MRNA COVID-19 Vaccines Effective in IBD Patients Receiving Biological Therapies

By Linda Carroll

April 26, 2021

(Reuters Health) - IBD patients, even those receiving biological therapies, were able to mount a significant immune response after getting mRNA COVID-19 vaccines, a new study finds.

In an analysis of data from 48 IBD patients, of whom 85.4% were taking biologics at the time of vaccination with either the Pfizer-BioNTech or NIH-Moderna shots, all had positive antibody responses and many achieved index levels that would qualify them for convalescent plasma donation, according to the report published in Gastroenterology.

"In a reassuring finding, this study shows that all IBD patients, regardless of the type of medication and the timing of the medication, made antibodies to the proteins the vaccines target," said the study's lead author, Dr. Serre-Yu Wong, an instructor in the division of gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City. "We will continue to follow them closely and will recommend IBD patients continue their biologics and not delay getting vaccinated."

Some experts had feared that the vaccines might not work as well in patients whose immune systems were being suppressed by medications, such as infliximab, Dr. Wong said.

All the patients in the new study were enrolled in the COVID-19 Therapeutic Infusion (CITI) study, an ongoing sero-survey of IBD patients at the Icahn School of Medicine. Specimens were collected at routine infusion center and clinic appointments, and were not timed to vaccination dates.

The control groups included 14 completely vaccinated healthcare workers without IBD who underwent a single blood draw and 29 vaccinated healthy volunteers without IBD who underwent a series of blood draws after vaccination.

In their analysis, the researchers also included antibody testing results from 21 study patients who had been infected with SARS-CoV-2 to compare naturally-generated antibodies to those evoked by the vaccines.

The study presented information from 23 Crohn's Disease patients and 25 ulcerative colitis patients, of whom 41 were receiving some kind of biologic at the time of vaccination, including 16 who were receiving TNF antagonist monotherapy, 17 receiving vedolizumab monotherapy, three receiving vedolizumab in combination with thiopurine, four receiving ustekinumab and one receiving guselkumab for psoriasis. In addition, three patients were on oral steroids at the time of vaccination. Five patients were on no medications.

All 26 patients who completed both COVID-19 vaccine doses had positive tests for antibodies against the SARS-CoV-2 spike protein receptor binding domain (RBD) encoded by the vaccines, and 22 of 26 achieved index levels that would qualify for convalescent plasma donation. Two patients had previously been infected with SARS-CoV-2 and responded with very high antibody levels after their first vaccine dose. Among the 26 patients, eight were receiving TNF antagonist monotherapy, 12 vedolizumab monotherapy, two ustekinumab, and four no medications. Twenty-two patients had only received one vaccine dose by the time the analysis was performed. There was no significant difference between their response to the vaccine and that of controls, Wong said.

"There has been a shared concern among physicians and some patients with IBD that individuals with IBD may not be as protected despite being vaccinated due to having a suboptimal response to the vaccine," said Dr. Elyse Johnston, MD, a gastroenterologist at UPMC in Pittsburgh. "This concern is predominantly in patients that are on immunosuppressive medications, such as Infliximab (Remicade)."

The concern is only theoretical and is based on data suggesting that these types of medications decrease protective immunity from other vaccinations, such as influenza or pneumococcal, Dr. Johnston said in an email.

"Unfortunately, because immunosuppressed patients were excluded from the initial clinical trials, we didn't know how well the vaccines will work for individuals with IBD, especially those on immunosuppressive therapy," she added. "This provides some initial data suggesting that IBD patients, even those on immunosuppressive therapy, had seroconversion, especially after the second dose of the Pfizer or Moderna vaccinations."

"While this study only includes a small number of people, it is a positive for many patients with IBD on immunosuppressive therapy as it provides additional data suggesting the efficacy of the vaccination," Dr. Johnston said.

The new study "gives us more support in terms of recommending the vaccines to our IBD patients since it's showing that they will mount some immune response," said Dr. Reezwana Chowdhury, an assistant professor of medicine at the Johns Hopkins University School of Medicine in Baltimore. "They should get whatever vaccine they can get," she added.

"I'm very happy the study is being published since it gives us more ammunition to convince patients that they shouldn't be concerned about getting the vaccine," Dr. Chowdhury said. "Having IBD, they are vulnerable. And we want to make sure they do not delay getting vaccinated and get protection."

SOURCE: Gastroenterology, online April 19, 2021.