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

Raffi Lev-Tzion; Gili Focht; Rona Lujan; Adi Mendelovici; Chagit Friss; Shira Greenfeld; Revital Kariv; Amir Ben-Tov; Eran Matz; Daniel Nevo; Yuval Barak-Corren; Iris Dotan; Dan Turner

doi:10.1016/j.cgh.2021.12.026

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

Raffi Lev-Tzion^*, Gili Focht, Rona Lujan, Adi Mendelovici, Chagit Friss, Shira Greenfeld, Revital Kariv, Amir Ben-Tov, Eran Matz, Daniel Nevo, Yuval Barak-Corren, Iris Dotan, Dan Turner

^*Corresponding author for this work

Faculty of Medicine

Research output: Contribution to journal › Article › peer-review

44 Scopus citations

Abstract

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.

Original language	American English
Pages (from-to)	e1263-e1282
Journal	Clinical Gastroenterology and Hepatology
Volume	20
Issue number	6
DOIs	https://doi.org/10.1016/j.cgh.2021.12.026
State	Published - Jun 2022

Bibliographical note

Funding 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 Information:
Funding The epiIIRN work is supported by an educational grant from The Leona M. and Harry B. Helmsley Charitable Trust .

Publisher Copyright:
© 2022

Keywords

Adult
Aged
BNT162 Vaccine
COVID-19 Vaccines/adverse effects
COVID-19/prevention & control
Chronic Disease
Crohn's Disease
Disease Progression
Humans
Inflammatory Bowel Diseases/complications
Middle Aged
SARS-CoV-2
Tumor Necrosis Factor Inhibitors
Ulcerative Colitis
Vaccination

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.cgh.2021.12.026

Cite this

Lev-Tzion, R., Focht, G., Lujan, R., Mendelovici, A., Friss, C., Greenfeld, S., Kariv, R., Ben-Tov, A., Matz, E., Nevo, D., Barak-Corren, Y., Dotan, I., & Turner, D. (2022). COVID-19 Vaccine Is Effective in Inflammatory Bowel Disease Patients and Is Not Associated With Disease Exacerbation. Clinical Gastroenterology and Hepatology, 20(6), e1263-e1282. https://doi.org/10.1016/j.cgh.2021.12.026

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

abstract = "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.",

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author = "Raffi Lev-Tzion and Gili Focht and Rona Lujan and Adi Mendelovici and Chagit Friss and Shira Greenfeld and Revital Kariv and Amir Ben-Tov and Eran Matz and Daniel Nevo and Yuval Barak-Corren and Iris Dotan and Dan Turner",

note = "Funding 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 Information: Funding The epiIIRN work is supported by an educational grant from The Leona M. and Harry B. Helmsley Charitable Trust . Publisher Copyright: {\textcopyright} 2022",

year = "2022",

month = jun,

doi = "10.1016/j.cgh.2021.12.026",

language = "American English",

volume = "20",

pages = "e1263--e1282",

journal = "Clinical Gastroenterology and Hepatology",

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Lev-Tzion, R, Focht, G, Lujan, R, Mendelovici, A, Friss, C, Greenfeld, S, Kariv, R, Ben-Tov, A, Matz, E, Nevo, D, Barak-Corren, Y, Dotan, I & Turner, D 2022, 'COVID-19 Vaccine Is Effective in Inflammatory Bowel Disease Patients and Is Not Associated With Disease Exacerbation', Clinical Gastroenterology and Hepatology, vol. 20, no. 6, pp. e1263-e1282. https://doi.org/10.1016/j.cgh.2021.12.026

TY - JOUR

T1 - COVID-19 Vaccine Is Effective in Inflammatory Bowel Disease Patients and Is Not Associated With Disease Exacerbation

AU - Lev-Tzion, Raffi

AU - Focht, Gili

AU - Lujan, Rona

AU - Mendelovici, Adi

AU - Friss, Chagit

AU - Greenfeld, Shira

AU - Kariv, Revital

AU - Ben-Tov, Amir

AU - Matz, Eran

AU - Nevo, Daniel

AU - Barak-Corren, Yuval

AU - Dotan, Iris

AU - Turner, Dan

N1 - Funding 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 Information: Funding The epiIIRN work is supported by an educational grant from The Leona M. and Harry B. Helmsley Charitable Trust . Publisher Copyright: © 2022

PY - 2022/6

Y1 - 2022/6

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - BNT162 Vaccine

KW - COVID-19 Vaccines/adverse effects

KW - COVID-19/prevention & control

KW - Chronic Disease

KW - Crohn's Disease

KW - Disease Progression

KW - Humans

KW - Inflammatory Bowel Diseases/complications

KW - Middle Aged

KW - SARS-CoV-2

KW - Tumor Necrosis Factor Inhibitors

KW - Ulcerative Colitis

KW - Vaccination

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U2 - 10.1016/j.cgh.2021.12.026

DO - 10.1016/j.cgh.2021.12.026

M3 - Article

C2 - 34954338

AN - SCOPUS:85124879296

SN - 1542-3565

VL - 20

SP - e1263-e1282

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

IS - 6

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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