Aikawa Nadia E, França Ivan L A, Ribeiro Ana C, Sallum Adriana M E, Bonfa Eloisa, Silva Clovis A
Pediatric Rheumatology Unit, University of Sao Paulo, Brazil; Division of Rheumatology, University of Sao Paulo, Brazil.
Division of Infectious Diseases, University of Sao Paulo, Brazil.
Vaccine. 2015 Jan 29;33(5):604-9. doi: 10.1016/j.vaccine.2014.12.030. Epub 2014 Dec 29.
To assess immunogenicity and safety of the 23-valent polysaccharide pneumococcal vaccine (PPV23) in juvenile idiopathic arthritis (JIA) patients under conventional DMARDs with or without anti-TNF therapy. The influences of demographic data, disease activity and treatment on immune response and the potential deleterious effects of vaccine on disease itself were also evaluated.
17 JIA patients immediately pre-etanercept (Group 1) and 10 JIA patients on stable dose of methotrexate (Group 2) received one dose of PPV23. All patients were evaluated pre-vaccination, 2 months and 12 months post-vaccination for seven pneumoccocal serotypes. Serology was performed by enzyme immunoassay and the immunogenicity endpoints included seroprotection (SP), seroconversion (SP) and geometric mean concentration of antibodies(GMC). Clinical and laboratorial parameters of JIA were evaluated before and after vaccination.
Groups 1 and 2 were comparable regarding age, gender, disease duration and other DMARDs use (p>0.05). Pre-immunization SP and GMC were alike in patients with and without anti-TNF therapy (p>0.05). The frequencies of patients achieving adequate vaccine response (seroconversion in ≥50% of all serotypes) at 2 months (53 vs. 30%, p=0.424) and 12 months (36 vs. 40%, p=1.0) were similar in JIA patients with and without anti-TNF therapy. Further comparison of patients with and without adequate response at 2 months revealed no influence of demographic, clinical and laboratorial JIA parameters (p>0.05). Serious adverse events were not observed.
Anti-TNF therapy in JIA patients does not seem to have an additional deleterious effect on short/long-term PPV23 immunogenicity compared to MTX alone and no influence on disease parameters was observed with this vaccine.
评估23价肺炎球菌多糖疫苗(PPV23)在接受传统改善病情抗风湿药(DMARDs)治疗、无论是否接受抗TNF治疗的幼年特发性关节炎(JIA)患者中的免疫原性和安全性。还评估了人口统计学数据、疾病活动度和治疗对免疫反应的影响,以及疫苗对疾病本身的潜在有害作用。
17例即将接受依那西普治疗的JIA患者(第1组)和10例接受稳定剂量甲氨蝶呤治疗的JIA患者(第2组)接种一剂PPV23。所有患者在接种疫苗前、接种后2个月和12个月针对7种肺炎球菌血清型进行评估。通过酶免疫测定法进行血清学检测,免疫原性终点包括血清保护(SP)、血清转化(SC)和抗体几何平均浓度(GMC)。在接种疫苗前后评估JIA的临床和实验室参数。
第1组和第2组在年龄、性别、病程和其他DMARDs使用情况方面具有可比性(p>0.05)。在接受和未接受抗TNF治疗的患者中,免疫前的SP和GMC相似(p>0.05)。在接受和未接受抗TNF治疗的JIA患者中,在2个月时(53%对30%,p=0.424)和12个月时(36%对40%,p=1.0)达到充分疫苗反应(所有血清型中≥50%出现血清转化)的患者频率相似。对2个月时有和没有充分反应的患者进行进一步比较,结果显示JIA的人口统计学、临床和实验室参数没有影响(p>0.05)。未观察到严重不良事件。
与单独使用甲氨蝶呤相比,JIA患者中的抗TNF治疗似乎对PPV23的短期/长期免疫原性没有额外的有害影响,并且该疫苗对疾病参数没有影响。