Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial
Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial
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DOI：
10.1136/annrheumdis-2017-211128
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发表时间：
2017-09-01
影响因子：
27.4
通讯作者：
Lee, Eun Bong
中科院分区：
文献类型：
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作者：
Park, Jin Kyun;Lee, Min Ah;Lee, Eun Bong
目的探讨暂停甲氨蝶呤（MTX）治疗对类风湿关节炎（RA）患者季节性流感疫苗接种效果的影响。方法采用前瞻性随机平行对照试验，将接受稳定剂量MTX治疗的RA患者按1：1：1：1的比例随机分为甲氨蝶呤组（1组）、甲氨蝶呤组（2组）、甲氨蝶呤组（3组）和甲氨蝶呤组（4组）。所有参与者均接种了含有H1N1、H3 N2和B-Yamagata的三价流感疫苗。主要结果是满意的疫苗应答频率（接种后4周滴度增加>= 4倍）。次要终点包括抗体滴度从基线的倍数变化。结果符合方案的人群包括199例患者（n=54，44，49和52组1，2，3和4，分别）。第3组对所有三种抗原的满意疫苗应答率均高于第1组（51.0% vs 31.5%，p=0.044）。第3组和第4组的抗H3 N2抗体增加倍数（95%CI）显著较高（12.2（8.4至17.5），p
Objective To investigate whether temporary discontinuation of methotrexate (MTX) improves the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA).Methods In this prospective randomised parallel-group trial, patients with RA taking stable dose of MTX were randomly assigned at a ratio of 1:1:1:1 to continue MIX (group 1), suspend MTX for 4 weeks before vaccination (group 2), suspend MTX for 2 weeks before and 2 weeks after vaccination (group 3) or suspend MTX for 4 weeks after vaccination (group 4). All participants were vaccinated with trivalent influenza vaccine containing H1N1, H3N2 and B-Yamagata. The primary outcome was frequency of satisfactory vaccine response (>= 4-fold titre increase 4 weeks postvaccination). Secondary endpoints included fold change in antibody titres from baseline.Results The per-protocol population consisted of 199 patients (n=54, 44, 49 and 52 in groups 1, 2, 3 and 4, respectively). Group 3 achieved higher satisfactory vaccine response against all three antigens than group 1 (51.0% vs 31.5%, p=0.044). The anti-H3N2 antibody fold increase (95% CI) was significantly higher in groups 3 and 4 (12.2 (8.4 to 17.5), p