CHICAGO – The shingles vaccine does not increase the risk of shingles in patients taking biologics for autoimmune or inflammatory conditions, based on data from more than 7,000 adults. The findings were presented at the annual meeting of the American College of Rheumatology.
The findings suggest that the current recommendations that biologics users avoid live virus vaccines may be overly cautious, said Dr. Jeffrey R. Curtis of the University of Alabama, Birmingham.
The shingles vaccine (Zostavax) is recommended to protect older adults against herpes zoster, Dr. Curtis said, but concerns have been raised that reactivation of the live virus after vaccination for patients taking immunosuppressive medications might increase their risk of a shingles eruption.
To determine the risk of shingles in a population taking immunosuppressive medication, Dr. Curtis and his colleagues reviewed Medicare data from 2006 to 2009. They identified 7,781 adults aged 60 years and older who had rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, or inflammatory bowel disease, and who had received a shingles vaccine while taking medication including biologics, disease modifying antirheumatic drugs (DMARDs), and oral glucocorticoids. The mean age of the study population was 74 years, most were white women, and none had any evidence of shingles infection at baseline.
Overall, the incidence rate for shingles at least 42 days after vaccination was 8 cases/1,000 person-years among vaccinated adults, compared with 12 cases/1,000 person-years in a cohort of unvaccinated adults.
In a subset of 636 vaccinated adults who were taking biologics (regardless of concomitant DMARDs or oral glucocorticoids), no cases of shingles were reported within the first 42 days after vaccination, Dr. Curtis emphasized. In fact, vaccination was associated with a decrease in herpes zoster incidence of approximately 30%, he added. By contrast, the incidence rate of shingles in unvaccinated patients taking biologics was 16 per 1,000 person-years. The incidence of infection was not significantly different in vaccinated patients taking biologics than in vaccinated patients taking non-biologic DMARDs, Dr. Curtis added.
The study was limited by the lack of information about the disease severity, Dr. Curtis noted. But the findings support the safety and effectiveness of the shingles vaccine for biologics users.
There are persistent unmet vaccination needs for patients with diseases that require immunosuppressive therapy, said Dr. Curtis. "A controlled safety trial of the zoster vaccine in biologic users may be indicated to further demonstrate its safety and effectiveness in preventing zoster infection," he said.
The study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. Dr. Curtis has received research grants and consulting fees from Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, Merck, Roche, and UCB.