甲氨蝶呤剂量对日本类风湿关节炎患者阿达木单抗疗效的影响：注册数据分析结果
Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis: Results from registered data analyses.
作者信息
Nakashima Yasuharu, Miyahara Hisaaki, Kondo Masakazu, Fukuda Takaaki, Harada Hiroshi, Haraguchi Akihisa, Inoue Yasushi, Ishinishi Takashi, Maekawa Masayuki, Maeyama Akira, Nakashima Munetoshi, Shono Eisuke, Suematsu Eiichi, Shimauchi Takashi, Tsuru Tomomi, Tsukamoto Hiroshi, Yoshizawa Shigeru, Yoshizawa Seiji, Iwamoto Yukihide
机构信息
a Department of Orthopaedic Surgery , Kyushu University , Fukuoka , Japan.
b Department of Orthopedics , National Hospital Organization Kyushu Medical Center , Fukuoka , Japan.
出版信息
Mod Rheumatol. 2017 Jan;27(1):15-21. doi: 10.3109/14397595.2016.1170958. Epub 2016 May 4.
OBJECTIVE
Upper limit of methotrexate (MTX) for patients with rheumatoid arthritis (RA) was recently increased from 8 to 16 mg/week in Japan. We therefore examined the effect of concomitant MTX dose on the efficacy of adalimumab (ADA) in clinical practice.
METHOD
Sixty-one consecutive RA patients treated with ADA were followed for minimum 52 weeks and retrospectively compared by MTX dose; patients receiving concomitant MTX of 10 mg/week or more (MTX ≥10 mg group) and <10 mg/week (MTX <10 mg group). Disease activity and remission were evaluated by the disease activity score 28 (DAS28) criteria.
RESULTS
The MTX ≥10 mg group consistently showed better improvement in DAS28 and resulted in more patients (52.8%) with DAS28-remission compared with the MTX <10 mg group (26.1%). Multivariate analysis showed that MTX ≥10 mg had a significant effect on DAS28 remission with odds ratio of 5.12. ADA retention rate was 72.2% in MTX ≥10 mg group compared with 52.0% in MTX <10 mg group. Discontinuation of ADA due to adverse events were comparable in the MTX ≥10 mg and MTX <10 mg groups (11.1% vs. 12.0%).
CONCLUSIONS
These findings support the critical role of concomitant MTX in the efficacy of ADA, and recommend use of MTX ≥10 mg in Japanese RA patients.
目的
在日本，类风湿关节炎（RA）患者甲氨蝶呤（MTX）的上限剂量最近已从每周8毫克提高到16毫克。因此，我们在临床实践中研究了联合使用MTX的剂量对阿达木单抗（ADA）疗效的影响。
方法
连续纳入61例接受ADA治疗的RA患者，随访至少52周，并根据MTX剂量进行回顾性比较；联合使用MTX剂量为每周10毫克或更高的患者（MTX≥10毫克组）和低于每周10毫克的患者（MTX<10毫克组）。采用疾病活动评分28（DAS28）标准评估疾病活动度和缓解情况。
结果
与MTX<10毫克组（26.1%）相比，MTX≥10毫克组的DAS28改善始终更好，达到DAS28缓解的患者更多（52.8%）。多变量分析显示，MTX≥10毫克对DAS28缓解有显著影响，优势比为5.12。MTX≥10毫克组的ADA保留率为72.2%，而MTX<10毫克组为52.0%。MTX≥10毫克组和MTX<10毫克组因不良事件停用ADA的情况相当（11.1%对12.0%）。
结论
这些发现支持联合使用MTX对ADA疗效的关键作用，并建议在日本RA患者中使用MTX≥10毫克。
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