Direct Comparison of Treatment Responses, Remission Rates, and Drug Adherence in Patients With Rheumatoid Arthritis Treated With Adalimumab, Etanercept, or Infliximab Results From Eight Years of Surveillance of Clinical Practice in the Nationwide Danish DANBIO Registry
Direct Comparison of Treatment Responses, Remission Rates, and Drug Adherence in Patients With Rheumatoid Arthritis Treated With Adalimumab, Etanercept, or Infliximab Results From Eight Years of Surveillance of Clinical Practice in the Nationwide Danish DANBIO Registry
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DOI：
10.1002/art.27227
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发表时间：
2010-01-01
影响因子：
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通讯作者：
Ostergaard, Mikkel
中科院分区：
文献类型：
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作者：
Hetland, Merete Lund;Christensen, Ib Jarle;Ostergaard, Mikkel
Objective.直接比较肿瘤坏死因子α抑制剂在类风湿关节炎（RA）患者中的治疗反应率、缓解率和药物存活率，并确定反应的临床预后因素。全国范围内的DANBIO登记处收集接受常规护理的风湿病患者的数据。在本研究中，我们纳入了来自DANBIO的RA患者（n = 2，326），其中首次开始生物治疗（29%接受阿达木单抗，22%接受依那西普，49%接受英夫利昔单抗）。确定了治疗应答的基线预测因子。计算临床反应和缓解的比值比（OR）和停药的风险比（HR），并根据年龄、病程、28个关节疾病活动评分（DAS 28）、血清阳性、合并甲氨蝶呤和泼尼松龙、既往疾病缓解药物数量、中心和功能状态（健康评估问卷评分）进行校正。6个月后，19%的患者根据美国流变学学会标准（ACR 70应答）获得了70%的改善。年龄较大、伴随泼尼松龙治疗和基线时功能状态低下是阴性预测因素。阿达木单抗与英夫利昔单抗相比，ACR 70缓解的OR（95%置信区间[ 95% CI]）为2.05（95% CI 1.52-2.76），依那西普与英夫利昔单抗相比为1.78（95% CI 1.28-2.50），阿达木单抗与依那西普相比为1.15（95% CI 0.82-1.60）。根据欧洲抗风湿联盟标准、DAS 28缓解和临床疾病活动指数缓解，观察到类似的预测因子和OR。在48个月时，英夫利西单抗与依那西普的停药HR分别为1.98（95%CI 1.63-2.40）、1.35（95%CI 1.15-1.58）和1.47（95%CI 1.20-1.80）。结论高龄、低功能状态和伴随泼尼松龙治疗是临床应答和缓解的阴性预测因素。英夫利西单抗的治疗应答率、疾病缓解率和药物依从性最低，阿达木单抗的治疗应答率和疾病缓解率最高，依那西普的药物生存率最长。在校正混杂因素和敏感性分析后，这些结果在结局指标和随访时间上是一致的。
Objective. To compare tumor necrosis factor alpha inhibitors directly regarding the rates of treatment response, remission, and the drug survival rate in patients with rheumatoid arthritis (RA), and to identify clinical prognostic factors for response.Methods. The nationwide DANBIO registry collects data on rheumatology patients receiving routine care. For the present study, we included patients from DANBIO who had RA (n = 2,326) in whom the first biologic treatment was initiated (29% received adalimumab, 22% received etanercept, and 49% received infliximab). Baseline predictors of treatment response were identified. The odds ratios (ORs) for clinical responses and remission and hazard ratios (HRs) for drug withdrawal were calculated, corrected for age, disease duration, the Disease Activity Score in 28 joints (DAS28), seropositivity, concomitant methotrexate and prednisolone, number of previous disease-modifying drugs, center, and functional status (Health Assessment Questionnaire score).Results. Seventy percent improvement according to the American College of Rheumatology criteria (an ACR70 response) was achieved in 19% of patients after 6 months. Older age, concomitant prednisolone treatment, and low functional status at baseline were negative predictors. The ORs (95% confidence intervals [ 95% CIs]) for an ACR70 response were 2.05 (95% CI 1.52-2.76) for adalimumab versus infliximab, 1.78 (95% CI 1.28-2.50) for etanercept versus infliximab, and 1.15 (95% CI 0.82-1.60) for adalimumab versus etanercept. Similar predictors and ORs were observed for a good response according to the European League Against Rheumatism criteria, DAS28 remission, and Clinical Disease Activity Index remission. At 48 months, the HRs for drug withdrawal were 1.98 for infliximab versus etanercept (95% 1.63-2.40), 1.35 for infliximab versus adalimumab (95% CI 1.15-1.58), and 1.47 for adalimumab versus etanercept (95% CI 1.20-1.80).Conclusion. Older age, low functional status, and concomitant prednisolone treatment were negative predictors of a clinical response and remission. Infliximab had the lowest rates of treatment response, disease remission, and drug adherence, adalimumab had the highest rates of treatment response and disease remission, and etanercept had the longest drug survival rates. These findings were consistent after correction for con-founders and sensitivity analyses and across outcome measures and followup times.