Breakthrough COVID-19 Milder in Vaccinated Patients With IBD

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Vaccination against SARS-CoV-2 appears to protect people with inflammatory bowel disease (IBD) from the more serious consequences of breakthrough COVID-19 infections, but results may vary by which vaccine was received, results of a small study suggest.

In a study of patients with IBD who had completed a primary vaccine series but went on to develop COVID-19, there were trends toward worse outcomes for patients who received a non-mRNA vaccine, older patients, and those who were on combination therapy rather than monotherapy, reported Emily Spiera, a medical student at the Icahn School of Medicine at Mount Sinai, New York.

“Overall, we saw that vaccinated patients who subsequently developed COVID-19 had low rates of hospitalization, severe COVID, and death,” she said in an oral abstract at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

The study was conducted before the highly infectious Omicron variant of SARS-CoV-2 became dominant, however, and the sample size of 88 patients, combined with a low number of study events, was too small for statistical significance to emerge for most measures, Spiera acknowledged.

Dr Freddy Caldera

Nonetheless, the findings support the protective benefit of vaccines in this population, said Freddy Caldera, DO, associate professor of gastroenterology at the University of Wisconsin–Madison, who was not involved in the study.

“In my mind, when we think about COVID vaccines, the whole goal is to prevent severe disease,” he said.

Caldera and colleagues conducted an earlier study of humoral immunogenicity of mRNA COVID-19 vaccines in 122 patients with IBD and 60 healthy controls, and found that all controls and 97% of patients with IBD developed antibodies, although antibody concentrations were lower in patients with IBD, compared with controls (P < .001). Those who received the mRNA-1273 (Moderna) COVID-19 had significantly higher antibody concentrations than those who received the Pfizer-BNT vaccine series (P < .001).

They also found that patients on immune-modifying therapy had lower antibody concentrations, compared with those who were not on such therapy, or those who received aminosalicylates or vedolizumab (Entyvio; P = .003).

The protective effect of vaccines in this population became even more apparent after patients received an additional vaccine dose.

“We actually have a study in preprint of what happens after a third dose, where everyone made antibodies,” he said. “What we tell patients is that vaccines work.”


The investigators at Mount Sinai, the University of North Carolina at Chapel Hill, and Tel Aviv University analyzed data from the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, an international web-based registry that includes reports from 74 countries, with data reported by 48 U.S. states.

The study sample consisted of patients enrolled from Dec. 12, 2020, to Oct. 1, 2021, who had completed a primary vaccination series with either mRNA vaccines (Pfizer or Moderna) adenoviral vector-based vaccines (AstraZeneca, Sputnik, CanSino, or Janssen/Johnson & Johnson), or an inactivated SARS-CoV-2 vaccine (Sinovac).

Of 2,477 patients with COVID-19 infections reported to SECURE-IBD, 160 reported being vaccinated. Of this group, 53 were excluded because they were only partially vaccinated, and 19 were excluded because of missing data on either vaccine type, number of doses, or COVID-19 outcomes, leaving 88 patients with completed primary vaccination series at the time of COVID-19 infection.

The median patient age was 40.1 years. Nearly two-thirds of the patients had a diagnosis of Crohn’s disease, and slightly more than one-third has a diagnosis of ulcerative colitis. The patients came from 18 countries, with 45.3% of the sample in the United States.

A total of 58% of patients were on biologic monotherapy, with either a tumor necrosis factor antagonist, integrin antagonist, or anti–interleukin-12/13. In addition, 3.4% were on immunomodulator monotherapy, 21.6% were on combination therapy, and 5.7% were receiving corticosteroids.

Lower Severity

COVID-19 severity was numerically but not significantly lower among the 88 vaccinated patients, with a rate of 5.7%, compared with 9.3% among 2,317 patients with COVID-19 infections in the database who were not vaccinated.

COVID-19 severity defined as a composite of ICU admission, need for mechanical ventilation and/or death was actually slightly higher among the vaccinated patients, with a rate of 3.4% versus 1.9% for nonvaccinated patients, but this difference was not statistically significant.

There was 1 death among vaccinated patients (1.1%) versus 29 among the unvaccinated (1.2%).

There were trends toward fewer hospitalizations and less-frequent severe COVID-19 infection among patients who received a mRNA vaccine, compared with other vaccine types, but again these differences did not reach statistical significance.

As noted before, there was a higher frequency of severe COVID-19 among patients on combination therapy than on monotherapy, but this difference too was not statistically significant.

As seen with COVID-19 in the general population older patients tended to have worse outcomes, with a mean age of 53 for patients requiring hospitalization, compared with 39 years for patients who stayed out of the hospital (P = .04), and a mean age of 59 among patients with severe COVID-19 infections, compared with 39 for patients with moderate or mild infections (P = .03).

Spiera described the case of the single vaccinated patient who died. The 63-year-old woman had moderately active Crohn’s disease treated with corticosteroids, adalimumab (Humira) and azathioprine at the time of COVID-19 infection. She had received the AstraZeneca adenoviral-based vaccine more than 30 days prior to infection. She was hospitalized and intubated, and died from gastrointestinal bleeding.

Spiera noted that, although the sample size was small, and only patients known to have COVID-19 were included, it is one of the largest cohorts to date of vaccinated patients with IBD who developed COVID-19. She said that the study supports prior studies showing that combination therapy and tumor necrosis factor antagonists may result in reduced immunity, and that mRNA vaccines may offer better protection against severe illness in this population.

The study was supported by a Digestive Disease Research Foundation Fellowship. Spiera and Caldera reported no relevant disclosures.

This article originally appeared on, part of the Medscape Professional Network.

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