Shehab Mohammad, Abu-Farha Mohamed, Alrashed Fatema, Alfadhli Ahmad, Alotaibi Khazna, Alsahli Abdullah, Alphonse Thanaraj Thangavel, Channanath Arshad, Ali Hamad, Abubaker Jehad, Almulla Fahd
Division of Gastroenterology, Department of Internal Medicine, Mubarak Alkabeer University Hospital, Kuwait University, Kuwait City 47060, Kuwait.
Department of Biochemistry and Molecular Biology, Dasman Diabetes Institute (DDI), Dasman 15462, Kuwait.
J Clin Med. 2021 Nov 18;10(22):5362. doi: 10.3390/jcm10225362.
Vaccination is a promising strategy to protect vulnerable groups like inflammatory bowel disease (IBD) patients against COVID-19 and associated severe outcomes. COVID-19 vaccine clinical trials excluded IBD patients taking infliximab with azathioprine or 6-mercaptopurine (infliximab combination). Therefore, we sought to evaluate serologic responses to COVID-19 vaccination with the mRNA vaccine, BNT162b2, in patients with IBD receiving infliximab combination therapy compared with healthy participants.
This was a multicenter prospective study. Patients with IBD were recruited at the time of attendance at infusion center between 1 August 2021, and 15 September 2021. Our primary outcome were the concentrations of SARS-CoV-2 antibodies 4-10 weeks after vaccination with two doses of BNT162b2 vaccine in patients with IBD taking infliximab combination therapy (study group) compared with a healthy participants group (control group). Both study and control groups were matched for age, sex, and time-since-last-vaccine-dose using optimal pair-matching method.
In total, 116 participants were recruited in the study, 58 patients in the study group and 58 in the control group. Median (IQR) IgG concentrations were lower in the study group (99 BAU/mL (40, 177)) than the control group (139 BAU/mL (120, 188)) following vaccination ( = 0.0032). Neutralizing antibodies were also lower in the study group compared with the control group (64% (23, 94) vs. 91% (85, 94), < 0.001). The median IgA levels in the study group were also significantly lower when compared with the control group (6 U/mL (3, 34) vs. 13 U/mL (7, 30), = 0.0097). In the study group, the percentages of patients who achieved positive IgG, neutralizing antibody and IgA levels were 81%, 75%, and 40%, respectively. In the control group, all participants (100%) had positive IgG and neutralizing antibody levels while 62% had positive IgA levels.
In patients with IBD receiving infliximab combination therapy, SARS-CoV2 IgG, IgA, and neutralizing antibody levels after BNT162b2 vaccination were lower compared with healthy participants. However, most patients treated with infliximab combination therapy seroconverted after two doses of the vaccine.
接种疫苗是保护炎症性肠病（IBD）患者等弱势群体免受新冠病毒感染及相关严重后果影响的一种有前景的策略。新冠病毒疫苗临床试验将正在服用英夫利昔单抗联合硫唑嘌呤或6-巯基嘌呤（英夫利昔单抗联合用药）的IBD患者排除在外。因此，我们试图评估接受英夫利昔单抗联合治疗的IBD患者与健康参与者相比，接种mRNA疫苗BNT162b2后对新冠病毒疫苗的血清学反应。
这是一项多中心前瞻性研究。2021年8月1日至2021年9月15日期间，在输液中心招募IBD患者。我们的主要结局是接受英夫利昔单抗联合治疗的IBD患者（研究组）与健康参与者组（对照组）在接种两剂BNT162b2疫苗后4至10周时的新冠病毒抗体浓度。研究组和对照组使用最佳配对法在年龄、性别和距上次接种疫苗的时间方面进行匹配。
该研究共招募了116名参与者，研究组58例患者，对照组58例。接种疫苗后，研究组的IgG浓度中位数（四分位间距）低于对照组（99 BAU/mL（40，177））（P = 0.0032）。研究组的中和抗体也低于对照组（64%（23，94）对91%（85，94），P < 0.001）。研究组的IgA水平中位数与对照组相比也显著降低（6 U/mL（3，34）对13 U/mL（7，30），P = 0.0097）。在研究组中，IgG、中和抗体和IgA水平呈阳性的患者百分比分别为81%、75%和40%。在对照组中，所有参与者（100%）的IgG和中和抗体水平呈阳性，而62%的参与者IgA水平呈阳性。
在接受英夫利昔单抗联合治疗的IBD患者中，接种BNT162b2疫苗后的新冠病毒IgG、IgA和中和抗体水平低于健康参与者。然而，大多数接受英夫利昔单抗联合治疗的患者在接种两剂疫苗后发生了血清转化。
