Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, Hindenburgdamm 30, 12200 Berlin, Germany.
Arthritis Res Ther. 2010;12(3):R117. doi: 10.1186/ar3054. Epub 2010 Jun 16.
INTRODUCTION: Tumor necrosis factor (TNF) antagonists reduce the signs and symptoms of spondyloarthritides, including ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Our objective was to evaluate the effectiveness and safety of adalimumab, 40 mg every other week, for patients with AS or PsA and prior treatment with infliximab (IFX) and/or etanercept (ETN). METHODS: Both trials were 12-week, open-label studies with an optional extension period up to week 20. Patients were stratified by history of anti-TNF treatment, prior anti-TNF therapy received (IFX, ETN, or both), and reason for discontinuation of prior TNF antagonist. ETN was discontinued>or=3 weeks, and IFX was discontinued>or=2 months before the first adalimumab administration. Effectiveness at week 12 was evaluated by using observed standard-outcome measurements for AS and PsA. RESULTS: At week 12 of adalimumab treatment, Bath Ankylosing Spondylitis Disease Activity Index 50 responses were achieved by 40.8% of 326 patients with AS who had received prior anti-TNF therapy and by 63.0% of 924 patients with AS who were naive to TNF antagonist. Observed response rates were generally greater for patients who discontinued the prior anti-TNF therapy because of loss of response or intolerance than for patients who discontinued because of lack of response. Median changes in swollen-joint count and in enthesitis score were similar in patients with and without prior TNF-antagonist treatment. Modified PsA response criteria were fulfilled by 71.2% of 66 patients with PsA, with prior exposure to TNF antagonists, and by 78.8% of 376 patients with no history of anti-TNF therapy. The percentages of patients with PsA attaining a Physician's Global Assessment of psoriasis of "Clear/Almost clear" increased from 33.3% to 61.0% for patients with prior IFX and/or ETN treatment and from 34.6% to 69.7% for patients without anti-TNF therapy. The median change in the Nail Psoriasis Severity Index was -6 for both groups. In both studies, patterns of adverse events were similar for patients with and without prior anti-TNF therapy and were consistent with the known safety profile of adalimumab. CONCLUSIONS: Patients with AS or PsA previously treated with IFX and/or ETN experienced clinically relevant improvements of their diseases after 12 weeks of adalimumab. TRIAL REGISTRATIONS: ClinicalTrials.gov NCT00478660 and NCT00235885.
介绍：肿瘤坏死因子（TNF）拮抗剂可减轻脊柱关节炎的症状和体征，包括强直性脊柱炎（AS）和银屑病关节炎（PsA）。我们的目的是评估阿达木单抗（adalimumab）40mg，每两周一次，在既往接受英夫利昔单抗（IFX）和/或依那西普（ETN）治疗的 AS 或 PsA 患者中的疗效和安全性。
方法：这两项试验均为 12 周的开放性研究，可选延长至 20 周。根据既往 TNF 治疗史、既往接受的 TNF 治疗（IFX、ETN 或两者均有）以及既往 TNF 拮抗剂停药原因进行分层。在开始首次阿达木单抗治疗前，ETN 停药>或=3 周，IFX 停药>或=2 个月。采用 AS 和 PsA 的观察性标准结局测量评估第 12 周的疗效。
结果：在阿达木单抗治疗的第 12 周，既往接受过 TNF 治疗的 326 例 AS 患者中有 40.8%达到 Bath 强直性脊柱炎疾病活动指数 50 缓解，而对 TNF 拮抗剂无反应的 924 例 AS 患者中有 63.0%达到缓解。对于因无应答或不耐受而停药的患者，观察到的应答率通常高于因无应答而停药的患者。既往接受过 TNF 拮抗剂治疗的患者和无 TNF 拮抗剂治疗史的患者的关节肿胀数和附着点压痛评分的中位数变化相似。既往接受过 TNF 拮抗剂治疗的 66 例 PsA 患者中有 71.2%符合改良 PsA 缓解标准，376 例无 TNF 治疗史的患者中有 78.8%符合该标准。既往接受 IFX 和/或 ETN 治疗的患者中有 33.3%的银屑病关节炎患者达到医生整体评估的银屑病“清除/几乎清除”，而无 TNF 治疗史的患者中有 69.7%达到该标准。既往接受 IFX 和/或 ETN 治疗的患者中有 61.0%的患者达到银屑病指甲严重程度指数的中位数改善为-6，而无 TNF 治疗史的患者中有 69.7%达到该标准。两项研究中，既往接受过 TNF 治疗和未接受 TNF 治疗的患者的不良反应模式相似，与阿达木单抗已知的安全性特征一致。
结论：既往接受过 IFX 和/或 ETN 治疗的 AS 或 PsA 患者在接受阿达木单抗治疗 12 周后，疾病有临床相关改善。
试验注册：ClinicalTrials.gov NCT00478660 和 NCT00235885。
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