Karolinska Institute, Stockholm, Sweden.
Arthritis Care Res (Hoboken). 2011 Jan;63(1):128-34. doi: 10.1002/acr.20331.
The American College of Rheumatology (ACR) hybrid (a modified mean percent response to treatment) was officially recommended by the ACR as a revision to 20%, 50%, and 70% response criteria (ACR20/50/70) scores, but has not been tested in clinical trials. We performed a post hoc analysis of a phase III study of certolizumab pegol (Rheumatoid Arthritis Prevention of Structural Damage 1 [RAPID 1]) using the ACR hybrid.
Patients with active rheumatoid arthritis were randomized to certolizumab pegol (200 mg or 400 mg every other week) plus methotrexate or placebo plus methotrexate. ACR hybrid scores were compared with ACR20/50/70 outcomes.
Differences between active treatment and placebo were significant throughout the study using the ACR20 and ACR hybrid outcomes. In the certolizumab pegol 200 mg group, the median ACR hybrid score at week 52 (last observation carried forward) was 49.99. A total of 258 (65.8%) of 392 and 172 (43.9%) of 392 patients had ACR20 and ACR50 responses, respectively. An additional 55 patients (14.0%) and 59 patients (15.1%) had mean improvements in ACR core measures of ≥ 20% and ≥ 50%, respectively, and therefore had positive ACR hybrid scores, despite lacking ACR20 and ACR50 responses, respectively. In the placebo group, median ACR hybrid scores were <10 at most time points; unlike other measures, the ACR hybrid measure indicated worsening scores for many patients.
ACR hybrid analysis had greater sensitivity than traditional ACR20/50/70 criteria, demonstrating improvements in ACR20 nonresponders treated with certolizumab pegol. Negligible benefit was observed with placebo using ACR hybrid analysis.
美国风湿病学会（ACR）的混合（治疗反应的平均百分比的修正）被ACR 正式推荐作为 20%、50%和 70%反应标准（ACR20/50/70）评分的修订版，但尚未在临床试验中进行测试。我们使用 ACR 混合方法对 certolizumab pegol 的 III 期研究（结构损伤预防类风湿关节炎 1[RAPID 1]）进行了事后分析。
患有活动性类风湿关节炎的患者被随机分配至 certolizumab pegol（每两周 200mg 或 400mg）加甲氨蝶呤或安慰剂加甲氨蝶呤。ACR 混合评分与 ACR20/50/70 结果进行比较。
使用 ACR20 和 ACR 混合结果，在整个研究过程中，积极治疗与安慰剂之间的差异均具有统计学意义。在 certolizumab pegol 200mg 组中，第 52 周（最后一次观测结转）的中位数 ACR 混合评分为 49.99。共有 258（65.8%）例 392 例和 172（43.9%）例 392 例患者达到 ACR20 和 ACR50 反应。另外，分别有 55 例（14.0%）和 59 例（15.1%）患者的 ACR 核心指标改善≥20%和≥50%，尽管分别缺乏 ACR20 和 ACR50 反应，但他们的 ACR 混合评分呈阳性。在安慰剂组中，大多数时间点的中位数 ACR 混合评分均<10；与其他指标不同，ACR 混合指标表明许多患者的评分恶化。
ACR 混合分析比传统的 ACR20/50/70 标准更敏感，表明 certolizumab pegol 治疗的 ACR20 无应答者的改善。使用 ACR 混合分析观察到安慰剂的获益微不足道。
