The Immunogenicity of the Influenza, Pneumococcal, and Hepatitis B Vaccines in Patients With Inflammatory Bowel Disease Treated With Vedolizumab.
The Immunogenicity of the Influenza, Pneumococcal, and Hepatitis B Vaccines in Patients With Inflammatory Bowel Disease Treated With Vedolizumab.
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DOI：
10.1093/crocol/otaa082
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发表时间：
2020-10
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炎症性肠病（IBD）患者感染的风险较高，免疫抑制药物会进一步增加感染的风险。本研究的目的是评估接受维多珠单抗治疗的 IBD 成人患者与接受抗肿瘤坏死因子 (TNF) 药物或非免疫抑制治疗的患者相比，流感、PVC13、PPSV23 和乙型肝炎疫苗的安全性和免疫原性。在这项前瞻性对照试验中，患者接种了流感、PVC13、PPSV23 和/或乙型肝炎疫苗。参与者根据 IBD 药物治疗方案进行分组：(1) 维多珠单抗单药治疗，(2) 维多珠单抗加免疫调节剂，(3) 抗 TNF 加免疫调节剂，(4) 不接受免疫抑制治疗（对照）。通过比较疫苗接种前和疫苗后的滴度来评估疫苗反应。通过哈维-布拉德肖指数或简单结肠炎临床活动指数以及标准化电话访谈来监测疾病活动和不良事件。没有报告严重不良事件或疾病活动的显着变化。对于流感疫苗，所有组的基线滴度都很高，并且没有后续滴度符合充分反应的标准。对于肺炎球菌疫苗，所有组均表现出对疫苗接种的反应；各组之间没有统计学上的显着差异。对于乙型肝炎疫苗，62.5% 接受维多珠单抗治疗的患者和 33.3% 接受抗 TNF 治疗的患者达到了 >10 mIU/mL 的缓解水平。无法观察对流感疫苗的反应是由于高基线滴度的影响。对于乙型肝炎疫苗，接受维多珠单抗治疗的患者对疫苗接种产生了免疫原性反应，该反应不劣于非免疫抑制对照。所有研究的疫苗均具有良好的耐受性。应鼓励所有成年 IBD 患者接种疫苗。
Patients with inflammatory bowel disease (IBD) have an elevated risk for infection which is further increased by immunosuppressive medications. The aim of this study was to evaluate the safety and immunogenicity of influenza, PVC13, PPSV23, and hepatitis B vaccines in adults with IBD treated with vedolizumab as compared to those treated with anti-tumor necrosis factor (TNF) agents or nonimmunosuppressive therapy. In this prospective controlled trial, patients were vaccinated with the influenza, PVC13, PPSV23, and/or hepatitis B vaccines. Participants were grouped based on IBD medication regimen: (1) vedolizumab monotherapy, (2) vedolizumab plus immunomodulator, (3) anti-TNF plus immunomodulator, and (4) no immunosuppressive therapy (control). Vaccine responses were evaluated by comparing pre- and postvaccination titers. Disease activity and adverse events were monitored by the Harvey–Bradshaw Index or Simple Colitis Clinical Activity Index and by standardized phone interviews. No serious adverse events or significant changes in disease activity were reported. For the influenza vaccine, baseline titers were high in all groups, and no follow-up titers met criteria for adequate response. For the pneumococcal vaccines, all groups showed response to vaccination; there was no statistically significant difference between the groups. For the hepatitis B vaccine, 62.5% of patients receiving vedolizumab and 33.3% receiving anti-TNF therapy achieved a level of response >10 mIU/mL. The inability to observe a response to the influenza vaccine was influenced by high baseline titers. For the hepatitis B vaccine, patients treated with vedolizumab experienced immunogenic response to vaccination that was noninferior to nonimmunosuppressed controls. All studied vaccines were well-tolerated. Vaccination should be encouraged in all adult patients with IBD.