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阿巴西普用于日本类风湿关节炎患者的多中心观察性临床研究。

Multicenter, observational clinical study of abatacept in Japanese patients with rheumatoid arthritis.

作者信息

Ogawa Noriyoshi, Ohashi Hiroyuki, Ota Yasuhiro, Kobori Kaori, Suzuki Motohiro, Tsuboi Seiji, Hayakawa Masakatsu, Goto Yoshinori, Karahashi Taro, Kimoto Osamu, Miyamoto Toshiaki, Furukawa Shogo, Shimoyama Kumiko, Suzuki Daisuke, Maekawa Yuichiro

机构信息

a Division of Immunology and Rheumatology, Department of Internal Medicine 3 , Hamamatsu University School of Medicine , Hamamatsu-City , Japan.

b Department of Rheumatology, Omaezaki Municipal Hospital , Omaezaki-City , Japan.

出版信息

Immunol Med. 2019 Mar;42(1):29-38. doi: 10.1080/25785826.2019.1605036. Epub 2019 May 8.

DOI:10.1080/25785826.2019.1605036
PMID:31067155
Abstract

The aim of this study was to assess abatacept in rheumatoid arthritis (RA) patient. Patients (20 men, 89 women, aged 61.9 ± 10.4 y) who responded inadequately to conventional synthetic disease-modifying anti-rheumatic drug were treated with abatacept for 24-months. Disease activity score in 28 joints (DAS28-CRP) was evaluated. Of 109 patients, 82 (75.2%) were on methotrexate (MTX; mean dosage 9.0 ± 2.7 mg/week); 48 (44.0%) were naive to biologics and 61 (56.0%) had failed biologics. The 1- and 2-year retention rates were 77% and 53%, respectively. At 24-months, the DAS28-CRP remission rates were 54.5% in the biologic-naïve patients, and 28.2% in the biologic-failure patients ( < .01), while the structural remission rates were 83.9% and 73.1%, respectively ( = .461). Abatacept was equally effective in RA patients who were and were not on concomitant MTX. Biologic-naïve was associated with better clinical outcome. Abatacept was effective in patients who showed decreasing anti-CCP antibody titers or serum MMP-3 levels during treatment. Infection was the most frequent adverse effect of abatacept therapy. In conclusion, abatacept is more effective in biologic-naïve than in biologic-failure RA patients with or without concomitant use of MTX. Abatacept is more effective in RA patients with than without decreasing serum MMP-3 or anti-CCP antibody titers during treatment.

摘要

本研究旨在评估阿巴西普在类风湿关节炎(RA)患者中的疗效。对传统合成抗风湿药物反应欠佳的患者(20名男性,89名女性,年龄61.9±10.4岁)接受阿巴西普治疗24个月。评估28个关节的疾病活动评分(DAS28-CRP)。109例患者中,82例(75.2%)正在使用甲氨蝶呤(MTX;平均剂量9.0±2.7mg/周);48例(44.0%)未使用过生物制剂,61例(56.0%)使用生物制剂失败。1年和2年的保留率分别为77%和53%。在24个月时,未使用过生物制剂的患者中DAS28-CRP缓解率为54.5%,使用生物制剂失败的患者中为28.2%(P<0.01),而结构缓解率分别为83.9%和73.1%(P=0.461)。阿巴西普在同时使用MTX和未使用MTX的RA患者中疗效相当。未使用过生物制剂与更好的临床结局相关。阿巴西普对治疗期间抗CCP抗体滴度或血清MMP-3水平降低的患者有效。感染是阿巴西普治疗最常见的不良反应。总之,对于未使用过生物制剂的RA患者,无论是否同时使用MTX,阿巴西普都比使用生物制剂失败的患者更有效。对于治疗期间血清MMP-3或抗CCP抗体滴度降低的RA患者,阿巴西普比未降低的患者更有效。

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