Examining the efficacy of recombinant zoster vaccination in patients with IBD

Aug. 22, 2024

Individuals diagnosed with inflammatory bowel disease (IBD) have an increased risk of developing herpes zoster (HZ) and HZ-related complications. Several studies, including work conducted by Mayo Clinic researchers, have shown that patients with IBD have a higher incidence of HZ compared with individuals without IBD.

"This risk is related, in part, to the underlying immune dysregulation associated with IBD, and to the use of certain commonly used therapies," explains Francis A. Farraye, M.D., M.S. "For example, prednisone, thiopurines, anti-TNFs and JAK inhibitors are associated with a significantly increased risk of shingles in patients with IBD." Dr. Farraye is a gastroenterologist and director of the Inflammatory Bowel Disease Center at Mayo Clinic in Jacksonville, Florida.

Recombinant zoster vaccine (RZV), an inactive vaccine that can be given to all patients regardless of immune suppression, reduces the short-term risk of HZ in patients with IBD. However, there is lack of data demonstrating the long-term effectiveness in this population. To address this knowledge gap, Dr. Farraye and colleagues conducted a retrospective cohort study examining the effectiveness of RZV in patients with IBD. Secondary aims of this study included identifying the risk of HZ complications among patients who developed HZ, the impact of IBD medications on the efficacy of RZV, and the risk of HZ in patients with diabetes mellitus and chronic lower respiratory diseases. The results of this study were published in the Journal of Crohn's and Colitis in 2024.

"In an earlier study that our group conducted and published in Alimentary Pharmacology and Therapeutics in 2023, we demonstrated that RZV was cost-effective for all patients with IBD. Based on this study and the new data demonstrating RZV effectiveness that we shared in our cohort study publication, and the recommendations by the Advisory Committee on Immunization Practices, I now offer RZV to all patients with IBD who are 19 and older."

— Francis A. Farraye, M.D., M.S.

Methods

This cohort study involved 5,489 adults age 50 years and older diagnosed with IBD (Crohn's disease and ulcerative colitis) who received two doses of RZV (the IBD-RZV cohort) and 5,265 adults with IBD who did not receive RZV (the IBD control cohort). The primary outcome was risk of incident HZ. The researchers performed a subgroup analysis for age, comorbid conditions and use of immunosuppressive therapy. Using propensity score matching (PSM), the researchers balanced the following covariates between cohorts: age, gender, race, diabetes mellitus, chronic lower respiratory disease, human immunodeficiency virus (HIV), chronic kidney disease, other autoimmune diseases and patients after transplantation. The patients were followed for a mean of over 900 days.

Results

"Overall, we demonstrated that vaccinated patients had a significantly lower risk of developing herpes zoster compared with the nonvaccinated IBD control cohort," explains Dr. Farraye.

  • The IBD-RZV cohort had a lower risk of HZ when compared with the IBD control cohort, with an adjusted odds ratio of 0.44, and a confidence interval of 95% (0.32-0.62). After PSM, 52 patients (1.09%) in the IBD-RZV cohort and 123 patients (2.4%) in the IBD control cohort developed HZ. The incidence rate of HZ was 10.9 per 1,000 person-years in the IBD-RZV cohort and 24.2 per 1,000 person-years in the IBD control cohort.
  • The risk of HZ was lower in patients age 50 to 65 years as well as in patients older than age 65 years in the IBD-RZV cohort compared with the IBD control cohort.
  • After PSM, among patients who developed HZ, the two cohorts had no significant difference in the risk of severe HZ complications and no significant difference in the risk of postherpetic neuralgia.
  • After PSM, patients in the IBD-RZV cohort on immunosuppressive therapy were at a lower risk of HZ compared with the IBD control cohort. Subgroup analysis of immunosuppressive therapy classes suggests that patients with chronic steroid use in the IBD-RZV cohort also were at lower risk of HZ compared with the IBD control cohort.

Dr. Farraye and co-authors recommend that all patients with IBD age 50 years and older receive the two-dose RZV 2 to 6 months apart. Although the authors acknowledge that their study did not assess the effectiveness of RZV in patients ages 18 to 49 years, they note that RZV is licensed for use in immunosuppressed populations in the United States and Europe.

"In an earlier study that our group conducted and published in Alimentary Pharmacology and Therapeutics in 2023, we demonstrated that RZV was cost-effective for all patients with IBD," explains Dr. Farraye. "Based on this study and the new data demonstrating RZV effectiveness that we shared in our cohort study publication, and the recommendations by the Advisory Committee on Immunization Practices, I now offer RZV to all patients with IBD who are 19 and older."

For more information

Desai A, et al. Recombinant zoster vaccine [RZV] is effective in patients with inflammatory bowel disease: A US propensity matched cohort study. Journal of Crohn's and Colitis. 2024;18:828.

Caldera F, et al. Cost-effectiveness of an adjuvanted recombinant zoster vaccine in adults with inflammatory bowel disease. Alimentary Pharmacology and Therapeutics. 2023; 57:1326.

Refer a patient to Mayo Clinic.