COVID-19 Vaccine Is Effective in Inflammatory Bowel Disease Patients and Is Not Associated With Disease Exacerbation

Abstract

Background Studies have shown decreased response to COVID-19 vaccinations in some populations. In addition, it is possible that vaccine-triggered immune activation could trigger immune-dysregulation and thus exacerbate inflammatory bowel diseases (IBD). In this population-based study we used the epi-Israeli IBD Research Nucleus (IIRN) validated cohort to explore the effectiveness of COVID-19 vaccination in IBD and to assess its effect on disease outcomes. Methods We included all IBD patients insured in two of the four Israeli health maintenance organizations (HMOs), covering 35% of the population. Patients receiving two Pfizer-BioNTech BNT162b2 vaccine doses between December 2020 to June 2021 were individually matched to non-IBD controls. To assess IBD outcomes, we matched vaccinated to unvaccinated IBD patients and response was analyzed per medical treatment. Results In total, 12,109 IBD patients received two vaccine doses, of whom 4,946 were matched to non-IBD controls (mean age 51±16 years and median follow-up 22 weeks (interquartile range [IQR], 4-24)). Fifteen patients in each group (0.3%) developed COVID-19 post vaccination (OR=1 [95%CI 0.49-2.05], P =1.0). Patients on tumor necrosis factor (TNF) inhibitors and/or corticosteroids did not have a higher incidence of infection. To explore IBD outcomes, 707 vaccinated IBD patients were compared to unvaccinated IBD patients by stringent matching (median follow-up, 14 weeks [IQR 2.3-20.4]). The risk of exacerbation was 29% in the vaccinated patients compared with 26% in unvaccinated patients ( P =.3). Conclusions COVID-19 vaccine effectiveness in IBD patients is comparable to that in non-IBD controls and is not influenced by treatment with TNF inhibitors or corticosteroids. The IBD exacerbation rate did not differ between vaccinated and unvaccinated patients.

Effectiveness and safety of SARS‐CoV‐2 vaccine in Inflammatory Bowel Disease patients: a systematic review, meta‐analysis and meta‐regression

“…Thus, 21 studies were included in their entirety as shown in Table 1. These included 11 prospective studies, seven retrospective studies and three survey‐based studies 16–21,27–41 . The PRISMA Flow chart is shown in Figure 1.…”

“…These included 11 prospective studies, seven retrospective studies and three survey‐based studies. 16 , 17 , 18 , 19 , 20 , 21 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 The PRISMA Flow chart is shown in Figure 1 . The study details are shown in Table 1 .…”

“…Four studies reported breakthrough infection after SARS‐CoV‐2 vaccination in IBD patients. 27 , 28 , 29 , 39 This yielded a total of 29 breakthrough infections in 6765 IBD patients after one dose. Thirty‐three breakthrough infections were reported in 12,674 IBD patients.…”

Recent advances in clinical practice: management of inflammatory bowel disease during the COVID-19 pandemic

“…Two other cohort studies have found no difference in rates of breakthrough infection following two doses of vaccination 167 168. One Israeli case–control study assessed 12 109 patients with IBD who had received two doses of BNT162b2 vaccine 167.…”

Is the attenuated humoral response to COVID-19 vaccination in anti-TNF users relevant?

“…Despite concerns surrounding the robustness of the immune response to vaccination among people being treated with anti-TNF therapies, these same patients do not seem to be at an increased risk of contracting COVID-19 compared with people with IBD not on biological therapy and the age-matched general population. [5][6][7] In fact, anti-TNF use might be a protective factor against severe COVID-19-related outcomes among individuals with autoimmune diseases, 8 which could be due to these therapies inhibiting the maladaptive systemic inflammatory response that often characterises severe COVID-19. This reduction in the risk of severe outcomes might also be related to the association between anti-TNF therapy and reduced IBD-related disease activity; higher levels of disease activity in IBD have been shown to increase the risk of adverse COVID-19-related outcomes.…”