Initial Serological Response after Prime-boost Pneumococcal Vaccination in Rheumatoid Arthritis Patients: Results of a Randomized Controlled Trial
Initial Serological Response after Prime-boost Pneumococcal Vaccination in Rheumatoid Arthritis Patients: Results of a Randomized Controlled Trial
复制标题
DOI：
10.3899/jrheum.161407
复制
发表时间：
2017-12-01
影响因子：
3.9
通讯作者：
Friis-Moller, Nina
中科院分区：
文献类型：
--
作者：
Nguyen, Mai T. T.;Lindegaard, Hanne;Friis-Moller, Nina
目标。根据给药剂量和免疫间隔，评价类风湿关节炎（RA）患者分别接种13价蛋白结合肺炎球菌疫苗（PCV13）和23价多糖肺炎球菌疫苗（PPV23）的初始血清学应答。研究者发起的临床试验。接受bDMARD的RA患者随机（1:1:1）接种单剂量PCV13, 16周或24周后接种PPV23，或16周后接种双剂量PCV13， PPV23。对照组接受常规合成DMARD治疗的RA患者在16周后接受单剂量PCV13和PPV23治疗。每次接种前和接种后4周采集肺炎球菌抗体。主要终点是两种疫苗接种后4周对>= 6/12肺炎球菌血清型反应的参与者比例。包括65名接受bDMARD的参与者和35名接受csDMARD的参与者。接种PPV23疫苗后，分别有87% （95% CI 0.76-0.94）和94% （95% CI 0.77-0.99）接受bDMARD和csDMARD治疗的参与者达到了主要终点。3个随机分组组的主要终点无显著差异。利妥昔单抗治疗的应答率为25%，而bDMARD联合其他作用方式治疗的应答率为89%。在接受bDMARD和csDMARD的参与者中，接种PCV13和PPV23的早期血清学反应非常相似。然而，根据个体bDMARD，观察到反应的显着差异。在规划类风湿关节炎患者的肺炎球菌疫苗接种时，考虑类风湿关节炎的治疗是很重要的。
Objective. To evaluate the initial serological responses to pneumococcal vaccination with the 13-valent protein-conjugated pneumococcal vaccine (PCV13) followed by the 23-valent polysaccharide pneumococcal vaccine (PPV23) among patients with rheumatoid arthritis (RA) treated with biological disease-modifying antirheumatic drugs (bDMARD) according to dosing and intervals between immunizations.Methods. Investigator-initiated clinical trial. Patients with RA receiving bDMARD were randomized (1: 1: 1) to immunization with single dose PCV13 followed by PPV23 after 16 or 24 weeks, or double dose PCV13 followed by PPV23 after 16 weeks. A comparison group of patients with RA treated with conventional synthetic (cs) DMARD received single dose PCV13 followed by PPV23 16 weeks later. Pneumococcal antibodies were collected before and 4 weeks after each vaccination. The primary endpoint was the proportion of participants responding to >= 6/12 pneumococcal serotypes 4 weeks after both vaccinations.Results. Sixty-five participants receiving bDMARD and 35 participants receiving csDMARD were included. After PPV23 vaccination, 87% (95% CI 0.76-0.94) and 94% (95% CI 0.77-0.99), respectively, of participants treated with bDMARD and csDMARD had reached the primary endpoint. There was no significant difference in primary endpoint between the 3 randomization arms. The response for rituximab-treated participants was 25% compared to >= 89% in participants treated with bDMARD with other mode of action.Conclusion. The early serological response to prime-boost vaccination with PCV13 followed by PPV23 was very similar among participants receiving bDMARD and csDMARD. However, notable differences in response were observed according to individual bDMARD. It is important to consider the RA treatment when planning pneumococcal vaccination in patients with RA.