Health Boards
Context:
Based on limited data, the live attenuated herpes zoster (HZ) vaccine is contraindicated in patients taking anti–tumor necrosis factor (anti-TNF) therapies or other biologics commonly used to treat immune-mediated diseases. The safety and effectiveness of the vaccine are unclear for these patients.
Objective:
To examine the association between HZ vaccination and HZ incidence within and beyond 42 days after vaccination in patients with selected immune-mediated diseases and in relation to biologics and other therapies used to treat these conditions.
Design, Setting, and Patients:
Retrospective cohort study of 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 1, 2006, through December 31, 2009.
Main Outcome Measures:
Herpes zoster incidence rate within 42 days after vaccination (a safety concern) and beyond 42 days; hazard ratios estimated using Cox proportional hazards models for HZ comparing vaccinated vs unvaccinated patients.
Results:
Median duration of follow-up was 2.0 years (interquartile range, 0.8-3.0); 4.0% of patients received HZ vaccine. The overall crude HZ incidence rate was 7.8 cases per 1000 person-years (95% CI, 3.7-16.5) within 42 days after vaccination. The rate among the unvaccinated was 11.6 cases per 1000 person-years (95% CI, 11.4-11.9). Among 633 patients exposed to biologics at the time of vaccination or within the subsequent 42 days, no case of HZ or varicella occurred. After multivariable adjustment, HZ vaccination was associated with a hazard ratio of 0.61 (95% CI, 0.52-0.71) for HZ risk after 42 days.
Conclusions:
Receipt of HZ vaccine was not associated with a short-term increase in HZ incidence among Medicare beneficiaries with selected immune-mediated diseases, including those exposed to biologics. The vaccine was associated with a lower HZ incidence over a median of 2 years of follow-up.
Herpes zoster (HZ), caused by the reactivation of latent varicella-zoster virus (VZV), manifests as an acute, painful vesicular rash and is often accompanied by chronic pain or postherpetic neuralgia. In the United States, the incidence rate of HZ in the unvaccinated general population 50 years or older is estimated to be 7.0 cases per 1000 person-years. A live attenuated vaccine reduces HZ risk by 70% and 51% among immunocompetent individuals 50 to 59 years and 60 years and older in 2 randomized blinded trials, respectively. The Advisory Committee on Immunization Practices (ACIP) recommends a single dose of the zoster vaccine for all people 60 years or older.
The risk of HZ is elevated by 1.5 to 2 times in patients with rheumatic and immune-mediated diseases such as rheumatoid arthritis (RA) and Crohn disease. This increase has been attributed to both the underlying disease process and treatments for these conditions. Currently, the Food and Drug Administration (FDA), the ACIP, and the American College of Rheumatology 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; some nonbiologic immunosuppressive medications, such as methotrexate at doses of greater than 0.4 mg per kg per week; and glucocorticoids at prednisone-equivalent doses of 20 mg or more per day. The safety concern is that these individuals may develop varicella infection from the vaccine virus strain. Based on the VZV incubation period, the first 42 days following vaccination was chosen as the primary safety risk window in the Shingles Prevention Study, a randomized blinded trial that preceded the FDA approval of the vaccine.
In light of the uncertainties regarding the safety and effectiveness of zoster vaccine in patients with immune-mediated diseases, we used administrative claims from US Medicare beneficiaries diagnosed with these diseases to evaluate the association between receipt of zoster vaccine and HZ risk within the first 42 days and up to 3.5 years following vaccination.
Source: jamanetwork.com
Based on limited data, the live attenuated herpes zoster (HZ) vaccine is contraindicated in patients taking anti–tumor necrosis factor (anti-TNF) therapies or other biologics commonly used to treat immune-mediated diseases. The safety and effectiveness of the vaccine are unclear for these patients.
Objective:
To examine the association between HZ vaccination and HZ incidence within and beyond 42 days after vaccination in patients with selected immune-mediated diseases and in relation to biologics and other therapies used to treat these conditions.
Design, Setting, and Patients:
Retrospective cohort study of 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 1, 2006, through December 31, 2009.
Main Outcome Measures:
Herpes zoster incidence rate within 42 days after vaccination (a safety concern) and beyond 42 days; hazard ratios estimated using Cox proportional hazards models for HZ comparing vaccinated vs unvaccinated patients.
Results:
Median duration of follow-up was 2.0 years (interquartile range, 0.8-3.0); 4.0% of patients received HZ vaccine. The overall crude HZ incidence rate was 7.8 cases per 1000 person-years (95% CI, 3.7-16.5) within 42 days after vaccination. The rate among the unvaccinated was 11.6 cases per 1000 person-years (95% CI, 11.4-11.9). Among 633 patients exposed to biologics at the time of vaccination or within the subsequent 42 days, no case of HZ or varicella occurred. After multivariable adjustment, HZ vaccination was associated with a hazard ratio of 0.61 (95% CI, 0.52-0.71) for HZ risk after 42 days.
Conclusions:
Receipt of HZ vaccine was not associated with a short-term increase in HZ incidence among Medicare beneficiaries with selected immune-mediated diseases, including those exposed to biologics. The vaccine was associated with a lower HZ incidence over a median of 2 years of follow-up.
Herpes zoster (HZ), caused by the reactivation of latent varicella-zoster virus (VZV), manifests as an acute, painful vesicular rash and is often accompanied by chronic pain or postherpetic neuralgia. In the United States, the incidence rate of HZ in the unvaccinated general population 50 years or older is estimated to be 7.0 cases per 1000 person-years. A live attenuated vaccine reduces HZ risk by 70% and 51% among immunocompetent individuals 50 to 59 years and 60 years and older in 2 randomized blinded trials, respectively. The Advisory Committee on Immunization Practices (ACIP) recommends a single dose of the zoster vaccine for all people 60 years or older.
The risk of HZ is elevated by 1.5 to 2 times in patients with rheumatic and immune-mediated diseases such as rheumatoid arthritis (RA) and Crohn disease. This increase has been attributed to both the underlying disease process and treatments for these conditions. Currently, the Food and Drug Administration (FDA), the ACIP, and the American College of Rheumatology 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; some nonbiologic immunosuppressive medications, such as methotrexate at doses of greater than 0.4 mg per kg per week; and glucocorticoids at prednisone-equivalent doses of 20 mg or more per day. The safety concern is that these individuals may develop varicella infection from the vaccine virus strain. Based on the VZV incubation period, the first 42 days following vaccination was chosen as the primary safety risk window in the Shingles Prevention Study, a randomized blinded trial that preceded the FDA approval of the vaccine.
In light of the uncertainties regarding the safety and effectiveness of zoster vaccine in patients with immune-mediated diseases, we used administrative claims from US Medicare beneficiaries diagnosed with these diseases to evaluate the association between receipt of zoster vaccine and HZ risk within the first 42 days and up to 3.5 years following vaccination.
Source: jamanetwork.com