The safety of live virus vaccines in patients receiving biologic therapies was confirmed in a study of 617 patients recently presented at the American College of Rheumatology (ACR) annual meeting this month.
The Varicella Zoster Vaccine (VERVE) study, by Jeffrey R. Curtis, M.D., of the University of Alabama at Birmingham, was a randomized placebo-controlled blindned trial of the live attenuated zoster vaccine in patients receiving TNF inhibitors (TNFi) for any indication.
“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. Shingles manifests in most patients as a painful blistering rash that lasts a few weeks, but serious complications such as disseminated disease, eye involvement and even strokes can occur,” Dr. Curtis said in a statement issued by ACR. “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. A major goal of the trial was to understand the safety of this live virus vaccine and to see if it caused infection in any of the participants.”
The patients (mean age 62.4 years, 66.9 percent female, 87.2% white, 8.8% black, 4.4% Hispanic). 87.2 percent white) were recruited from 33 centers. Most of the patients had rheumatoid arthritis (59.6%) and 24.5% had psoriatic arthritis. At baseline, 32.7% were taking adalimumab, 31.3% infliximab, 21.2% etanercept, 9.1% golimumab, and 5.7% certolizumab. Nearly half (48%) of patients were also receiving background methotrexate and 10.5% were taking oral glucocorticoids.
Patients were followed during the six week period after the vaccination because this is the period of time in which vaccine-related infectisons would most ofte occur. No varicella infections were reported during this period or follow-up through six months.
“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. “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.”
REFERENCE: Jeffrey Curtis, S Louis Bridges, Stacey S Cofield, et al. "Results from a Randomized Controlled Trial of the Safety of the Live Varicella Vaccine in TNF-Treated Patients." 2019 ACR/ARP Annual Meeting. ABSTRACT NUMBER: 824