维得利珠单抗治疗的炎症性肠病患者中流感、肺炎球菌和乙型肝炎疫苗的免疫原性。
The Immunogenicity of the Influenza, Pneumococcal, and Hepatitis B Vaccines in Patients With Inflammatory Bowel Disease Treated With Vedolizumab.
作者信息
Harrington Jill E, Hamilton Rachel E, Ganley-Leal Lisa, Farraye Francis A, Wasan Sharmeel K
机构信息
Department of Medicine, Boston Medical Center, Boston, Massachusetts, USA.
Department of Environmental Health, Boston University School of Public Health, Boston, Massachusetts, USA.
出版信息
Crohns Colitis 360. 2020 Oct 27;2(4):otaa082. doi: 10.1093/crocol/otaa082. eCollection 2020 Oct.
BACKGROUND
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.
METHODS
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.
RESULTS
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.
DISCUSSION
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.
背景
炎症性肠病（IBD）患者感染风险升高，免疫抑制药物会进一步增加该风险。本研究旨在评估与接受抗肿瘤坏死因子（TNF）药物治疗或非免疫抑制治疗的IBD成年患者相比，接受维多珠单抗治疗的IBD成年患者接种流感疫苗、13价肺炎球菌结合疫苗（PVC13）、23价肺炎球菌多糖疫苗（PPSV23）和乙肝疫苗的安全性和免疫原性。
方法
在这项前瞻性对照试验中，患者接种了流感疫苗、PVC13、PPSV23和/或乙肝疫苗。参与者根据IBD药物治疗方案分组：（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）无免疫抑制治疗（对照）。通过比较接种前和接种后的滴度评估疫苗反应。通过哈维-布拉德肖指数或单纯性结肠炎临床活动指数以及标准化电话访谈监测疾病活动和不良事件。
结果
未报告严重不良事件或疾病活动的显著变化。对于流感疫苗，所有组的基线滴度都很高，且没有随访滴度达到充分反应的标准。对于肺炎球菌疫苗，所有组都显示出对疫苗接种有反应；各组之间无统计学显著差异。对于乙肝疫苗，接受维多珠单抗治疗的患者中有62.5%、接受抗TNF治疗的患者中有33.3%达到了>10 mIU/mL的反应水平。
讨论
无法观察到对流感疫苗的反应受高基线滴度影响。对于乙肝疫苗，接受维多珠单抗治疗的患者对疫苗接种产生的免疫原性反应不劣于未接受免疫抑制的对照。所有研究的疫苗耐受性良好。应鼓励所有成年IBD患者接种疫苗。
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