Migita Kiyoshi, Akeda Yukihiro, Akazawa Manabu, Tohma Shigeto, Hirano Fuminori, Ideguchi Haruko, Kozuru Hideko, Jiuchi Yuka, Matsumura Ryutaro, Suematsu Eiichi, Miyamura Tomoya, Mori Shunsuke, Fukui Takahiro, Izumi Yasumori, Iwanaga Nozomi, Tsutani Hiroshi, Saisyo Kouichirou, Yamanaka Takao, Ohshima Shiro, Mori Naoya, Matsumori Akinori, Takahi Koichiro, Yoshizawa Shigeru, Kawabe Yojiro, Suenaga Yasuo, Ozawa Tetsuo, Hamada Norikazu, Komiya Yasuhiro, Matsui Toshihiro, Furukawa Hiroshi, Oishi Kazunori
Japanese National Hospital Organization (NHO) multi-center clinical studies for evidence-based medicine study group: Japanese study of Randomized controlled study for patients with RA using 23-valent pneumococcal polysaccharide vaccine (RA-PPV23), Higashigaoka 2-5-23, Meguro, Tokyo, 152-8621, Japan.
Clinical Research Center, NHO Nagasaki Medical Center, Kubara 2-1001-1, Omura, 856-8652, Japan.
Arthritis Res Ther. 2015 Dec 10;17:357. doi: 10.1186/s13075-015-0863-3.
Patients with rheumatoid arthritis (RA) treated with abatacept (ABT) are at increased risk for vaccine-preventable infections. The aim of the present study is to evaluate the humoral response to 23-valent pneumococcal polysaccharide (PPSV23) vaccination in RA patients receiving ABT.
The immunogenicity study was nested within a randomized, double-blind placebo-controlled study, designed to evaluate the efficacy of the PPSV23. PPSV23 was given to 111 RA patients, who were classified into three groups: RA control (n = 35), methotrexate (MTX) alone (n = 55), and ABT (n = 21). Before and 4-6 weeks after vaccination, we measured the patients' concentrations of antibodies against pneumococcal serotypes 6B and 23F using an enzyme-linked immunosorbent assay and determined their antibody functionality using a multiplexed opsonophagocytic killing assay, reported as the opsonization index (OI).
The pneumococcal serotype-specific IgG concentrations and OIs were both significantly increased in all treatment groups in response to PPSV23 vaccination. In the ABT group, the IgG responses for the 6B serotype were lower compared with those in the MTX alone or control groups, whereas the OI responses were similar to those in the other two groups. In a subgroup analysis, the pneumococcal serotype-specific IgG responses were significantly lower in both serotypes (6B and 23F) in the ABT/MTX group; however, the OI responses in the ABT group were not different from the control group. There was no association between the pneumococcal serotype-specific IgG and OI responses for the 6B serotype in patients receiving ABT in contrast to the control or MTX alone patients. No severe adverse effects were observed in any of the treatment groups.
OI responses indicate antibody functionality rather than simply their amount, so the similarity of these measurements between all three groups suggests that RA patients receiving ABT still benefit from receiving the PPSV23 vaccination, even though they produce less IgG in response to it. The results suggest an influence of ABT on the humoral response to PPSV23 vaccination under MTX treatment; however, preserved opsonin responses are expected in RA patients treated with ABT plus MTX.
University Hospital Medical Information Network Clinical Trials Registry: UMIN000009566. Registered 12 December 2012.
接受阿巴西普（ABT）治疗的类风湿关节炎（RA）患者发生疫苗可预防感染的风险增加。本研究的目的是评估接受ABT治疗的RA患者对23价肺炎球菌多糖（PPSV23）疫苗接种的体液反应。
这项免疫原性研究嵌套在一项随机、双盲、安慰剂对照研究中，旨在评估PPSV23的疗效。PPSV23给予111例RA患者，这些患者被分为三组：RA对照组（n = 35）、单用甲氨蝶呤（MTX）组（n = 55）和ABT组（n = 21）。在接种疫苗前及接种后4 - 6周，我们采用酶联免疫吸附测定法测量患者针对肺炎球菌6B和23F血清型的抗体浓度，并使用多重调理吞噬杀菌测定法测定其抗体功能，以调理指数（OI）表示。
所有治疗组对PPSV23疫苗接种的反应中，肺炎球菌血清型特异性IgG浓度和OI均显著升高。在ABT组中，6B血清型的IgG反应低于单用MTX组或对照组，而OI反应与其他两组相似。在亚组分析中，ABT/MTX组中两种血清型（6B和23F）的肺炎球菌血清型特异性IgG反应均显著较低；然而，ABT组的OI反应与对照组无差异。与对照组或单用MTX的患者相比，接受ABT治疗的患者中6B血清型的肺炎球菌血清型特异性IgG与OI反应之间无关联。在任何治疗组中均未观察到严重不良反应。
OI反应表明抗体功能而非仅仅其数量，因此所有三组之间这些测量值的相似性表明，接受ABT治疗的RA患者尽管对PPSV23疫苗接种产生的IgG较少，但仍能从接种中获益。结果表明ABT对MTX治疗下PPSV23疫苗接种的体液反应有影响；然而，预计接受ABT加MTX治疗的RA患者调理素反应会得以保留。
大学医院医学信息网络临床试验注册中心：UMIN000009566。2012年12月12日注册。
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