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Zoster and Patients on Biologics: To Vaccinate or Not?

VERVE study aims for answers

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By Leonard Calabrese, DO, and Elizabeth Kirchner, CNP

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When it comes to herpes zoster, patients taking immune-modulating biologic therapies are in a double bind. Although they are at heightened risk for zoster due to underlying problems with their integrated immune response, they are not currently candidates for the FDA-approved vaccine against herpes zoster, Zostavax®, because it is a live attenuated vaccine.

To further complicate matters, most epidemiologic studies suggest that glucocorticoids and biologic agents greatly increase the risk for zoster, although some differing results have been reported.

These considerations have sparked debate about whether and when to consider zoster vaccination in patients receiving or about to begin anti-tumor necrosis factor (TNF) therapies or other immune-modulating biologic agents.

Why try to prevent zoster?

The incidence of zoster in individuals increases with age, starting at about age 50. Zoster represents a reactivation of latent varicella zoster virus (VZV), which most older adults experienced as chicken pox and most younger adults got through a varicella vaccine.

Zoster is a painful condition with significant associated morbidity and costs. Moreover, it can lead to a host of complications, including postherpetic neuralgia, and recent data suggest that zoster is a significant risk factor for stroke. All these factors underscore the need for strategies to prevent zoster in the immunosuppressed population.

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Vaccinating immunosuppressed patients: Knowns and unknowns

The live zoster vaccine is highly effective in reducing the incidence of shingles and even better at preventing complications. In fact, the CDC’s Advisory Committee on Immunization Practices (ACIP) encourages its use for patients age 60 or older with rheumatic and immunologic diseases even if they are on glucocorticoids in doses up to 20 mg/day and standard doses of nonbiologic immunosuppressants.

In contrast, the ACIP advises that the live zoster vaccine is contraindicated in patients on immune-modulating biologics, due to concerns that these patients could develop a disseminated varicella-like infection from the vaccine’s live virus strain. Yet recent studies, including a retrospective analysis of Medicare claims and an abstract presented at the American College of Rheumatology’s 2014 annual meeting, suggest that the zoster vaccine may be safe for patients receiving biologics.

Enter the VERVE study

To address this question, a large multicenter trial called Safety and Effectiveness of the Live Zoster Vaccine in Anti-TNF Users (VERVE) was recently launched under the direction of Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham. Cleveland Clinic is a participating center, and one of this article’s authors (Dr. Calabrese) has been closely involved in VERVE trial planning.

This randomized, double-blind, placebo-controlled investigation will evaluate the zoster vaccine in 1,000 patients over age 50 who are taking any anti-TNF biologic therapy. The primary outcome measure is immunogenicity (VZV-specific T-cell response) at six weeks after vaccination vs. baseline. Secondary outcomes include safety measures (serious adverse events, injection-site reactions and rheumatoid arthritis flares) for six weeks after vaccination and clinical effectiveness for zoster prevention over two years.

To be clear, there are currently no formal recommendations that patients on biologics should be vaccinated against zoster. But the questions the VERVE trial is pursuing are of paramount clinical importance, and we are proud to be a participating site.

Dr. Calabrese is Director of the R.J. Fasenmyer Center for Clinical Immunology in Cleveland Clinic’s Department of Rheumatic and Immunologic Diseases.

Ms. Kirchner is a certified nurse practitioner in the Department of Rheumatic and Immunologic Diseases.

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