Vaccine efficacy and antibody response among patients with IBD and recipients of immunosuppressive agents

April 19, 2022

Clinicians who care for patients with inflammatory bowel disease (IBD) or other autoimmune diseases are concerned about the efficacy of coronavirus disease 2019 (COVID-19) vaccines and whether treatment with immunosuppressive therapies blunt these patients' response to the vaccines. To address this question, Mayo Clinic researchers and collaborators from the University of Wisconsin examined antibody response to two doses of COVID-19 messenger RNA (mRNA) vaccine in two cohorts of study participants: 122 individuals with IBD (IBD cohort) and 60 healthy individuals (HC cohort). Study results were published in the American Journal of Gastroenterology in 2022.

Methods

Study participants in the IBD cohort were individuals ages 18 to 85 years who were on stable doses of maintenance therapy for at least two months and had completed an mRNA vaccine series. Study participants in the HC cohort were not treated with immunosuppressive agents and had completed an mRNA vaccine series. All participants had no clinical history of COVID-19 infection and no serologic evidence of asymptomatic infection.

The researchers measured nucleocapsid and spike protein S1 receptor-binding domain-specific immunoglobulin G antibodies in sera after participants completed the two-dose mRNA series. This test was performed 28 to 35 days after the second vaccination for participants in the IBD cohort and approximately 30 days after the second vaccination in participants in the HC cohort.

Results

Francis (Frank) A. Farraye, M.D., M.S., corresponding author of the American Journal of Gastroenterology article and a gastroenterologist at Mayo Clinic in Florida, notes that the study yielded several key findings. Over the past 12 years, Dr. Farraye's research has focused on the efficacy and safety of vaccinations in patients with ulcerative colitis and Crohn's disease.

"Although almost all patients with IBD mounted an antibody response, there was a decrease in antibody response in patients on immunosuppressive therapy," summarizes Dr. Farraye. "Immune response was higher in participants receiving the Moderna vaccine when compared with response levels observed in participants receiving the Pfizer vaccine. Only four of the 122 patients with IBD did not mount an antibody response one month after their second dose of the mRNA vaccine."

Additional study findings and data include the following:

All participants in the HC cohort and 97% of participants in the IBD cohort developed antibodies.
Antibody concentrations were lower in the IBD cohort when compared with those in the HC cohort (median 31 mcg/mL for the IBD group versus 118 mcg/mL for the HC group; P < 0.001).
Participants who received the mRNA-1273 (Moderna) COVID-19 vaccine series had higher antibody concentrations — median 38 mcg/mL; interquartile range [IQR] 24 to 75 mcg/mL — when compared with participants who received the Pfizer-BioNTech vaccine series (median 22 mcg/mL; IQR 11 to 42 mcg/mL; P < 0.001).
Participants in the IBD cohort who were treated with immune-modifying therapy had lower antibody concentrations (median 26 mcg/mL; IQR 13 to 50 mcg/mL) when compared with participants in this group who received no IBD treatment or treatment with aminosalicylates or vedolizumab (median 59 mcg/mL; IQR 31 to 75 mcg/mL; P = 0.003).

Related research

Dr. Farraye and co-investigators are involved in several additional avenues of research investigating addressing how individuals with IBD respond to vaccines for COVID-19 and other illnesses.

Ability of patients with IBD to mount a cell-mediated immune response (CMIR) to vaccination with an mRNA vaccine. This study, submitted for publication, enrolled 151 patients with IBD and 20 healthy controls. The majority of patients with IBD (89%) developed a CMIR that did not differ from the CMIR found in the healthy control group (confidence interval of 94%, P = 0.67). Interestingly, there was no significant difference (P = 0.76) in CMIR response between participants who were immunosuppressed and participants who were not. There was also no correlation between antibody responses and CMIR (P = 0.53).

"These data demonstrate that most patients with IBD achieved a CMIR to a COVID-19 vaccine," explains Dr. Farraye. "We are also assessing both a humoral response and CMIR after a third dose of mRNA vaccine. We are hopeful that this additional assessment will better inform clinicians about which patients with IBD should receive a fourth dose of vaccine."
Incidence, outcomes and impact of COVID-19 among patients with IBD. In a paper published in Alimentary Pharmacology and Therapeutics in 2022, Dr. Farraye and co-authors observed no increase in risk of COVID-19 in patients with IBD or risk of de novo IBD after COVID-19 infection.
Retrospective study comparing the efficacy of the adjuvanted hepatitis B vaccine (Heplisav-B) and the Engerix-B vaccine in patients with IBD. In a presentation delivered at Digestive Disease Week in 2021 and accepted for publication in Inflammatory Bowel Diseases, Dr. Farraye noted that overall, 78.3% of patients with IBD who received the Heplisav-B vaccine developed a protective anti-hepatitis B antibody, while patients with IBD receiving the Engerix-B vaccine had historical seroconversion rates of 36% to 80%.
Immunization safety in patients with IBD. In a meta-analysis published in Inflammatory Bowel Diseases in 2022, Dr. Farraye and collaborators from the University of Massachusetts and elsewhere demonstrated that patients with IBD who were vaccinated for influenza, pneumococcal pneumonia, herpes zoster and hepatitis B did not experience an increased risk of disease exacerbation.