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比较依那西普、阿达木单抗和英夫利昔单抗在既往改善病情抗风湿药物治疗反应不佳的银屑病关节炎患者中的有效性和安全性。

Comparison of effectiveness and safety of infliximab, etanercept, and adalimumab in psoriatic arthritis patients who experienced an inadequate response to previous disease-modifying antirheumatic drugs.

机构信息

Department of Clinical and Experimental Medicine, Early Psoriatic Arthritis Clinic, University Federico II, Naples, Italy.

出版信息

Clin Rheumatol. 2010 Apr;29(4):399-403. doi: 10.1007/s10067-009-1340-7.

DOI:10.1007/s10067-009-1340-7
PMID:20066450
Abstract

The aim of this study is to compare effectiveness and safety of Infliximab (INF), Etanercept (ETN), and Adalimumab (ADA) in patients with psoriatic arthritis (PsA) with inadequate response to a previous disease-modifying antirheumatic drug (DMARD). One hundred consecutive PsA patients with inadequate response to a previous DMARD entered this study. Clinical and laboratory assessment at baseline (T0) and 12 (T12) months were performed and included physical examination, vital signs, global Psoriasis Area and Severity Index (PASI; extension of psoriasis), tender joints count (TJC), swollen joint count, health assessment questionnaire (HAQ; questionnaire for measuring disability), and monitoring of adverse events (AEs). After enrollment, all patients were randomly given INF 5 mg/Kg every 6-8 weeks, ETN 50 mg weekly, or ADA 40 mg every other week. Baseline therapy with DMARD remained unchanged. Effectiveness was defined as percentage of ACR20 responders and as clinical remission and/or minimal disease activity at 12 months treatment. INF, ETN, and ADA all effectively controlled signs and symptoms of PsA. All variables tested showed at T12 for each treatment a significant variation from the baseline value. In particular, patients on INF and ADA showed the greatest improvement in terms of PASI, while patients on ETN showed the greatest improvement on TJC and HAQ. ACR response rates were 72% of patients on ETN, 70% of those on ADA, and 75% of those patients on INF. Occurrence of AEs was reported in 15% of the cases. Only two AEs in patients on INF were considered drug related, pneumonitis and thrombocytopenia, respectively. All tumor necrosis factor-alpha blockers significantly controlled signs and symptoms of PsA. An increased knowledge of the different profiles of these agents may help in optimizing their use.

摘要

本研究旨在比较英夫利昔单抗(INF)、依那西普(ETN)和阿达木单抗(ADA)在对先前的疾病修饰抗风湿药物(DMARD)反应不足的银屑病关节炎(PsA)患者中的疗效和安全性。100 例对先前 DMARD 反应不足的 PsA 患者进入本研究。在基线(T0)和 12 个月(T12)时进行临床和实验室评估,包括体格检查、生命体征、全身银屑病面积和严重程度指数(PASI;银屑病扩展)、压痛关节计数(TJC)、肿胀关节计数、健康评估问卷(HAQ;衡量残疾的问卷)和不良事件(AE)监测。入组后,所有患者均随机给予 INF 5mg/Kg,每 6-8 周一次、ETN 50mg 每周一次或 ADA 40mg 每两周一次。DMARD 的基础治疗保持不变。疗效定义为 ACR20 应答者的百分比以及治疗 12 个月时的临床缓解和/或最小疾病活动度。INF、ETN 和 ADA 均有效控制了 PsA 的体征和症状。所有测试变量在每种治疗的 T12 时均与基线值相比显示出显著变化。特别是,接受 INF 和 ADA 的患者在 PASI 方面表现出最大的改善,而接受 ETN 的患者在 TJC 和 HAQ 方面表现出最大的改善。接受 ETN 的患者 ACR 应答率为 72%,接受 ADA 的患者为 70%,接受 INF 的患者为 75%。报告了 15%的病例发生 AE。仅 INF 组的两名患者的 AE 被认为与药物相关,分别为肺炎和血小板减少症。所有肿瘤坏死因子-α 阻滞剂均显著控制了 PsA 的体征和症状。对这些药物不同特征的更多了解可能有助于优化其使用。

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