CHICAGO - Although some have suggested that patients receiving medication for immune-mediated diseases such as rheumatoid arthritis or psoriasis may be at increased risk of herpes zoster (HZ; shingles) shortly after receipt of the vaccine, an analysis that included nearly 20,000 vaccinated Medicare beneficiaries finds that the live zoster vaccine is not associated with an increased risk of HZ shortly after vaccination in patients currently treated with biologics, and that it is associated with a significantly reduced longer-term risk of HZ in patients with an immune-mediated disease, according to a study in the July 4 issue of JAMA.
"A live attenuated vaccine reduces HZ risk by 70 percent and 51 percent among immunocompetent individuals 50 to 59 years and 60 years and older in 2 randomized blinded trials, respectively," according to background information in the article. "The risk of HZ is elevated by 1.5 to 2 times in patients with rheumatic and immune-mediated diseases such as rheumatoid arthritis and Crohn's disease. This increase has been attributed to both the underlying disease process and treatments for these conditions." Currently, the Food and Drug Administration (FDA) and other organizations consider the live HZ vaccine to be contraindicated in patients receiving some immunosuppressive medications commonly used to treat these conditions, including all immune-modulating biologic agents and some nonbiologic immunosuppressive medications. The safety concern is that these individuals may develop varicella infection from the vaccine virus strain, the authors write.
Jie Zhang, Ph.D., of the University of Alabama at Birmingham, and colleagues, evaluated patients with immune-mediated diseases. The retrospective cohort study included 463,541 Medicare beneficiaries 60 years and older with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis (a form of chronic inflammation of the spine), or inflammatory bowel disease using Medicare claims data from January 2006 through December 2009. The researchers measured the incidence rate of herpes zoster within 42 days after vaccination (a safety concern) and beyond 42 days.
The average age of the patients at the start of follow-up was 74 years, with the median (midpoint) duration of follow-up being 2 years; 72 percent of the patients were women, and 86 percent were white. During the study, 18,683 patients (4.0 percent) received the zoster vaccine.
The researchers found that among 633 patients exposed to biologics, including 551 patients exposed to anti-tumor necrosis factor (TNF) biologics, no cases of varicella or HZ occurred within the 42 days following vaccination. Among all patients, only 1 case of primary varicella was identified within the 42-day risk window, occurring on day 10 after vaccination.
During the period of more than 42 days after vaccination, the researchers observed 138 HZ cases. After controlling for demographics, type of immune-mediated disease, health care utilization, and exposure to biologic and nonbiologic disease-modifying antirheumatic drugs (DMARDs) and oral glucocorticoids, data indicated that vaccination was associated with decreased HZ risk over a median of 2 years of follow-up.
"Despite the recognition that patients with immune-mediated conditions are at increased risk of HZ, this and previous studies have shown that only a small fraction of these patients received the vaccine, likely in part due to safety concerns. Our data call into question the current recommendations that HZ vaccine is contraindicated in patients receiving biologics and suggest a need for a randomized controlled trial to specifically address the safety and effectiveness of HZ vaccination among patients receiving biologics," the authors conclude.
(JAMA. 2012;308:43-49. Available pre-embargo to the media at http://media.
Editor's Note: This project was supported by the Agency for Healthcare Research and Quality (AHRQ). Dr. Zhang received support from the AHRQ, and Dr. Curtis received support from AHRQ and the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.
To contact corresponding author Jeffrey R. Curtis, M.D., M.S., M.P.H., call Bob Shepard at 205-934-8934 or email Bshep@uab.edu.