Intest Res.  2024 Jul;22(3):336-350. 10.5217/ir.2023.00077.

Effects of COVID-19 vaccines on patient-reported outcomes in patients with inflammatory bowel disease: a multicenter survey study in Korea

Affiliations
  • 1Department of Internal Medicine and Institute of Gastroenterology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 2Division of Gastroenterology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 3Division of Gastroenterology, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea
  • 4Division of Gastroenterology, Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Korea

Abstract

Background/Aims
The impact of vaccination on inflammatory bowel disease (IBD) patients is still unknown, and no studies have assessed the changes in patient-reported outcomes (PROs) after vaccination in patients with IBD. Therefore, in this study, we investigated the impact of vaccines on the PROs of patients with IBD.
Methods
We conducted a questionnaire survey of patients with IBD who visited outpatient clinics at 4 specialized IBD clinics of referral university hospitals from April 2022 to June 2022. A total of 309 IBD patients were included in the study. Patient information was collected from a questionnaire and their medical records, including laboratory findings, were reviewed retrospectively. Risk factors associated with an increase in PROs after COVID-19 vaccination were analyzed using logistic regression analyses. In addition, we assessed whether there were differences in variables by vaccine order using the linear mixed model.
Results
In multivariate analysis, young age ( < 40 years) and ulcerative colitis (UC) were found to be independent risk factors for aggravation of PROs in patients with IBD. In all patients, platelet count significantly increased with continued vaccination in multiple pairwise comparisons. In UC patients, PROs such as the short health scale, UC-abdominal signs and symptoms, and UC-bowel signs and symptoms were aggravated significantly with continued vaccination. There was no significant increase in the variables of patients with Crohn’s disease.
Conclusions
Therefore, there may be a need to counsel patients with IBD younger than 40 years of age, and patients with UC before they receive COVID-19 vaccinations.

Keyword

Inflammatory bowel disease; COVID-19 vaccination; Patient-reported outcome measures

Figure

  • Fig. 1. Study flowchart. IBD, inflammatory bowel disease; COVID-19, coronavirus disease.

  • Fig. 2. The comparison of the serial patient-reported outcome scores and laboratory data by vaccine orders in the patients with inflammatory bowel disease vaccinated against COVID-19 using a linear mixed model: focusing on the variables evaluated as statistically significant. (A) In all patients, the platelet count significantly increased with continued vaccination. (B-D) In patients with ulcerative colitis (UC), SHS, UC-PRO/SS(A), UC-PRO/SS(B) were significantly aggravated with continued vaccination. SHS, short health scale; UC-PRO/SS(A), patient- reported outcomes signs and symptoms (abdominal symptoms) of UC; UC-PRO/SS(B), patient-reported outcomes signs and symptoms (bowel signs and symptoms) of UC; COVID-19, coronavirus disease.


