A new study at the University of Wisconsin School of Medicine and Public Health is looking at the immune response to COVID-19 vaccines in patients with inflammatory bowel disease (IBD). Enrollment is open now for patients who fit the criteria.

IBD affects approximately 1.3% of US adults and is a term for two conditions (Crohn’s disease and ulcerative colitis) that are characterized by chronic inflammation of the gastrointestinal tract. The inflammation can cause persistent diarrhea, abdominal pain, rectal bleeding and/or weight loss. IBD is different from irritable bowel syndrome (IBS). While IBS impacts quality of life, it does not have the significant complications of IBD.

Freddy Caldera
Freddy Caldera

Patients with IBD are often treated with immunosuppressant drugs to treat and manage their conditions. Patients who take immunosuppressants are considered immunocompromised and are at higher risk for infections. Certain immunosuppressants drugs such as steroids may increase the risk of a severe outcome from COVID-19. It is important to see how these vaccines work for patients with weakened immune systems, because studies have shown that certain medications may blunt the immune response to certain vaccines. Furthermore, many immunosuppressive mediations are used by transplant patients and others with autoimmune disorders such as rheumatoid arthritis, psoriasis, and multiple sclerosis.

The study takes place at the University Hospital in Madison and will involve blood draws from patients to examine the immune system response after vaccination by evaluating antibodies and T cells. Researchers are looking to enroll approximately 210 participants who have IBD and have gotten or are planning to get a COVID-19 vaccine. The study is led by Freddy Caldera, DO, a UW Health gastrointestinal physician and associate professor of medicine at the UW School of Medicine and Public Health.

“Most of my IBD patients are immunocompromised but they are also often younger and don’t have any comorbidities. So, getting data from this group will help us better understand the impact of immunosuppressive regimens on the immune response to COVID 19 vaccines,” said Caldera. “The vaccines on the market are very effective for most people. We believe they will also create an immune response in people who are immunocompromised, but we need the data to be sure, since certain immunosuppressive medication may blunt the vaccine response.”

Caldera also says this has been a particularly difficult year for his patients.

“Many of my patients have barely left their homes because of COVID-19 due to concerns that the virus may be devastating for them. We need to make sure the vaccine is effective for them so they can feel safe when we resume some normal activities,” he said.

According to Caldera, four million Americans have IBD and UW Health treats 1,500-1,800 patients living with IBD every year.

The study is run by the UW Clinical Research Office and funded by the American College of Gastroenterology and Takeda Pharmaceuticals.