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We appreciate the comments by David Felson on our report. In addition to evaluating remission-defined as disease activity score using 28 joints (DAS28) of less than 2.6-we did exploratory post-hoc analyses to assess clinical disease activity index (CDAI), simplified disease activity index (SDAI), and American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Boolean-based remission rates. Consistent with results using remission defined as DAS28 of less than 2.6, more patients who received tocilizumab achieved remission using these alternative criteria than patients who received adalimumab (CDAI: 17.2% vs 9.3%, p=0.0389; SDAI: 18.4% vs 8.0%, p<0.0067; and ACR/EULAR Boolean-based remission: 18.4% vs11.1%,p=0.0569). As Felson noted, we stated that the efficacy results for adalimumab in the ADACTA trial were similar to those published previously, citing a study of adalimumab as mono-therapy conducted by van de Putte and colleagues. Aaltonen and colleagues' meta-analysis cited by Felson reports ACR50 responses for five adalimumab trials-three of which include adalimumab as combination therapy and two of which focus on adalimumab monotherapy. ACR50 responses in both monotherapy trials are comparable to those observed in the ADACTA trial. The report by Aaltonen and colleagues showed no difference in efficacy between high and usual doses of TNF inhibitors, including adalimumab. In the ADACTA trial, patients who did not have improvement of at least 20% in tender and swollen joint counts could receive an increase to weekly administration in the blinded subcutaneous medication dose by becoming part of an escape arm.
机译:我们感谢David Felson对我们报告的评论。除了使用少于2.6的28个关节(DAS28)评估定义为疾病活动评分的缓解外,我们还进行了事后探索性分析,以评估临床疾病活动指数(CDAI),简化疾病活动指数(SDAI)和美国大学风湿病学(ACR)/欧洲抗风湿病联盟(EULAR)基于布尔的缓解率。与定义为DAS28小于2.6的缓解结果一致,使用这些替代标准的托珠单抗患者比接受阿达木单抗的患者多(CDAI:17.2%vs 9.3%,p = 0.0389; SDAI:18.4%vs 8.0%, p <0.0067;以及基于ACR / EULAR布尔值的缓解:18.4%vs11.1%,p = 0.0569)。正如Felson指出的那样,我们指出ADACTA试验中阿达木单抗的疗效结果与之前发表的结果相似,并引用了范德普特及其同事进行的阿达木单抗作为单一疗法的研究。 Falson引用的Aaltonen及其同事的荟萃分析报告了5项阿达木单抗试验的ACR50反应-其中3例包括阿达木单抗作为联合治疗,另2例侧重于阿达木单抗治疗。在两项单一疗法试验中,ACR50反应均与在ADACTA试验中观察到的反应相当。 Aaltonen及其同事的报告显示,高剂量和常规剂量的TNF抑制剂(包括阿达木单抗)的疗效没有差异。在ADACTA试验中,压痛和关节肿胀没有改善至少20%的患者可以通过成为逃生手臂的一部分来增加每周服用的盲皮下药物剂量。

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