Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate:: a randomised phase III trial
Infliximab (chimeric anti-tumour necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate:: a randomised phase III trial
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DOI：
10.1016/s0140-6736(99)05246-0
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发表时间：
1999-12-04
期刊：
影响因子：
168.9
通讯作者：
Lipsky, P
中科院分区：
文献类型：
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作者：
Maini, R;St Clair, EW;Lipsky, P
背景并非所有类风湿性关节炎患者都能耐受或对甲氨蝶呤有反应，甲氨蝶呤是类风湿性关节炎的标准治疗方法。有证据表明，抗肿瘤坏死因子α（TNF α）可有效缓解体征和症状。因此，我们研究了英夫利西单抗，一种嵌合的人-鼠抗TNF α单克隆抗体是否会为尽管接受了甲氨蝶呤治疗但仍患有活动性类风湿关节炎的患者提供额外的临床益处。连续接受甲氨蝶呤治疗至少3个月，稳定剂量治疗至少4周的患者，在第0、2和6周随机接受安慰剂（n=88）或英夫利昔单抗的4种治疗方案之一。此后，在稳定剂量甲氨蝶呤（中位数15 mg/周，持续≥ 6个月;范围10-35 mg/周）的背景下，每4或8周一次给予相同剂量的额外输注。结果在30周时，接受3 mg/kg每4周或8周或10 mg/kg每4周或8周的患者中，分别有53、50、58和52%达到美国流变学学会（20）反应标准，代表较基线改善20%，与接受安慰剂加甲氨蝶呤的20%的患者相比（p
Background Not all patients with rheumatoid arthritis can tolerate or respond to methotrexate, a standard treatment for this disease. There is evidence that antitumour necrosis factor alpha (TNF alpha) is efficacious in relief of signs and symptoms. We therefore investigated whether infliximab, a chimeric human-mouse anti-TNF alpha monoclonal antibody would provide additional clinical benefit to patients who had active rheumatoid arthritis despite receiving methotrexate.Methods In an international double-blind placebo-controlled phase III clinical trial, 428 patients who had active rheumatoid arthritis, who had received continuous methotrexate for at least 3 months and at a stable dose for at least 4 weeks, were randomised to placebo (n=88) or one of four regimens of infliximab at weeks 0, 2, and 6. Additional infusions of the same dose were given every 4 or 8 weeks thereafter on a background of a stable dose of methotrexate (median 15 mg/week for greater than or equal to 6 months; range 10-35 mg/wk). Patients were assessed every 4 weeks for 30 weeks.Findings At 30 weeks, the American College of Rheumatology (20) response criteria, representing a 20% improvement from baseline, were achieved in 53, 50, 58, and 52% of patients receiving 3 mg/kg every 4 or 8 weeks or 10 mg/kg every 4 or 8 weeks, respectively, compared with 20% of patients receiving placebo plus methotrexate (p