Drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-α antibody compared with methotrexate in long-standing rheumatoid arthritis
Drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-α antibody compared with methotrexate in long-standing rheumatoid arthritis
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DOI：
10.1093/rheumatology/41.4.430
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发表时间：
2002-04-01
期刊：
影响因子：
5.5
通讯作者：
van Riel, PLCM
中科院分区：
文献类型：
--
作者：
Barrera, P;van der Maas, A;van Riel, PLCM
目标.比较全人源抗肿瘤坏死因子-α（TNF-α）单克隆抗体（moAb）和甲氨蝶呤（MTX）单药治疗活动性长期类风湿关节炎（RA）患者的48周药物生存期、疗效和毒性。次要目的是确定临床反应的潜在预测因素。RA患者，参加了I期试验与人类抗TNF-α单克隆抗体，并在我们的中心随访至少48周，与接受MTX单药治疗而不补充叶酸的患者进行了比较。抗TNF治疗的前6周为安慰剂对照，随后为开放标签研究。接受MTX治疗的患者参加了一项为期48周的双盲III期研究，该研究比较了MTX单药治疗与MTX联合叶酸补充治疗，该研究由我科协调。抗TNF-α和MTX的研究在同一时期进行，并且具有非常相似的纳入、排除、反应和停止标准。61例接受抗TNF-α单克隆抗体治疗的患者与137例接受MTX单药治疗的患者进行了比较。基线时，抗TNF-α组患者的病程较长（中位数108 vs 50个月，P=0.0001），二线抗风湿药物治疗史较长（中位数4 vs 1，P=0.0001）。抗TNF治疗组的48周脱落率较低（MTX组为23%对45%，P
Objectives. To compare the 48-week drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-alpha (TNF-alpha) monoclonal antibody (moAb) and methotrexate (MTX) in patients with active long-standing rheumatoid arthritis (RA). Secondary aims were to identify potential predictors for clinical response.Methods. Patients with RA, enrolled in phase I trials with a human anti-TNF-alpha moAb and followed for at least 48 weeks at our centre, were compared with patients receiving MTX monotherapy without folate supplementation. The first 6 weeks of anti-TNF therapy were placebo-controlled and followed by an open-label study. Patients treated with MTX participated in a 48-week, double-blind, phase III study of MTX alone vs MTX with folate supplementation, which was co-ordinated by our department. The studies with anti-TNF-alpha and MTX were performed in the same period and had very similar inclusion, exclusion, response and stop criteria.Results. Sixty-one patients treated with anti-TNF-alpha moAb were compared with 137 receiving MTX monotherapy. At baseline, patients in the anti-TNF-alpha group had a longer disease duration (median 108 vs 50 months, P=0.0001) and a more protracted history of second-line anti-rheumatic drugs than those treated with MTX (median 4 vs 1, P=0.0001). The 48-week dropout rate was lower among patients treated with anti-TNF (23 vs 45% in the MTX group, P