Joel Pekow, MD

The efficacy of vaccination against SARS-CoV-2 in patients with IBD and complications from a COVID-19 infection unique to patients with IBD have not been well elucidated. This month, three manuscripts were published in Gastroenterology examining real-world data on vaccine efficacy and COVID infection outcomes in IBD patients.

Over 60% of Israelis have been fully vaccinated.  Ben-Tov and colleagues evaluated the efficacy of BNT162b2 vaccination in 12,231 IBD patients matched to 36,254 using data from the second largest state-mandated healthcare provider in Israel. Seven days after the second vaccination, breakthrough infections were observed in 0.19% of IBD patients and 0.15% of control patients.  Of the 23 breakthrough infections in IBD patients, 2 patients were hospitalized, and one patient died.  Crohn’s disease patients were at greater risk of breakthrough infections in a multivariable analysis [HR3.56 (95% CI-1.29,9.83). Patients with UC and those on immune modifying agents did not have a higher risk of breakthrough infections. It should be noted that that these results may not be generalizable to other populations, as the median age was 47 and there were limited patients on immunosuppressive therapies (10.8% on anti-TNF, 1.4% on methotrexate, 4.8% on thiopurines).

A similar study by Hadi et al.  retrospectively examined the safety and efficacy of vaccination in IBD patients using a large United States research network encompassing >800,000 vaccinated patients. Of these patients, 5,562 had a diagnosis of IBD (3,740 received both vaccine doses). In contrast to the previous study, 53% of patients were on a biologic and/or thiopurine. In this analysis, there were no differences in the rate of adverse events reported, subsequent COVID-19 infections, or COVID-19 related hospitalizations between IBD and non-IBD patients. In addition, there was not a higher rate of adverse events after vaccination between those on a biologic or immunomodulator compared. The authors state that there were ≤10 breakthrough infections in patients on a biologic or immunomodulator, although did not perform a statistical comparison to IBD patients not on immunosuppressive therapies.

These manuscripts evaluated outcomes in large cohorts of IBD patients, although the results are limited by the fact that they relied on diagnosis coding for inclusion of IBD patients and recording of events. Furthermore, it is likely that many patients with SARS-CoV-2 infections are diagnosed outside an individuals’ healthcare system limiting capturing of events for their analyses. Nevertheless, these studies clearly demonstrate safety and efficacy of COVID-19 vaccination in patients with IBD. Further work is needed, however, to evaluate real-world long-term efficacy of vaccination in IBD patients on immunosuppressive therapy.

Both IBD and SARS-CoV-2 increase an individual’s risk of a venous thromboembolism (VTE). Using a veteran’s administrations (VA) cohort, Mahmud and colleagues identified 428 patients with IBD who developed a VTE within the one year study period. After adjusting for recent hospitalizations and steroid exposure, SARS-CoV-2 infection was associated with an 8.15-fold increased risk of VTE (95% CI 4.34-15.30). This study is limited by the fact that there were just 21 events of VTE after a SARS-CoV-2 infection. If the results are validated in an independent larger cohort of patients, however, practitioners should consider VTE prophylaxis in IBD patients with a SARS-CoV-2 infection.

The efficacy of vaccination against SARS-CoV-2 in patients with IBD and complications from a COVID-19 infection unique to patients with IBD have not been well elucidated. This month, three manuscripts were published in Gastroenterology examining real-world data on vaccine efficacy and COVID infection outcomes in IBD patients.

Over 60% of Israelis have been fully vaccinated.  Ben-Tov and colleagues evaluated the efficacy of BNT162b2 vaccination in 12,231 IBD patients matched to 36,254 using data from the second largest state-mandated healthcare provider in Israel. Seven days after the second vaccination, breakthrough infections were observed in 0.19% of IBD patients and 0.15% of control patients.  Of the 23 breakthrough infections in IBD patients, 2 patients were hospitalized, and one patient died.  Crohn’s disease patients were at greater risk of breakthrough infections in a multivariable analysis [HR3.56 (95% CI-1.29,9.83). Patients with UC and those on immune modifying agents did not have a higher risk of breakthrough infections. It should be noted that that these results may not be generalizable to other populations, as the median age was 47 and there were limited patients on immunosuppressive therapies (10.8% on anti-TNF, 1.4% on methotrexate, 4.8% on thiopurines).

