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Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease

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Abstract

Background

Patients with inflammatory bowel disease (IBD) are at increased risk of developing herpes zoster. In October 2017, the FDA approved a two-dose adjuvanted, recombinant herpes zoster vaccine (RZV). There is a theoretical concern that vaccine adjuvants may cause flares in patients with immune-mediated diseases. We aimed to assess the rates of IBD flare and adverse reactions after administration of RZV in a cohort of patients with IBD.

Methods

We conducted a prospective observational study of patients with IBD who received RZV between February 2018 and July 2019 at a tertiary IBD referral center. IBD activity scores were collected from patients during office visit or phone call after vaccination. The primary outcome was rate of IBD flare, defined as an increase in IBD activity, resulting in escalation of medical therapy, following vaccination. The secondary outcomes were rates of local and systemic adverse reactions after vaccination.

Results

We identified 67 patients (28 with ulcerative colitis and 39 with Crohn’s disease) who received at least one dose of RZV. The two-dose vaccine series was completed by 55 patients (82%). Median duration of follow-up after vaccination was 207 days. One case of IBD flare was identified. No cases of herpes zoster were identified. Local and systemic adverse reactions were reported in 74.6% and 56.7% of patients, respectively.

Conclusions

In this cohort of 67 patients, a low rate of IBD flare (1.5%) was observed after RZV administration. Rates of local and systemic adverse reactions were comparable to those seen in the RZV clinical trials.

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Acknowledgments

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Funding

No financial support was provided for this manuscript.

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Authors and Affiliations

  1. Department of Medicine, Boston Medical Center, Boston University School of Medicine, 72 East Concord St, Evans 124, Boston, MA, 02118, USA

    Venkata R. Satyam

  2. Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA

    Pei-Hsuan Li, Jason Reich, Taha Qazi, Ansu Noronha, Sharmeel K. Wasan & Francis A. Farraye

  3. Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA

    Francis A. Farraye

  4. Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, OH, USA

    Taha Qazi

Authors
  1. Venkata R. Satyam
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Contributions

VRS, JR, and FAF helped in study concept and design; VRS and P-HL contributed to acquisition of data; VRS, P-HL, JR, TQ, AN, SKW, and FAF analyzed and interpreted the data; VRS, P-HL, JR, TQ, AN, SKW, and FAF drafted the manuscript; VRS, P-HL, JR, TQ, AN, SKW, and FAF critically revised the manuscript for important intellectual content; VRS helped in statistical analysis; and FAF supervised the study. Each author has approved the final draft of this manuscript

Corresponding author

Correspondence to Venkata R. Satyam.

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Conflict of interest

Dr. Francis A. Farraye has served on advisory board for Glaxo Smith Kline. Venkata R. Satyam, Pei-Hsuan Li, Jason Reich, Taha Qazi, Ansu Noronha, Sharmeel K. Wasan declared that they have no conflict of interest.

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Satyam, V.R., Li, PH., Reich, J. et al. Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease. Dig Dis Sci 65, 2986–2991 (2020). https://doi.org/10.1007/s10620-019-06016-4

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  • DOI: https://doi.org/10.1007/s10620-019-06016-4

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