Combination of infliximab and methotrexate therapy for early rheumatoid arthritis - A randomized, controlled trial
Combination of infliximab and methotrexate therapy for early rheumatoid arthritis - A randomized, controlled trial
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DOI：
10.1002/art.20568
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发表时间：
2004-11-01
影响因子：
--
通讯作者：
Baker, D
中科院分区：
文献类型：
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作者：
Clair, EWS;van der Heijde, DMFM;Baker, D
客观的。比较病程小于或等于 3 年的类风湿性关节炎 (RA) 患者开始使用甲氨蝶呤 (MTX) 和英夫利昔单抗（抗肿瘤坏死因子 α [抗 TNFα] 单克隆抗体）治疗与单独使用 MTX 治疗的益处。方法。如果 RA 患者患有活动性疾病且之前未接受过 MTX 或 TNFα 抑制剂治疗，则符合资格。 1,049 名患者按 4:5:5 的比例随机分配到 3 个治疗组：MTX 安慰剂、MTX-3 mg/kg 英夫利昔单抗和 MTX-6 mg/kg 英夫利昔单抗。 MTX 剂量迅速增加至 20 毫克/周，并在第 0、2 和 6 周给予英夫利昔单抗或安慰剂输注，此后每 8 周一次直至第 46 周。 结果。第 54 周时，MTX-3 mg/kg 英夫利昔单抗组和 MTX-6 mg/kg 英夫利昔单抗组的美国风湿病学会 (ACR-N) 改善中位百分比高于 MTX 安慰剂组（分别为 38.9% 和 46.7% vs 26.4%；两项比较 P < 0.001）。 MTX-3 mg/kg 英夫利昔单抗组和 MTX-6 mg/kg 英夫利昔单抗组的患者也比单独接受 MTX 的患者表现出更少的放射学进展（第 54 周总 Sharp 评分的 van der Heijde 修正的平均+/- SD 变化：分别为 0.4 +/- 5.8 和 0.5 +/- 5.6 对比 3.7 +/- 9.6；每次比较 P < 0.001）。此外，MTX-3 mg/kg 英夫利昔单抗组和 MTX-6 mg/kg 英夫利昔单抗组的身体功能比 MTX 安慰剂组显着改善。英夫利昔单抗治疗与严重感染（尤其是肺炎）发生率显着升高相关。结论。对于早期活动性 RA 患者，MTX 和英夫利昔单抗联合治疗比单独使用 MTX 治疗可提供更大的临床、放射学和功能益处。
Objective. To compare the benefits of initiating treatment with methotrexate (MTX) and infliximab (anti-tumor necrosis factor alpha [anti-TNFalpha] monoclonal antibody) with those of MTX treatment alone in patients with rheumatoid arthritis (RA) of less than or equal to3 years' duration.Methods. RA patients were eligible if they had active disease and no prior treatment with MTX or a TNFalpha inhibitor. One thousand forty-nine patients were randomly assigned in a 4:5:5 ratio to 3 treatment groups: MTX-placebo, MTX-3 mg/kg infliximab, and MTX-6 mg/kg infliximab. MTX dosages were rapidly escalated to 20 mg/week, and infliximab or placebo infusions were given at weeks 0, 2, and 6, and every 8 weeks thereafter through week 46.Results. At week 54, the median percentage of American College of Rheumatology improvement (ACR-N) was higher for the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups than for the MTX-placebo group (38.9% and 46.7% versus 26.4%, respectively; P < 0.001 for both comparisons). Patients in the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups also showed less radiographic progression than those receiving MTX alone (mean +/- SD changes in van der Heijde modification of the total Sharp score at week 54: 0.4 +/- 5.8 and 0.5 +/- 5.6 versus 3.7 +/- 9.6, respectively; P < 0.001 for each comparison). In addition, physical function improved significantly more in the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups than in the MTX-placebo group. Infliximab therapy was associated with a significantly higher incidence of serious infections, especially pneumonia.Conclusion. For patients with active RA in its early stages, combination therapy with MTX and infliximab provides greater clinical, radiographic, and functional benefits than treatment with MTX alone.