Shingles Vaccine Doesn't Increase Risk in Taking Biologics for Autoimmune and Inflammatory Diseases

The live attenuated shingles (herpes zoster) vaccine (Zostavax®) does not appear to increase the short-term risk of developing shingles infection in people taking biologics for autoimmune and inflammatory diseases, according to research presented this week at the American College of Rheumatology annual scientific meeting in Chicago.

The shingles vaccine is approved in the United States for people over the age of 50 to reduce the risk of developing the infection. This infection is essentially a re-activation of the same virus that causes chickenpox, typically during childhood. The virus remains dormant (or sleeping) in the body from the time someone develops chickenpox and can manifest itself as a painful, blistering rash in later adulthood. It can also have more serious complications that threaten vision and internal organs. For some patients, due to nerve damage, the pain remains persistent at the site of the rash for months or years long after the rash has resolved. Shingles affects about one in 50 older people with autoimmune diseases (e.g. rheumatoid arthritis and lupus) each year.

The vaccine has been shown to be very effective to reduce the risk for shingles infection in older adults and is currently recommended for all older patients who are not receiving immunosuppressive medications, explains the studys lead investigator, Jeffrey Curtis, MD, MPH; assistant professor, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham. The concern for people who are taking immunosuppressive medications, such as patients with rheumatoid arthritis taking anti-TNF therapies [e.g. Enbrel®, Humira®, Remicade®, Cimzia®, Simponi®] is that since the vaccine contains a weakened version of the live virus, it could allow the virus to reactivate and cause a short-term increase in the risk for shingles infection within six weeks of vaccination. Beyond that initial time period, the vaccine would likely decrease the risk for shingles infection by helping the body form natural protective antibodies to prevent the infection.

Using data from the U.S. Medicare program in 2006 to 2009, Curtis team identified 6,793 patients with autoimmune diseases who were over the age of 60 and who received the live zoster vaccine. The majority were Caucasian women with an average age of 74-and-a-half. Seventy-six vaccinated patients had ankylosing spondylitis; 1,260 had inflammatory bowel disease; 161 had psoriatic arthritis; 1,745 had psoriasis; 3,246 had rheumatoid arthritis; and 305 had two or more of these diseases.

At the time of vaccination, or within the previous 60 days, 580 patients were taking biologics (mostly anti-TNF therapy); 1,825 were taking disease-modifying anti-rheumatic drugs (commonly called DMARDS); and 1,432 were taking steroids (such as prednisone).

There were 387 people vaccinated who were current users of biologic medications and not steroids. Among these people, there were no cases of shingles in the six weeks following vaccination. Another 193 people on biologics and steroids were vaccinated, and their rate of the shingles infection was no higher than that of vaccinated people taking non-biologic DMARDs and steroids, but no biologics.

In both of these groups taking steroids, only about five out of 1,000 people [less than one percent] developed the infection, says Curtis. Steroids have been previously shown to significantly increase the risk for shingles infection, so this finding was not a surprise.

These findings led the researchers to conclude that people taking biologics may be able to receive the zoster vaccine safely and may not be at an increased, short-term risk of developing shingles from the vaccine. Curtis and his team have received funding through the ACR Research and Education Foundations Within Our Reach campaign to continue this research as a clinical trial in hopes of demonstrating the safety of the live zoster vaccine in people receiving biologic medications.