Clinical and Research Centre for Inflammatory Bowel Disease ISCARE and First Faculty of Medicine, Charles University, Prague, Czech Republic.
GENNET Prague, Czech Republic.
Inflamm Bowel Dis. 2022 Oct 3;28(10):1506-1512. doi: 10.1093/ibd/izab301.
Patients with inflammatory bowel disease (IBD) on immune-modifying treatment could be at an increased risk for severe coronavirus disease 2019 (COVID-19); thus, data on the efficacy and safety of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are essential. We conducted a prospective study of IBD patients vaccinated with BNT162b2, CX-024414, and ChAdOx1 nCoV-19 vaccines. The aim was to evaluate the rate and magnitude of seroconversion, assess the effect of different immune-modifying treatment modalities on the magnitude of anti-SARS-CoV-2 IgG antibody levels, and analyze the impact of anti-SARS-CoV-2 vaccination on the inflammatory biomarkers of IBD.
The study included 602 IBD patients and 168 immunocompetent health care workers serving as controls. Serum anti-SARS-CoV-2 IgG antibodies were measured by chemiluminescent microparticle immunoassay before the vaccination and 8 weeks after the vaccination.
Of IBD patients, 82.2% were receiving biological treatment: most of them were treated with antitumor necrosis factor (TNF)-α inhibitors (48.5%), and just under half of them were treated with concomitant thiopurines or methotrexate, followed by vedolizumab (18.6%) and ustekinumab (15.1%). Only 8.1% of patients were on 5-aminosalicylates, and a minority (2.2%) were treatment-free. The postvaccine seropositivity rate among IBD patients and controls was 97.8% vs 100%. Median anti-SARS-CoV-2 IgG levels were lower among IBD recipients of ChAdOx1 nCoV-19 compared with 2 other vaccines (P < .0001) and control ChAdOx1 nCoV-19 recipients (P = .01). No correlation was found between serum trough levels and anti-SARS-CoV-2 IgG concentrations for any of the biological drugs used. The TNF-α inhibitors with concomitant immunosuppressive treatment but no other treatment modalities were associated with a lower postvaccination antibody response (P < .0001). When evaluating the laboratory activity of IBD by C-reactive protein and fecal calprotectin levels, no significant differences were found before the vaccination and 8 weeks after its completion.
Our findings warrant particular attention to the anti-SARS-CoV-2 vaccination of IBD patients treated with TNF-α inhibitors with concomitant immunomodulators and show the priority of mRNA vaccines in this specific group of patients.
接受免疫调节治疗的炎症性肠病(IBD)患者患严重 2019 年冠状病毒病(COVID-19)的风险可能增加;因此,关于严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)疫苗的疗效和安全性的数据至关重要。我们对接受 BNT162b2、CX-024414 和 ChAdOx1 nCoV-19 疫苗接种的 IBD 患者进行了前瞻性研究。目的是评估血清转化率的速率和幅度,评估不同免疫调节治疗方式对 SARS-CoV-2 IgG 抗体水平幅度的影响,并分析 SARS-CoV-2 疫苗接种对 IBD 炎症生物标志物的影响。
该研究纳入了 602 名 IBD 患者和 168 名免疫功能正常的医护人员作为对照组。在接种疫苗前和接种疫苗 8 周后,通过化学发光微粒子免疫分析法检测血清 SARS-CoV-2 IgG 抗体。
IBD 患者中,82.2%接受生物治疗:大多数患者接受抗肿瘤坏死因子(TNF)-α 抑制剂治疗(48.5%),近一半患者同时接受硫嘌呤或甲氨蝶呤治疗,其次是维得利珠单抗(18.6%)和乌司奴单抗(15.1%)。只有 8.1%的患者接受 5-氨基水杨酸治疗,少数(2.2%)患者未接受治疗。IBD 患者和对照组的疫苗接种后血清阳性率分别为 97.8%和 100%。与其他两种疫苗相比(P<0.0001),接受 ChAdOx1 nCoV-19 疫苗接种的 IBD 患者的 SARS-CoV-2 IgG 中位数较低,与 ChAdOx1 nCoV-19 对照组相比也较低(P=0.01)。对于任何使用的生物药物,均未发现血清谷值水平与 SARS-CoV-2 IgG 浓度之间存在相关性。同时接受免疫抑制治疗但未接受其他治疗方式的 TNF-α 抑制剂与较低的疫苗接种后抗体反应相关(P<0.0001)。在评估 C 反应蛋白和粪便钙卫蛋白水平的 IBD 实验室活动时,在接种疫苗前后 8 周均未发现显著差异。
我们的研究结果特别需要关注接受同时接受免疫调节剂治疗的 TNF-α 抑制剂治疗的 IBD 患者的 SARS-CoV-2 疫苗接种,并表明在这一特定患者群体中,mRNA 疫苗具有优先权。