stability of DAS28-dcrit responses and European League Against Rheumatism (EULAR) good responses was determined by evaluating repeated responses at subsequent timepoints. A logistic regression model was used to calculate p values for differences in response rates between active agents. Patient-reported outcomes (PROs; pain, global health, function, and fatigue) in DAS28-dcrit responder versus non-responder groups were compared with an ANCOVA model. DAS28-dcrit individual response rates were 78.2% in tocilizumab-treated patients and 58.2% in anti-TNF-treated patients at week 52 in the ACT-ion study (p = 0.0001) and 90.1% versus 59.1% at week 24 in the ADACTA study (p < 0.0001). DAS28-dcrit responses showed greater stability over time (up to 52 weeks) than EULAR good responses. For both active treatments, DAS28-dcrit responses were associated with statistically significant improvements in mean PRO values compared with non-responders. The DAS28-dcrit response criterion provides robust assessments of individual responses to RA therapy and may be useful for discriminating between active agents in clinical studies and guiding treat-to-target decisions in daily practice.

中文翻译：

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单独的DAS28-dcrit治疗反应可区分类风湿关节炎疗法的疗效，并反映患者报告的结果：在比较tocilizumab研究中对DAS28反应的回顾性分析。

对个体治疗反应的评估提供了有关个体患者治疗获益的有价值的信息。我们评估了由疾病活动评分-28关节临界差异改善（DAS28-dcrit）确定的个体治疗反应，该类疾病在接受静脉内接受环磷珠单抗或比较剂抗肿瘤坏死因子（TNF）药物治疗的类风湿关节炎（RA）患者中。先前发表的DAS28-dcrit值[DAS28下降（改善）≥1.8]追溯应用于来自RA的托珠单抗的两项研究，52周的ACT-iON观察性研究和24周的ADACTA随机研究。在研究中（而不是在研究之间）比较了数据。以红细胞沉降率作为炎症指标计算DAS28。DAS28-dcrit反应和欧洲抗风湿病联盟（EULAR）良好反应的稳定性通过评估在随后时间点的重复反应来确定。使用逻辑回归模型计算活性剂之间反应率差异的p值。将DAS28-dcrit反应组与无反应组的患者报告结果（PRO；疼痛，整体健康，功能和疲劳）进行比较，并与ANCOVA模型进行了比较。在ACT-ion研究中，在第52周时，接受tocilizumab治疗的患者的DAS28-dcrit个体缓解率为78.2％，接受抗TNF治疗的患者为58.2％（p = 0.0001），而在ADACTA的第24周，DAS28-dcrit个体缓解率为90.1％，而在24周时为59.1％研究（p <0.0001）。与EULAR的良好响应相比，DAS28-dcrit响应在一段时间（长达52周）内显示出更高的稳定性。对于两种主动治疗，与无应答者相比，DAS28-dcrit应答与平均PRO值的统计学显着改善相关。DAS28-dcrit反应标准可对RA治疗的个体反应进行可靠的评估，可能有助于区分临床研究中的活性药物，并指导日常实践中针对目标的治疗决策。