IMS Consulting Group, Alexandria, VA, USA.
Curr Med Res Opin. 2012 Apr;28(4):569-80. doi: 10.1185/03007995.2012.656844. Epub 2012 Mar 6.
Rheumatoid arthritis (RA) is a chronic disease that if left untreated may substantially impair physical functioning. Etanercept, infliximab, and adalimumab are tumor necrosis factor (TNF) blockers whose FDA-approved indications in the US include moderate to severe RA. TNF-blocker dose escalation has been well documented in the literature; however, the comparative effectiveness of these agents remains uncertain.
To compare the effectiveness and dose escalation rates of etanercept, adalimumab, and infliximab in US community settings. We hypothesized that etanercept would be equivalent to infliximab and adalimumab in patient-reported disability 9-15 months after therapy initiation, and that fewer etanercept patients would experience dose escalation.
This is a retrospective analysis of the Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS). Adult patients with no biologic use 6 months before TNF-blocker initiation (index) and with Health Assessment Questionnaire Disability Index (HAQ-DI) scores at index and 9-15 months after index were analyzed (218 etanercept, 93 infliximab, and 40 adalimumab).
HAQ-DI change scores at 9-15 months did not differ by treatment (-0.12, -0.10, and -0.08 points for etanercept, infliximab, and adalimumab, respectively; p = 0.52). Dose increases were observed in 1.4% of etanercept, 10.8% of infliximab (p < 0.001), and 12.5% of adalimumab patients (p = 0.004). HAQ-DI change was associated with pre-index HAQ-DI score (p < 0.0001) and disease duration (p = 0.001).
Fewer etanercept patients escalated dose than infliximab or adalimumab patients, but improvements in functional disability were similar. These differences may have been influenced by package labeling, mode of administration, or other factors. RA treatment with infliximab and adalimumab in community settings, characterized by dose escalation, did not yield greater disability improvements compared to etanercept, which remained at a relatively stable dose. Uncontrolled treatment selection in this observational design may have influenced outcomes, and prior methotrexate treatment may partly explain disability improvements smaller than typically observed in clinical trials.
类风湿关节炎（RA）是一种慢性疾病，如果不进行治疗，可能会严重影响身体功能。依那西普、英夫利昔单抗和阿达木单抗是肿瘤坏死因子（TNF）阻滞剂，其在美国的 FDA 批准适应症包括中重度 RA。文献中已有充分记载 TNF 阻滞剂的剂量升级；然而，这些药物的比较效果仍不确定。
比较依那西普、阿达木单抗和英夫利昔单抗在美国社区环境中的有效性和剂量升级率。我们假设在治疗开始后 9-15 个月，依那西普在患者报告的残疾方面与英夫利昔单抗和阿达木单抗相当，并且依那西普患者经历剂量升级的情况较少。
这是对关节炎、风湿病和衰老医学信息系统（ARAMIS）的回顾性分析。在 TNF 阻滞剂开始前 6 个月没有使用生物制剂的成年患者（指数），以及在指数和指数后 9-15 个月有健康评估问卷残疾指数（HAQ-DI）评分的患者进行了分析（218 例依那西普、93 例英夫利昔单抗和 40 例阿达木单抗）。
9-15 个月时的 HAQ-DI 变化评分在治疗组之间没有差异（依那西普、英夫利昔单抗和阿达木单抗分别为-0.12、-0.10 和-0.08 分；p=0.52）。依那西普患者中有 1.4%、英夫利昔单抗患者中有 10.8%（p<0.001）和阿达木单抗患者中有 12.5%（p=0.004）增加了剂量。HAQ-DI 变化与指数前的 HAQ-DI 评分（p<0.0001）和疾病持续时间（p=0.001）相关。
与英夫利昔单抗或阿达木单抗患者相比，依那西普患者剂量升级的比例较少，但功能残疾的改善情况相似。这些差异可能受到包装标签、给药方式或其他因素的影响。在社区环境中使用英夫利昔单抗和阿达木单抗治疗 RA，其特点是剂量升级，与依那西普相比，并没有带来更大的残疾改善，因为依那西普的剂量相对稳定。在这种观察性设计中，未经控制的治疗选择可能影响了结果，并且之前使用甲氨蝶呤治疗可能部分解释了残疾改善小于临床试验中通常观察到的情况。
