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

• Published in: PloS one 2022-09, Vol.17 (9), p.e0273612-e0273612
• Main Authors: Wasserbauer, Martin, Hlava, Stepan, Trojanek, Milan, Stovicek, Jan, Milota, Tomas, Drabek, Jiri, Koptová, Petra, Cupkova, Andrea, Pichlerová, Dita, Kucerova, Barbora, Coufal, Stepan, Keil, Radan
• Format: Article
• Language: English
• Subjects: Adverse events; Age; Anaphylaxis; Antibodies; Azathioprine; Biological products; Biology and life sciences; Care and treatment; Consent; Control; Coronaviruses; COVID-19; COVID-19 vaccines; Czech Republic; Disease transmission; Dosage and administration; Effectiveness; Enzymes; Epidemics; Evaluation; Health aspects; Immunoglobulin G; Immunosuppressive agents; Immunotherapy; Infections; Inflammatory bowel disease; Inflammatory bowel diseases; Intestine; Medical treatment; Medicine and health sciences; Methods; Mortality; Observational studies; Pandemics; Patients; Questionnaires; Safety; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Statistical analysis; Tertiary; Therapy; Vaccination; Vaccines; Viral diseases
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0273612

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. 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 antiTNF[alpha] group were indicated to vaccination against SARS-CoV-2. Effectiveness of vaccination was evaluated by the values of antibodies before and 4 weeks after 2.sup.nd dose of vaccine. Additional goal was to evaluate adverse events of vaccination. Before the 2.sup.nd 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 2.sup.nd 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. 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.