CHARLOTTE, N.C.—Patients with inflammatory bowel disease can safely continue biologic drugs around the time they receive mRNA COVID-19 vaccination, with no increase in disease flares, according to the prospective, observational PREVENT-COVID study.
“We recommend continuing IBD medications without interruption while receiving mRNA COVID-19 vaccinations,” said lead investigator Kiran Motwani, MD, a gastroenterology fellow at the University of Maryland Medical Center, in Baltimore, who reported the findings at the 2022 annual meeting of the American College of Gastroenterology. The abstract earned an ACG Governors Award for Excellence in Clinical Research.
Continuing versus holding immunosuppressive IBD therapy around mRNA COVID-19 vaccination had neither a significant impact on anti–receptor-binding domain (RBD) antibody titers, nor on the rate of COVID-19 infections or hospitalizations and disease flare at 60 days or six months, Dr. Motwani reported.
These findings are important, the researchers said, as patients on these medications—biologic and immunomodulating agents—were originally excluded from the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccine study populations. However, under real-world conditions, patients receive immunizations, and the ACG strongly supports COVID-19 vaccination in this population. Patients on anti–tumor necrosis factor (TNF) agents can have an attenuated antibody response. It has been suggested that immunogenicity might be improved by holding the biologic, or by giving the vaccines at the end of an anti-TNF treatment cycle, she said.
To Hold or Not
The PREVENT-COVID investigators aimed to evaluate antibody response and subsequent COVID-19 infections in 1,730 patients on active treatment for IBD (abstract S720/oral paper presentation 60). Mean disease duration was 16 years, and 54% had active disease during the study period.
For 201 of the patients, IBD treatments were held for at least 14 days before or after their second vaccination. Researchers measured anti-RBD immunoglobulin (Ig)G antibodies to SARS-CoV-2 (by LabCorp Cov2Quant IgG assay) eight weeks after completion of the vaccination series.
Most patients were receiving anti-TNF agents (n=910). Other patients were prescribed mesalamine (n=348), thiopurine (n=318), ustekinumab (Stelara, Janssen) (n=259), vedolizumab (Entyvio, Takeda) (n=208), combination anti-TNF and thiopurine-methotrexate (n=191), or methotrexate (n=110).
No Effect From Holding
There was no significant difference in COVID-19 antibody titers whether or not medication was held around the time of the second vaccination. Post-vaccination titers were similar between the two cohorts and for all the main drugs, Dr. Motwani reported.
“Patients on anti-TNFs or combination therapy had lower titers than those on novel biologics, but there was no statistically significant difference whether therapy was held or continued before or after vaccination, regardless of vaccination type,” Dr. Motwani said.
There was also no significant difference in the occurrence of breakthrough COVID-19 infection for all drug classes and anti-TNF agents in particular. By vaccination type, COVID-19 infection was diagnosed in 24% of anti-TNF therapy “holders” and 28% of “non-holders” vaccinated with BNT162b2 (P=0.564), and for 19% and 29%, respectively, vaccinated with the mRNA-1273 vaccine (P=0.259).
For all classes of IBD medications, infection occurred in 28% of holders and 29% of non-holders receiving the BNT162b2 vaccine. A numerical trend favoring holding was observed in the mRNA-1273 vaccine cohort, in whom infection was diagnosed in 19% of holders and 31% of non-holders (P=0.074). Only three hospitalizations occurred due to infection, and these were in individuals not holding medications.
Holding medications also did not lead to a significant increase in disease flares at 60 days or six months from second vaccination (Table). A flare was defined as worsening of at least one of these symptoms: abdominal pain, bowel frequency, rectal bleeding, or extraintestinal manifestation after the first or second vaccine, along with the need to add or change IBD medication due to symptoms.
| Table. Flare of IBD According to Medication Holding | |||
| Disease flare and timing | Any IBD medication, % (n=1,730) | Holding, % (n=140) | Non-holding, % (n=1,590) |
|---|---|---|---|
| Flare at 60 days | 5.4 | 6.4 | 5.3 |
| Flare at 6 months | 8.6 | 6.4 | 8.7 |
Session co-moderator Lisa B. Malter, MD, a professor of medicine at NYU Grossman School of Medicine and the director of the IBD program at Bellevue Hospital, in New York City, told Gastroenterology & Endoscopy News that holding IBD medications was never a formally recommended strategy, “but people talked about it.” While many advocated vaccinating IBD patients at the time they came in for infusions or other treatments—“to just get it done”—some of her colleagues hesitated to do so, she said.
“Is this study still relevant? I don’t know,” Dr. Malter said, noting that there has been poor uptake of the latest boosters, and the general attitude of patients is that “COVID is over.” On the other hand, she said, some providers may still be holding medications out of an abundance of caution. “The study reconfirms that there is not a link between the holding of medication and disease flares. … When you have the opportunity to vaccinate, take it.”
—Caroline Helwick
Dr. Malter reported financial relationships with AbbVie, Bristol Myers Squibb, Janssen, Merck, Pfizer and Takeda. Dr. Motwani reported no relevant financial disclosures.
This article is from the January 2023 print issue.