Kaunas Medical University Hospital, Kaunas, Lithuania.
Ann Rheum Dis. 2012 Apr;71(4):541-8. doi: 10.1136/ard.2011.152223. Epub 2011 Oct 12.
To compare the efficacy and safety of treatment with infliximab plus methotrexate with methotrexate alone in methotrexate-naive patients with active psoriatic arthritis (PsA).
In this open-label study, patients 18 years and older with active PsA who were naive to methotrexate and not receiving disease-modifying therapy (N=115) were randomly assigned (1:1) to receive either infliximab (5 mg/kg) at weeks 0, 2, 6 and 14 plus methotrexate (15 mg/week); or methotrexate (15 mg/week) alone. The primary assessment was American College of Rheumatology (ACR) 20 response at week 16. Secondary outcome measures included psoriasis area and severity index (PASI), disease activity score in 28 joints (DAS28) and dactylitis and enthesitis assessments.
At week 16, 86.3% of patients receiving infliximab plus methotrexate and 66.7% of those receiving methotrexate alone achieved an ACR20 response (p<0.02). Of patients whose baseline PASI was 2.5 or greater, 97.1% receiving infliximab plus methotrexate compared with 54.3% receiving methotrexate alone experienced a 75% or greater improvement in PASI (p<0.0001). Improvements in C-reactive protein levels, DAS28 response and remission rates, dactylitis, fatigue and morning stiffness duration were also significantly greater in the group receiving infliximab. In the infliximab plus methotrexate group, 46% (26/57) had treatment-related adverse events (AE) and two patients had serious AE, compared with 24% with AE (13/54) and no serious AE in the methotrexate-alone group.
Treatment with infliximab plus methotrexate in methotrexate-naive patients with active PsA demonstrated significantly greater ACR20 response rates and PASI75 improvement compared with methotrexate alone and was generally well tolerated. This trial is registered in the US National Institutes of Health clinicaltrials.gov database, identifier NCT00367237.
比较英夫利昔单抗联合甲氨蝶呤与单纯甲氨蝶呤治疗甲氨蝶呤初治活动性银屑病关节炎（PsA）患者的疗效和安全性。
在这项开放性研究中，18 岁及以上、甲氨蝶呤初治且未接受疾病修正治疗（N=115）的活动性 PsA 患者，以 1:1 的比例随机分配（随机分组），分别接受英夫利昔单抗（5mg/kg）于第 0、2、6 和 14 周联合甲氨蝶呤（15mg/周）；或单纯甲氨蝶呤（15mg/周）治疗。主要评估指标为第 16 周美国风湿病学会（ACR）20 缓解率。次要结局指标包括银屑病面积和严重程度指数（PASI）、28 个关节疾病活动度评分（DAS28）、指（趾）炎和附着点炎评估。
第 16 周时，接受英夫利昔单抗联合甲氨蝶呤治疗的患者中有 86.3%，接受单纯甲氨蝶呤治疗的患者中有 66.7%达到 ACR20 缓解（p<0.02）。基线 PASI 为 2.5 或更高的患者中，接受英夫利昔单抗联合甲氨蝶呤治疗的患者中有 97.1%，而接受单纯甲氨蝶呤治疗的患者中有 54.3%，其 PASI 改善程度达到 75%或更高（p<0.0001）。接受英夫利昔单抗治疗的患者，C 反应蛋白水平、DAS28 缓解率和缓解率、指（趾）炎、疲劳和晨僵持续时间也有显著改善。在英夫利昔单抗联合甲氨蝶呤组中，46%（26/57）的患者发生与治疗相关的不良事件（AE），2 例患者发生严重 AE，而甲氨蝶呤组中 AE 发生率为 24%（13/54），无严重 AE。
在甲氨蝶呤初治的活动性 PsA 患者中，英夫利昔单抗联合甲氨蝶呤治疗较单纯甲氨蝶呤治疗可显著提高 ACR20 缓解率和 PASI75 改善率，且耐受性良好。本试验在美国国立卫生研究院临床试验.gov 数据库注册，标识符为 NCT00367237。
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