SARS-CoV-2 vaccination does not induce relapses of patients with inflammatory bowel disease

Abstract

Background Vaccination against SARS-CoV-2 is a promising strategy to protect immunocompromised IBD patients from a severe course of COVID-19. As these patients were excluded from initial clinical vaccination trials, patients frequently express concerns regarding the safety of these vaccines, especially whether vaccination might trigger IBD flares (“hit-and-run-hypothesis”).

Methods In order to assess the risk of an IBD flare after vaccination against SARS-CoV-2, an anonymous survey was performed at five German IBD centers and one patient organization (Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung (DCCV) e.V.) in August and October 2021.

Results The questionnaire was answered by 914 patients, 781 of whom reported a previous vaccination against SARS-CoV-2 (85.4%). Vaccination against SARS-CoV-2 was not associated with an increased risk of IBD flares (p=0.319) or unscheduled visits to the IBD physician (p=0.848). Furthermore, typical symptoms of an IBD flare including abdominal pain, increases in stool frequency, or rectal bleeding were not influenced by the vaccination.

Conclusion Vaccination against SARS-CoV-2 is safe in IBD patients. These results may help to reduce fears regarding the vaccination in IBD patients. Our results can help to reduce fears in IBD patients regarding the SARS-CoV-2 vaccine. A close communication between patients and physicians before and after the vaccination may be beneficial.

Zusammenfassung

Hintergrund Die Impfung gegen SARS-CoV-2 kann immunkompromittierte Patienten mit einer chronisch-entzündlichen Darmerkrankung (CED) vor einem schweren Verlauf einer COVID-19-Erkrankung schützen. Da diese Patientengruppe in den Zulassungsstudien nicht eingeschlossen wurde, werden vielfach von Patienten Sorgen im Hinblick auf die Sicherheit geäußert, insbesondere bestehen Ängste vor der Auslösung eines akuten CED-Schubs.

Methoden Zwischen August und Oktober 2021 wurde eine retrospektive Umfrage an 5 deutschen CED-Zentren und unter den Mitgliedern der „Deutschen Morbus Crohn/Colitis ulcerosa Vereinigung (DCCV) e.V.“ durchgeführt, um das Auftreten eines Schubs nach SARS-CoV-2-Impfung zu erfassen.

Resultate Der Fragebogen wurde von 914 Patienten beantwortet. Von diesen haben 781 (85,4%) berichtet, mindestens eine Impfung gegen SARS-CoV-2 erhalten zu haben. Die Vakzinierung gegen SARS-CoV-2 war nicht mit einer erhöhten Frequenz an CED-Schüben (p=0,319) oder ungeplanten Vorstellungen beim CED-Behandler (p=0,848) assoziiert. Des Weiteren war die Impfung nicht mit einer erhöhten Stuhlfrequenz, vermehrten abdominellen Schmerzen oder rektalen Blutabgängen assoziiert.

Schlussfolgerungen Die Vakzinierung gegen SARS-CoV-2 war in unserem Kollektiv nicht mit einer nachfolgend gesteigerten Krankheitsaktivität der CED assoziiert. Unsere Resultate können helfen, Ängste von CED-Patienten vor einer Impfung gegen SARS-CoV-2 zu reduzieren.

