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Observational Study
. 2022 Sep 2;17(9):e0273612.
doi: 10.1371/journal.pone.0273612. eCollection 2022.

Efficacy and safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease on immunosuppressive and biological therapy: Prospective observational study

Martin Wasserbauer  1 , Stepan Hlava  1 , Milan Trojanek  2 , Jan Stovicek  1 , Tomas Milota  3 , Jiri Drabek  1 , Petra Koptová  1 , Andrea Cupkova  1 , Dita Pichlerová  1 , Barbora Kucerova  4 , Stepan Coufal  5 , Radan Keil  1
Affiliations
Observational Study

Efficacy and safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease on immunosuppressive and biological therapy: Prospective observational study

Martin Wasserbauer et al. PLoS One. .

Abstract

Background and aims: SARS-CoV-2 is a worldwide serious health problem and vaccination seems to have a crucial role in managing the COVID-19 pandemic. The aim of this prospective observational study was to monitor the trend of antibodies against SARS-CoV-2 after vaccination with BNT162b2 (COMIRNATY) in patients with inflammatory bowel disease treated by immunosuppressive and/or biological therapy, demonstrate whether any type of this therapy is associated with poorer production of antibodies against COVID-19 and evaluate the safety of vaccination against COVID-19 in these patients.

Methods: Eighty-seven eligible patients from one tertiary gastroenterological center with inflammatory bowel disease (60 with CD, 27 with UC) treated by immunosuppressive and/or biological therapy from the antiTNFα group were indicated to vaccination against SARS-CoV-2. Effectiveness of vaccination was evaluated by the values of antibodies before and 4 weeks after 2nd dose of vaccine. Additional goal was to evaluate adverse events of vaccination.

Results: Before the 2nd dose of vaccine, geometric mean of SARS-CoV-2 IgG antibodies were 40.7 U/ml in the biological therapy group, 34.8 U/ml in the azathioprine group and 44.8 U/ml in the combination therapy group of patients. The geometric means were 676.5.7 U/ml in the biological therapy group, 614.4 U/ml in the azathioprine group and 500.1 U/ml in the combination therapy group of patients four weeks after 2nd dose. Statistically significant differences between these groups were not proved. Several non-severe local and general adverse events were present in our patients with a majority of these events on the day of vaccine administration and the day after, no anaphylactic reactions were present.

Conclusions: Our measurements proved the efficacy and safety of vaccination against SARS-CoV-2 in patients with inflammatory bowel disease treated by immunosuppressive and/or biological therapy. Statistically significant differences between our groups of patients were not proved.

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Conflict of interest statement

he authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Comparison of IgG antibodies values (geometric means) against SARS-CoV-2 in all 3 groups of patients.
Fig 2
Fig 2. Comparison of responders, partial responders and non-responders between all 3 groups of patients based on the value of antibodies against SARS-CoV-2.
Fig 3
Fig 3. Local adverse reactions after SARS-CoV-2 vaccination—development in time.
Fig 4
Fig 4. General adverse reactions after SARS-CoV-2 vaccination—development in time.
Fig 5
Fig 5. General well-being after SARS-CoV-2 vaccination—development in time.
See this image and copyright information in PMC

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