Reference

1. World Health Organization (WHO). WHO coronavirus (COVID-19) dashboard [Internet]. c2022 [cited 2022 Oct 19]. https://covid19.who.int/.
2. Lee YJ, Kim SE, Park YE, et al. SARS-CoV-2 vaccination for adult patients with inflammatory bowel disease: expert consensus statement by KASID. Intest Res. 2022; 20:171–183.
Article
3. Haas EJ, Angulo FJ, McLaughlin JM, et al. Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data. Lancet. 2021; 397:1819–1829.
Article
4. Satyam VR, Li PH, Reich J, et al. Safety of recombinant zoster vaccine in patients with inflammatory bowel disease. Dig Dis Sci. 2020; 65:2986–2991.
Article
5. Launay O, Abitbol V, Krivine A, et al. Immunogenicity and safety of influenza vaccine in inflammatory bowel disease patients treated or not with immunomodulators and/or biologics: a two-year prospective study. J Crohns Colitis. 2015; 9:1096–1107.
Article
6. Pittet LF, Verolet CM, Michetti P, et al. High immunogenicity of the pneumococcal conjugated vaccine in immunocompromised adults with inflammatory bowel disease. Am J Gastroenterol. 2019; 114:1130–1141.
Article
7. Jackson BD, Con D, Gorelik A, Liew D, Knowles S, De Cruz P. Examination of the relationship between disease activity and patient-reported outcome measures in an inflammatory bowel disease cohort. Intern Med J. 2018; 48:1234–1241.
Article
8. El-Matary W. Patient-reported outcome measures in inflammatory bowel disease. Can J Gastroenterol Hepatol. 2014; 28:536–542.
Article
9. Speight J, Barendse SM. FDA guidance on patient reported outcomes. BMJ. 2010; 340–c2921.
Article
10. Kim ES, Cho KB, Park KS, et al. Predictive factors of impaired quality of life in Korean patients with inactive inflammatory bowel disease: association with functional gastrointestinal disorders and mood disorders. J Clin Gastroenterol. 2013; 47:e38–e44.
11. Farrokhyar F, Marshall JK, Easterbrook B, Irvine EJ. Functional gastrointestinal disorders and mood disorders in patients with inactive inflammatory bowel disease: prevalence and impact on health. Inflamm Bowel Dis. 2006; 12:38–46.
Article
12. Higgins PD, Harding G, Revicki DA, et al. Development and validation of the ulcerative colitis patient-reported outcomes signs and symptoms (UC-PRO/SS) diary. J Patient Rep Outcomes. 2017; 2:26.
Article
13. Higgins PD, Harding G, Leidy NK, et al. Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary. J Patient Rep Outcomes. 2017; 2:24.
14. Hjortswang H, Järnerot G, Curman B, et al. The short health scale: a valid measure of subjective health in ulcerative colitis. Scand J Gastroenterol. 2006; 41:1196–1203.
Article
15. Stjernman H, Grännö C, Järnerot G, et al. Short health scale: a valid, reliable, and responsive instrument for subjective health assessment in Crohn’s disease. Inflamm Bowel Dis. 2008; 14:47–52.
Article
16. Park SK, Ko BM, Goong HJ, et al. Short health scale: a valid measure of health-related quality of life in Korean-speaking patients with inflammatory bowel disease. World J Gastroenterol. 2017; 23:3530–3537.
Article
17. McDermott E, Keegan D, Byrne K, Doherty GA, Mulcahy HE. The short health scale: a valid and reliable measure of health related quality of life in English speaking inflammatory bowel disease patients. J Crohns Colitis. 2013; 7:616–621.
Article
18. Coenen S, Weyts E, Geens P, et al. Short health scale: a valid and reliable measure of quality of life in Dutch speaking patients with inflammatory bowel disease. Scand J Gastroenterol. 2019; 54:592–596.
Article
19. Dalal RS, McClure E, Marcus J, Winter RW, Hamilton MJ, Allegretti JR. COVID-19 vaccination intent and perceptions among patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2021; 19:1730–1732.
Article
20. Botwin GJ, Li D, Figueiredo J, et al. Adverse events after SARS-CoV-2 mRNA vaccination among patients with inflammatory bowel disease. Am J Gastroenterol. 2021; 116:1746–1751.
Article
21. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020; 383:2603–2615.
Article
22. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021; 384:403–416.
Article
23. Desalermos A, Pimienta M, Kalligeros M, et al. Safety of immunizations for the adult patient with inflammatory bowel disease: a systematic review and meta-analysis. Inflamm Bowel Dis. 2022; 28:1430–1442.
24. Lev-Tzion R, Focht G, Lujan R, et al. COVID-19 vaccine is effective in inflammatory bowel disease patients and is not associated with disease exacerbation. Clin Gastroenterol Hepatol. 2022; 20:e1263–e1282.
Article
25. Turner D, Ricciuto A, Lewis A, et al. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD). Determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology. 2021; 160:1570–1583.
Article
26. Sartor RB. Mechanisms of disease: pathogenesis of Crohn’s disease and ulcerative colitis. Nat Clin Pract Gastroenterol Hepatol. 2006; 3:390–407.
Article
27. Fuss IJ, Heller F, Boirivant M, et al. Nonclassical CD1d-restricted NK T cells that produce IL-13 characterize an atypical Th2 response in ulcerative colitis. J Clin Invest. 2004; 113:1490–1497.
Article
28. Heller F, Fuss IJ, Nieuwenhuis EE, Blumberg RS, Strober W. Oxazolone colitis, a Th2 colitis model resembling ulcerative colitis, is mediated by IL-13-producing NK-T cells. Immunity. 2002; 17:629–638.
Article
29. Collier DA, Ferreira IA, Kotagiri P, et al. Age-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b2. Nature. 2021; 596:417–422.
30. Park SH, Kim YJ, Rhee KH, et al. A 30-year trend analysis in the epidemiology of inflammatory bowel disease in the Songpa-Kangdong District of Seoul, Korea in 1986-2015. J Crohns Colitis. 2019; 13:1410–1417.
Article
31. Mazor Y, Maza I, Kaufman E, et al. Prediction of disease complication occurrence in Crohn’s disease using phenotype and genotype parameters at diagnosis. J Crohns Colitis. 2011; 5:592–597.
Article
32. Heits F, Stahl M, Ludwig D, Stange EF, Jelkmann W. Elevated serum thrombopoietin and interleukin-6 concentrations in thrombocytosis associated with inflammatory bowel disease. J Interferon Cytokine Res. 1999; 19:757–760.
Article
33. Yan SL, Russell J, Harris NR, Senchenkova EY, Yildirim A, Granger DN. Platelet abnormalities during colonic inflammation. Inflamm Bowel Dis. 2013; 19:1245–1253.
Article
34. Nielsen OH, Vainer B, Madsen SM, Seidelin JB, Heegaard NH. Established and emerging biological activity markers of inflammatory bowel disease. Am J Gastroenterol. 2000; 95:359–367.
Article
35. Harries AD, Fitzsimons E, Fifield R, Dew MJ, Rhoades J. Platelet count: a simple measure of activity in Crohn’s disease. Br Med J (Clin Res Ed). 1983; 286:1476.
Article
36. Korea Disease Control and Prevention Agency. Infection disease [Internet]. c2022 [cited 2022 Nov 11]. https://ncv.kdca.go.kr/.
Full Text Links
  • IR
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2025 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr