July 11, 2012

Shingles Vaccine May Not Be a Problem With
Immune-Mediated Diseases

Birmingham, ALContrary to current contraindications, the shingles vaccine appears safe for patients taking medications for immune-mediated diseases such as rheumatoid arthritis or psoriasis, according to a new study.

The study, published in the Journal of the American Medical Association, sought to determine if those patients would be at increased risk of herpes zoster (HZ) shortly after receiving a vaccine.

The analysis, which included nearly 20,000 vaccinated Medicare beneficiaries, concludes that the live zoster vaccine is not associated with an increased risk of herpes zoster shortly after vaccination in patients currently treated with biologics, but is associated with a significantly reduced longer-term risk of developing shingles.

"A live attenuated vaccine reduces HZ risk by 70% and 51% among immunocompetent individuals 50 to 59 years and 60 years and older in two 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."

The live HZ vaccine is currently contraindicated in patients receiving some immunosuppressive medications, including all immune-modulating biologic agents and some nonbiologic immunosuppressive medications, the study noted.

For the retrospective cohort study, researchers from the University of Alabama at Birmingham reviewed medical records for 463,541 Medicare beneficiaries 60 years and older with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease, using Medicare claims data from January 2006 through December 2009. They tracked incidence rates of HZ within 42 days after vaccination as well as beyond 42 days.

During the study period, 18,683 patients, 4%, received the zoster vaccine. Of the 633 patients exposed to biologics, including 551 patients exposed to antitumor necrosis factor biologics, no cases of varicella or HZ occurred within the 42 days following vaccination, researchers found. In fact, among all patients, only one case of primary varicella was identified within the 42-day risk window, occurring on Day 10 after vaccination.

Looking beyond the initial 42-day period, researchers observed 138 cases of HZ. After controlling for demographics, type of immune-mediated disease, health care utilization, and exposure to biologic and nonbiologic disease-modifying antirheumatic drugs and oral glucocorticoids, they determined that vaccination was associated with decreased shingles 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," the authors concluded. "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."

U.S. Pharmacist Social Connect