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SAFETY OF COVID-19 VACCINATION IN INFLAMMATORY BOWEL DISEASE PATIENTS ON BIOLOGIC THERAPY
Gastroenterology ; 162(7):S-601, 2022.
Article in English | EMBASE | ID: covidwho-1967350
ABSTRACT

Introduction:

The International Organization for the Study of Inflammatory Bowel Disease (IBD) has recommended vaccination of all patients with IBD as soon as they are able to receive the vaccine, regardless of immune-modifying therapies or disease activity. Nevertheless, some articles have shown a large percentage of individuals who are unwilling to receive the COVID-19 vaccine with fear of potential adverse events. Moreover, IBD patients were excluded from safety and efficacy phase III vaccine trials, as well as those treated with immunosuppressive therapies. Thus, we performed a monocentric real-life survey to assess the adverse events of COVID-19 vaccination among patients with IBD under biologic therapy.

Methods:

All adult individuals with IBD undergoing biological treatment and followed at Centro Hospitalar Universitário de São João were included. Each patient answered a telephone questionnaire conducted by a gastroenterologist.

Results:

A total of 301 patients agreed to participate in the study, the majority females (53.2%), with a median age of 42 years old (IQR 32-54). IBD diagnosis included Crohn's disease (76.7%) and ulcerative colitis (23.3%). The proportions of patients receiving tumor necrosis factor inhibitors, ustekinumab and vedolizumab were 75.4%, 13.0% and 11.6%, respectively. This cohort included 239 vaccinated patients (59.0% Pfizer-BioNTech, 20.5% Moderna, 14.2% Janssen and 6.3% AstraZeneca), 173 (57.5%) of whom had complete vaccination. Of the remaining individuals, only 12 did not intend to be vaccinated. The main reasons were fear of potential adverse events (50.0%), lack of confidence in the vaccine development process (25.0%) and little information about vaccination in IBD patients (16.6%). Among vaccinated patients, the overall adverse events frequency was 56.8% after dose 1 (D1) and 74.1% after dose 2 (D2). The most common symptoms were localized injection-site reactions and fatigue. The vast majority of adverse events were mild and lasted only a few days. Only 4 (1.7%) patients had IBD exacerbation after the vaccine. No serious adverse events were reported and any patient was hospitalized. The percentage of adverse events was higher among patients younger than 50 years (77.6% vs 62.5% after D1, p=0.011;83.0% vs 58.8% after D2, p=0.002). No significant differences were seen based on sex, vaccine type, biologic drug or disease type. Compared to the general population, a lower percentage of IBD patients suffered from local or systemic reactions during the first week after vaccination (Figure 1).

Conclusion:

We found a high acceptance rate and a good safety profile of SARS-CoV-2 vaccination in IBD patients treated with biologics drugs. Indeed, adverse events were common but overall mild and transitory. These data support the prioritization and rapid vaccination of these individuals. (Figure Presented) Figure 1 – Adverse reactions occurring within seven days after vaccination in IBD patients compared with the general population.
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Full text: Available Collection: Databases of international organizations Database: EMBASE Topics: Vaccines Language: English Journal: Gastroenterology Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Topics: Vaccines Language: English Journal: Gastroenterology Year: 2022 Document Type: Article