November 22, 2019
By Reuters Staff
NEW YORK (Reuters Health) - Patients with rheumatic diseases who are on tumor-necrosis-factor inhibitor (TNFi) therapy can safely receive the live varicella zoster vaccine, without risking vaccine-related infection, a new study suggests.
"Because patients with rheumatic diseases are at higher risk for reactivation of herpes zoster, also known as shingles, prevention of this painful condition is exceedingly important," Dr. Jeffrey R. Curtis of the University of Alabama at Birmingham, who worked on the study, said in a news release.
"While the need for prevention in patients with rheumatic diseases is compelling, use of any weakened (attenuated) live virus vaccine is potentially a safety risk. There is a theoretical risk that a live virus vaccine could give a patient the weakened form of infection," Dr. Curtis added.
A major goal of the Varicella Zoster Vaccine (VERVE) trial was to better understand the safety of the live attenuated zoster virus vaccine and determine whether it caused infection in these patients, he explained.
Participants included 617 adults who were currently receiving TNFi therapy and had no prior zoster vaccination. Their mean age was 62, 66% were women, 87% white, about 9% African American, and 4% Hispanic.
The most common indications for TNFi therapy were rheumatoid arthritis (59%) and psoriatic arthritis (24.5%). The most common TNFi medication was adalimumab (32.7%), followed by infliximab (31.3%), etanercept (21.2%), golimumab (9.1%), certolizumab (5.7%).
Through the sixth week after vaccination - the U.S. Food and Drug Administration-specified risk window for vaccine-related infections that might occur - there were no cases of confirmed disseminated or local varicella infection of either wild-type or vaccine strain, yielding an upper bound of the 95% confidence interval for a vaccine-related varicella infection of less than 1%.
Eight patients who developed a rash were tested for varicella by PCR, but none were positive for infection.
Dr. Curtis reported the study results November 9 in Atlanta during the American College of Rheumatology annual meeting.
"The clinical significance of the trial is to provide high quality direct evidence of the safety of this live virus vaccine in patients who previously were warned not to use it because of the theoretical risk for it to cause infection," Dr. Curtis said in the news release.
"It also opens the door for the idea that for TNFi users, perhaps other live virus vaccines also may be safe and might be considered in certain circumstances. Future directions for this research group are to rigorously study the new adjuvanted shingles vaccine to better understand its safety, tolerability and effectiveness in patients with RA and inflammatory bowel disease, using similar methods. A trial of this new shingles vaccine is being planned for these patients and likely will begin in 2020," added Dr. Curtis.
The VERVE study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health. The authors have disclosed no conflicts of interest.
American College of Rheumatology 2019.
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