Background & Aims: Studies have shown decreased response to coronavirus disease 2019 (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 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 2 of the 4 Israeli health maintenance organizations, covering 35% of the population. Patients receiving 2 Pfizer-BioNTech BNT162b2 vaccine doses between December 2020 and 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 2 vaccine doses, of whom 4946 were matched to non-IBD controls (mean age, 51 ± 16 years; median follow-up, 22 weeks; interquartile range, 4–24). Fifteen patients in each group (0.3%) developed COVID-19 after vaccination (odds ratio, 1; 95% confidence interval, 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 with unvaccinated IBD patients by stringent matching (median follow-up, 14 weeks; interquartile range, 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 with 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.
Bibliographical noteFunding Information:
Funding The epiIIRN work is supported by an educational grant from The Leona M. and Harry B. Helmsley Charitable Trust. Conflicts of interest These authors disclose the following: DT received consultation fee, research grant, royalties, or honorarium from Janssen, Pfizer, Ferring, AbbVie, Takeda, Atlantic Health, Shire, Celgene, Lilly, Roche, Thermo Fisher, BMS, SorrisoPharma, and Cytoreason. RK received consultation fee, research grant, royalties, or honorarium from Takeda and Pfizer. ID received consultation fee, research grant, royalties, or honorarium from Janssen, Pfizer, Ferring, AbbVie, Takeda, Celgene/BMS, Roche/Genentech Janssen, Arena, Neopharm, Gilead, Galapagos, Celltrion, Rafa Laboratories, Falk Pharma, MSD, Cambridge Healthcare, Sublimity, Nestle, Wild Biotech, Food Industries Organization, Integra Holdings, Abbott, Athos, Peer Voice, Medscape, Mediahuset, and GSK. The remaining authors disclose no conflicts.
Funding The epiIIRN work is supported by an educational grant from The Leona M. and Harry B. Helmsley Charitable Trust .
- BNT162 Vaccine
- COVID-19 Vaccines/adverse effects
- COVID-19/prevention & control
- Chronic Disease
- Crohn's Disease
- Disease Progression
- Inflammatory Bowel Diseases/complications
- Middle Aged
- Tumor Necrosis Factor Inhibitors
- Ulcerative Colitis