Gao Guo-hua, Li Juan, Xie Hong-wei, Lü Zhuo
Department of Traditional Chinese Medicine for Rheumatology, Nanfang Hospital, Guangzhou 510515, China.
Nan Fang Yi Ke Da Xue Xue Bao. 2010 Apr;30(4):724-6.
To evaluate the clinical efficacy of infliximab in the treatment of moderate and severe active rheumatoid arthritis (RA).
This randomized double-blind II/III clinical trial involved 30 patients with moderate and severe active RA, who were randomly allocated into 3 groups (groups A, B, and C) at the ratio of 3:1:1. At weeks 0, 2, 6, and 14, the patients in groups A and C received infliximab or placebo, and those in group B had placebo at week 14 with a stable background dose of methotrexate. The indicators for efficacy evaluation included the proportions of ACR20/50/70 of the responders and DAS28. The sharp scores of the hand joints were recorded before and after the treatment.
Twenty-nine patients completed the clinical trial (18 in group A, 5 in group B, and 6 in group C). At week 14, the proportions of ACR20/50/70 in the 3 groups reached 83.33%, 60%, and 33.33%, respectively (P<0.05), as compared to 100%, 100%, and 33.33% at week 18 (P<0.05). The other indicators for clinical efficacy evaluation also suggested similar clinical improvement of the patients (P=0.000). The proportions of the patients with DAS28<3.2 and DAS28<2.6 were significantly different. Compared to the baseline, the Sharp scores in group A showed no significant changes at week 18 (P>0.930), while those in group C exhibited significant radiographic progression (P<0.044).
Infliximab produces good short-term therapeutic effect against moderate and severe active RA and may help arrest the radiographic progression of the diseases, which can be more obvious in patients with moderate severity.
评估英夫利昔单抗治疗中重度活动性类风湿关节炎（RA）的临床疗效。
本随机双盲II/III期临床试验纳入30例中重度活动性RA患者，按3:1:1的比例随机分为3组（A组、B组和C组）。在第0、2、6和14周，A组和C组患者接受英夫利昔单抗或安慰剂治疗，B组患者在第14周接受安慰剂治疗，同时维持稳定剂量的甲氨蝶呤作为背景治疗。疗效评估指标包括缓解者的美国风湿病学会（ACR）20/50/70达标率以及疾病活动度评分（DAS28）。记录治疗前后手部关节的Sharp评分。
29例患者完成了临床试验（A组18例，B组5例，C组6例）。在第14周时，3组患者的ACR20/50/70达标率分别为83.33%、60%和33.33%（P<0.05），而在第18周时分别为100%、100%和33.33%（P<0.05）。其他临床疗效评估指标也显示患者有相似的临床改善（P=0.000）。DAS28<3.2和DAS28<2.6的患者比例有显著差异。与基线相比，A组在第18周时Sharp评分无显著变化（P>0.930），而C组则出现了显著的影像学进展（P<0.044）。
英夫利昔单抗对中重度活动性RA有良好的短期治疗效果，且可能有助于阻止疾病的影像学进展，在中度病情患者中这种效果可能更明显。
