Edelman-Klapper Hadar, Rabinowitz Keren Masha, Zittan Eran, Bar-Gil Shitrit Ariella, Goren Idan, Avni-Biron Irit, Ollech Jacob E, Lichtenstein Lev, Banai-Eran Hagar, Yanai Henit, Snir Yifat, Pauker Maor H, Friedenberg Adi, Levy-Barda Adva, Broitman Yelena, Ben Zvi Haim, Perets Tsachi-Tsadok, Eliakim Rami, Barkan Revital, Goren Sophy, Cohen Dani, Dotan Iris
Division of Gastroenterology, Rabin Medical Center, Petah Tikva 4941492, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.
Vaccines (Basel). 2023 Jul 20;11(7):1263. doi: 10.3390/vaccines11071263.
Vaccines are pivotal for control of the coronavirus disease (COVID-19) pandemic. Patients with inflammatory bowel diseases (IBDs) treated with antitumor necrosis factor (TNF)-α have lower serologic response after two COVID-19 vaccine doses. Data regarding a third vaccine dose are scarce. An Israeli multicenter prospective observational study recruited 319 subjects: 220 with IBD (79 treated with anti-TNFα) and 99 healthy control (HC) participants. All patients received two mRNA-BNT162b2 vaccines (Pfizer/BioNTech), 80% of whom received a third vaccine dose. Evaluation included disease activity, anti-spike (S) and nucleocapsid (N) antibody levels, anti-TNFα drug levels, and adverse events (AEs). All participants showed significant serologic response one month after receiving a third dose. However, three months later, the anti-S levels decreased significantly in patients treated with anti-TNFα compared with the non-anti-TNFα and HC groups. A correlation between serologic response to the third vaccine dose and anti-TNF drug levels was not found. No significant AE or IBD exacerbation was observed. Importantly, lower serologic response after the third vaccine dose predicted infection. A third dose of BNT162b2 is effective and safe in patients with IBD. Lower serologic response predicted infection, even in seropositive subjects. Lower serologic responses and their rapid decline suggest a fourth vaccine dose in this patient population.
疫苗对于控制冠状病毒病（COVID-19）大流行至关重要。接受抗肿瘤坏死因子（TNF）-α治疗的炎症性肠病（IBD）患者在接种两剂COVID-19疫苗后的血清学反应较低。关于第三剂疫苗的数据很少。一项以色列多中心前瞻性观察研究招募了319名受试者：220名IBD患者（79名接受抗TNFα治疗）和99名健康对照（HC）参与者。所有患者均接种了两剂mRNA-BNT162b2疫苗（辉瑞/ BioNTech），其中80%的人接种了第三剂疫苗。评估包括疾病活动度、抗刺突（S）和核衣壳（N）抗体水平、抗TNFα药物水平以及不良事件（AE）。所有参与者在接种第三剂疫苗一个月后均表现出显著的血清学反应。然而，三个月后，与未接受抗TNFα治疗的组和HC组相比，接受抗TNFα治疗的患者的抗S水平显著下降。未发现对第三剂疫苗的血清学反应与抗TNF药物水平之间存在相关性。未观察到明显的AE或IBD病情加重。重要的是，第三剂疫苗接种后较低的血清学反应预示着感染。第三剂BNT162b2对IBD患者有效且安全。较低的血清学反应预示着感染，即使在血清阳性的受试者中也是如此。较低的血清学反应及其快速下降表明该患者群体需要接种第四剂疫苗。
