Shingles Vaccine Safe for Those With Autoimmune Diseases: Study
Posted Jul 03 2012 1:00pm
Study allays fears that the shot might raise shingles risk in people with psoriasis, rheumatoid arthritis.
By Steven Reinberg HealthDay Reporter
TUESDAY, July 3 (HealthDay News) -- For those suffering from the chronic skin disorder psoriasis and other autoimmune diseases, a new study finds the shingles vaccine appears to be both safe and effective.
It had been thought the vaccine might boost the risk of developing shingles in these patients, the researchers explained.
"The findings are reassuring for a very specific group of patients," said Dr. Bruce Hirsch, an attending physician in infectious diseases at North Shore University Hospital in Manhasset, N.Y., who was not involved in the study.
"Patients who have weak immune systems are vulnerable to getting shingles and the shingles vaccine is a live vaccine," he added.
The study looked at patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis (an inflammation of the spine), or inflammatory bowel disease.
The risk is that patients with these conditions are taking drugs that work by suppressing the immune system, which can leave them at risk for infections.
"I would tell these patients to have the vaccine," Hirsch said. "The vaccine seems to be effective and provides some advantage in patients who are getting treatment for these conditions."
This study, however, does not address the vaccine in patients who have weakened immune systems related to other causes, Hirsch said.
He cautions that the vaccine does have some risks and there is no long-term data on its effectiveness in these patients.
"I don't consider this study to be completely definitive," Hirsch said. "The book isn't closed, but I am cautiously optimistic. The vaccine seems to be safe and these kinds of patients are able to handle the vaccine and get a benefit from it."
Because the shingles vaccine is a live vaccine, the U.S. Food and Drug Administration and other organizations say the vaccine should not be used in patients taking immunosuppressive drugs including all biologic agents and some nonbiologics.
The concern is that these patients may develop shingles from the vaccine virus strain, the researchers explained.
"A live attenuated vaccine reduces [shingles] risk by 70 percent and 51 percent among immunocompetent individuals 50 to 59 years and 60 years and older in two randomized, blinded trials, respectively," the researchers wrote.
"The risk of [shingles] is elevated by 1.5 to two 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 authors added in the report published July 4 in the Journal of the American Medical Association.
For the study, a team led by Jie Zhang, of the University of Alabama at Birmingham, collected data on more than 460,000 Medicare patients who had one of several rheumatic or immune-mediated diseases.
Specifically, they looked at the cases of shingles that developed in the months after being vaccinated with the shingles vaccine.
Among the over 18,600 patients who received the shingles vaccine, there were no cases of shingles in the 42 days after vaccination, including among the over 600 who were taking so-called anti-tumor necrosis factor biologics to treat their other conditions, the researchers found.
There was only one case of shingles seen among all the patients during that time, they noted.
More than 42 days after being vaccinated, 138 patients did develop shingles, which is in the range of the effectiveness of the vaccine, the researchers reported.
All in all, after two years of follow-up, the investigators concluded that the vaccine reduces the risk of shingles in these patients.
That conclusion was also based on accounting for the type of immune disease, treatment, the use of arthritis drugs and steroids.
"Despite the recognition that patients with immune-mediated conditions are at increased risk of [shingles], 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 [shingles] vaccine is contraindicated in patients receiving biologics and suggest a need for a randomized controlled trial to specifically address the safety and effectiveness of [shingles] vaccination among patients receiving biologics," Zhang's group concluded.
Another expert, Dr. Doris Day, a dermatologist at Lenox Hill Hospital in New York City, said that "the shingles vaccine is a little controversial, but as a dermatologist who sees shingles, I can tell you that it can be a very painful, scarring process that goes beyond the skin and lasts beyond the rash."
Currently, the vaccine is recommended for those aged 60 and over. Shingles tends to be more severe and painful in older patients, she noted.
"I recommend that people get the vaccine no matter what their underlying disease state or health," Day added.
(SOURCES: Doris Day, M.D., dermatologist, Lenox Hill Hospital, New York City; Bruce Hirsch, M.D., attending physician, infectious diseases, North Shore University Hospital, Manhasset, N.Y.; July 4, 2012, Journal of the American Medical Association