From the Department of Infectious Diseases, and Department of Rheumatology, and Odense Patient data Explorative Network (OPEN), Odense University Hospital; Institute of Clinical Research, University of Southern Denmark; Institute of Regional Research, University of Southern Denmark, Odense; Department of Rheumatology, King Christian Xth Hospital for Rheumatic Disease, Graasten; Department of Microbiology and Virology, Statens Serum Institut, Copenhagen; Unit of Infectious Diseases, Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.
M.T. Nguyen, MD, Department of Infectious Diseases, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, and OPEN, Odense University Hospital; H. Lindegaard, MD, PhD, Institute of Clinical Research, University of Southern Denmark, and Department of Rheumatology, Odense University Hospital; O. Hendricks, MD, PhD, Department of Rheumatology, King Christian Xth Hospital for Rheumatic Disease, and Institute of Regional Research, University of Southern Denmark; C.S. Jørgensen, MSc, PhD, Department of Microbiology and Virology, Statens Serum Institut; B. Kantsø, MSc, PhD, Department of Microbiology and Virology, Statens Serum Institut; N. Friis-Møller, MD, DMSc, Department of Infectious Diseases, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, and Unit of Infectious Diseases, Department of Internal Medicine, Zealand University Hospital.
J Rheumatol. 2017 Dec;44(12):1794-1803. doi: 10.3899/jrheum.161407. Epub 2017 Oct 1.
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.
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.
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.
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.
评估接受生物改善病情抗风湿药物（bDMARD）治疗的类风湿关节炎（RA）患者根据免疫接种剂量和间隔用 13 价蛋白结合肺炎球菌疫苗（PCV13）序贯 23 价肺炎球菌多糖疫苗（PPV23）进行初始血清学应答。
研究者发起的临床试验。接受 bDMARD 治疗的 RA 患者随机（1:1:1）接受单剂量 PCV13 免疫接种，然后在 16 或 24 周后接受 PPV23 免疫接种，或接受双剂量 PCV13 免疫接种，然后在 16 周后接受 PPV23 免疫接种。RA 接受传统合成（cs）DMARD 治疗的患者组接受单剂量 PCV13，16 周后接受 PPV23 免疫接种。在每次接种前后采集肺炎球菌抗体。主要终点是在两次接种后 4 周时，≥6/12 型肺炎球菌血清型的参与者比例。
共纳入 65 名接受 bDMARD 治疗和 35 名接受 csDMARD 治疗的患者。在接受 PPV23 免疫接种后，分别有 87%（95%CI 0.76-0.94）和 94%（95%CI 0.77-0.99）接受 bDMARD 和 csDMARD 治疗的患者达到了主要终点。3 个随机分组组之间在主要终点上没有显著差异。利妥昔单抗治疗组的反应率为 25%，而其他作用模式的 bDMARD 治疗组的反应率为≥89%。
接受 PCV13 序贯 PPV23 基础-加强免疫接种的早期血清学应答在接受 bDMARD 和 csDMARD 治疗的患者中非常相似。然而，根据个体 bDMARD，观察到明显的反应差异。在规划 RA 患者的肺炎球菌疫苗接种时，需要考虑 RA 治疗。