A similar study by Hadi et al.  retrospectively examined the safety and efficacy of vaccination in IBD patients using a large United States research network encompassing >800,000 vaccinated patients. Of these patients, 5,562 had a diagnosis of IBD (3,740 received both vaccine doses). In contrast to the previous study, 53% of patients were on a biologic and/or thiopurine. In this analysis, there were no differences in the rate of adverse events reported, subsequent COVID-19 infections, or COVID-19 related hospitalizations between IBD and non-IBD patients. In addition, there was not a higher rate of adverse events after vaccination between those on a biologic or immunomodulator compared. The authors state that there were ≤10 breakthrough infections in patients on a biologic or immunomodulator, although did not perform a statistical comparison to IBD patients not on immunosuppressive therapies.

These manuscripts evaluated outcomes in large cohorts of IBD patients, although the results are limited by the fact that they relied on diagnosis coding for inclusion of IBD patients and recording of events. Furthermore, it is likely that many patients with SARS-CoV-2 infections are diagnosed outside an individuals’ healthcare system limiting capturing of events for their analyses. Nevertheless, these studies clearly demonstrate safety and efficacy of COVID-19 vaccination in patients with IBD. Further work is needed, however, to evaluate real-world long-term efficacy of vaccination in IBD patients on immunosuppressive therapy.

Both IBD and SARS-CoV-2 increase an individual’s risk of a venous thromboembolism (VTE). Using a veteran’s administrations (VA) cohort, Mahmud and colleagues identified 428 patients with IBD who developed a VTE within the one year study period. After adjusting for recent hospitalizations and steroid exposure, SARS-CoV-2 infection was associated with an 8.15-fold increased risk of VTE (95% CI 4.34-15.30). This study is limited by the fact that there were just 21 events of VTE after a SARS-CoV-2 infection. If the results are validated in an independent larger cohort of patients, however, practitioners should consider VTE prophylaxis in IBD patients with a SARS-CoV-2 infection.

The efficacy of vaccination against SARS-CoV-2 in patients with IBD and complications from a COVID-19 infection unique to patients with IBD have not been well elucidated. This month, three manuscripts were published in Gastroenterology examining real-world data on vaccine efficacy and COVID infection outcomes in IBD patients.

Over 60% of Israelis have been fully vaccinated.  Ben-Tov and colleagues evaluated the efficacy of BNT162b2 vaccination in 12,231 IBD patients matched to 36,254 using data from the second largest state-mandated healthcare provider in Israel. Seven days after the second vaccination, breakthrough infections were observed in 0.19% of IBD patients and 0.15% of control patients.  Of the 23 breakthrough infections in IBD patients, 2 patients were hospitalized, and one patient died.  Crohn’s disease patients were at greater risk of breakthrough infections in a multivariable analysis [HR3.56 (95% CI-1.29,9.83). Patients with UC and those on immune modifying agents did not have a higher risk of breakthrough infections. It should be noted that that these results may not be generalizable to other populations, as the median age was 47 and there were limited patients on immunosuppressive therapies (10.8% on anti-TNF, 1.4% on methotrexate, 4.8% on thiopurines).

A similar study by Hadi et al.  retrospectively examined the safety and efficacy of vaccination in IBD patients using a large United States research network encompassing >800,000 vaccinated patients. Of these patients, 5,562 had a diagnosis of IBD (3,740 received both vaccine doses). In contrast to the previous study, 53% of patients were on a biologic and/or thiopurine. In this analysis, there were no differences in the rate of adverse events reported, subsequent COVID-19 infections, or COVID-19 related hospitalizations between IBD and non-IBD patients. In addition, there was not a higher rate of adverse events after vaccination between those on a biologic or immunomodulator compared. The authors state that there were ≤10 breakthrough infections in patients on a biologic or immunomodulator, although did not perform a statistical comparison to IBD patients not on immunosuppressive therapies.

These manuscripts evaluated outcomes in large cohorts of IBD patients, although the results are limited by the fact that they relied on diagnosis coding for inclusion of IBD patients and recording of events. Furthermore, it is likely that many patients with SARS-CoV-2 infections are diagnosed outside an individuals’ healthcare system limiting capturing of events for their analyses. Nevertheless, these studies clearly demonstrate safety and efficacy of COVID-19 vaccination in patients with IBD. Further work is needed, however, to evaluate real-world long-term efficacy of vaccination in IBD patients on immunosuppressive therapy.

Both IBD and SARS-CoV-2 increase an individual’s risk of a venous thromboembolism (VTE). Using a veteran’s administrations (VA) cohort, Mahmud and colleagues identified 428 patients with IBD who developed a VTE within the one year study period. After adjusting for recent hospitalizations and steroid exposure, SARS-CoV-2 infection was associated with an 8.15-fold increased risk of VTE (95% CI 4.34-15.30). This study is limited by the fact that there were just 21 events of VTE after a SARS-CoV-2 infection. If the results are validated in an independent larger cohort of patients, however, practitioners should consider VTE prophylaxis in IBD patients with a SARS-CoV-2 infection.