Schlüsselwörter

IBD - Impfung - SARS-CoV-2 - COVID-19 - Nebeneffekt

Keywords

IBD - vaccination - SARS-CoV-2 - COVID-19 - side effect

Publication History

Received: 05 November 2021

Accepted after revision: 25 November 2021

Article published online:
18 January 2022

• References

• 1 Wise J. COVID-19: Rare immune response may cause clots after AstraZeneca vaccine, say researchers. BMJ 2021; n954 DOI: 10.1136/bmj.n954.
• 2 Hargreaves Heap S, Koop C, Matakos K. et al. Good News for Whom? The Pfizer/BioNTech Vaccine Announcement Reduced Political Trust. SSRN Journal 2021; DOI: 10.2139/ssrn.3769205.
• 3 Castells MC, Phillips EJ. Maintaining Safety with SARS-CoV-2 Vaccines. N Engl J Med 2021; 384: 643-649 DOI: 10.1056/NEJMra2035343. (PMID: 33378605)
• 4 Talotta R. Do COVID-19 RNA-based vaccines put at risk of immune-mediated diseases? In reply to “potential antigenic cross-reactivity between SARS-CoV-2 and human tissue with a possible link to an increase in autoimmune diseases”. Clinical Immunology 2021; 224: 108665 DOI: 10.1016/j.clim.2021.108665. (PMID: 33429060)
• 5 Ferretti F, Cannatelli R, Benucci M. et al. How to Manage COVID-19 Vaccination in Immune-Mediated Inflammatory Diseases: An Expert Opinion by IMIDs Study Group. Front Immunol 2021; 12: 656362 DOI: 10.3389/fimmu.2021.656362. (PMID: 33936084)
• 6 Kumar A, Quraishi MN, Segal JP. et al. COVID-19 vaccinations in patients with inflammatory bowel disease. Lancet Gastroenterol Hepatol 2020; 5: 965-966 DOI: 10.1016/S2468-1253(20)30295-8. (PMID: 32971020)
• 7 Vojdani A, Kharrazian D. Potenzial antigenic cross-reactivity between SARS-CoV-2 and human tissue with a possible link to an increase in autoimmune diseases. Clin Immunol 2020; 217: 108480 DOI: 10.1016/j.clim.2020.108480. (PMID: 32461193)
• 8 Watad A, De Marco G, Mahajna H. et al. Immune-Mediated Disease Flares or New-Onset Disease in 27 Subjects Following mRNA/DNA SARS-CoV-2. Vaccines 2021; 9: 435 DOI: 10.3390/vaccines9050435. (PMID: 33946748)
• 9 Sangha M, Roitman I, Sultan K. et al. SARS-CoV-2 Immunization in Patients With Inflammatory Bowel Disease May Result in Disease Flares. Am J Gastroenterol 2021; DOI: 10.14309/ajg.0000000000001416. (PMID: 34406140)
• 10 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 DOI: 10.1056/NEJMoa2034577. (PMID: 33301246)
• 11 Ishay Y, Kenig A, Tsemach-Toren T. et al. Autoimmune phenomena following SARS-CoV-2 vaccination. Int Immunopharmacol 2021; 99: 107970 DOI: 10.1016/j.intimp.2021.107970. (PMID: 34280851)
• 12 Walldorf J, von Arnim U, Schmelz R. et al. SARS-CoV-2 Vaccination in Patients With Inflammatory Bowel Disease – Fear and Desire. Inflamm Bowel Dis 2021; izab150 DOI: 10.1093/ibd/izab150.
• 13 Narula N, Yamamura DLR, Marshall JK. Should my patient with inflammatory bowel disease on immunosuppressive therapy be vaccinated against influenza virus?. Can J Gastroenterol 2010; 24: 121-125 DOI: 10.1155/2010/375878.
• 14 Shah BB, Goenka MK. A comprehensive review of vaccination in patients with inflammatory bowel diseases: An Indian perspective. Indian J Gastroenterol 2020; 39: 321-330 DOI: 10.1007/s12664-020-01069-0. (PMID: 32844299)
• 15 Piovani D, Danese S, Peyrin-Biroulet L. et al. Environmental Risk Factors for Inflammatory Bowel Diseases: An Umbrella Review of Meta-analyses. Gastroenterology 2019; 157: 647-659.e4 DOI: 10.1053/j.gastro.2019.04.016. (PMID: 31014995)
• 16 Botwin GJ, Li D, Figueiredo J. et al. Adverse Events Following SARS-CoV-2 mRNA Vaccination Among Patients with Inflammatory Bowel Disease. medRxiv 2021; DOI: 10.1101/2021.03.30.21254607.
• 17 Sattui SE, Liew JW, Kennedy K. et al. Early experience of COVID-19 vaccination in adults with systemic rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey. RMD Open 2021; 7: e001814 DOI: 10.1136/rmdopen-2021-001814. (PMID: 34493645)
• 18 Geisen UM, Berner DK, Tran F. et al. Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort. Ann Rheum Dis 2021; 80: 1306-1311 DOI: 10.1136/annrheumdis-2021-220272. (PMID: 33762264)
• 19 Hadi YB, Thakkar S, Shah-Khan SM. et al. COVID-19 Vaccination Is Safe and Effective in Patients With Inflammatory Bowel Disease: Analysis of a Large Multi-institutional Research Network in the United States. Gastroenterology 2021; 161: 1336-1339.e3 DOI: 10.1053/j.gastro.2021.06.014.
• 20 Rahier J-F, Papay P, Salleron J. et al. H1N1 vaccines in a large observational cohort of patients with inflammatory bowel disease treated with immunomodulators and biological therapy. Gut 2011; 60: 456-462 DOI: 10.1136/gut.2010.233981.
• 21 Mok CC, Chan KH, Ho LY. et al. Safety and immune response of a live-attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial. Ann Rheum Dis 2019; 78: 1663-1668 DOI: 10.1136/annrheumdis-2019-215925. (PMID: 31530556)
• 22 Ray P, Black S, Shinefield H. et al. Risk of rheumatoid arthritis following vaccination with tetanus, influenza and hepatitis B vaccines among persons 15–59 years of age. Vaccine 2011; 29: 6592-6597 DOI: 10.1016/j.vaccine.2011.06.112. (PMID: 21763385)
• 23 Nakafero G, Grainge MJ, Myles PR. et al. Association between inactivated influenza vaccine and primary care consultations for autoimmune rheumatic disease flares: a self-controlled case series study using data from the Clinical Practice Research Datalink. Ann Rheum Dis 2019; 78: 1122-1126 DOI: 10.1136/annrheumdis-2019-215086. (PMID: 31036623)
• 24 Wintjens D, Bergey F, Saccenti E. et al. Disease Activity Patterns of Crohn’s Disease in the First Ten Years After Diagnosis in the Population-based IBD South Limburg Cohort. JCrohns Colitis 2021; 15: 391-400 DOI: 10.1093/ecco-jcc/jjaa173. (PMID: 32845291)
• 25 Fumery M, Singh S, Dulai PS. et al. Natural History of Adult Ulcerative Colitis in Population-based Cohorts: A Systematic Review. Clin Gastroenterol Hepatol 2018; 16: 343-356.e3 DOI: 10.1016/j.cgh.2017.06.016. (PMID: 28625817)