Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease
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ORIGINAL ARTICLE
Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease Venkata R. Satyam1 · Pei‑Hsuan Li2 · Jason Reich2 · Taha Qazi2,4 · Ansu Noronha2 · Sharmeel K. Wasan2 · Francis A. Farraye2,3 Received: 9 October 2019 / Accepted: 14 December 2019 © Springer Science+Business Media, LLC, part of Springer Nature 2020
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. Keywords Inflammatory bowel disease · Crohn’s disease · Ulcerative colitis · Vaccination · Vaccine adjuvant · Herpes zoster
Presented in part at Digestive Diseases Week (May 19, 2019) in San Diego, CA. * Venkata R. Satyam [email protected]
Francis A. Farraye [email protected]
Pei‑Hsuan Li [email protected]
1
Jason Reich [email protected]
Department of Medicine, Boston Medical Center, Boston University School of Medicine, 72 East Concord St, Evans 124, Boston, MA 02118, USA
2
Taha Qazi [email protected]
Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA
3
Ansu Noronha [email protected]
Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA
4
Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, OH, USA
Sharmeel K. Wasan [email protected]
13
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Introduction Characterized by a painful, dermatomal vesicular eruption, herpes zoster (HZ) results from reactivation of latent varicella-zoster virus (VZV) [1]. Patients wi
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