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. 2023 Sep 1;118(9):1693-1697.
doi: 10.14309/ajg.0000000000002337. Epub 2023 Jun 22.

Adverse Events and Serological Responses After SARS-CoV-2 Vaccination in Individuals With Inflammatory Bowel Disease

Ante Markovinović  1 , Joshua Quan  1 , Michelle Herauf  1 , Lindsay Hracs  1 , Joseph W Windsor  1 , Nastaran Sharifi  1 , Stephanie Coward  1 , Léa Caplan  1 , Julia Gorospe  1 , Kenneth Ernest-Suarez  1 , Christopher Ma  1 , Remo Panaccione  1 , Richard J M Ingram  1 , Jamil N Kanji  2   3   4 , Graham Tipples  2   5 , Jessalyn K Holodinsky  6 , Charles N Bernstein  7 , Douglas J Mahoney  8 , Sasha Bernatsky  9 , Eric I Benchimol  10   11   12 , Gilaad G Kaplan  1 ; STOP COVID-19 in IBD Research Group; STOP COVID-19 in IBD Research Group
Affiliations

Adverse Events and Serological Responses After SARS-CoV-2 Vaccination in Individuals With Inflammatory Bowel Disease

Ante Markovinović et al. Am J Gastroenterol. .

Abstract

Introduction: We determined adverse events after 4 doses of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine in those with inflammatory bowel disease (IBD), associations between antibodies and injection site reactions (ISR), and risk of IBD flare.

Methods: Individuals with IBD were interviewed for adverse events to SARS-CoV-2 vaccine. Multivariable linear regression assessed the association between antibody titers and ISR.

Results: Severe adverse events occurred in 0.03%. ISR were significantly associated with antibody levels after the fourth dose (geometric mean ratio = 2.56; 95% confidence interval 1.18-5.57). No cases of IBD flare occurred.

Discussion: SARS-CoV-2 vaccines are safe for those with IBD. ISR after the fourth dose may indicate increased antibodies.

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Conflict of interest statement

Guarantor of the article: Gilaad G. Kaplan, MD, MPH, FRCPC.

Specific author contributions: G.G.K. has full access to all data in the study and takes responsibility for the integrity of the data and accuracy of the data analysis. G.G.K., A.M., C.M., J.Q., J.K., G.T., and R.P. conceived and designed the study. G.G.K., C.M., R.P., N.S., M.H., R.J.I., and A.M. were responsible for clinical data. J.K. and G.T. were responsible for serological data. J.Q. and G.G.K. analyzed the data. A.M., J.Q., and G.K. drafted the manuscript. All authors interpreted the data and provided critical revisions of the manuscript for important intellectual content. All authors have approved the final draft of the manuscript.

Financial support: (i) Canadian Institutes of Health Research Operating Grant: COVID-19 Rapid Research Funding Opportunity funding reference number VR5-172684.·(ii) Crohn's and Colitis Canada COVID-19 and IBD Taskforce. (iii) Public Health Agency of Canada through the Vaccine Surveillance Reference Group (VSRG) and the COVID-19 Immunity Task Force (CITY). (iv) The Leona M. and Harry B. Helmsley Charitable Trust Grant #G-2209-05501.

Potential competing interests: C.G.K. has received honoraria for speaking or consultancy from AbbVie, Janssen, Pfizer, Amgen, and Takeda. He has received research support from Ferring, Janssen, AbbVie, GlaxoSmith Kline, Merck, and Shire. He has been a consultant for Gilead. He shares ownership of a patent: Treatment of Inflammatory Disorders, Autoimmune Disease, and PBC. UTI Limited Partnership, assignee. Patent WO2019046959A1·PCT/CA2018/051098 September 7, 2018.·C.N.B. is supported by the Bingham Chair in Gastroenterology. C.N.B. has served on advisory Boards for AbbVie Canada, Amgen Canada, Avir Pharmaceuticals, Bristol Myers Squibb Canada, Roche Canada, JAMP Pharmaceuticals Canada, Janssen Canada, Sandoz Canada, Takeda Canada, and Pfizer Canada; Consultant for Mylan Pharmaceuticals and Takeda; Educational grants from Abbvie Canada, Pfizer Canada, Takeda Canada, and Janssen Canada; speaker's panel for Abbvie Canada, Janssen Canada, and Takeda Canada. Received research funding from Abbvie Canada, Amgen Canada, Sandoz Canada, and Pfizer Canada. C.M. has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc., BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pendopharm, Pfizer, and Roche; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc., Alimentiv, Ferring, Janssen, Takeda, and Pfizer; research support from Ferring and Pfizer. R.P. has received consulting fees, speaker fees, and research support from AbbVie, Abbott, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Fresnius Kabi, Galapagos, Genentech, Gilead Sciences, Glaxo-Smith Kline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Satisfai Health, Sandoz, Schering-Plough, Shire, Sublimity Therapeutics, Theravance Biopharma, UCB, and Takeda Pharmaceuticals. E.I.B. has acted as a legal consultant for Hoffman La-Roche Limited and Peabody & Arnold LLP for matters unrelated to medications used to treat inflammatory bowel disease. He has also acted as a consultant for McKesson Canada and the Dairy Farmers of Ontario for matters unrelated to medications used to treat inflammatory bowel disease. K.E.-S. has received consulting fees and speaker fees from Janssen, Ferring, AstraZeneca, Sandoz, and Pfizer. The remaining authors report no conflict of interests.

Ethical considerations: All participants provided informed consent, and the study was approved by the University of Calgary's Conjoint Health Research Ethics Board (REB20-1082).

Data sharing: Data are available on an open-access online interactive dashboard found here: https://kaplan-gi.shinyapps.io/COVID_Serology/.

Figures

Figure 1.
Figure 1.
Log-transformed anti–SARS-CoV-2 spike antibody concentration across 4 doses of SARS-CoV-2 vaccine for participants who reported injection site reactions compared with participants who did not. IgG, immunoglobulin G; SARS-CoV-2, severe acute respiratory syndrome coronavirus-2.
See this image and copyright information in PMC

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