Tanaka Yoshiya, Takeuchi Tsutomu, Inoue Eisuke, Saito Kazuyoshi, Sekiguchi Naoya, Sato Eri, Nawata Masao, Kameda Hideto, Iwata Shigeru, Amano Kouichi, Yamanaka Hisashi
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Mod Rheumatol. 2008;18(2):146-52. doi: 10.1007/s10165-008-0026-3. Epub 2008 Feb 19.
Biologics targeting TNF have brought about a paradigm shift in the treatment of rheumatoid arthritis (RA) and infliximab, anti-TNF-alpha chimeric monoclonal antibody, was marketed in 2003 in Japan. We previously reported on the RECONFIRM study, a retrospective clinical study on the efficacy of infliximab therapy in a RA management group in Japan, where we evaluated the clinical response after 22 weeks of the therapy in 258 patients. The study reported here was aimed at reconfirming the clinical efficacy of the infliximab therapy and demographic factors related to the efficacy over a 54-week study period in 410 RA patients in the same study group. Infliximab was infused according to the domestically approved method, and the clinical response was evaluated following 54 weeks of infliximab therapy using the European League Against Rheumatism (EULAR) response criteria. Disease activity was assessed by DAS28-CRP (Disease Activity Score including a 28-joint count/C-reactive protein). Infliximab was discontinued in 24.4% of the 410 patients at 54 weeks and 9.3% and 8.1% discontinued the therapy due to adverse events and inefficiency, respectively. Average DAS28-CRP decreased from 5.5 at week 0 to 3.1 at week 54 after the therapy. Patients in remission and those showing low-, moderate-, and high-disease activity changed from 0.0, 1.0, 9.0 and 90.0%, respectively, at the start of the study to 27.6, 11.7, 34.4 and 26.3%, respectively, at week 54. Younger age, RF-negativity and low scores of DAS28-CRP showed significant correlations with remission at week 54. EULAR response criteria -- good, moderate, and no response to infliximab -- were 37.0, 41.7 and 21.2%, respectively. In conclusion, we reconfirmed the clinical efficacy of infliximab and demographic factors related to the efficacy over a 54-week study period in 410 Japanese patients with RA using DAS28-CRP and EULAR response criteria.
针对肿瘤坏死因子（TNF）的生物制剂给类风湿关节炎（RA）的治疗带来了范式转变，抗TNF-α嵌合单克隆抗体英夫利昔单抗于2003年在日本上市。我们之前报道了RECONFIRM研究，这是一项关于日本RA管理组中英夫利昔单抗治疗疗效的回顾性临床研究，我们评估了258例患者治疗22周后的临床反应。此处报道的研究旨在在同一研究组的410例RA患者中，在54周的研究期内再次确认英夫利昔单抗治疗的临床疗效以及与疗效相关的人口统计学因素。英夫利昔单抗按照国内批准的方法输注，并在英夫利昔单抗治疗54周后使用欧洲抗风湿病联盟（EULAR）反应标准评估临床反应。疾病活动度通过DAS28-CRP（包括28个关节计数/C反应蛋白的疾病活动评分）进行评估。在54周时，410例患者中有24.4%停用了英夫利昔单抗，分别有9.3%和8.1%的患者因不良事件和治疗无效而停药。治疗后平均DAS28-CRP从第0周的5.5降至第54周的3.1。缓解以及疾病活动度为低、中、高的患者分别从研究开始时的0.0%、1.0%、9.0%和90.0%变为第54周时的27.6%、11.7%、34.4%和26.3%。年龄较小、RF阴性以及DAS28-CRP评分较低与第54周时的缓解显著相关。英夫利昔单抗的EULAR反应标准——良好、中等和无反应——分别为37.0%、41.7%和21.2%。总之，我们使用DAS28-CRP和EULAR反应标准，在410例日本RA患者中，在54周的研究期内再次确认了英夫利昔单抗的临床疗效以及与疗效相关的人口统计学因素。
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